CLASSES
Ophthalmological Corticosteroids
Respiratory Corticosteroids
Systemic Corticosteroid Combinations
Systemic Corticosteroids, Plain
DESCRIPTION
An oral, parenteral, and ophthalmic glucocorticoid with little to no mineralocorticoid activity
Used in adult and pediatric patients, for many uses, including cerebral edema, in antiemetic regimens for chemotherapy, and for allergic or inflammatory dermatologic, ophthalmic, or systemic conditions
Systemic dexamethasone is helpful for the treatment of cerebral edema because of its superior ability to penetrate the CNS
COMMON BRAND NAMES
AK-Dex, Baycadron, CUSHINGS SYNDROME DIAGNOSTIC, Decadron, Dexabliss, DexPak Jr TaperPak, DexPak TaperPak, Dextenza, DEXYCU, DoubleDex, Dxevo, Hemady, HiDex, Maxidex, Ozurdex, ReadySharp Dexamethasone, Simplist Dexamethasone, Solurex, TaperDex, ZCORT, Zema-Pak, ZoDex, ZonaCort 11 Day, ZonaCort 7 Day
HOW SUPPLIED
AK-Dex/Decadron/Dexamethasone/Dexamethasone Sodium Phosphate Auricular (Otic) Drops: 0.1%
AK-Dex/Decadron/Dexamethasone/Dexamethasone Sodium Phosphate Auricular (Otic) Sol: 0.1%
AK-Dex/Decadron/Dexamethasone/Dexamethasone Sodium Phosphate Ophthalmic Drops: 0.1%
AK-Dex/Decadron/Dexamethasone/Dexamethasone Sodium Phosphate Ophthalmic Sol: 0.1%
Baycadron/Decadron/Dexamethasone Oral Sol: 0.5mg, 1mg, 1mL, 5mL
CUSHINGS SYNDROME DIAGNOSTIC/Decadron/Dexabliss/Dexamethasone/DexPak Jr TaperPak/DexPak TaperPak/Dxevo/Hemady/HiDex/TaperDex/ZCORT/Zema-Pak/ZoDex/ZonaCort 11 Day/ZonaCort 7 Day Oral Tab: 0.5mg, 0.75mg, 1mg, 1.5mg, 2mg, 4mg, 6mg, 20mg
Decadron/Dexamethasone/Dexamethasone Sodium Phosphate/DoubleDex/ReadySharp Dexamethasone/Simplist Dexamethasone/Solurex Intramuscular Inj Sol: 1mL, 4mg, 10mg
Decadron/Dexamethasone/Dexamethasone Sodium Phosphate/DoubleDex/ReadySharp Dexamethasone/Simplist Dexamethasone/Solurex Intravenous Inj Sol: 1mL, 4mg, 10mg
Decadron/Dexamethasone/Dexamethasone Sodium Phosphate/DoubleDex/Simplist Dexamethasone/Solurex Intra-Articular Inj Sol: 1mL, 4mg, 10mg
Decadron/Dexamethasone/Dexamethasone Sodium Phosphate/DoubleDex/Simplist Dexamethasone/Solurex Intralesional Inj Sol: 1mL, 4mg, 10mg
Decadron/Dexamethasone/Dexamethasone Sodium Phosphate/DoubleDex/Simplist Dexamethasone/Solurex Soft Tissue Inj Sol: 1mL, 4mg, 10mg
Dextenza Ophthalmic Insert: 0.4mg
DEXYCU Intraocular Inj Susp: 9%
Maxidex Ophthalmic Susp: 0.1%
Ozurdex Intravitreal Imp: 0.7mg
DOSAGE & INDICATIONS
For the treatment of adrenocortical function abnormalities, such as adrenocortical insufficiency, congenital adrenal hyperplasia, chronic primary (Addison's disease) or secondary adrenocortical insufficiency, or adrenogenital syndrome.
Oral dosage (dexamethasone)
Adults
Initially, 0.75 to 9 mg/day PO, given in 2 to 4 divided doses. Adjust according to patient response. NOTE: Parenteral therapy may be needed in acute insufficiency. Hydrocortisone and cortisone are preferred for these conditions; dexamethasone has no mineralocorticoid properties. Dosages required may be variable.
Infants, Children, and Adolescents
0.15 to 0.375 mg/m2/day PO once daily has been recommended for patients with congenital adrenal hyperplasia. Although most experts recommend hydrocortisone as first-line treatment of adrenal insufficiency in pediatric patients whose linear growth is incomplete due to a lower incidence of growth suppression, other authors have stated that dexamethasone may be used safely with close monitoring and individualization of dose based on growth, bone age, and hormone levels. Liquid formulations of dexamethasone are recommended for more precise titration of doses. 0.02 to 0.3 mg/kg/day or 0.6 to 9 mg/m2/day PO given in 3 to 4 divided doses is the FDA-approved general dosage range. Parenteral therapy may be needed in acute insufficiency.
Intravenous or Intramuscular dosage (dexamethasone sodium phosphate)
Adults
Initially, 0.5 to 9 mg/day IV or IM, divided every 6 to 12 hours. Adjust according to patient response. NOTE: Hydrocortisone and cortisone are preferred for these conditions; dexamethasone has no mineralocorticoid properties. Dosages required may be variable.
Infants, Children and Adolescents
0.02 to 0.3 mg/kg/day or 0.6 to 9 mg/m2/day IV or IM given in 3 to 4 divided doses is the FDA-approved general dosage range. Adjust according to patient response.
For hypothalamic-pituitary-adrenal (HPA) suppression diagnosis (e.g., dexamethasone suppression tests).
For use as a test for Cushing's syndrome.
Oral dosage (dexamethasone)
Adults
0.5 mg PO every 6 hours for 48 hours. 24-hour urine collections are made for determination of 17-hydroxycorticosteroid excretion. Alternatively, 1 mg PO at 11:00 p.m. with plasma cortisol concentration measured at 8:00 a.m. the following morning.
Children and Adolescents
25 to 30 mcg/kg/dose PO (Max: 2 mg/dose PO) given at 11:00 p.m. with a plasma cortisol concentration measured at 8:00 a.m. the following morning. A plasma cortisol concentration of less than 5 mcg/dL occurs in normal individuals but not those with Cushing's syndrome. Measure a dexamethasone concentration concurrently with the cortisol concentration to ensure adequacy of the dexamethasone dose.
For use as a test to distinguish Cushing's syndrome secondary to pituitary ACTH excess from Cushing's syndrome secondary to other causes.
Oral dosage (dexamethasone)
Adults
2 mg PO every 6 hours for 48 hours. 24-hour urine collections are made for determination of 17-hydroxycorticosteroid excretion.
Children and Adolescents
120 mcg/kg/dose PO (Max: 8 mg/dose PO) given at 11:00 p.m. with a plasma cortisol concentration measured at 8:00 a.m. the following morning. A decrease in the morning cortisol of 20% or more from baseline had a 97.5% sensitivity and 100% specificity in distinguishing patients with Cushing's disease from those with primary adrenal disorders in a retrospective study (n = 125, age 3 to 18 years). Measure a dexamethasone concentration concurrently with the cortisol concentration to ensure adequacy of the dexamethasone dose. Alternatively, a 2 day test consisting of 30 mcg/kg/day PO on day 1 and 120 mcg/kg/day PO on day 2, each given in 4 divided doses, has been recommended. Cortisol concentrations are suppressed in patients with pituitary Cushing's syndrome after the larger dose but not the smaller dose; cortisol concentrations are not suppressed after dexamethasone in patients with adrenocorticotropic hormone-independent Cushing syndrome.
For the treatment of allergic disorders including anaphylaxis, anaphylactic shock, or anaphylactoid reactions, angioedema, acute noninfectious laryngeal edema, hypersensitivity reactions (drug or food allergy), transfusion-related reactions, urticaria, serum sickness, and severe perennial allergies or seasonal allergies, including allergic rhinitis.
Tapering regimen for acute, self-limited allergic disorders or acute exacerbations of chronic allergic disorders.
Intramuscular and Oral dosage
Adults
4 to 8 mg IM as a single dose on day 1. Then change to oral therapy, 1.5 mg PO twice daily on days 2 and 3; then 0.75 mg PO twice daily on day 4; then 0.75 mg PO once daily on days 5 and 6, then discontinue.
For unresponsive anaphylactic shock.
Intravenous dosage (dexamethasone sodium phosphate injection)
Adults
Various dosage regimens have been used. 1 to 6 mg/kg IV or 40 mg IV every 4 to 6 hours while shock persists. Alternatively, 20 mg IV injection followed by an IV infusion of 3 mg/kg over 24 hours. Corticosteroids are given as adjunctive therapy to epinephrine.
For treatment of anaphylaxis or other severe allergic disorders.
Intravenous or Intramuscular dosage (dexamethasone sodium phosphate injection)
Adults
Initially, 0.5 to 9 mg/day IV or IM, in 2 to 4 divided doses. Adjust according to patient response. Corticosteroids are not indicated as initial treatment for anaphylaxis, but can be given as adjunctive therapy after the administration of epinephrine.
Infants, Children, and Adolescents
0.02 to 0.3 mg/kg/day or 0.6 to 9 mg/m2/day IV or IM given in 3 to 4 divided doses is the FDA-approved general dosage range. Adjust according to patient response. Corticosteroids are not indicated as initial treatment for anaphylaxis, but can be given as adjunctive therapy after the administration of epinephrine.
Oral dosage (dexamethasone)
Adults
Initially, 0.75 to 9 mg/day PO, given in 2 to 4 divided doses. Adjust according to patient response.
Infants, Children, and Adolescents
0.02 to 0.3 mg/kg/day or 0.6 to 9 mg/m2/day PO given in 3 to 4 divided doses is the FDA-approved general dosage range. Adjust according to patient response.
For the treatment of cerebral edema associated with primary or metastatic brain tumor, craniotomy, or head injury.
For treatment of cerebral edema in pediatric patients.
Intravenous and Intramuscular dosage (dexamethasone sodium phosphate)
Infants, Children, and Adolescents
Initially, 1 to 1.5 mg/kg/dose IV, then 1 to 1.5 mg/kg/day IV in divided doses every 3 to 4 hours was used in conjunction with hyperventilation, control of body temperature, barbiturates, and continuous intracranial and arterial pressure monitoring in pediatric patients with severe head injury (n = 24, age 3 months to 14 years). 0.02 to 0.3 mg/kg/day or 0.6 to 9 mg/m2/day IV or IM given in 3 to 4 divided doses is the FDA-approved dosage range. Adjust according to patient response. Use is not a substitute for neurosurgical evaluation and definitive management such as neurosurgery, etc.
Oral dosage (dexamethasone)
Infants, Children, and Adolescents
0.02 to 0.3 mg/kg/day PO or 0.6 to 9 mg/m2/day PO given in 3 to 4 divided doses is the FDA-approved general dosage range. Adjust according to patient response. Use is not a substitute for neurosurgical evaluation and definitive management such as neurosurgery, etc.
Intravenous or Intramuscular dosage (dexamethasone sodium phosphate injection)
Adults
10 mg IV or IM as a single dose, followed by 4 mg IV or IM every 6 hours, until symptoms subside, then reduce dosage. A response should be seen within 12 to 24 hours, and a gradual dose reduction begun after 2 to 4 days, reducing over another 5 to 7 days. Replace with oral dosage as soon as possible. For palliative maintenance therapy when oral therapy is not feasible, 2 mg IM or IV can be given 2 to 3 times per day, if needed. Use is not a substitute for neurosurgical evaluation and definitive management such as neurosurgery, etc.
Oral dosage (dexamethasone)
Adults
For cerebral edema, 1 to 3 mg PO three times daily, can follow parenteral therapy; then, taper off over a period of 5 to 7 days. For palliative management of recurrent or inoperable brain tumors, maintenance with 2 mg PO given 2 or 3 times daily may be effective.
For the treatment of kidney transplant rejection in conjunction with other immunosuppressants or for the treatment of acute graft-versus-host disease (GVHD).
Intravenous or Intramuscular dosage (dexamethasone sodium phosphate solution for injection)
Adults
Initially, 0.5 to 9 mg/day IV or IM, in divided doses. Adjust according to patient response. Renal transplant guidelines recommend corticosteroids for the initial treatment of acute rejection.
Children and Adolescents
0.06 to 0.3 mg/kg/day or 1.2 to 10 mg/m2/day IM or IV in divided doses every 6 to 12 hours. Renal transplant guidelines recommend corticosteroids for the initial treatment of acute rejection.
For the treatment of drug-susceptible tuberculosis infection or drug-resistant tuberculosis infection as adjunctive therapy in combination with antituberculous therapy.
For the treatment of tuberculosis infection as adjunctive therapy in combination with antituberculous therapy in persons without HIV.
Oral dosage
Adults
0.4 mg/kg/day PO with a taper over 6 to 8 weeks. Guidelines recommend as adjunct therapy for meningitis. Routine use outside of CNS involvement is not recommended; however, select patients may benefit.[54286] [61094] [65619] [65758]
Infants, Children, and Adolescents
0.3 to 0.6 mg/kg/day PO for 4 to 6 weeks, then taper over 2 to 4 weeks. Guidelines recommend as adjunct therapy for meningitis. Routine use outside of CNS involvement is not recommended; however, select patients may benefit.[54286] [61094] [65619] [65758]
Intravenous or Intramuscular dosage
Adults
0.4 mg/kg/day IV or IM with a taper over 6 to 8 weeks. Guidelines recommend as adjunct therapy for meningitis. Routine use outside of CNS involvement is not recommended; however, select patients may benefit.
Infants, Children, and Adolescents
0.3 to 0.6 mg/kg/day IV or IM for 4 to 6 weeks, then taper over 2 to 4 weeks. Guidelines recommend as adjunct therapy for meningitis. Routine use outside of CNS involvement is not recommended; however, select patients may benefit.
For the treatment of tuberculosis infection as adjunctive therapy in combination with antituberculous therapy in persons living with HIV.
Oral dosage
Adults
0.3 to 0.4 mg/kg/day PO for 2 to 4 weeks, then taper by 0.1 mg/kg/week until 0.1 mg/kg/day PO, then 4 mg/day PO and taper by 1 mg/week for a total duration of 12 weeks. Guidelines recommend as adjunct therapy for meningitis. Routine use outside of CNS involvement is not recommended; however, select patients may benefit.[34362] [54286] [61094] [65619] [65758]
Adolescents
0.3 to 0.4 mg/kg/day PO for 2 to 4 weeks, then taper by 0.1 mg/kg/week until 0.1 mg/kg/day PO, then 4 mg/day PO and taper by 1 mg/week for a total duration of 12 weeks. Guidelines recommend as adjunct therapy for meningitis. Routine use outside of CNS involvement is not recommended; however, select patients may benefit.[34362] [54286] [61094] [65619] [65758]
Infants and Children
0.3 to 0.6 mg/kg/day PO for 4 to 6 weeks, then taper over 2 to 4 weeks. Guidelines recommend as adjunct therapy for meningitis. Routine use outside of CNS involvement is not recommended; however, select patients may benefit. [54286] [61094] [65619] [65758]
Intravenous or Intramuscular dosage
Adults
0.3 to 0.4 mg/kg/day IV or IM for 2 to 4 weeks, then taper by 0.1 mg/kg/week until 0.1 mg/kg/day IV or IM, then 4 mg/day IV or IM and taper by 1 mg/week for a total duration of 12 weeks. Guidelines recommend as adjunct therapy for meningitis. Routine use outside of CNS involvement is not recommended; however, select patients may benefit.[34362] [61094]
Adolescents
0.3 to 0.4 mg/kg/day IV or IM for 2 to 4 weeks, then taper by 0.1 mg/kg/week until 0.1 mg/kg/day IV or IM, then 4 mg/day IV or IM and taper by 1 mg/week for a total duration of 12 weeks. Guidelines recommend as adjunct therapy for meningitis. Routine use outside of CNS involvement is not recommended; however, select patients may benefit.[34362] [61094]
Infants and Children
0.3 to 0.6 mg/kg/day IV or IM for 4 to 6 weeks, then taper over 2 to 4 weeks. Guidelines recommend as adjunct therapy for meningitis. Routine use outside of CNS involvement is not recommended; however, select patients may benefit.
For the reduction of edema and inflammation associated with selected cases of otitis externa.
Otic dosage (using dexamethasone sodium phosphate ophthalmic solution)
Adults, Adolescents, and Children
Instill 3 or 4 drops (ophthalmic solution) into the aural canal 2 to 3 times per day. When a favorable response is obtained, reduce dosage gradually and eventually discontinue. If preferred, the aural canal may be packed with a gauze wick saturated with solution. Keep the wick moist with solution and remove from the ear after 12 to 24 hours. May repeat as needed at the discretion of the prescriber. There is no specific otic solution preparation; use ophthalmic solution. Used for steroid responsive inflammatory conditions of the external auditory meatus, such as allergic otitis externa, selected purulent and nonpurulent infective otitis externa when the hazard of steroid use is accepted to decrease edema and inflammation.
For adjunctive therapy in the treatment of rheumatic disorders including acute gouty arthritis, ankylosing spondylitis, rheumatoid arthritis, juvenile rheumatoid arthritis (JRA)/juvenile idiopathic arthritis (JIA), post-traumatic osteoarthritis, synovitis of osteoarthritis, and for psoriatic arthritis; or for the treatment of acute episodes or exacerbation of nonrheumatic inflammatory conditions including acute and subacute bursitis, epicondylitis, acute non-specific tenosynovitis, and cystic tumors of an aponeurosis tendon (ganglia).
Oral dosage (dexamethasone)
Adults
Initially, 0.75 to 9 mg/day PO, given in 2 to 4 divided doses. Adjust according to patient response.
Infants, Children, and Adolescents
0.02 to 0.3 mg/kg/day or 0.6 to 9 mg/m2/day PO given in 3 to 4 divided doses is the FDA-approved general dosage range. Adjust according to patient response.
Intravenous or Intramuscular dosage (dexamethasone sodium phosphate injection solution)
Adults
Initially, 0.5 to 9 mg/day IV or IM, in 2 to 4 divided doses. Adjust maintenance dosage according to patient response.
Infants, Children, and Adolescents
0.02 to 0.3 mg/kg/day or 0.6 to 9 mg/m2/day IV or IM given in 3 to 4 divided doses is the FDA-approved general dosage range. Adjust according to patient response.
Intra-Articular or Intrasynovial injection dosage (dexamethasone sodium phosphate injection solution)
Adults
Dosage ranges from 2 to 4 mg for large joints and 0.8 to 1 mg for small joints. Injection into intervertebral joints should not be attempted at any time and hip joint injection cannot be recommended as an office procedure. Intrasynovial should be employed only when affected areas are limited to 1 or 2 sites. May repeat from once every 3 to 5 days to once every 2 to 3 weeks.
Intralesional or Soft Tissue dosage (dexamethasone sodium phosphate injection solution)
Adults
The 4 mg/mL injection strength may be used for intralesional and soft tissue administration. Doses range from 0.2 mg to 4 mg injected as a single dose at the appropriate site. For soft tissue and bursal injections a dose of 2 to 4 mg is recommended. Ganglia require a dose of 1 to 2 mg. A dose of 0.4 to 1 mg is used for injection into tendon sheaths. Usually employed when condition to be treated is limited to 1 or 2 sites. Dosage dependent upon degree of inflammation, size, disease state, and location of affected area. Repeat doses may be given from once every 3 to 5 days to once every 2 to 3 weeks.
For the treatment of hematologic disorders such as secondary thrombocytopenia in adults, autoimmune hemolytic anemia, erythroblastopenia, congenital hypoplastic anemia, and thrombocytopenia associated with immune thrombocytopenic purpura (ITP).
Oral dosage (dexamethasone)
Adults
Initially, 0.75 to 9 mg/day PO, given in 2 to 4 divided doses. For many conditions, the dosing of corticosteroids is highly variable. Adjust according to patient response. In an open study of 10 patients with ITP, pulse dosing produced a sustained improvement in platelet count with a total daily dose of 40 mg/day PO for 4 consecutive days out of each 28 day cycle for 6 consecutive cycles.
Infants, Children and Adolescents
0.02 to 0.3 mg/kg/day or 0.6 to 9 mg/m2/day PO given in 3 to 4 divided doses is the FDA-approved general dosage range. Adjust according to patient response.
Intramuscular or Intravenous dosage (dexamethasone sodium phosphate)
Adults
Initially, 0.5 to 9 mg/day IV or IM, given in 2 to 4 divided doses. For many conditions, the dosing of corticosteroids is highly variable. Adjust according to patient response.
Infants, Children, and Adolescents
0.02 to 0.3 mg/kg/day or 0.6 to 9 mg/m2/day IV or IM given in 3 to 4 divided doses is the FDA-approved general dosage range. Adjust according to patient response.
For the treatment of respiratory conditions including aspiration pneumonitis, berylliosis, chronic obstructive pulmonary disease (COPD) exacerbations, Loeffler's syndrome.
Oral dosage (dexamethasone)
Adults
Initially, 0.75 to 9 mg/day PO, given in 2 to 4 divided doses. Dosage of corticosteroids can be highly variable, depending on patient condition. Adjust according to patient response.
Infants, Children and Adolescents
0.02 to 0.3 mg/kg/day or 0.6 to 9 mg/m2/day PO given in 3 to 4 divided doses is the FDA-approved general dosage range. Adjust according to patient response. Administer dexamethasone IV or IM initially for the treatment of severe respiratory conditions or those compromising the airway.
Intravenous or Intramuscular dosage (dexamethasone sodium phosphate)
Adults
Initially, 0.5 to 9 mg/day IV or IM, in 2 to 4 divided doses. Dosage of corticosteroids can be highly variable, depending on patient condition. Adjust according to patient response.
Infants, Children, and Adolescents
0.02 to 0.3 mg/kg/day or 0.6 to 9 mg/m2/day IV or IM given in 3 to 4 divided doses is the FDA-approved general dosage range. Adjust according to patient response. Administer dexamethasone IV or IM initially for the treatment of severe respiratory conditions or those compromising the airway.
For asthma exacerbation.
Oral dosage
Adults
Initially, 0.75 to 9 mg/day PO, given in 2 to 4 divided doses. Adjust according to patient response. Use of dexamethasone for longer than 2 days may increase the potential for metabolic side effects. Use parenteral dexamethasone dosage for severe respiratory conditions or those compromising the airway. Although prednisone, prednisolone, or methylprednisolone are the systemic corticosteroids of choice for the management of moderate to severe asthma exacerbations, other corticosteroids such as dexamethasone, given in equipotent daily doses are likely to be as effective.[33558]
Infants, Children, and Adolescents
0.6 mg/kg/dose PO as a single dose or once daily for 2 days. Max: 16 mg/dose.[54531] [54533] [59736] [59737] [64934] Administer dexamethasone IV or IM initially for the treatment of severe respiratory conditions or those compromising the airway. Single or 2-day regimens of dexamethasone have shown similar efficacy, less vomiting, and improved compliance when compared to a 5-day course of oral prednisone or prednisolone.[54531] [54533] [59736] [59737] Use of dexamethasone for longer than 2 days may increase the potential for metabolic side effects. Although prednisone, prednisolone, or methylprednisolone are the systemic corticosteroids of choice for the management of moderate to severe asthma exacerbations, other corticosteroids such as dexamethasone, given in equipotent daily doses are likely to be as effective.[33558] Of note, 0.02 to 0.3 mg/kg/day or 0.6 to 9 mg/m2/day PO given in 3 to 4 divided doses is the FDA-approved initial dosage range for dexamethasone; however, this is significantly lower than the range used in clinical practice.[54286]
Intravenous or Intramuscular dosage (dexamethasone sodium phosphate solution injection)
Adults
Initially, 0.5 to 9 mg/day IV or IM, in 2 to 4 divided doses. Adjust according to patient response. Use of dexamethasone for longer than 2 days may increase the potential for metabolic side effects. Although prednisone, prednisolone, or methylprednisolone are the systemic corticosteroids of choice for the management of moderate to severe asthma exacerbations, other corticosteroids such as dexamethasone, given in equipotent daily doses are likely to be as effective.[33558]
Infants, Children, and Adolescents
0.6 mg/kg/dose IV or IM as a single dose or once daily for 2 days. Max: 16 mg/dose.[54357] [59738] [64934] Single-dose regimens ranging from 0.3 to 1.7 mg/kg/dose have been reported. Max: 36 mg/dose.[59736] In a study of young children with moderate exacerbations, a single day regimen of parenteral dexamethasone resulted in similar efficacy as a 5-day course of oral prednisolone.[59738] Use of dexamethasone for longer than 2 days may increase the potential for metabolic side effects. Although prednisone, prednisolone, or methylprednisolone are the systemic corticosteroids of choice for the management of moderate to severe asthma exacerbations, other corticosteroids such as dexamethasone, given in equipotent daily doses are likely to be as effective.[33558] Of note, 0.5 to 9 mg per day IV or IM is the FDA-approved initial dosage range depending on the condition being treated; however, higher doses are sometimes used in clinical practice.[54285] [54286]
For the treatment of nephrotic syndrome to induce diuresis or decrease proteinuria.
Oral dosage
Adults
Initially, 0.75 to 9 mg/day PO, given in 2 to 4 divided doses. Adjust according to patient response until urine is protein-free, then slowly taper as indicated. Some patients may require long-term dosing.
Infants, Children, and Adolescents
0.02 to 0.3 mg/kg/day or 0.6 to 9 mg/m2/day PO given in 3 to 4 divided doses is the FDA-approved general dosage range. Adjust according to patient response.
Intravenous or Intramuscular dosage
Infants, Children, and Adolescents
0.02 to 0.3 mg/kg/day or 0.6 to 9 mg/m2/day IV or IM given in 3 to 4 divided doses is the FDA-approved general dosage range. Adjust according to patient response.
For the treatment of hypercalcemia related to sarcoidosis or cancer, or for the treatment of nonsuppurative thyroiditis, or for severe cases of myasthenia gravis not controlled by antimyasthenic agents alone.
For the treatment of hypercalcemia related to cancer or for the treatment of nonsuppurative thyroiditis in pediatric patients.
Oral dosage
Infants, Children, and Adolescents
0.02 to 0.3 mg/kg/day or 0.6 to 9 mg/m2/day PO given in 3 to 4 divided doses is the FDA-approved general dosage range. Adjust according to patient response.
Intravenous and Intramuscular dosage
Infants, Children, and Adolescents
0.02 to 0.3 mg/kg/day or 0.6 to 9 mg/m2/day IV or IM given in 3 to 4 divided doses is the FDA-approved general dosage range. Adjust according to patient response.
Oral dosage (dexamethasone)
Adults
Initially, 0.75 to 9 mg/day PO, given in 2 to 4 divided doses. For many conditions, the dosing of corticosteroids is highly variable. Adjust to patient response.
Infants, Children, and Adolescents
0.02 to 0.3 mg/kg/day or 0.6 to 9 mg/m2/day PO given in 3 to 4 divided doses is the FDA-approved general dosage range. Adjust according to patient response.
Intravenous or Intramuscular dosage
Infants, Children, and Adolescents
0.02 to 0.3 mg/kg/day or 0.6 to 9 mg/m2/day IV or IM given in 3 to 4 divided doses is the FDA-approved general dosage range. Adjust according to patient response.
For the treatment of Hodgkin lymphoma.
Oral dosage
Adults and Children
Dosages vary depending upon the chemotherapy protocol. Common doses include 1.5 to 6 mg/m2/day PO for 8 to 21 days or 8 mg PO every 8 hours for 10 days.
For the treatment of non-Hodgkin's lymphoma (NHL).
For the palliative treatment of NHL.
Oral dosage
Adults
initial, 0.75 to 9 mg orally daily; dose is dependent on the disease being treated and should be individualized based on patient response. Maintenance therapy may be given; use the lowest dose that produces an adequate clinical response. Taper dexamethasone gradually in patients on long-term therapy; do not abruptly stop therapy in these patients.
Infants, Children, and Adolescents
initial, 0.02 to 0.3 mg/kg (0.6 mg to 9 mg/m2) orally daily in 3 or 4 divided doses. Dose is dependent on the disease being treated and should be individualized based on patient response. Maintenance therapy may be given; use the lowest dose that produces an adequate clinical response. Taper dexamethasone gradually in patients on long-term therapy; do not abruptly stop therapy in these patients.
Intravenous dosage (dexamethasone sodium phosphate injection)
Adults
initial, 0.5 to 9 mg IV daily; dose is dependent on the disease being treated and should be individualized based on patient response. Maintenance therapy may be given; use the lowest dose that produces an adequate clinical response. Taper dexamethasone gradually in patients receiving IV therapy for more than a few days; do not abruptly stop therapy in these patients.
For the treatment of relapsed or refractory, aggressive NHL in transplant eligible patients, in combination with gemcitabine and cisplatin (and rituximab for CD20-positive disease)†.
Oral dosage
Adults
40 mg orally daily on days 1, 2, 3, and 4 in combination with gemcitabine 1,000 mg/m2 IV on days 1 and 8 and cisplatin 75 mg/m2 IV on day 1 (GDP regimen) every 21 days for 2 cycles was evaluated in a randomized, phase III trial (NCIC-CTG LY.12 trial). In patients with CD20-positive lymphoma, rituximab 375 mg/m2 IV was added on day 1 of each treatment cycle (R-GDP regimen). Patients in the trial could receive a third cycle of therapy if they did not achieve a complete or partial response after the second cycle. Patients with CD20-positive lymphoma who received an autologous stem-cell transplant (ASCT) were randomized to receive either rituximab 375 mg/m2 IV every 2 months for 6 cycles or observation starting 28 days post ASCT.
For the treatment of relapsed or refractory diffuse large B-cell lymphoma in transplant eligible patients, in combination with cisplatin and cytarabine (DHAP regimen) and ofatumumab†.
Oral or Intravenous dosage
Adults
40 mg orally or IV on days 1, 2, 3, and 4 as part of the DHAP regimen with cisplatin 100 mg/m2 as a continuous IV infusion over 24 hours on day 1 and cytarabine 2 grams/m2 IV over 3 hours every 12 hours for 2 doses on day 2 in combination with ofatumumab 1,000 mg IV on days 1 and 8 of cycle 1 then ofatumumab 1,000 mg IV on day 1 of cycles 2 and 3 was evaluated in a randomized, phase III trial (n = 445; the ORCHARRD trial). Cycles were repeated every 21 days for a total of 3 cycles of therapy. Premedication with acetaminophen, diphenhydramine, and an IV glucocorticoid was administered prior to each ofatumumab infusion. If dexamethasone from the DHAP chemotherapy was dosed on the same day as ofatumumab, then the glucocorticoid premedication was omitted and substituted with the 40-mg dose of dexamethasone. Granulocyte colony-stimulating factor use was recommended as follows: filgrastim 5 micrograms (mcg)/kg on days 6 to 13 or pegfilgrastim 6 mg on day 6 on cycles of therapy with no stem-cell mobilization and filgrastim 5 to 10 mcg/kg on days 6 to 13 on cycles of therapy that were followed by stem-cell mobilization. Central nervous system prophylaxis using intrathecal therapy was permitted. Supportive care during treatment consisted of irradiated blood products, oral antibiotics, and antifungal prophylaxis as clinically indicated.
For the treatment of acute lymphocytic leukemia (ALL).
Oral dosage
Adults
6 to 10 mg/m2/day PO for 14 days as part of induction, consolidation, or intensification combination regimens.
Infants, Children, and Adolescents
0.02 to 0.3 mg/kg/day or 0.6 to 9 mg/m2/day PO given in 3 to 4 divided doses is the FDA-approved general dosage range ; however, doses may vary according to the specific protocol used.
Intravenous or Intramuscular dosage
Adults
Initially, 0.5 to 9 mg IV or IM daily; dose is dependent on the disease being treated and should be individualized based on patient response. Maintenance therapy may be given; use the lowest dose that produces an adequate response. Taper dexamethasone gradually in patients receiving parenteral therapy for more than a few days; do not abruptly stop treatment.
Adolescents, Children, and Infants
0.02 to 0.3 mg/kg/day or 0.6 to 9 mg/m2/day IV or IM given in 3 to 4 divided doses is the FDA-approved general dosage range ; however, doses may vary according to the specific protocol used.
For the treatment of acute exacerbations of multiple sclerosis.
Oral dosage
Adults
30 mg/day PO for 7 days, followed by doses of 4 to 12 mg PO every other day for 1 month have been shown to be effective. Controlled clinical trials have shown corticosteroids to be effective in speeding the resolution of acute exacerbations, they do not show that they affect the ultimate outcome or natural history of the disease.
Infants, Children, and Adolescents
0.02 to 0.3 mg/kg/day or 0.6 to 9 mg/m2/day PO given in 3 to 4 divided doses is the FDA-approved general dosage range. Adjust according to patient response.
Intravenous†or Intramuscular dosageâ€
Infants, Children, and Adolescents
0.02 to 0.3 mg/kg/day or 0.6 to 9 mg/m2/day IV or IM given in 3 to 4 divided doses is the FDA-approved general dosage range. Adjust according to patient response.
For the treatment of multiple myeloma.
NOTE: Dexamethasone has been designated an orphan drug by the FDA for the treatment of multiple myeloma.
For the treatment of multiple myeloma in patients who have received at least 1 prior therapy, in combination with lenalidomide.
NOTE: Lenalidomide is FDA approved in combination with dexamethasone for the treatment of multiple myeloma in patients that have failed at least 1 prior therapy.
Oral dosage
Adults
40 mg orally daily on days 1 to 4, 9 to 12, and 17 to 20 every 28 days for the first 4 cycles of therapy, and then 40 mg orally daily on days 1 to 4 every 28 days starting with cycle 5. Given in combination with lenalidomide (25 mg orally daily on days 1 to 21 of each cycle). Continue or modify dosing based on clinical and laboratory findings.
For the treatment of patients with newly diagnosed multiple myeloma, in combination with lenalidomide.
NOTE: Lenalidomide is FDA approved in combination with dexamethasone for this indication.
Oral dosage
Adults 75 years and younger
40 mg orally on days 1, 8, 15, and 22; administer in combination with lenalidomide (25 mg orally daily for 21 days followed by 7 days off treatment). Continue 28-day treatment cycles until disease progression in patients who are ineligible for an autologous stem-cell transplantation (ASCT); hematopoietic stem-cell mobilization should occur within four 28-day treatment cycles in patients who are eligible for an ASCT.
Geriatric Adults older than 75 years
20 mg orally on days 1, 8, 15, and 22; administer in combination with lenalidomide (25 mg orally daily for 21 days followed by 7 days off treatment). Continue 28-day treatment cycles until disease progression.
For newly diagnosed multiple myeloma as induction therapy prior to autologous stem-cell transplantation, in combination with doxorubicin and vincristine†.
Oral dosage
Adults 65 years and younger
40 mg orally daily on days 1 to 4, days 9 to 12, and days 17 to 20 or dexamethasone 40 mg orally daily on days 1 to 4 on all cycles and days 9 to 12 and days 17 to 20 of cycles 1 and 2 only, plus doxorubicin 9 mg/m2 IV daily and vincristine 0.4 mg IV daily on days 1 to 4 (VAD regimen) has been studied. Doxorubicin and vincristine were administered as a continuous IV infusion over 24 hours/day [49477] or as a daily IV infusion. Cycles were repeated every 4 weeks for 3 to 4 cycles as induction therapy prior to autologous stem-cell transplantation.[49477] [49478]
For newly diagnosed multiple myeloma, in combination with thalidomide.
NOTE: Thalidomide is FDA approved in combination with dexamethasone for this indication.
Oral dosage
Adults
40 mg orally daily on days 1 to 4, days 9 to 12, and days 17 to 20 of every 28-day treatment cycle plus thalidomide 200 mg orally daily (given at bedtime and at least 1 hour after the evening meal).
For newly diagnosed multiple myeloma as induction therapy prior to autologous stem-cell transplantation, in combination with bortezomib†.
Oral dosage
Adults 65 years and younger
40 mg orally daily on days 1 to 4 during all cycles and on days 9 to 12 for cycles 1 and 2 only plus bortezomib (1.3 mg/m2 IV on days 1, 4, 8, and 11) repeated every 3 weeks for 4 cycles as induction therapy prior to autologous stem-cell transplantation has been evaluated in newly diagnosed multiple myeloma patients in randomized, phase 3 studies.
For newly diagnosed multiple myeloma as induction therapy prior to autologous stem-cell transplantation, in combination with bortezomib and thalidomide†.
Oral dosage
Adults 65 years and younger
40 mg orally on days 1, 2, 4, 5, 8, 9, 11, and 12 plus bortezomib (1.3 mg/m2 IV on days 1, 4, 8, and 11) and thalidomide (100 mg orally daily for the first 14 days during cycle 1 only, and then 200 mg orally daily thereafter). Regimen is known as the VTD regimen. Repeated every 21 days for 3 cycles prior to a double (tandem) autologous stem-cell transplant (ASCT). This regimen was studied in a multicenter, randomized, phase 3 study. Patients randomized to induction therapy with VTD also received two 35-day consolidation cycles with VTD (bortezomib 1.3 mg/m2 on days 1, 8, 15, and 22 plus thalidomide 100 mg orally daily and dexamethasone 40 mg orally on days 1, 2, 8, 9, 15, 16, 22, and 23) following the second transplantation. Patients also received maintenance therapy with dexamethasone 40 mg orally on days 1 to 4 every 28 days until relapse or disease progression.[49746] Additionally in a randomized, phase 3 study, dexamethasone 40 mg orally daily on days 1 to 4 and 9 to 12 plus bortezomib (1.3 mg/m2 on days 1, 4, 8, and 11) and thalidomide (200 mg orally daily after dose escalation as follows in the first cycle: thalidomide 50 mg/day on days 1 to 14 and 100 mg/day on days 15 to 28) repeated every 4 weeks for 6 cycles prior to an ASCT was studied. In this study, patients who received up to 3 years of maintenance therapy (starting 3 months after ASCT) with bortezomib (1.3 mg/m2 IV on days 1, 4, 8, and 11 repeated every 3 months) plus thalidomide (100 mg/day) had significantly improved 2-year progression-free survival compared with thalidomide or interferon alfa-2b maintenance therapy.[49747]
For the treatment of multiple myeloma in patients who have received at least 2 prior therapies (including bortezomib and an immunomodulatory agent), in combination with panobinostat and bortezomib.
NOTE: Panobinostat is FDA approved in combination with bortezomib and dexamethasone this indication.
Oral dosage
Adults
20 mg orally on days 1, 2, 4, 5, 8, 9, 11, and 12 during cycles 1 to 8, then dexamethasone 20 mg orally on days 1, 2, 8, and 9 during cycles 9 to 16. Administer in combination with bortezomib (1.3 mg/m2 IV bolus over 3 to 5 seconds on days 1, 4, 8, and 11 in cycles 1 to 8) then bortezomib (1.3 mg/m2 on days 1 and 8 in cycles 9 to 16) and panobinostat (20 mg orally on days 1, 3, 5, 8, 10, and 12). Continue every 21-day treatment cycles for up to 8 cycles; consider giving up to an additional 8 cycles (maximum of 16 treatment cycles) in patients who experience clinical benefit without unresolved severe or medically significant toxicity.[58821] Treatment with panobinostat, bortezomib, and dexamethasone (n = 387; median therapy duration of 5 months) was compared with placebo, bortezomib, and dexamethasone (n = 381; median therapy duration of 6.1 months) in patients with relapsed or relapsed and refractory multiple myeloma who had received 1 to 3 prior therapies in a multinational, randomized, phase 3 trial (the PANORAMA1 trial). The median patient age was 63 years (range, 56 to 69 years), about 51% of patients had received 1 prior therapy, and approximately 57% of patients had previously received a stem-cell transplantation. Patients with primary refractory or bortezomib-refractory disease were ineligible for this study. At a median follow-up time of 6.47 months (interquartile range, 1.81 to 13.47 months), the median progression-free survival time (primary endpoint) was significantly improved in the panobinostat arm (11.99 months) compared with the placebo arm (8.08 months; hazard ratio (HR) = 0.63; 95% CI, 0.52 to 0.76; p less than 0.0001). The overall survival (OS) time was not significantly improved in the panobinostat arm (33.64 months vs. 30.39 months; HR = 0.87; 95% CI, 0.69 to 1.1); however, OS data are not mature. Crossover from the placebo arm to the panobinostat arm was not permitted.[58822]
For the treatment of relapsed multiple myeloma in patients who have received 1 to 3 prior lines of therapy, in combination with carfilzomib and lenalidomide.
NOTE: Carfilzomib is FDA approved in combination with lenalidomide and dexamethasone for this indication.
Oral and Intravenous dosage
Adults
40 mg PO or IV on days 1, 8, 15, and 22 in combination with lenalidomide (25 mg orally daily for 21 days) and carfilzomib as specified in the protocol. Treatment cycles are repeated every 28 days until disease progression or unacceptable toxicity; maximum of 18 cycles for carfilzomib only. CYCLE 1: carfilzomib 20 mg/m2 IV over 10 minutes on days 1 and 2; if tolerated, increase to a target dose of 27 mg/m2 IV over 10 minutes on days 8, 9, 15, and 16. CYCLES 2 to 12: carfilzomib 27 mg/m2 IV over 10 minutes on days 1, 2, 8, 9, 15, and 16. CYCLES 13 to 18: carfilzomib 27 mg/m2 IV over 10 minutes on days 1, 2, 15, and 16. Dose carfilzomib at a maximum body surface area (BSA) of 2.2 m2; dose adjustment is not necessary for patients with a weight change of 20% or less. Give dexamethasone 30 minutes to 4 hours prior to the carfilzomib (on carfilzomib dosing days only). Give hydration with both oral fluids and IV fluids prior to each carfilzomib dose in cycle 1. Additional IV hydration may be given after the carfilzomib infusion in cycle 1. Oral and/or IV hydration may be continued as needed in subsequent cycles; adjust hydration to individual patient needs. Thromboprophylaxis is recommended. Consider giving an antiviral agent and an antacid medication. In a prespecified interim analysis of a multinational, randomized, open-label, phase 3 trial (n = 792; the ASPIRE trial), the median progression-free survival time (primary endpoint) was significantly increased with carfilzomib plus lenalidomide/dexamethasone (26.3 months) compared with lenalidomide/dexamethasone alone (17.6 months; hazard ratio (HR) = 0.69; 95% CI, 0.57 to 0.83; p = 0.0001) in patients with relapsed multiple myeloma who had received 1 to 3 prior therapies (age range, 31 to 91 years; median of 2 prior therapies). In this study, some patients had previously received bortezomib (65.8%) and/or lenalidomide (19.8%). The median overall survival (OS) time had not been reached in either study arm at the time of the interim analysis (median follow-up: carfilzomib arm, 32.3 months; lenalidomide/dexamethasone alone, 31.5 months). The estimated 24-month OS rates were 73.3% and 65% in the carfilzomib/lenalidomide/dexamethasone and lenalidomide/dexamethasone arms, respectively (HR = 0.79; 95% CI, 0.63 to 0.99; p = 0.04); prespecified criteria for stopping the study due to OS benefit was not met and this study is ongoing.
For the treatment multiple myeloma in patients who have received at least 1 prior therapy, in combination with daratumumab and bortezomib.
NOTE: Daratumumab is FDA approved in combination with bortezomib and dexamethasone for this indication.
Oral or Intravenous dosage
Adults 75 years or younger
20 mg orally or IV on days 1, 2, 4, 5, 8, 9, 11, and 12 (or 20 mg orally/IV once weekly in patients with a body-mass index less than 18.5, poorly controlled diabetes mellitus, or a prior intolerance to glucocorticoid therapy) repeated every 3 weeks for 8 cycles in combination with daratumumab and bortezomib. The bortezomib dosage is 1.3 mg/m2 as a subcutaneous injection or IV infusion on days 1, 4, 8, and 11 repeated every 3 weeks for 8 cycles. The daratumumab dosage is 16 mg/kg (actual body weight) IV weekly on weeks 1 to 9 (9 doses), 16 mg/kg IV every 3 weeks on weeks 10 to 24 (5 doses), and then 16 mg/kg IV every 4 weeks starting on week 25 until disease progression. Administer standard pre-and post-infusion medications with daratumumab infusions. Give dexamethasone prior to the daratumumab infusion when these drugs are scheduled on the same day.
Geriatric Adults over 75 years
20 mg orally or IV once weekly repeated every 3 weeks for 8 cycles in combination with daratumumab and bortezomib. The bortezomib dosage is 1.3 mg/m2 as a subcutaneous injection or IV infusion on days 1, 4, 8, and 11 repeated every 3 weeks for 8 cycles. The daratumumab dosage is 16 mg/kg (actual body weight) IV weekly on weeks 1 to 9 (9 doses), 16 mg/kg IV every 3 weeks on weeks 10 to 24 (5 doses), and then 16 mg/kg IV every 4 weeks starting on week 25 until disease progression. Administer standard pre-and post-infusion medications with daratumumab infusions. Give dexamethasone prior to the daratumumab infusion when these drugs are scheduled on the same day.
For the treatment of multiple myeloma in patients who have received at least 1 prior therapy, in combination with daratumumab and lenalidomide.
NOTE: Daratumumab is FDA-approved in combination with lenalidomide and dexamethasone for this indication.
Oral or Intravenous dosage
Adults 75 years or younger
40 mg orally or IV once weekly (or 20 mg orally or IV once weekly for patients with a body-mass index less than 18.5) in combination with lenalidomide and daratumumab until disease progression or unacceptable toxicity. The lenalidomide dosage is 25 mg orally daily on days 1 to 21 repeated every 28 days in patients with creatinine clearance (CrCl) greater than 60 mL/min and 10 mg orally daily on days 1 to 21 repeated every 28 days in patients with a CrCl of 30 to 60 mL/min. The daratumumab dosage is 16 mg/kg (actual body weight) IV weekly on weeks 1 to 8 (8 doses), 16 mg/kg IV every other week on weeks 9 to 24 (8 doses), and then 16 mg/kg IV every 4 weeks starting on week 25 until disease progression. Administer standard pre-and post-infusion medications with daratumumab infusions. In patients receiving full dose dexamethasone, administer as 20 mg IV prior to the daratumumab infusion and then 20 mg PO the next day when these drugs are scheduled on the same week; patients receiving a 20 mg/week dexamethasone dose should receive the entire dose administered prior to the daratumumab infusion.[61407] [60311]
Geriatric Adults over 75 years
20 mg orally or IV once weekly in combination with lenalidomide and daratumumab until disease progression or unacceptable toxicity. The lenalidomide dosage is 25 mg orally daily on days 1 to 21 repeated every 28 days in patients with creatinine clearance (CrCl) greater than 60 mL/min and 10 mg orally daily on days 1 to 21 repeated every 28 days in patients with a CrCl of 30 to 60 mL/min. The daratumumab dosage is 16 mg/kg (actual body weight) IV weekly on weeks 1 to 8 (8 doses), 16 mg/kg IV every 2 weeks on weeks 9 to 24 (8 doses), and then 16 mg/kg IV every 4 weeks starting on week 25 until disease progression. Administer standard pre-and post-infusion medications with daratumumab infusions. Give dexamethasone prior to the daratumumab infusion when these drugs are scheduled on the same week.
For the treatment of newly diagnosed multiple myeloma, in combination with bortezomib and lenalidomide†.
Oral dosage
Adults
20 mg orally on days 1, 2, 4, 5, 8, 9, 11, and 12 repeated every 21 days for 8 cycles (SWOG S0777 trial); 20 mg orally on days 1, 2, 4, 5, 8, 9, 11, and 12 repeated every 21 days for 3 cycles prior to stem-cell transplantation (SCT) followed by 10 mg orally on days 1, 2, 4, 5, 8, 9, 11, and 12 repeated every 21 days for 2 cycles after SCT (IFM 2009 trial); and 20 mg orally on days 1, 2, 4, 5, 8, 9, 11, and 12 repeated every 21 days for 4 cycles, 10 mg orally on days 1, 2, 4, 5, 8, 9, 11, and 12 on cycles 5 to 9, and then 10 mg orally on days 1, 2, 8, and 9 on cycles 9 to 12 (ENDURANCE trial) in combination with bortezomib and lenalidomide (VRd regimen) have been evaluated in 3 randomized, phase 3 trials. Maintenance therapy consisted of lenalidomide and dexamethasone or lenalidomide only.Â
For the treatment of multiple myeloma in patients who have received at least 2 prior therapies including lenalidomide and a proteasome inhibitor, in combination with pomalidomide and daratumumab.
NOTE: Daratumumab is FDA-approved in combination with pomalidomide and dexamethasone for this indication.
Oral or Intravenous dosage
Adults 75 years or younger
40 mg orally or IV once weekly (or 20 mg IV/PO once weekly for patients with a body-mass index less than 18.5) in combination with pomalidomide (4 mg orally daily on days 1 to 21 repeated every 28 days) and daratumumab (16 mg/kg of actual body weight IV weekly on weeks 1 to 8 (8 doses), 16 mg/kg IV every other week on weeks 9 to 24 (8 doses), and then 16 mg/kg IV every 4 weeks starting on week 25) until disease progression was evaluated in a nonrandomized, phase 1b trial (n = 103; EQUULEUS trial). Administer standard pre-and post-infusion medications with daratumumab infusions. In patients receiving full dose dexamethasone, administer as 20 mg IV prior to the daratumumab infusion and then 20 mg orally the next day when these drugs are scheduled on the same week; patients receiving a 20 mg/week dexamethasone dose should receive the entire dose administered prior to the daratumumab infusion. [60311]
Geriatric Adults over 75 years
20 mg orally or IV once weekly in combination with pomalidomide (4 mg orally daily on days 1 to 21 repeated every 28 days) and daratumumab (16 mg/kg of actual body weight IV weekly on weeks 1 to 8 (8 doses), 16 mg/kg IV every other week on weeks 9 to 24 (8 doses), and then 16 mg/kg IV every 4 weeks starting on week 25) until disease progression was evaluated in a nonrandomized, phase 1b trial (n = 103; EQUULEUS trial). Administer standard pre-and post-infusion medications with daratumumab infusions. Give dexamethasone prior to the daratumumab infusion when these drugs are scheduled on the same week.
For the treatment of multiple myeloma in patients who have received at least 2 prior therapies including lenalidomide and a proteasome inhibitor, in combination with elotuzumab and pomalidomide.
Elotuzumab is FDA approved in combination with pomalidomide and dexamethasone for this indication.
Oral dosage
Adults 75 years or younger
28 mg orally (at 3 to 24 hours prior to elotuzumab) on days 1, 8, 15, and 22 on cycles 1 and 2 and on day 1 of subsequent cycles in combination with elotuzumab 10 mg/kg IV once weekly on cycles 1 and 2 (on days 1, 8, 15, and 22) followed by 20 mg/kg IV every 4 weeks (on day 1) starting on cycle 3 and pomalidomide 4 mg orally daily on days 1 through 21. Additionally, give dexamethasone 40 mg (at 3 to 24 hours prior to elotuzumab) on days 8, 15, and 22 of cycles 3 and beyond. Repeat treatment cycles every 28 days until disease progression. Administer the following premedications 45 to 90 minutes prior to each elotuzumab infusion: acetaminophen 650 to 1,000 mg orally, diphenhydramine 25 to 50 mg orally or IV (or equivalent), ranitidine 50 mg IV or 150 mg orally (or equivalent), and dexamethasone 8 mg IV. At a minimum follow-up time of 9.1 months, the median investigator-assessed progression-free survival time was significantly improved with elotuzumab plus pomalidomide and dexamethasone (median number of treatment cycles, 9) compared with pomalidomide and dexamethasone alone (10.25 months vs. 4.67 months; hazard ratio (HR) = 0.54; 95% CI, 0.34 to 0.86; p = 0.0078) in patients with relapsed or refractory multiple myeloma in a randomized, phase 2 trial (n = 117; the ELOQUENT-3 trial). In this study, patients had received a median of 3 prior therapies; 70% of patients had refractory disease after both lenalidomide and a proteasome inhibitor and 55% of patients had previously received an autologous stem cell transplantation.
Geriatric Adults over 75 years
8 mg orally (at 3 to 24 hours prior to elotuzumab) on days 1, 8, 15, and 22 on cycles 1 and 2 and on day 1 of subsequent cycles in combination with elotuzumab 10 mg/kg IV once weekly on cycles 1 and 2 (on days 1, 8, 15, and 22) followed by 20 mg/kg IV every 4 weeks (on day 1) starting on cycle 3 and pomalidomide 4 mg orally daily on days 1 through 21. Additionally, give dexamethasone 20 mg orally (at 3 to 24 hours prior to elotuzumab) on days 8, 15, and 22 of cycles 3 and beyond. Repeat treatment cycles every 28 days until disease progression. Administer the following premedications 45 to 90 minutes prior to each elotuzumab infusion: acetaminophen 650 to 1,000 mg orally, diphenhydramine 25 to 50 mg orally or IV (or equivalent), ranitidine 50 mg IV or 150 mg orally (or equivalent), and dexamethasone 8 mg IV. At a minimum follow-up time of 9.1 months, the median investigator-assessed progression-free survival time was significantly improved with elotuzumab plus pomalidomide and dexamethasone (median number of treatment cycles, 9) compared with pomalidomide and dexamethasone alone (10.25 months vs. 4.67 months; hazard ratio (HR) = 0.54; 95% CI, 0.34 to 0.86; p = 0.0078) in patients with relapsed or refractory multiple myeloma in a randomized, phase 2 trial (n = 117; the ELOQUENT-3 trial). In this study, patients had received a median of 3 prior therapies; 70% of patients had refractory disease after both lenalidomide and a proteasome inhibitor and 55% of patients had previously received an autologous stem cell transplantation.[60354]
For the treatment of multiple myeloma in patients who have received 1 to 3 prior therapies, in combination with elotuzumab and lenalidomide.
Elotuzumab is FDA approved in combination with lenalidomide and dexamethasone for this indication.
Oral dosage
Adults
28 mg orally (taken 3 to 24 hours prior to elotuzumab) on days 1, 8, 15, and 22 on cycles 1 and 2 and on days 1 and 15 of subsequent cycles in combination with lenalidomide 25 mg orally daily on days 1 through 21 and elotuzumab 10 mg/kg IV once weekly on cycles 1 and 2 (on days 1, 8, 15, and 22), then 10 mg/kg IV every 2 weeks (on days 1 and 15) thereafter. Give dexamethasone 40 mg orally on days 8 and 22 of cycles 3 and beyond. Repeat treatment cycles every 28 days until disease progression. Administer the following premedications 45 to 90 minutes prior to each elotuzumab infusion: acetaminophen 650 to 1,000 mg PO, diphenhydramine 25 to 50 mg PO or IV (or equivalent), ranitidine 50 mg IV or 150 mg PO (or equivalent), and dexamethasone 8 mg IV.[60354] At a median follow-up time of 24.5 months, the median progression-free survival time was significantly improved with elotuzumab plus lenalidomide and dexamethasone (median duration of therapy, 17 months) compared with lenalidomide and dexamethasone alone (19.4 months vs. 14.9 months; hazard ratio (HR) = 0.7; 95% CI, 0.57 to 0.85; p less than 0.001) in patients with relapsed and/or refractory multiple myeloma in a planned interim analysis of a multicenter, randomized, open-label, phase 3 trial (n = 646; the ELOQUENT-2 trial). In this study, patients had received a median of 2 prior therapies (range, 1 to 4 therapies); 35% of patients had refractory disease to the last therapy and 54% of patients had previously received an autologous stem cell transplantation.[60353] The overall survival time was improved in the elotuzumab-containing arm (48.3 months vs. 39.6 months; HR = 0.82; 95% CI, 0.68 to 1) at the final analysis (minimum follow-up time of 70.6 months). In subgroup analyses, the median OS times were significantly improved in elotuzumab-treated patients who had received 2 or 3 prior therapies (51 months vs. 33.6 months; HR = 0.71; 95% CI, 0.54 to 0.92), were refractory to their most recent therapy (40.4 months vs. 25.9 months; HR = 0.67; 95% CI, 0.49 to 0.91), or were less than 65 years of age (63.5 months vs. 47.7 months; HR = 0.7; 95% CI, 0.52 to 0.96).
For the treatment of newly diagnosed multiple myeloma in patients ineligible for autologous stem-cell transplant, in combination with daratumumab and lenalidomide.
NOTE: Daratumumab is FDA-approved in combination with lenalidomide and dexamethasone for this indication.
Oral or Intravenous dosage
Adults 75 years or younger
40 mg orally or IV once weekly (or 20 mg orally or IV once weekly for patients with a body-mass index less than 18.5) in combination with lenalidomide and daratumumab until disease progression or unacceptable toxicity. Give dexamethasone IV prior to the first infusion; oral administration may be considered thereafter. Give the treatment dexamethasone dose as the daratumumab premedication steroid when these drugs are scheduled on the same day. Consider giving a low-dose oral corticosteroid (equivalent to methylprednisolone 20 mg or less) on the day after every infusion. The lenalidomide dosage is 25 mg orally daily on days 1 to 21 repeated every 28 days in patients with creatinine clearance (CrCl) greater than 50 mL/min and 10 mg orally daily on days 1 to 21 repeated every 28 days in patients with a CrCl of 30 to 50 mL/min. The daratumumab dosage is 16 mg/kg (actual body weight) IV weekly on weeks 1 to 8 (8 doses), 16 mg/kg IV every 2 weeks on weeks 9 to 24 (8 doses), and then 16 mg/kg IV every 4 weeks starting on week 25 until disease progression. Administer standard pre-and post-infusion medications with daratumumab infusions.[60311] In the MAIA trial (median follow-up, 56.2 months), the median progression-free survival (time not reached vs. 34.4 months; hazard ratio (HR) = 0.53; 95% CI, 0.43 to 0.66, p less than 0.0001) and overall survival (time not reached in either arm; HR = 0.68; 95% CI, 0.53 to 0.86) times were significantly improved in the daratumumab plus lenalidomide and dexamethasone arm compared with the lenalidomide and dexamethasone arm in patients (median age, 73 years; range, 45 to 90 years) with newly diagnosed multiple myeloma who were ineligible for a stem-cell transplant.
Geriatric Adults over 75 years
20 mg orally or IV once weekly in combination with lenalidomide and daratumumab until disease progression or unacceptable toxicity. Give dexamethasone IV prior to the first infusion; oral administration may be considered thereafter. Give the treatment dexamethasone dose as the daratumumab premedication steroid when these drugs are scheduled on the same day. Consider giving a low-dose oral corticosteroid (equivalent to methylprednisolone 20 mg or less) on the day after every infusion. The lenalidomide dosage is 25 mg orally daily on days 1 to 21 repeated every 28 days in patients with creatinine clearance (CrCl) greater than 50 mL/min and 10 mg orally daily on days 1 to 21 repeated every 28 days in patients with a CrCl of 30 to 50 mL/min. The daratumumab dosage is 16 mg/kg (actual body weight) IV weekly on weeks 1 to 8 (8 doses), 16 mg/kg IV every 2 weeks on weeks 9 to 24 (8 doses), and then 16 mg/kg IV every 4 weeks starting on week 25 until disease progression. Administer standard pre-and post-infusion medications with daratumumab infusions. Give dexamethasone prior to the daratumumab infusion when these drugs are scheduled on the same week.[60311] In the MAIA trial (median follow-up, 56.2 months), the median progression-free survival (time not reached vs. 34.4 months; hazard ratio (HR) = 0.53; 95% CI, 0.43 to 0.66, p less than 0.0001) and overall survival (time not reached in either arm; HR = 0.68; 95% CI, 0.53 to 0.86) times were significantly improved in the daratumumab plus lenalidomide and dexamethasone arm compared with the lenalidomide and dexamethasone arm in patients (median age, 73 years; range, 45 to 90 years) with newly diagnosed multiple myeloma who were ineligible for a stem-cell transplant.
For the treatment of relapsed or refractory multiple myeloma in patients who have received 1 to 3 prior therapies including lenalidomide, in combination with pomalidomide and bortezomib †.
Oral dosage
Adults 75 years or younger
20 mg orally on days 1, 2, 4, 5, 8, 9, 11, and 12 repeated every 21 days on cycles 1 to 8 and then 20 mg orally on days 1, 2, 8, and 9 starting on cycle 9 in combination with pomalidomide (4 mg orally daily on days 1 to 14) and bortezomib was evaluated in a randomized, phase 3 trial (n = 559; the OPTIMISMM trial). Bortezomib was administered as follows: 1.3 mg/m2 IV or subcutaneously on days 1, 4, 8, and 11 on cycles 1 to 8 then 1.3 mg/m2 IV or subcutaneously on days 1 and 8 starting on cycle 9. Treatment cycles were repeated every 21 days until disease progression.
Geriatric Adults older than 75 years
10 mg orally on days 1, 2, 4, 5, 8, 9, 11, and 12 repeated every 21 days on cycles 1 to 8 and then 10 mg orally on days 1, 2, 8, and 9 starting on cycle 9 in combination with pomalidomide (4 mg orally daily on days 1 to 14) and bortezomib. Bortezomib was administered as follows: 1.3 mg/m2 IV or subcutaneously on days 1, 4, 8, and 11 on cycles 1 to 8 then 1.3 mg/m2 IV or subcutaneously on days 1 and 8 starting on cycle 9. Treatment cycles were repeated every 21 days until disease progression.[64412]
For the treatment of newly diagnosed multiple myeloma as induction and consolidation therapy in patients who are eligible for autologous stem-cell transplant, in combination with daratumumab, bortezomib, and thalidomide.
NOTE: Daratumumab is FDA approved in combination with bortezomib, thalidomide, and dexamethasone for this indication.
Oral and Intravenous dosage
Adults 65 years and younger
40 mg orally or IV on days 1, 2, 8, 9, 15, 16, 22, and 23 in induction cycles 1 and 2; 40 mg orally or IV on days 1 and 2 and 20 mg PO or IV on days 8, 9, 15, and 16 in induction cycles 3 and 4; and 20 mg orally or IV on days 1, 2, 8, 9, 15, and 16 for 2 consolidation cycles in combination with daratumumab, bortezomib, and thalidomide was evaluated in a multicenter, randomized, phase 3 trial (n = 1,085; the CASSIOPEIA trial). In this trial, dexamethasone was administered for up to four 28-day induction therapy cycles and two 28-day consolidation therapy cycles with daratumumab (16 mg/kg IV weekly in induction cycles 1 and 2 then 16 mg/kg IV every 2 weeks in induction cycles 3 and 4 and for both consolidation cycles; bortezomib 1.3 mg/m2 subcutaneously on days 1, 4, 8, and 11 in each induction and consolidation cycle; and thalidomide 100 mg orally daily. Consolidation therapy was begun after hematopoietic reconstitution but not earlier than 30 days after transplant.[64528]
For the treatment of multiple myeloma in patients who have received at least 2 prior therapies including lenalidomide and a proteasome inhibitor, in combination with isatuximab and pomalidomide.
NOTE: Isatuximab is FDA approved in combination with pomalidomide and dexamethasone for this indication.
Oral and Intravenous dosage
Adults 74 years and younger
40 mg IV or orally on days 1, 8, 15, and 22 repeated every 28 days until disease progression. Give in combination with isatuximab 10 mg/kg (actual body weight) IV on days 1, 8, 15, and 22 on cycle 1 and isatuximab 10 mg/kg (actual body weight) IV on days 1 and 15 starting on cycle 2 and pomalidomide 4 mg orally daily on days 1 to 21. The scheduled dexamethasone dose should be given prior to isatuximab and pomalidomide on days these drugs are given together. At a median follow-up time of 11.6 months, the median progression-free survival time (evaluated by an independent response committee) was significantly improved in patients with relapsed or refractory multiple myeloma who received isatuximab, pomalidomide, and low-dose dexamethasone compared with pomalidomide and low-dose dexamethasone alone (11.5 months vs. 6.5 months; hazard ratio (HR) = 0.596; 95% CI, 0.44 to 0.81; p = 0.001) in a multinational, randomized, phase 3 trial (the ICARIA-MM trial; n = 307). Patients (median age, 67 years) in this study had received a median of 3 prior therapies including lenalidomide and a proteasome inhibitor; 56% of patients had previously received an autologous stem-cell transplantation. At a second interim analysis (median follow-up, 35.3 months), the median overall survival time was 24.6 months in patients who received isatuximab, pomalidomide, and dexamethasone compared with 17.7 months in patients who received pomalidomide and dexamethasone (HR = 0.76; 95% CI, 0.57 to 1.01). Subsequent therapy was given at disease progression in 60% and 72% of patients in the isatuximab-containing and control arms, respectively. Of patients who received subsequent therapy, fewer patients received daratumumab in the isatuximab-containing arm (24% vs. 58%).
Geriatric Adults 75 years and older
20 mg IV or orally on days 1, 8, 15, and 22 repeated every 28 days until disease progression. Give in combination with isatuximab 10 mg/kg (actual body weight) IV on days 1, 8, 15, and 22 on cycle 1 and isatuximab 10 mg/kg (actual body weight) IV on days 1 and 15 starting on cycle 2 and pomalidomide 4 mg orally daily on days 1 to 21. The scheduled dexamethasone dose should be given prior to isatuximab and pomalidomide on days these drugs are given together. At a median follow-up time of 11.6 months, the median progression-free survival was significantly improved in patients with relapsed or refractory multiple myeloma who received isatuximab, pomalidomide, and low-dose dexamethasone compared with pomalidomide and low-dose dexamethasone alone (11.5 months vs. 6.5 months; hazard ratio = 0.596; 95% CI, 0.44 to 0.81; p = 0.001) in a multinational, randomized, phase 3 trial (the ICARIA-MM trial; n = 307). Patients (median age, 67 years) in this study had received a median of 3 prior therapies including lenalidomide and a proteasome inhibitor; 56% of patients had previously received an autologous stem-cell transplantation.
For the treatment of relapsed or refractory multiple myeloma in patients who have received at least 1 prior therapy, in combination with daratumumab/hyaluronidase and lenalidomide.
NOTE: Daratumumab; hyaluronidase is FDA approved in combination with lenalidomide and dexamethasone for this indication.
Oral and Intravenous dosage
Adults 75 years or younger
40 mg IV/PO (or 20 mg PO/IV in patients with a body-mass index less than 18.5) once weekly plus lenalidomide 25 mg PO daily on days 1 to 21 repeated every 28 days in combination with 1,800 mg daratumumab and 30,000 units hyaluronidase subcutaneously weekly on weeks 1 to 8 (8 doses), 1,800 mg daratumumab and 30,000 units hyaluronidase every other week on weeks 9 to 24 (8 doses), and then 1,800 mg daratumumab and 30,000 units hyaluronidase every 4 weeks starting on week 25 until disease progression was evaluated in a single-arm cohort (n = 65) of a multicohort, open-label trial (the PLEIADES trial). The overall response rate was 91% in patients with relapsed or refractory multiple myeloma who received daratumumab/hyaluronidase, lenalidomide, and dexamethasone.
Geriatric Adults over 75 years
20 mg PO/IV once weekly plus lenalidomide 25 mg PO daily on days 1 to 21 repeated every 28 days in combination with 1,800 mg daratumumab and 30,000 units hyaluronidase subcutaneously weekly on weeks 1 to 8 (8 doses), 1,800 mg daratumumab and 30,000 units hyaluronidase every other week on weeks 9 to 24 (8 doses), and then 1,800 mg daratumumab and 30,000 units hyaluronidase every 4 weeks starting on week 25 until disease progression was evaluated in a single-arm cohort (n = 65) of a multicohort, open-label trial (the PLEIADES trial). The overall response rate was 91% in patients with relapsed or refractory multiple myeloma who received daratumumab/hyaluronidase, lenalidomide, and dexamethasone.
For the treatment of relapsed or refractory multiple myeloma in patients who have received 1 to 3 prior lines of therapy, in combination with and carfilzomib and daratumumab.
NOTE: Carfilzomib and daratumumab are FDA approved in combination with dexamethasone for this indication.
Oral and Intravenous dosage
Adults 75 years or younger
20 mg PO/IV on days 1, 2, 8, 9, 15, and 16 and 40 mg PO/IV on day 22 repeated every 28 days in combination with IV carfilzomib (20 mg/m2 and 56 mg/m2 twice weekly regimen) and IV daratumumab until disease progression or unacceptable toxicity. Alternatively, dexamethasone may be given as follows: 20 mg PO/IV on days 1, 2, 8, 9, 15, 16, 22, and 23 in cycles 1 and 2; 20 mg PO/IV on days 1, 2, 15, and 16 and 40 mg PO/IV on days 8 and 22 in cycles 3, 4, 5, and 6; and 20 mg PO/IV on days 1 and 2 and 40 mg PO/IV on days 8, 15, and 22 in cycles 7 and beyond in combination with IV carfilzomib (20 mg/m2 and 70 mg/m2 once weekly regimen) and IV daratumumab until disease progression or unacceptable toxicity. Treatment cycles are repeated every 28 days. Give dexamethasone 30 minutes to 4 hours prior to the carfilzomib dose and 1 to 3 hours prior to daratumumab. At a median follow-up time of about 17 months, the median progression-free survival was significantly improved in patients with relapsed or refractory multiple myeloma who received carfilzomib 20 mg/m2 and 56 mg/m2 twice weekly regimen, daratumumab, and dexamethasone compared with carfilzomib and dexamethasone alone (median time not reached vs. 15.8 months; hazard ratio = 0.63; 95% CI, 0.46 to 0.85; p = 0.0027) in a multicenter, randomized (2:1), open-label, phase 3 trial (n = 466; the CANDOR trial). At a median follow-up time of 16.6 months (range, 0.5 to 27.4 months), the overall response rate was 84% (complete response rate, 33%) in patients with relapsed or refractory multiple myeloma who received carfilzomib 20 mg/m2 and 70 mg/m2 once weekly regimen, daratuzumab, and dexamethasone in a multicenter, multi-arm, phase 1b trial (n = 85; EQUULEUS trial).
Geriatric Adults older than 75 years
20 mg PO/IV on days 1 and 2 of cycle 1 only and then 20 mg PO/IV weekly in combination with IV carfilzomib and IV daratumumab until disease progression or unacceptable toxicity. Treatment cycles are repeated every 28 days. Give dexamethasone 30 minutes to 4 hours prior to the carfilzomib dose and 1 to 3 hours prior to daratumumab. At a median follow-up time of about 17 months, the median progression-free survival was significantly improved in patients with relapsed or refractory multiple myeloma who received carfilzomib 20 mg/m2 and 56 mg/m2 twice weekly regimen, daratumumab, and dexamethasone compared with carfilzomib and dexamethasone alone (median time not reached vs. 15.8 months; hazard ratio = 0.63; 95% CI, 0.46 to 0.85; p = 0.0027) in a multicenter, randomized (2:1), open-label, phase 3 trial (n = 466; the CANDOR trial). At a median follow-up time of 16.6 months (range, 0.5 to 27.4 months), the overall response rate was 84% (complete response rate, 33%) in patients with relapsed or refractory multiple myeloma who received carfilzomib 20 mg/m2 and 70 mg/m2 once weekly regimen, daratuzumab, and dexamethasone in a multicenter, multi-arm, phase 1b trial (n = 85; EQUULEUS trial).
For the treatment of newly diagnosed multiple myeloma in patients who are eligible for autologous stem-cell transplant, in combination with daratumumab, bortezomib, and lenalidomide†.
Oral dosage
Adults 70 years or younger
20 mg on days 1, 2, 8, 9, 15, and 16 repeated every 21 days on cycles 1, 2, 3, and 4 followed by high-dose chemotherapy and an autologous stem-cell transplant and then 2 additional cycles of dexamethasone 20 mg on days 1, 2, 8, 9, 15, and 16 repeated every 21 days (cycles 5 and 6) plus lenalidomide 25 mg orally daily on days 1 to 14 and bortezomib 1.3 mg/m2 subcutaneously on days 1, 4, 8, and 11 repeated every 21 days for 6 cycles (VRd regimen) with daratumumab was evaluated in a randomized, phase 2 trial (the GRIFFIN trial; n = 207). Daratumumab treatment consisted of 16 mg/kg IV on days 1, 8, and 15 repeated every 21 days on cycles 1, 2, 3, and 4 and 16 mg/kg IV day 1 repeated every 21 days on cycles 5 and 6. Maintenance therapy was given for up to 2 years and consisted of daratumumab 16 mg/kg IV on day 1 repeated every 4 or 8 weeks and lenalidomide 10 mg orally daily on days 1 to 21 (increased to 15 mg after 3 cycles if tolerated) repeated every 28 days.
For the treatment of multiple myeloma in patients who have received at least 1 prior therapy, in combination with selinexor and bortezomib†.
NOTE: Selinexor is FDA approved in combination with bortezomib and dexamethasone for this indication.
Oral dosage
Adults
20 mg PO on days 1 and 2 in combination with selinexor 100 mg orally on day 1 once weekly and bortezomib 1.3 mg/m2 subcutaneously on day 1 once weekly for 4 weeks followed by 1 week off; repeat cycles until disease progression. Treatment with a once-weekly regimen of selinexor plus bortezomib, and dexamethasone (SVd regimen) led to a significantly improved median progression-free survival time compared with bortezomib and dexamethasone (13.93 months vs. 9.46 months; hazard ratio (HR) = 0.7; 95% CI, 0.53 to 0.93) in a randomized, phase 3 trial (n = 402; the Boston trial). At a median follow-up of 17.3 months, the median overall survival (OS) time was not significantly improved in the SVd arm (HR = 0.84; 95% CI, 0.57 to 1.23); however, OS data was not mature at the time of this analysis. Patients (median age, 67 years) in this trial had received a median of 2 prior regimens (range, 1 to 2 regimens) and approximately 70% of patients had received prior bortezomib therapy; 35% of patients had previously received a stem-cell transplant.
For the treatment of multiple myeloma in patients who have received at least 4 prior therapies and who are refractory to at least 1 proteasome inhibitor, 1 immunomodulatory agent, and 1 anti-CD38 monoclonal antibody, in combination with melphalan flufenamide.
NOTE: Melphalan flufenamide is FDA approved in combination with dexamethasone for this indication.
Oral and Intravenous dosage
Adults younger than 75 years
40 mg orally or IV on days 1, 8, 15, and 22 in combination with melphalan flufenamide 40 mg IV on day 1 repeated every 28 days until disease progression. Treatment with melphalan flufenamide plus dexamethasone resulted in an overall response rate of 23.7% in 97 patients with multiple myeloma who had received 4 or more previous lines of therapy and were refractory to at least 1 proteasome inhibitor, 1 immunomodulatory agent, and a CD38-directed monoclonal antibody in a nonrandomized phase 2 trial (the HORIZON trial). No patient achieved a complete response. In this trial, the median duration of response was 4.2 months. Patients (median age, 65 years; range, 35 to 86 years) had received a median of 6 prior regimens (range, 4 to 12 regimens); 75% of patients had alkylator refractory disease and 70% of patients had previously received a stem-cell transplant.
Geriatrics 75 years or older
20 mg orally or IV on days 1, 8, 15, and 22 in combination with melphalan flufenamide 40 mg IV on day 1 repeated every 28 days until disease progression. Treatment with melphalan flufenamide plus dexamethasone resulted in an overall response rate of 23.7% in 97 patients with multiple myeloma who had received 4 or more previous lines of therapy and were refractory to at least 1 proteasome inhibitor, 1 immunomodulatory agent, and a CD38-directed monoclonal antibody in a nonrandomized phase 2 trial (the HORIZON trial). No patient achieved a complete response. In this trial, the median duration of response was 4.2 months. Patients (median age, 65 years; range, 35 to 86 years) had received a median of 6 prior regimens (range, 4 to 12 regimens); 75% of patients had alkylator refractory disease and 70% of patients had previously received a stem-cell transplant.
For the treatment of relapsed or refractory multiple myeloma in patients who have received 1 to 3 prior lines of therapy, in combination with isatuximab and carfilzomib.
NOTE: Isatuximab and carfilzomib are FDA approved in combination with dexamethasone for this indication.
Oral or Intravenous dosage
Adults
20 mg on days 1, 2, 8, 9, 15, 16, 22, and 23 in combination with isatuximab (cycle 1: 10 mg/kg IV on days 1, 8, 15, and 22; cycle 2 and beyond: 10 mg/kg IV on days 1 and 15) and carfilzomib (cycle 1: 20 mg/m2 IV on days 1 and 2 and then 56 mg/m2 on days 8, 9, 15, and 16; cycle 2 and beyond: 56 mg/m2 IV on days 1, 2, 8, 9, 15, and 16). Repeat treatment cycles every 28 days until disease progression. Give IV dexamethasone prior to isatuximab and/or carfilzomib on days these agents are given on the same day and then give dexamethasone orally for other scheduled doses. At a median follow-up time of 20.7 months, the median progression-free survival was significantly improved in patients with relapsed or refractory multiple myeloma who received isatuximab, carfilzomib, and dexamethasone compared with carfilzomib and dexamethasone alone (median time not calculated vs. 19.15 months; hazard ratio = 0.53; 95% CI, 0.32 to 0.79; p = 0.0007) in a prespecified interim analysis of a multinational, randomized, phase 3 trial (the IKEMA trial; n = 302). Patients (median age, 64 years) in this study had received a median of 2 prior therapies; 61% of patients had previously received a stem-cell transplantation.
For the treatment of multiple myeloma in patients who have received at least 1 prior therapy, in combination with ixazomib and lenalidomide.
NOTE: Ixazomib is FDA approved in combination with lenalidomide and dexamethasone for the treatment of multiple myeloma in patients who have received at least 1 prior therapy.
Oral dosage
Adults
40 mg orally on days 1, 8, 15, and 22 in combination with ixazomib 4 mg orally on days 1, 8, and 15 and lenalidomide 25 mg orally daily on days 1 through 21. Repeat treatment cycles every 28 days until disease progression. The median progression-free survival time was significantly improved with ixazomib plus lenalidomide and dexamethasone compared with placebo plus lenalidomide and dexamethasone (20.6 months vs. 14.7 months; hazard ratio (HR) = 0.74; 95% CI, 0.59 to 0.94; p = 0.01) in patients with relapsed and/or refractory multiple myeloma who had received 1 to 3 prior therapies in a multinational, randomized, double-blind, phase 3 trial (n = 722; TOURMALINE-MM1 trial). At a median follow-up time of 85 months, the median overall survival time was not significantly improved in the ixazomib-containing arm (53.6 months vs. 51.6 months; HR = 0.939; 95%CI, 0.784 to 1.125). In this trial, subsequent lines of therapy were given in 71.7% and 69.9% of patients who received ixazomib plus lenalidomide and dexamethasone (median, 2 subsequent therapies; range, 1 to 9) and lenalidomide and dexamethasone (median, 3 subsequent therapies; range, 1 to 12), respectively. The median age of patients in this study was 66 years (range, 30 to 91 years); prior therapy included a stem-cell transplant in 57% of patients, proteasome inhibitor therapy in 70% of patients, and immunomodulatory drug therapy in 55% of patients. Thromboprophylaxis was recommended for all patients.
For the treatment of relapsed or refractory multiple myeloma in patients who have received at least 1 prior therapy including lenalidomide and a proteasome inhibitor, in combination with daratumumab/ hyaluronidase and pomalidomide.
NOTE: Daratumumab/hyaluronidase is FDA approved in combination with pomalidomide and dexamethasone for this indication.
Oral dosage
Adults and Geriatric patients younger than 75 years
40 mg orally once weekly (on days 1, 8, 15, and 22) repeated every 28 days until disease progression; give in combination with daratumumab/hyaluronidase (1,800 mg daratumumab and 30,000 units hyaluronidase subcutaneously weekly on weeks 1 to 8 (8 doses), every other week on weeks 9 to 24 (8 doses), and then every 4 weeks starting on week 25 until disease progression) and pomalidomide (4 mg PO daily on days 1 to 21 repeated every 28 days). At a median follow-up of 16.9 months, the median progression-free survival was significantly improved (12.4 months vs. 6.9 months; hazard ratio, 0.63; 95%CI, 0.47 to 0.85) in patients with relapsed or refractory multiple myeloma who received daratumumab/hyaluronidase plus pomalidomide and dexamethasone compared with pomalidomide and dexamethasone alone in a randomized, phase 3 trial (n = 304; the APOLLO trial). Overall survival data were not mature at the time of this analysis. In this trial, eligible patients had received at least 1 previous line of therapy with both lenalidomide and a proteasome inhibitor, had a partial response or better to one or more previous lines of antimyeloma therapy, and were refractory to lenalidomide if they had received only 1 previous line of treatment. Patients (median age, 67 years; range, 42 to 86 years) in the daratumumab/hyaluronidase arm had received a median of 2 (range, 1 to 5) prior therapies; 60% of patients had received a prior autologous stem-cell transplantation.
Geriatric patients 75 years and older
20 mg orally once weekly (on days 1, 8, 15, and 22) repeated every 28 days until disease progression; give in combination with daratumumab/hyaluronidase (1,800 mg daratumumab and 30,000 units hyaluronidase subcutaneously weekly on weeks 1 to 8 (8 doses), every other week on weeks 9 to 24 (8 doses), and then every 4 weeks starting on week 25 until disease progression) and pomalidomide (4 mg PO daily on days 1 to 21 repeated every 28 days). At a median follow-up of 16.9 months, the median progression-free survival was significantly improved (12.4 months vs. 6.9 months; hazard ratio, 0.63; 95%CI, 0.47 to 0.85) in patients with relapsed or refractory multiple myeloma who received daratumumab/hyaluronidase plus pomalidomide and dexamethasone compared with pomalidomide and dexamethasone alone in a randomized, phase 3 trial (n = 304; the APOLLO trial). Overall survival data were not mature at the time of this analysis. In this trial, eligible patients had received at least 1 previous line of therapy with both lenalidomide and a proteasome inhibitor, had a partial response or better to one or more previous lines of antimyeloma therapy, and were refractory to lenalidomide if they had received only 1 previous line of treatment. Patients (median age, 67 years; range, 42 to 86 years) in the daratumumab/hyaluronidase arm had received a median of 2 (range, 1 to 5) prior therapies; 60% of patients had received a prior autologous stem-cell transplantation.
For the treatment of relapsed or refractory multiple myeloma in patients who have received 1 to 3 prior lines of therapy, in combination with daratumumab/hyaluronidase and carfilzomib.
NOTE: Carfilzomib and daratumumab/hyaluronidase are both FDA approved in combination with dexamethasone for this indication.
Oral and Intravenous dosage
Adults 75 years or younger
40 mg PO or IV per week in combination with carfilzomib and daratumumab/hyaluronidase; treatment cycles are repeated every 28 days until disease progression or unacceptable toxicity. Dexamethasone dosing day(s)/schedule differ with twice weekly or once weekly carfilzomib regimens. Give dexamethasone 30 minutes to 4 hours prior to the carfilzomib. Give the treatment dexamethasone dose as the premedication steroid when these drugs are scheduled on the same day as daratumumab; hyaluronidase. With carfilzomib 20 mg/m2 and 56 mg/m2 twice weekly regimen, give dexamethasone 20 mg PO/IV on days 1, 2, 8, 9, 15, 16, 22 and 23 on cycles 1 and 2 and then 20 mg PO/IV on days 1, 2, 8, 9, 15, and 16 and 40 mg PO/IV on day 22 on subsequent cycles. With carfilzomib 20 mg/m2 and 70 mg/m2 once weekly regimen, give dexamethasone 20 mg PO/IV on days 1, 2, 8, 9, 15, 16, 22, and 23 on cycles 1 and 2; 20 mg PO/IV on days 1, 2, 15, and 16 and 40 mg PO/IV on days 8 and 22 on cycles 3, 4, 5, and 6; and 20 mg PO/IV on days 1 and 2 and 40 mg PO/IV on days 8, 15, and 22 on cycles 7 and beyond. In patients with a BMI of less than 18.5 who received the carfilzomib once weekly regimen, give a reduced dexamethasone dosage of 20 mg PO/IV on days 1 and 2 of cycle 1 then 20 mg PO/IV weekly. Daratumumab; hyaluronidase is administered as follows: 1,800 mg daratumumab and 30,000 units hyaluronidase subcutaneously weekly on weeks 1 to 8 (8 doses), 1,800 mg daratumumab and 30,000 units hyaluronidase every 2 weeks on weeks 9 to 24 (8 doses), and then 1,800 mg daratumumab and 30,000 units hyaluronidase every 4 weeks starting on week 25 until disease progression. The overall response rate was 84.8% in 66 patients with relapsed or refractory multiple myeloma who received carfilzomib (20 mg/m2 and 70 mg/m2 once weekly regimen), daratumumab/hyaluronidase, and dexamethasone in a multicohort, phase 2 trial (the PLEIADES trial). The stringent complete response rate was 16.7% and the complete response rate was 21.2%. At a median follow-up time of 9.2 months, the median duration of response was not reached. Patients (median age, 61 years; range, 42 to 84 years) in this trial had received at least 1 previous therapy line that contained lenalidomide; 79% of patients had a prior stem-cell transplant.
Adults older than 75 years
20 mg PO/IV on days 1 and 2 of week 1 and then 20 mg PO/IV once weekly in combination with carfilzomib and daratumumab/hyaluronidase; treatment cycles are repeated every 28 days until disease progression or unacceptable toxicity. Give dexamethasone 30 minutes to 4 hours prior to the carfilzomib. Carfilzomib is administered as either a 20 mg/m2 and 56 mg/m2 twice weekly or a 20 mg/m2 and 70 mg/m2 once weekly regimen. Give the treatment dexamethasone dose as the premedication steroid when these scheduled on the same day as daratumumab; hyaluronidase. Daratumumab; hyaluronidase is administered as follows: 1,800 mg daratumumab and 30,000 units hyaluronidase subcutaneously weekly on weeks 1 to 8 (8 doses), 1,800 mg daratumumab and 30,000 units hyaluronidase every 2 weeks on weeks 9 to 24 (8 doses), and then 1,800 mg daratumumab and 30,000 units hyaluronidase every 4 weeks starting on week 25 until disease progression. The overall response rate was 84.8% in 66 patients with relapsed or refractory multiple myeloma who received carfilzomib (20 mg/m2 and 70 mg/m2 once weekly regimen), daratumumab/hyaluronidase, and dexamethasone in a multicohort, phase 2 trial (the PLEIADES trial). The stringent complete response rate was 16.7% and the complete response rate was 21.2%. At a median follow-up time of 9.2 months, the median duration of response was not reached. Patients (median age, 61 years; range, 42 to 84 years) in this trial had received at least 1 previous therapy line that contained lenalidomide; 79% of patients had a prior stem-cell transplant.
For the treatment of a critical period of regional gastroenteritis (Crohn's disease) or ulcerative colitis.
Oral dosage (dexamethasone)
Adults
Initially, 0.75 to 9 mg/day PO, given in 2 to 4 divided doses. Adjust according to patient response. Because of the potential complications of steroid use, steroids should be used selectively and in the lowest dose possible for the shortest duration as possible.
Children and Adolescents
0.02 to 0.3 mg/kg/day or 0.6 to 9 mg/m2/day PO given in 3 to 4 divided doses is the FDA-approved general dosage range. Adjust according to patient response. Because of the potential complications of steroid use, steroids should be used selectively and in the lowest dose possible for the shortest duration as possible.
Intravenous or Intramuscular dosage (dexamethasone sodium phosphate injection solution)
Adults
Initially, 0.5 to 9 mg/day IV or IM, in 2 to 4 divided doses. Adjust according to patient response. Because of the potential complications of steroid use, steroids should be used selectively and in the lowest dose possible for the shortest duration as possible.
Children and Adolescents
0.02 to 0.3 mg/kg/day or 0.6 to 9 mg/m2/day IV or IM given in 3 to 4 divided doses is the FDA-approved general dosage range. Adjust according to patient response. Because of the potential complications of steroid use, steroids should be used selectively and in the lowest dose possible for the shortest duration as possible.
For the treatment of diabetic macular edema.
Intravitreal dosage (ophthalmic implant)
Adults
0.7 mg implant by intravitreal injection in the affected eye(s). Guidelines recommend intravitreous steroids as a second-line alternative treatment for central-involved diabetic macular edema (CIDME). Steroid therapies are associated with inferior visual acuity outcomes and increased rate of cataracts and glaucoma when compared against intravitreal injections of anti-vascular endothelial growth factor (anti-VEGF) agents.
For the treatment of macular edema following retinal vein occlusion, including branch retinal vein occlusion (BRVO) or central retinal vein occlusion (CRVO).
Intravitreal dosage (ophthalmic implant)
Adults
0.7 mg implant by intravitreal injection in the affected eye(s). Retreatment will generally be performed after 3 to 4 months with a mean of approximately 2 to 3 injections/year. Guidelines suggest switching to a steroid in nonresponders who have already been treated with anti-vascular endothelial growth factor (VEGF) (after 3 to 6 injections, depending on the specific response of each patient) is reasonable. Steroids may be considered as a first-line therapy for patients who have a recent history of a major cardiovascular event or those who are unwilling to come for monthly injections (and/or monitoring) in the first 6 months of therapy; however, intraocular pressure still needs to be monitored every 2 to 8 weeks after dexamethasone implant injection.
For the treatment of postoperative ocular inflammation.
For the treatment of postoperative ocular inflammation and ocular pain following ophthalmic surgery.
Intracanalicular insert dosage (Dextenza ophthalmic insert only)
Adults
Place the insert containing 0.4 mg of dexamethasone into the lower lacrimal canaliculus, just below the punctal opening. A single insert releases a 0.4 mg dose for up to 30 days following insertion.
Intraocular suspension dosage (Dexycu intraocular suspension only)
Adults
0.005 mL of dexamethasone 9% (equivalent to 517 mcg) as a single dose as directed, intraocularly in the posterior chamber at the end of surgery.
INVESTIGATIONAL USE: For adjunctive use in the treatment of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection†, the virus that causes coronavirus disease 2019 (COVID-19)†.
For the treatment of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection†, the virus that causes coronavirus disease 2019 (COVID-19)†in hospitalized patients.
Oral dosage
Adults
6 mg PO once daily for up to 10 days or until hospital discharge (whichever comes first) is recommended by the National Institutes of Health (NIH) COVID-19 treatment guidelines for use in hospitalized patients who require supplemental oxygen, including those on high-flow oxygen, noninvasive ventilation, mechanical ventilation, or extracorporeal membrane oxygenation (ECMO). This recommendation also applies to pregnant women, as the potential benefit of decreased maternal mortality justifies the low risk of fetal adverse effects with the short course of therapy. The NIH advises clinicians to review the patient's medical history and assess the potential risks and benefits before starting dexamethasone. The World Health Organization (WHO) strongly recommends the use of systemic corticosteroids for 7 to 10 days in patients with severe or critical COVID-19.
Children and Adolescents
0.15 mg/kg/dose (Max: 6 mg/dose) PO once daily for up to 10 days, although data are limited. The National Institutes of Health (NIH) COVID-19 treatment guidelines recommend dexamethasone (with or without remdesivir) for hospitalized pediatric patients who require high-flow oxygen or noninvasive ventilation. Dexamethasone (without remdesivir) is also recommended for pediatric patients requiring mechanical ventilation or extracorporeal membrane oxygenation (ECMO). The addition of baricitinib or tocilizumab may be considered for patients who do not have rapid (e.g., within 24 hours) improvement in oxygenation after initiation of dexamethasone. Corticosteroids are not routinely recommended for pediatric patients who require only conventional oxygen, but corticosteroids can be considered in combination with remdesivir for patients with increasing oxygen needs, particularly adolescents. The use of dexamethasone for treatment of severe COVID-19 in pediatric patients who are profoundly immunocompromised has not been evaluated and may be harmful; in such cases, treatment should be considered on a case-by-case basis.[65314]
Intravenous dosage
Adults
6 mg IV once daily for up to 10 days or until hospital discharge (whichever comes first) is recommended by the National Institutes of Health (NIH) COVID-19 treatment guidelines for use in hospitalized patients who require supplemental oxygen, including those on high-flow oxygen, noninvasive ventilation, mechanical ventilation, or extracorporeal membrane oxygenation (ECMO). This recommendation also applies to pregnant women, as the potential benefit of decreased maternal mortality justifies the low risk of fetal adverse effects with the short course of therapy. The NIH advises clinicians to review the patient's medical history and assess the potential risks and benefits before starting dexamethasone. The World Health Organization (WHO) strongly recommends the use of systemic corticosteroids for 7 to 10 days in patients with severe or critical COVID-19.
Children and Adolescents
0.15 mg/kg/dose (Max: 6 mg/dose) IV once daily for up to 10 days, although data are limited. The National Institutes of Health (NIH) COVID-19 treatment guidelines recommend dexamethasone (with or without remdesivir) for hospitalized pediatric patients who require high-flow oxygen or noninvasive ventilation. Dexamethasone (without remdesivir) is also recommended for pediatric patients requiring mechanical ventilation or extracorporeal membrane oxygenation (ECMO). The addition of baricitinib or tocilizumab may be considered for patients who do not have rapid (e.g., within 24 hours) improvement in oxygenation after initiation of dexamethasone. Corticosteroids are not routinely recommended for pediatric patients who require only conventional oxygen, but corticosteroids can be considered in combination with remdesivir for patients with increasing oxygen needs, particularly adolescents. The use of dexamethasone for treatment of severe COVID-19 in pediatric patients who are profoundly immunocompromised has not been evaluated and may be harmful; in such cases, treatment should be considered on a case-by-case basis.
For the treatment of hyperinflammation in pediatric coronavirus disease 2019 (COVID-19)†.
Oral dosage
Children and Adolescents
0.15 to 0.3 mg/kg/dose (Max: 6 mg/dose) PO once daily for up to 10 days is recommended as first-line immunomodulatory treatment in patients with persistent oxygen requirements due to COVID-19.
Intravenous dosage
Children and Adolescents
0.15 to 0.3 mg/kg/dose (Max: 6 mg/dose) IV once daily for up to 10 days is recommended as first-line immunomodulatory treatment in patients with persistent oxygen requirements due to COVID-19.
For the prevention of extubation failure in pediatric patients at increased risk for laryngeal edema (i.e., laryngeal edema prophylaxis†).
Intravenous dosage
Infants, Children, and Adolescents
0.5 mg/kg/dose (Max: 10 mg/dose) IV every 6 hours for 6 doses with the first dose given 6 to 12 hours prior to extubation. One prospective, randomized study (n = 153) found no significant difference in the risk of postextubation stridor, the average number of racemic epinephrine treatments, or the number of patients requiring reintubation in patients receiving dexamethasone compared to those receiving placebo. Another prospective, randomized study (n = 66) found that dexamethasone-treated patients had a significantly lower rate of postextubation stridor at 10 minutes, 6 hours, and 12 hours but not 24 hours and fewer patients requiring epinephrine or reintubation compared to placebo-treated patients. A systematic review of clinical trials of dexamethasone for the prevention of postextubation stridor concluded that therapy may be beneficial in high-risk patients, such as those with underlying airway anomalies or multiple airway manipulations.
Neonates
Various regimens have been used. 0.25 mg/kg/dose IV every 8 hours for 3 doses with the first dose given approximately 4 hours prior to scheduled extubation was studied in a prospective, randomized trial in 50 premature neonates (mean gestational age, 27.7 to 28.7 weeks) who were at high risk for airway edema. The rate of postextubation stridor and reintubation was significantly lower in the dexamethasone group compared to the placebo group. A systematic review of clinical trials of dexamethasone for the prevention of extubation failure recommends therapy be reserved for use in high risk neonates, such as those with repeated or prolonged intubations, due to a lack of benefit in low risk neonates and the risk of adverse effects. Use preservative-free products for administration to neonates when possible.
For use as an adjunct in the management of extradural malignant spinal cord compression†(MSCC†) associated with metastatic disease.
To mitigate the effects of acute spinal cord compression†or large mediastinal masses†that are causing respiratory failure in pediatric patients with cancer.
Intravenous dosage
Infants, Children, and Adolescents
1 to 2 mg/kg IV load followed by 0.25 to 0.5 mg/kg/dose IV every 6 hours. Max: 16 mg/dose.
Oral dosage (dexamethasone) or Intravenous dosage (dexamethasone sodium phosphate)
Adults
A bolus of 8 to 10 mg dexamethasone (or equivalent) PO or IV, followed by 16 mg/day PO (usually in twice-daily to four-times-daily doses for tolerance) is a typical dose; doses are adjusted to patient condition and are either maintained or tapered over a few weeks dependent on radiation therapy cycles and/or anticipated surgery. A broad dosage range of 16 to 100 mg/day has been used depending on the presence of paraparesis, etc. Higher quality data are needed to establish the benefits vs. risks and optimal dose and duration of therapy. Experts generally agree that patients who have neurologic deficits should receive dexamethasone; many patients with MSCC require corticosteroids to help preserve neurologic function, such as ambulation.
For the adjunctive treatment of bacterial meningitis†.
NOTE: For CNS infections related to tuberculosis, see tuberculosis.
Intravenous dosage
Adults
0.15 mg/kg/dose IV every 6 hours for 2 to 4 days for pneumococcal meningitis; administer the first dose 10 to 20 minutes before or concomitantly with the first dose of antimicrobial agent. Do not administer to patients who have already received antimicrobial therapy as this is unlikely to improve patient outcome.[32690]
Infants, Children, and Adolescents
0.15 mg/kg/dose IV every 6 hours for 2 to 4 days for H. influenzae type b; administer the first dose 10 to 20 minutes before or concomitantly with the first dose of antimicrobial agent. Do not administer to patients who have already received antimicrobial therapy as this is unlikely to improve patient outcome. Use in pneumococcal meningitis is controversial and may be considered in those older than 6 weeks of age after weighing the possible benefits and risks.[32690]
Oral dosage
Adults
0.15 mg/kg/dose PO every 6 hours for 2 to 4 days for pneumococcal meningitis; administer the first dose 10 to 20 minutes before or concomitantly with the first dose of antimicrobial agent. Do not administer to patients who have already received antimicrobial therapy as this is unlikely to improve patient outcome.[32690]
Infants, Children, and Adolescents
0.15 mg/kg/dose PO every 6 hours for 2 to 4 days for H. influenzae type b; administer the first dose 10 to 20 minutes before or concomitantly with the first dose of antimicrobial agent. Do not administer to patients who have already received antimicrobial therapy as this is unlikely to improve patient outcome. Use in pneumococcal meningitis is controversial and may be considered in those older than 6 weeks of age after weighing the possible benefits and risks.[32690]
For the treatment of chemotherapy-induced nausea/vomiting†(CINV†) and for chemotherapy-induced nausea/vomiting prophylaxis†.
Intravenous (dexamethasone sodium phosphate injection solution) or Oral dosage (dexamethasone)
Adults
American Society of Clinical Oncology (ASCO) guideline-based dosage regimens are stratified according to patient risk. HIGHLY EMETOGENIC CHEMOTHERAPY: 12 mg PO or IV prior to chemotherapy, then 8 mg PO or IV on days 2 to 3 or days 2 to 4. If an NK1 receptor antagonist is not included in the anti-emetic regimen, increase to dexamethasone 20 mg PO or IV prior to chemotherapy, then 16 mg PO or IV on days 2 to 3 or days 2 to 4. MODERATELY EMETOGENIC CHEMOTHERAPY: 8 mg PO or IV prior to chemotherapy, then 8 mg PO or IV on days 2 and 3. LOW EMOTOGENIC RISK CHEMOTHERAPY: 8 mg PO or IV as a single dose prior to chemotherapy. (NOTE: Other regimens have been used historically during chemotherapy - e.g., 10 to 20 mg IV before administration of chemotherapy, with additional, lower doses given for 24 to 72 hours, as needed).
Children and Adolescents
10 to 14 mg/m2/dose IV is usually used prior to chemotherapy. A 5-HT3 antagonist is usually given along with dexamethasone for highly-emetogenic chemotherapy. An example regimen: dexamethasone 10 mg/m2/dose IV once daily, along with ondansetron. Some patients receive repeat dexamethasone every 12 hours, either IV or PO, but optimal regimens for repeat dosing are not established. For chemotherapy that is less emetogenic, doses as low as 6 mg/m2/dose PO have been given. The optimal dose of steroids for chemotherapy-induced nausea/vomiting (CINV) in children is not determined, and there are safety considerations.
For the treatment of pruritus and inflammatory effects of corticosteroid-responsive dermatoses and dermatologic disorders, including alopecia areata, atopic dermatitis, bullous dermatitis herpetiformis, contact dermatitis, cutaneous T-cell lymphoma (CTCL) or mycosis fungoides, discoid lupus erythematosus, exfoliative dermatitis, granuloma annulare, keloids, lichen planus, lichen simplex chronicus or neurodermatitis, necrobiosis lipoidica diabeticorum, pemphigus, plaque psoriasis, severe seborrheic dermatitis, severe erythema multiforme, Stevens-Johnson syndrome (SJS), and toxic epidermal necrolysis†(TEN).
For the treatment of atopic dermatitis, bullous dermatitis herpetiformis, contact dermatitis, cutaneous T-cell lymphoma (CTCL) or mycosis fungoides, exfoliative dermatitis, pemphigus, severe seborrheic dermatitis, and severe erythema multiforme.
Oral dosage (dexamethasone)
Adults
0.75 to 9 mg/day PO in 2 to 4 divided doses. Adjust dose according to response.
Infants, Children, and Adolescents
0.02 to 0.3 mg/kg/day or 0.6 to 9 mg/m2/day PO in 3 to 4 divided doses, initially. Adjust dose according to response.
Intravenous or Intramuscular dosage (dexamethasone sodium phosphate)
Adults
0.5 to 9 mg/day IV or IM in 2 to 4 divided doses. Adjust dose according to response.
Infants, Children, and Adolescents
0.02 to 0.3 mg/kg/day or 0.6 to 9 mg/m2/day IV or IM in 3 to 4 divided doses. Adjust dose according to response.
For the treatment of alopecia areata, aponeurosis or tendon (ganglia) cystic tumors, discoid lupus erythematosus, granuloma annulare, keloids, lichen planus, lichen simplex, necrobiosis lipoidica diabeticorum, and plaque psoriasis.
Intralesional or Soft Tissue dosage (dexamethasone sodium phosphate)
Adults
2 to 6 mg by intralesional injection; may repeat dose every 3 to 5 days to every 2 to 3 weeks. Dosage dependent upon degree of inflammation, size, disease state, and location of affected area. Usually employed when condition to be treated is limited to 1 or 2 sites.
For the treatment of Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis†(TEN).
Intravenous or Intramuscular dosage (dexamethasone sodium phosphate, standard dose)
Adults
8 to 16 mg or 0.1 to 0.3 mg/kg/dose IV or IM once daily, then taper dose over 7 to 10 days.
Infants, Children, and Adolescents
0.1 to 0.3 mg/kg/dose IV or IM once daily, then taper dose over 7 to 10 days.
Intravenous or Intramuscular dosage (dexamethasone sodium phosphate, pulse dose)
Adults
100 mg or 1 to 1.5 mg/kg/dose IV or IM once daily for 3 days.
Infants, Children, and Adolescents
1 to 1.5 mg/kg/dose IV or IM once daily for 3 days.
For the treatment of acute respiratory distress syndrome (ARDS)†.
Intravenous or Intramuscular dosage (dexamethasone sodium phosphate)
Adults
Initially, 0.5 to 9 mg/day IV or IM, in 2 to 4 divided doses. Adjust according to patient response.
Children and Adolescents
0.06 to 0.3 mg/kg/day or 1.2 to 10 mg/m2/day IV or IM, in divided doses every 6 to 12 hours.
For fetal lung maturation and neonatal respiratory distress syndrome prophylaxis†in patients at risk for preterm delivery.
Intramuscular dosage (dexamethasone sodium phosphate)
Pregnant females
6 mg IM every 12 hours for 4 doses in all pregnant women between 24 and 34 weeks gestation who are at risk for preterm delivery within 7 days. A single course of corticosteroids may also be considered starting at 23 weeks gestation for pregnant women who are at risk of preterm delivery within 7 days, regardless of membrane status. If labor is impending and further doses are unlikely, the first dose of dexamethasone should still be given because treatment with corticosteroids for less than 24 hours is still associated with a significant reduction in neonatal morbidity/mortality. However, no additional benefit has been demonstrated for courses of antenatal steroids with shorter dosage intervals than those recommended, often referred to as accelerated dosing, even when delivery is imminent. A repeat or rescue course of corticosteroids may be considered in women who are less than 34 weeks gestation, who are at risk of preterm delivery within the next 7 days, and whose prior course of antenatal corticosteroids was administered more than 14 days previously. Rescue course corticosteroids could be provided as early as 7 days from the prior dose if indicated by the clinical situation.[64435] Dexamethasone is comparable to betamethasone in preventing adverse outcomes and reducing neonatal intensive care unit (NICU) stays.[60414]
For the treatment of laryngotracheobronchitis (croup)†.
Oral dosage
Infants, Children, and Adolescents
0.15 to 0.6 mg/kg/dose (Usual Max: 16 mg/dose) PO as a single dose. Â
Intravenous and Intramuscular dosage
Infants, Children, and Adolescents
0.15 to 0.6 mg/kg/dose (Usual Max: 16 mg/dose) IV or IM as a single dose.
For the prevention of chronic lung disease (CLD)†in mechanically ventilated neonates.
Intravenous dosage (dexamethasone sodium phosphate)
Preterm Neonates
Numerous dosing schedules have been studied. The Dexamethasone: A Randomized Trial (DART) study (n = 70, median gestational age 25 weeks) used the following tapering dose schedule over 10 days: 0.075 mg/kg/dose IV twice daily for 3 days, 0.05 mg/kg/dose IV twice daily for 3 days, 0.025 mg/kg/dose IV twice daily for 2 days, and 0.01 mg/kg/dose IV twice daily for 2 days. This dosing regimen facilitated extubation by day 10 but did not significantly improve mortality or oxygen dependence at 36 weeks; follow-up at 2 years of age did not indicate any significant adverse neurodevelopmental outcomes in patients treated with dexamethasone. Use is somewhat controversial, and most experts suggest using low doses and careful patient selection. The American Academy of Pediatrics (AAP) recommends against the use of high-dose dexamethasone (greater than 0.5 mg/kg/day) due to the risk of short- and long-term adverse effects, including neurodevelopmental effects. Late corticosteroid therapy (initiated after 7 days of age) may be preferred over early therapy (initiated at less than 7 days of age). Late therapy may reduce neonatal mortality without significantly increasing potential adverse long-term neurodevelopmental outcomes.
For therapy in selected cases of acute rheumatic carditis, systemic dermatomyositis (polymyositis), systemic lupus erythematosus (SLE), temporal arteritis, Churg-Strauss syndrome†, mixed connective tissue disease†, polyarteritis nodosa†, relapsing polychondritis†, polymyalgia rheumatica†, symptomatic sarcoidosis, vasculitis†, or granulomatosis with polyangiitis†; also for the treatment of neurologic or myocardial involvement associated with trichinosis.
Oral dosage
Adults
Initially, 0.75 to 9 mg/day PO, given in 2 to 4 divided doses. Dosing can be quite variable, depending on the patient's condition. Adjust according to patient response.
Infants, Children, and Adolescents
0.02 to 0.3 mg/kg/day or 0.6 to 9 mg/m2/day PO given in 3 to 4 divided doses is the FDA-approved general dosage range. Adjust according to patient response.
Intramuscular or Intravenous dosage (dexamethasone sodium phosphate)
Adults
Initially, 0.5 to 9 mg/day IV or IM, in 2 to 4 divided doses. Adjust according to patient response.
Infants, Children, and Adolescents
0.02 to 0.3 mg/kg/day or 0.6 to 9 mg/m2/day IV or IM given in 3 to 4 divided doses is the FDA-approved general dosage range. Adjust according to patient response.
For the treatment of corticosteroid-responsive ocular inflammation of the palpebral and bulbar conjunctiva, cornea, and anterior segment inflammation of the globe, such as allergic conjunctivitis, including ocular pruritus associated with allergic conjunctivitis, dry eye disease†, eyelid acne rosacea, superficial punctate keratitis, herpes zoster ocular infection associated keratitis, iritis, cyclitis, uveitis, and selected infective bacterial conjunctivitis and viral conjunctivitis, when the inherent hazard of steroid use is accepted to obtain an advisable diminution in edema and inflammation and for corneal abrasion, corneal ulcer, or corneal injury from chemical or thermal ocular burns or penetration of foreign bodies.
For the treatment of non-infectious uveitis affecting the posterior segment of the eye.
Intravitreal dosage (ophthalmic implant)
Adults
0.7 mg implant by intravitreal injection.
For the treatment of ocular pruritus associated with allergic conjunctivitis.
Intraocular dosage (ophthalmic insert)
Adults
0.4 mg in the lower lacrimal punctum into the canaliculus as a single dose. A single insert releases a 0.4 mg dose od dexamethasone for up to 30 days after insertion.
For the treatment of steroid-responsive inflammatory ocular conditions of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the globe.
Ophthalmic dosage (0.1% ophthalmic solution)
Adults
1 to 2 drops in the affected eye(s) every hour during the day and every 2 hours during the night, initially. Reduce dose to 1 drop in the affected eye(s) every 4 hours when a favorable response occurs, and then 1 drop in the affected eye(s) 3 to 4 times daily as warranted.
Ophthalmic dosage (0.1% ophthalmic suspension)
Adults
1 to 2 drops in the affected eye(s) every hour for severe disease and every 4 to 6 hours for mild disease. Taper dose to discontinuation as inflammation subsides.
Children and Adolescents
1 to 2 drops in the affected eye(s) every hour for severe disease and every 4 to 6 hours for mild disease. Taper dose to discontinuation as inflammation subsides.
Oral dosage
Adults
0.75 to 9 mg/day PO in 2 to 4 divided doses, initially. Adjust according to patient response.
Infants, Children, and Adolescents
0.02 to 0.3 mg/kg/day or 0.6 to 9 mg/m2/day PO in 3 to 4 divided doses, initially. Adjust according to patient response.
Intravenous or Intramuscular dosage (dexamethasone sodium phosphate)
Adults
0.5 to 9 mg/day IV or IM in 2 to 4 divided doses, initially. Adjust according to patient response.
Infants, Children, and Adolescents
0.02 to 0.3 mg/kg/day or 0.6 to 9 mg/m2/day IV or IM in 3 to 4 divided doses. Adjust according to patient response.
For the treatment of dry eye disease†.
Ophthalmic dosage (0.1% ophthalmic solution or suspension)
Adults
1 to 2 drops in each eye 4 times daily, initially. Reduce dose to 1 to 2 drops in each eye twice daily after 1 to 2 weeks if positive response in signs and/or symptoms and start cyclosporine, then taper or discontinue steroid therapy after 2 to 4 weeks. Consider extending duration to 4 weeks if no response at 2 weeks, especially in patients with moderate to severe disease.
For the adjunctive treatment of infertility†in combination with clomiphene therapy.
Oral dosage
Adult females
0.5 mg PO once daily at bedtime, administered on cycle days 3 to 12, days 5 to 9, or starting on day 5 and continuing through conception, in combination with clomiphene (doses ranging from 50 to 200 mg/day) has been studied. Alternatively, dexamethasone 2 mg PO once daily on cycle days 5 to 14 in combination with clomiphene 200 mg/day or dexamethasone 1 mg PO twice daily on cycle days 3 to 12 in combination with clomiphene 100 mg/day PO has also been studied; HCG was administered to augment ovulation. Optimal timing and dose of dexamethasone is not clear and has varied from study to study. Combination therapy has been shown to increase ovulation rates (range, 75% to 100%) and pregnancy rates (range, 38% to 74%) in women with both normal and elevated DHEA-S concentrations and in those women with or without polycystic ovary syndrome (PCOS). A Cochrane's review indicates that dexamethasone-clomiphene combination is one of the few adjunctive therapies for infertility that has been shown to improve pregnancy rates (fixed OR 11.3, 95% CI 5.3 to 24; NNT 2.7, 95% CI 2.1 to 3.6) ; the 2 studies in this review used differing doses of 0.5 mg PO at bedtime on days 5 to 9 or 2 mg PO/day on days 5 to 14. Several theories on the mechanism of dexamethasone in infertility exist. One theory is that dexamethasone enhances folliculogenesis by suppressing adrenal androgen hypersecretion, which should augment the actions of clomiphene. Dexamethasone may increase FSH concentrations thereby facilitating folliculogenesis. Finally, dexamethasone may decrease the elevated LH concentrations in patients with PCOS.
For the treatment of acute altitude sickness†, including high altitude cerebral edema†.
For the treatment of acute altitude sickness without high altitude cerebral edema†.
Oral dosage
Adults
4 mg PO every 6 hours until symptoms resolve.Â
Infants, Children, and Adolescents
0.15 mg/kg/dose (Max: 4 mg/dose) PO every 6 hours until symptoms resolve.
Intravenous or Intramuscular dosage
Adults
4 mg IV or IM every 6 hours until symptoms resolve.Â
Infants, Children, and Adolescents
0.15 mg/kg/dose (Max: 4 mg/dose) IV or IM every 6 hours until symptoms resolve.
For the treatment of acute altitude sickness with high altitude cerebral edema†.
Oral dosage
Adults
8 mg PO once, then 4 mg PO every 6 hours until symptoms resolve. May add acetazolamide.Â
Infants, Children, and Adolescents
0.15 mg/kg/dose (Max: 4 mg/dose) PO every 6 hours until symptoms resolve. May add acetazolamide.
Intravenous or Intramuscular dosage
Adults
8 mg IV or IM once, then 4 mg IV or IM every 6 hours until symptoms resolve. May add acetazolamide.Â
Infants, Children, and Adolescents
0.15 mg/kg/dose (Max: 4 mg/dose) IV or IM every 6 hours until symptoms resolve. May add acetazolamide.
For the treatment of post-operative nausea/vomiting (PONV)†.
Intravenous dosage (dexamethasone sodium phosphate injection)
Adults
2 to 4 mg IV once for established post-operative nausea/vomiting (PONV), per treatment guidelines; readministration of longer-acting drugs, such as dexamethasone, is not recommended. If PONV prophylaxis was either inadequate or not initially given, dexamethasone is an appropriate rescue treatment option if not initially used for PONV prophylaxis. Of note, the 5-HT3 antagonists are the only class of drugs that have been adequately studied for the treatment of established PONV.
For altitude sickness prophylaxis†, including prevention of high altitude cerebral edema†.
Oral dosage
Adults
2 mg PO every 6 hours or 4 mg PO every 12 hours starting the day of ascent and continuing for 2 to 3 days after reaching the target altitude or until descent is initiated. Do not exceed 10 days to prevent glucocorticoid toxicity or adrenal suppression. May consider 4 mg PO every 6 hours for very high risk situations (e.g., military or search and rescue personnel being airlifted to altitudes higher than 3,500 meters with immediate performance of physical activity). Prophylactic medications should be considered in addition to slow ascent for moderate- to high-risk situations. Dexamethasone is suggested as an alternative in individuals with a history of intolerance or allergy to acetazolamide or as an adjunct to acetazolamide in rare, emergency circumstances requiring rapid ascent and immediate performance of physical activity.
For post-operative nausea/vomiting (PONV) prophylaxis†.
Intravenous dosage (dexamethasone sodium phosphate injection solution)
Adults
4 to 5 mg IV at anesthesia induction is recommended by treatment guidelines for patients at an increased risk for post-operative nausea and vomiting (PONV); administration at induction rather than at the end of surgery is preferred. Some studies suggest that 8 mg IV is associated with a dose-dependent increase in quality of recovery, including reduced fatigue, postoperative pain, and need for opioid analgesia; however, further confirmation is necessary before larger doses are universally recommend. Safety data regarding the perioperative use of dexamethasone point to a possible increased risk of wound infection and/or increased blood glucose in some patients. A single dexamethasone dose (4 to 8 mg IV) is, however, considered safe for PONV prophylaxis. For patients with labile glucose control, dexamethasone use is relatively contraindicated.
Children and Adolescents
0.15 to 1 mg/kg/dose IV (Max: 8 to 25 mg/dose IV) given as a single intraoperative dose reduces the incidence of postoperative nausea/vomiting in the first 24 hours, improves postoperative pain control, and decreases the time to resumption of soft/solid diet without adverse effects and is recommended in patients undergoing tonsillectomy. A lower dose of 0.015 mg/kg/dose (Max: 5 mg/dose) in combination with ondansetron 0.1 mg/kg/dose (Max: 4 mg) is recommended first-line for postoperative vomiting prophylaxis in children by the Society for Ambulatory Anesthesiology.
For the treatment of bronchiolitis†.
Oral dosage
Infants
Due to the lack of consistent efficacy data and the high risk of adverse effects, the American Academy of Pediatrics does not recommend systemic corticosteroids for the management of bronchiolitis in any setting. However, other authors state corticosteroids may be beneficial in severely ill or mechanically ventilated patients. One randomized trial of 800 infants seen in the emergency department used 1 mg/kg PO once (Max: 10 mg/dose) followed by 0.6 mg/kg/dose PO once daily (Max: 10 mg/dose) for 5 days. Dexamethasone in combination with nebulized epinephrine was effective in reducing hospital admissions by day 7 of illness compared to treatment with dexamethasone alone, epinephrine alone, or placebo. In a study of 200 infants (median age 3.5 months) with an asthma risk, as determined by eczema or a family history of asthma in a first-degree relative, dexamethasone 1 mg/kg (single dose) PO then 0.6 mg/kg/dose PO once daily for 4 more days was administered with salbutamol. In infants receiving dexamethasone with salbutamol, the time to readiness for discharge was 18.6 hours vs. 27.1 hours in patients not receiving dexamethasone (p = 0.015). In contrast, 1 mg/kg/dose PO (Max: 12 mg/dose) given as a single dose did not reduce hospitalization rates, Respiratory Assessment Change Scores (RACS), length of hospitalization for those patients who required admission, or subsequent hospitalizations within 7 days compared to placebo in another large, randomized trial (n = 600).
Intravenous dosage (dexamethasone sodium phosphate injection solution)
Infants
Due to the lack of consistent efficacy data and the high risk of adverse effects, the American Academy of Pediatrics does not recommend systemic corticosteroids for the management of bronchiolitis in any setting. However, other authors state corticosteroids may be beneficial in severely ill or mechanically ventilated patients. 0.15 mg/kg/dose IV every 6 hours for 48 hours with the first dose administered within 24 hours of mechanical ventilation was used in patients with respiratory syncytial virus. In a post hoc analysis of patients with bronchiolitis (n = 39), the mean duration of mechanical ventilation and of supplemental oxygen were significantly shorter in patients receiving dexamethasone compared to those receiving placebo (4.9 and 7.7 days vs. 9.2 and 11.3 days, respectively); no differences were seen in the length of intensive care unit or hospital stay.
For the treatment of Waldenstrom macroglobulinemia†.
For the treatment of newly diagnosed Waldenstrom macroglobulinemia, in combination with rituximab and cyclophosphamide†.
Intravenous dosage (dexamethasone sodium phosphate)
Adults
20 mg IV on day 1 in combination with rituximab 375 mg/m2 IV on day 1 and cyclophosphamide 100 mg/m2 orally twice daily on days 1 to 5 (total dose of 1,000 mg/m2/cycle) repeated every 21 days for 6 cycles was evaluated in a single-arm, phase II trial.
For the treatment of newly diagnosed Waldenstrom macroglobulinemia, in combination with bortezomib and rituximab†.
Intravenous dosage (dexamethasone sodium phosphate)
Adults
40 mg IV on days 1, 8, 15, and 22 in cycles 2 and 5 in combination with bortezomib and rituximab was evaluated in a nonrandomized phase II trial. Bortezomib was given as follows: 1.3 mg/m2 IV on days 1, 4, 8, and 11 for the first 21-day cycle (cycle 1) then 1.6 mg/m2 IV on days 1, 8, 15, and 22 repeated every 35 days for 4 additional cycles (cycles 2, 3, 4, and 5). Rituximab was given as 375 mg/m2 IV on days 1, 8, 15, and 22 in cycles 2 and 5 (for 8 total doses). All patients received premedication with acetaminophen 1,000 mg PO and diphenhydramine 50 mg IV prior to rituximab and herpes zoster prophylaxis with valacyclovir or acyclovir.
For the treatment of amyloidosis†.
For the treatment of systemic amyloid light-chain amyloidosis, in combination with lenalidomide and cyclophosphamide†.
Oral dosage
Adults
Dexamethasone in combination with lenalidomide (15 mg PO daily on days 1 to 21) and cyclophosphamide repeated every 28 days has been evaluated in nonrandomized, phase II studies. Treatment duration, drug dosages of cyclophosphamide and dexamethasone, and thromboprophylaxis agents/recommendations varied in these studies. In one study, 12 cycles of dexamethasone (20 mg PO on days 1, 2, 3, 4, 9, 10, 11, and 12 for 6 cycles; then 20 mg PO on days 1, 2, 3, and 4 for an additional 6 cycles), lenalidomide, and cyclophosphamide (300 mg/m2 IV on days 1 and 8 for 6 cycles; then 300 mg/m2 IV on day 1 for an additional 6 cycles) were given and then maintenance therapy with lenalidomide and dexamethasone was administered for 3 additional years or until disease progression. Patients with cardiac stage III had an upfront dose modification of dexamethasone. In another study, dexamethasone (40 mg PO on days 1, 8, 15, and 22), lenalidomide, and cyclophosphamide (500 mg PO on days 1, 8, and 15) therapy was given for a maximum of 9 cycles; treatment was discontinued after cycle 6 if a complete response or partial response/very good partial response plus organ response was obtained. In this study, patients with fluid retention over 3% of body weight despite optimal diuretic use received a lower dose of dexamethasone (20 mg once weekly). In a third study, cycles of dexamethasone (40 mg PO on days 1, 8, 15, and 22), lenalidomide, and cyclophosphamide (300 mg/m2 PO on days 1, 8, and 15) were continued until disease progression, unacceptable toxicity, or up to 2 years; however, cyclophosphamide was given for up to a maximum of 12 cycles only.
For the treatment of systemic amyloid light-chain amyloidosis, in combination with lenalidomide and melphalan†.
Oral dosage
Adults
40 mg orally on days 1, 8, 15, and 22 in combination with lenalidomide (10 mg PO daily on days 1 to 21) and melphalan repeated every 28 days has been evaluated in nonrandomized studies. Treatment duration, the melphalan dosage, and thromboprophylaxis agents/recommendations varied in these studies. In one study, melphalan (0.18 mg/kg PO daily on days 1, 2, 3, and 4), lenalidomide, and dexamethasone therapy was given for a maximum of 9 cycles; single-agent lenalidomide was continued in responding patients. In another study, lenalidomide, melphalan (5 mg/m2 PO daily on days 1, 2, 3, and 4), and dexamethasone were continued until disease progression, unacceptable toxicity, or up to 12 cycles.
For the treatment of newly diagnosed systemic amyloid light-chain amyloidosis in patients who are ineligible for stem-cell transplantation, in combination with bortezomib and melphalan†.
Oral dosage
Adults
40 mg orally daily on days 1, 2, 3, and 4 repeated every 28 days on cycles 1 and 2 and then 40 mg orally daily on days 1, 2, 3, and 4 repeated every 35 days up to a maximum of 8 cycles in combination with bortezomib and melphalan (BMdex regimen) was evaluated in a multicenter, randomized, open-label, phase 3 trial (n = 109). Patients were evaluated for response after 3 and 6 cycles of therapy; patients with a partial response (PR) or better after cycle 3 received an additional 3 cycles of therapy. Patients with a complete response (CR) or a PR and organ response stopped treatment after cycle 6.
For the treatment of newly diagnosed light-chain amyloidosis, in combination with daratumumab; hyaluronidase, bortezomib, and cyclophosphamide†.
NOTE: Daratumumab; hyaluronidase is FDA approved in combination with bortezomib, cyclophosphamide, and dexamethasone for the treatment of newly diagnosed light-chain amyloidosis.
Intravenous and Oral dosage
Adults
40 mg IV or PO in combination with bortezomib 1.3 mg/m2 subcutaneously and cyclophosphamide 300 mg/m2 (Max dose of 500 mg) IV or PO each given weekly on days 1, 8, 15, and 22 repeated every 28 days for a maximum of 6 cycles (VCd) plus up to 2 years of subcutaneous daratumumab; hyaluronidase (D-VCd) was evaluated in transplant eligible, newly diagnosed light-chain amyloidosis patients in a randomized, phase 3 trial (n = 388; the ANDROMEDA trial). The dose of dexamethasone was reduced to 20 mg in patients older than 70 years or who had a body mass index less than 18.5, hypervolemia, poorly controlled diabetes mellitus, or prior intolerance to steroid therapy. Daratumumab; hyaluronidase was administered as follows: 1,800 mg daratumumab and 30,000 units hyaluronidase subcutaneously weekly on weeks 1 to 8 (8 doses), 1,800 mg daratumumab and 30,000 units hyaluronidase every 2 weeks on weeks 9 to 24 (8 doses), and then 1,800 mg daratumumab and 30,000 units hyaluronidase every 4 weeks starting on week 25 until disease progression or for a maximum of 2 years. At a median follow-up time of 11.4 (range, 0.03 to 21.3) months, the hematologic complete response rate was significantly improved (53.3% vs. 18.1%; relative risk ratio = 2.9; 95% CI, 2.1 to 4.1; p less than 0.001) in patients who received D-VCd compared with VCd in the ANDROMEDA trial. The median time to hemCR was 60 and 85 days in the D-VCd and VCd arms, respectively.
For the treatment of pharyngitis†.
Oral dosage
Adults
10 mg PO once daily for 1 to 2 days.
Children and Adolescents 5 to 17 years
0.6 mg/kg/dose (Max: 10 mg/dose) PO once daily for 1 to 2 days.
Intramuscular dosage
Adults
10 mg IM once daily for 1 to 2 days.
Children and Adolescents 5 to 17 years
0.6 mg/kg/dose (Max: 10 mg/dose) IM once daily for 1 to 2 days.
For the treatment of thyrotoxicosis†, including thyroid storm†.
Oral dosage
Adults
2 mg PO every 6 hours. Taper dose based on clinical response and the duration of steroid therapy.
Intravenous dosage
Adults
2 mg IV every 6 hours. Taper dose based on clinical response and the duration of steroid therapy.
For the treatment of neurocysticercosis†as adjunctive therapy in combination with antiparasitics.
Oral dosage
Adults
6 to 8 mg PO divided into 3 daily doses starting 3 days before antiparasitics and continuing for the duration of therapy. Titrate based on clinical response. Taper over 6 to 8 weeks to avoid rebound symptoms.
Children and Adolescents
0.1 to 0.2 mg/kg/day PO starting 3 days before antiparasitics and continuing for the duration of therapy. Titrate based on clinical response. Taper over 6 to 8 weeks after antiparasitic therapy is complete to avoid rebound symptoms.
†Indicates off-label use
MAXIMUM DOSAGE
Dosage must be individualized and is highly variable depending on the nature and severity of the disease, route of dexamethasone treatment, and on patient response.
DOSING CONSIDERATIONS
Hepatic Impairment
Specific guidelines for systemic dosage adjustments in hepatic impairment are not available; it appears that no dosage adjustments are needed.
Renal Impairment
Specific guidelines for dosage adjustments in renal impairment are not available; it appears that no dosage adjustments are needed.
ADMINISTRATION
Oral Administration
Administer with food to minimize GI upset.
If given once daily, give in the morning to coincide with the body's normal cortisol secretion.
Oral Liquid Formulations
Dexamethasone Intensol (Oral Solution Concentrate)
1 mg/mL concentrated solution; contains 30% alcohol.
Measure the appropriate dose, using only the calibrated dropper provided with product.
Mix the dose with liquid or semi-solid food such as water, juice, soda, applesauce, or pudding and stir the preparation for a few seconds.
Consume the entire mixture immediately; do not store for future use.
Injectable Administration
Visually inspect parenteral products for particulate matter and discoloration prior to administration whenever solution and container permit.
Some injectable formulations contain benzyl alcohol; avoid the use of these formulations in premature neonates, and use with caution in neonates.
Intravenous Administration
Direct IV injection:
Dexamethasone sodium phosphate solution for injection 4 mg/mL or 10 mg/mL may be given directly from the vial.
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Intermittent or continuous IV infusion:
Dexamethasone sodium phosphate solution for injection 4 mg/mL or 10 mg/mL may be added to 5% Dextrose injection or 0.9% Sodium Chloride injection, USP and given by IV infusion.
Use diluted solutions within 24 hours, as infusion solutions generally do not contain preservatives.
Intramuscular Administration
Dexamethasone sodium phosphate solution for injection 4 mg/mL or 10 mg/mL may be administered intramuscularly.
Other Injectable Administration
Intra-articular, Soft tissue, or Intralesional injection
Dexamethasone sodium phosphate solution for injection 4 mg/mL may be administered into joints, soft tissues, or lesions, but administration of dexamethasone via these routes requires specialized techniques.
Only clinicians familiar with these methods of administration and with management of potential complications should administer dexamethasone by these routes.
Frequent intra-articular injections may result in damage to joint tissues.
Dexamethasone sodium phosphate injection is particularly recommended for use in conjunction with one of the less soluble, longer-acting steroids for intra-articular and soft tissue injection.
Ophthalmic Administration
Ophthalmic solution or suspension:
Apply ophthalmic solution or suspension topically to the eye.
For ophthalmic suspensions, shake well prior to each administration.
Instruct patient on appropriate instillation technique.
Do not to touch the tip of the dropper or tube to the eye, fingertips, or other surfaces.
To prevent contamination, each dropper is for 1 individual, do not share among patients.
The initial prescription and renewal of the ophthalmic suspension should be made by a physician only after examination of the patient with the aid of magnification, such as slit lamp biomicroscopy and fluorescein staining (where appropriate). Prescribe no more than 1 bottle at a time.[54348] [61633]
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Intraocular Administration
For administration by the physician at the end of the ophthalmic surgical procedure.
Dexycu Intraocular Suspension
Preparation of intraocular suspension:
Prepare a sterile field. Remove the components of the administration kit from their respective pouches and place onto the sterile field.
Withdraw the syringe plunger approximately 1 inch. Place the syringe ring on the plunger (slit facing the plunger). Apply slight downward pressure until the syringe ring "snaps" into place.
Place the 18-gauge needle firmly on the syringe. Remove the cap from the needle. Depress the plunger completely and then withdraw the plunger to fill the syringe with air.
Mix using a vortex mixer or vigorously shake the vial sideways for a minimum of 30 seconds; the suspended drug material must be used immediately after shaking.
Remove the blue plastic flip-cap from the vial and wipe the top of the rubber stopper with an alcohol pad. Invert the vial.
Insert the needle into the vial and inject the air into the vial. Making sure the needle tip is immersed in the drug material pooled in the neck of the inverted vial, fill the syringe by slowly withdrawing the plunger approximately 0.2 mL. Remove the needle from the vial and discard the unused portion in the vial.
Remove the needle from the syringe. Firmly place the cannula on the syringe and remove the plastic cap. Hold the syringe vertically with the cannula pointing up. Depress the plunger to expel air bubbles from the syringe.
Affix the syringe guide over the syringe ring on the plunger.
Depress the plunger until the syringe guide/ring mechanism comes gently into contact with the flange of the syringe. Lightly tap/flick the barrel of the syringe to remove any excess drug from the tip of the cannula. Do not wipe or touch the tip of the cannula to remove excess drug.
Remove the syringe guide, leaving the syringe ring in place. CAUTION: DO NOT MOVE THE PLUNGER. The space between the syringe ring and the top of the plunger is the medication injection volume that will be applied to the patient's eye; the syringe is now ready for injection.[48640]
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Intraocular Administration:
In a single slow-motion, inject 0.005 mL of the drug material behind the iris in the inferior portion of the posterior chamber. If the sphere of the administered drug after intraocular injection appears to be larger than 2 mm in diameter, excess drug material may be removed by irrigation and aspiration in the sterile surgical setting.
Some drug material will remain in the syringe after the injection; this is necessary for accurate dosing. Discard the unused portion remaining in the syringe after administration.[48640]
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Dextenza Ophthalmic Insert
Intracanalicular Administration:
Do not use if pouch has been damaged or opened. Do not re-sterilize.
Carefully remove foam carrier and transfer to a clean and dry area. If necessary, dilate the punctum with an ophthalmic dilator. Care should be taken not to perforate the canaliculus during dilation or placement of the insert. If perforation occurs, do not place the insert in the eye.
After drying the punctal area, using blunt (non-toothed) forceps, grasp the insert and place into the lower lacrimal canaliculus by pulling the lid temporally and inserting nasally. Ensure the insert is placed just below the punctal opening. Excessive squeezing of the insert with forceps may cause deformation.
To aid in the hydration of the insert, 1 to 2 drops of balanced salt solution can be instilled into the punctum. The insert hydrates quickly upon contact with moisture. If the insert begins to hydrate before fully inserted, discard the product and use a new insert.
The insert can be visualized when illuminated by a blue light source (e.g., slit lamp or hand held blue light) with yellow filter.[63796]
The insert is for single-use only.
Insert is resorbable; removal not required.
Otic Administration
Otic Administration of Ophthalmic Solution:
Clean the ear canal thoroughly and sponge dry prior to administration.
Instill the solution directly into the ear canal.
Alternatively, a gauze wick may be saturated with solution and packed into the ear canal. Keep the gauze wick moist with solution and remove from ear after 12 to 24 hours.
Other Administration Route(s)
Intravitreal Implant Administration
Intravitreal implantation should be performed only by surgeons who have observed or assisted in surgical implantation of the implant. Consult specialized instructions regarding insertion of the implant.
Administer via intravitreal injection with the provided single-use plastic applicator.
Use controlled aseptic conditions, which include the use of sterile gloves, a sterile drape, and a sterile eyelid speculum (or equivalent).
Use each applicator for a single treatment only. If the contralateral eye requires treatment, a new applicator must be used and the sterile field should be changed.
After the intravitreal injection, monitor patients for elevation in intraocular pressure and for endophthalmitis. Monitoring may consist of a check for reperfusion of the optic nerve head immediately after the injection, tonometry within 30 minutes after the injection, and biomicroscopy 2 to 7 days after the injection.
Instruct patients to promptly report any symptoms suggestive of endophthalmitis.
STORAGE
Generic:
- Keep from freezing
- Protect from moisture
- Store between 68 to 77 degrees F, excursions permitted 59 to 86 degrees F
AK-Dex:
- Store at room temperature (between 59 to 86 degrees F)
Baycadron:
- Keep from freezing
- Store at controlled room temperature (between 68 and 77 degrees F)
CUSHINGS SYNDROME DIAGNOSTIC :
- Store at controlled room temperature (between 68 and 77 degrees F)
Decadron:
- Protect from moisture
- Store between 68 to 77 degrees F, excursions permitted 59 to 86 degrees F
Dexabliss:
- Keep from freezing
- Protect from moisture
- Store between 68 to 77 degrees F, excursions permitted 59 to 86 degrees F
DexPak Jr TaperPak:
- Keep from freezing
- Protect from moisture
- Store between 68 to 77 degrees F, excursions permitted 59 to 86 degrees F
DexPak TaperPak:
- Keep from freezing
- Protect from moisture
- Store between 68 to 77 degrees F, excursions permitted 59 to 86 degrees F
Dextenza:
- Do not freeze
- Protect from light
- Refrigerate (between 36 and 46 degrees F)
- Store in original package until time of use
DEXYCU:
- Store at controlled room temperature (between 68 and 77 degrees F)
DoubleDex:
- Discard product if it contains particulate matter, is cloudy, or discolored
- Discard unused portion. Do not store for later use.
- Protect from light
- Store between 68 to 77 degrees F, excursions permitted 59 to 86 degrees F
- Store in carton until time of use
Dxevo:
- Keep from freezing
- Protect from moisture
- Store between 68 to 77 degrees F, excursions permitted 59 to 86 degrees F
Hemady:
- Store between 68 to 77 degrees F, excursions permitted 59 to 86 degrees F
HiDex:
- Keep from freezing
- Protect from moisture
- Store between 68 to 77 degrees F, excursions permitted 59 to 86 degrees F
Maxidex:
- Store between 46 to 80 degrees F
- Store in a cool, dry place
- Store upright
Ozurdex:
- Store at room temperature (between 59 to 86 degrees F)
ReadySharp Dexamethasone:
- Discard product if it contains particulate matter, is cloudy, or discolored
- Protect from freezing
- Protect from light
- Store between 68 to 77 degrees F, excursions permitted 59 to 86 degrees F
- Store in carton until time of use
Simplist Dexamethasone:
- Avoid exposure to heat
- Discard product if it contains particulate matter, is cloudy, or discolored
- Do not autoclave
- Protect from freezing
- Protect from light
- Store at controlled room temperature (between 68 and 77 degrees F)
Solurex:
- Avoid exposure to heat
- Discard product if it contains particulate matter, is cloudy, or discolored
- Do not autoclave
- Protect from freezing
- Protect from light
- Store at controlled room temperature (between 68 and 77 degrees F)
TaperDex:
- Keep from freezing
- Protect from moisture
- Store between 68 to 77 degrees F, excursions permitted 59 to 86 degrees F
ZCORT:
- Keep from freezing
- Protect from moisture
- Store between 68 to 77 degrees F, excursions permitted 59 to 86 degrees F
Zema-Pak:
- Keep from freezing
- Protect from moisture
- Store between 68 to 77 degrees F, excursions permitted 59 to 86 degrees F
ZoDex:
- Keep from freezing
- Protect from moisture
- Store between 68 to 77 degrees F, excursions permitted 59 to 86 degrees F
ZonaCort 11 Day:
- Keep from freezing
- Protect from moisture
- Store between 68 to 77 degrees F, excursions permitted 59 to 86 degrees F
ZonaCort 7 Day:
- Keep from freezing
- Protect from moisture
- Store between 68 to 77 degrees F, excursions permitted 59 to 86 degrees F
CONTRAINDICATIONS / PRECAUTIONS
Epidural administration
Epidural administration of corticosteroids should be used with great caution. Rare, but serious adverse reactions, including cortical blindness, stroke, spinal cord infarction, paralysis, seizures, nerve injury, brain edema, and death have been associated with epidural administration of injectable corticosteroids. These events have been reported with and without the use of fluoroscopy. Many cases were temporally associated with the corticosteroid injection; reactions occurred within minutes to 48 hours after injection. Some cases of neurologic events were confirmed through magnetic resonance imaging (MRI) or computed tomography (CT) scan. Many patients did not recover from the reported adverse effects. Discuss the benefits and risks of epidural corticosteroid injections with the patient before treatment. If a decision is made to proceed with corticosteroid epidural administration, counsel patients to seek emergency medical attention if they experience symptoms after injection such as vision changes, tingling in the arms or legs, dizziness, severe headache, seizures, or sudden weakness or numbness of face, arm, or leg.
Corticosteroid hypersensitivity
Dexamethasone is contraindicated in patients with a hypersensitivity to the drug or any of its components. Although true corticosteroid hypersensitivity is rare, it is possible, though also rare, that such patients will display cross-hypersensitivity to other corticosteroids. It is advisable that patients who have a hypersensitivity reaction to any corticosteroid undergo skin testing, which, although not a conclusive predictor, may help to determine if hypersensitivity to another corticosteroid exists. Such patients should be carefully monitored during and following the administration of any corticosteroid.
Abrupt discontinuation, adrenal insufficiency, Cushing's syndrome, hypothalamic-pituitary-adrenal (HPA) suppression, increased intracranial pressure
Prolonged administration of pharmacological doses of systemic, nasal, inhaled or topical corticosteroids (resulting in systemic absorption) may result in hypothalamic-pituitary-adrenal (HPA) suppression and/or manifestations of Cushing's syndrome in some patients. Adrenal suppression and increased intracranial pressure have been reported with the use and/or withdrawal of various corticosteroid formulations in pediatric patients. Acute adrenal insufficiency and even death may occur following abrupt discontinuation of systemic therapy. In addition, a withdrawal syndrome unrelated to adrenocortical insufficiency may occur following sudden discontinuation of corticosteroid therapy. These effects are thought to be due to the sudden change in glucocorticoid concentration rather than to low corticosteroid concentrations. Withdraw prolonged systemic corticosteroid therapy (duration of treatment of more than 2 weeks) gradually. HPA suppression can last for up to 12 months following cessation of systemic therapy. Recovery of HPA axis function is generally prompt and complete upon discontinuation of the topical corticosteroid. HPA-suppressed patients may need supplemental corticosteroid treatment during periods of physiologic stress, such as post-surgical stress, acute blood loss, or infectious conditions, even after the corticosteroid has been discontinued. Encourage patients currently receiving chronic corticosteroid therapy or who have had corticosteroids discontinued within the last 12 months to carry identification advising the need for administration of corticosteroids in situations of increased stress.Â
Growth inhibition, osteopenia, osteoporosis
Potential adverse effects of chronic corticosteroid therapy should be weighed against the clinical benefits obtained and the availability of other treatment alternatives. Prolonged systemic corticosteroid therapy can lead to osteopenia, osteoporosis, vertebral compression fractures, aseptic necrosis of femoral and humeral heads, and pathologic fractures of long bones secondary to decreased bone formation, increased bone resorption, and protein catabolism in any patient. A high-protein diet may alleviate or prevent the adverse effects associated with protein catabolism. The elderly, post-menopausal, and pediatric patients may be more susceptible to the effects on bone. Chronic systemic dexamethasone therapy may cause growth inhibition in pediatric patients due to hypothalamic-pituitary-adrenal axis suppression and inhibition of bone growth. Corticosteroids should be titrated to the lowest effective dose. Because bone development is critical in pediatric patients, monitoring is warranted in patients receiving high-dose or chronic corticosteroid treatment. Use of the lowest effective dose is recommended to minimize the occurrence of systemic adverse effects. Monitor growth routinely. Â
Immunosuppression
Patients receiving high-dose (e.g., equivalent to 1 mg/kg or more of prednisone daily) or systemic corticosteroid therapy, such as dexamethasone, for any period of time, particularly in conjunction with corticosteroid-sparing drugs (e.g., troleandomycin) are at risk to develop immunosuppression; however, patients receiving moderate dosages of systemic corticosteroids for short periods or low dosages for prolonged periods also may be at risk. Treatment with topical or inhaled corticosteroids lessens the risk of immunosuppression; although localized effects may be seen in some patients. When given in combination with other immunosuppressive agents, there is a risk of over-immunosuppression. Intra-articularly injected corticosteroids are systemically absorbed and may cause immunosuppression. Advise patients to contact their health care provider if they develop fever or other signs or symptoms of an infectious process. Local injection of a corticosteroid into a previously infected joint is not usually recommended. Examine any joint fluid to exclude a septic process. Injection into unstable joints is generally not recommended.
Surgery
If surgery is required, patients should advise their physician that they received prolonged systemic corticosteroid therapy, such as dexamethasone, within the last 12 months and state the disease for which they were being treated. For systemic therapy, identification cards that include disease state, type and dose of corticosteroid, and physician should always be carried with the patient. Long-acting dexamethasone injection preparations, which are no longer marketed in the U.S., are not suitable for use in acute stress situations. To avoid drug-induced adrenal insufficiency, a supportive corticosteroid dosage may be required in times of stress (such as trauma, surgery, or severe illness) both during treatment with these injections and for a year afterward.Â
Fungal infection, helminth infection, herpes infection, herpes simplex virus epithelial keratitis, infection, measles, ocular infection, tuberculosis, varicella, viral infection
Corticosteroids may increase the risks related to infections with any pathogen, including viral, bacterial, fungal, protozoan, or helminth infection. The degree to which the dose, route, and duration of corticosteroid administration correlate with the specific risks of infection is not well characterized, however, with increasing doses of corticosteroids, the rate of occurrence of infectious complications increases. Corticosteroids may also mask some signs of current infection. Although the FDA-approved product labeling states that corticosteroids are contraindicated in patients with systemic fungal infections, most clinicians believe that systemic corticosteroids can be administered to these patients as long as appropriate therapy is administered simultaneously. Avoid the use in patients with a fungal infection or bacterial infection that is not adequately controlled with anti-infective agents. Activation of latent disease or exacerbation of intercurrent infection due to pathogens such as Amoeba, Candida, Cryptococcus, Mycobacterium, Nocardia, Pneumocystis, or Toxoplasma can occur in patients receiving systemic corticosteroids. Rule out infection with latent or active amebiasis before initiating corticosteroid therapy in patients who have spent time in the tropics or who have unexplained diarrhea. Use corticosteroids with caution in patients with known or suspected Strongyloides (threadworm) infestation as the immunosuppressive effects may lead to disseminated infection, severe enterocolitis, and sepsis. Cases of severe and disseminated strongyloidiasis have been reported following use of corticosteroids in combination with tocilizumab to treat patients with coronavirus disease 2019 (COVID-19). Before giving these drugs together to patients from strongyloidiasis endemic areas, consider administering ivermectin as prophylactic treatment. Reserve systemic corticosteroid therapy in active tuberculosis for patients with fulminating or disseminated disease and only in conjunction with appropriate antituberculosis therapy. Reactivation of tuberculosis may occur in patients with latent tuberculosis or tuberculin reactivity; close observation for disease reactivation is needed if corticosteroids are indicated in such patients. Furthermore, chemoprophylaxis is advised if prolonged corticosteroid therapy is needed. Advise patients receiving immunosuppressive doses of systemic corticosteroids to avoid exposure to persons with a viral infection (i.e., measles or varicella) because these diseases may be more serious or even fatal in immunosuppressed patients. Instruct patients to get immediate medical advice if exposure occurs. If exposed to chickenpox, prophylaxis with varicella-zoster immune globulin may be indicated. If exposed to measles, prophylaxis with pooled intramuscular immunoglobulin may be indicated. Avoid the use of corticosteroids in active ocular herpes infection due to the risk of corneal perforation. Corticosteroids should not be used in cerebral malaria. The use of ophthalmic dexamethasone formulations is contraindicated in most forms of cornea and conjunctiva viral ocular infections including herpes simplex virus epithelial keratitis, ocular vaccinia, and ocular varicella, and also in mycobacterial infection of the eye or fungal diseases of the eye.
Head trauma
Do not use high doses of systemic corticosteroids such as dexamethasone for the treatment of traumatic brain injury. An increase in early mortality (at 2 weeks) and late mortality (at 6 months) was noted in patients with head trauma who were determined not to have other clear indications for corticosteroid treatment; in the trial, patients received methylprednisolone hemisuccinate.
Heart failure, hypertension, myocardial infarction, renal disease
Corticosteroid therapy, including systemic dexamethasone therapy, has been associated with left ventricular free-wall rupture in patients with recent myocardial infarction, and should therefore be used cautiously in these patients. As sodium retention with resultant edema and potassium loss may occur in patients receiving systemic corticosteroids, these agents should be used with caution in patients with congestive heart failure, hypertension, or renal disease or insufficiency.
Diabetes mellitus
Systemic corticosteroids, such as dexamethasone, may decrease glucose tolerance, produce hyperglycemia, and aggravate or precipitate diabetes mellitus. This may especially occur in patients predisposed to diabetes mellitus. When corticosteroid therapy is necessary for patients with diabetes mellitus, changes in insulin, oral antidiabetic agent dosage, and/or diet may be required.
Myasthenia gravis, neuromuscular disease
An acute myopathy has been observed with the use of high doses of systemic corticosteroids, most often occurring in patients with neuromuscular disease disorders (e.g., myasthenia gravis), or in patients receiving concomitant therapy with neuromuscular blocking drugs. This acute myopathy is generalized, may involve ocular and respiratory muscles, and may result in quadriparesis. Elevation of creatinine kinase may occur. Clinical improvement or recovery after stopping corticosteroids may require weeks to years.
Psychosis, seizure disorder
Existing emotional instability or psychosis may be aggravated by corticosteroids. Psychiatric derangements may appear when corticosteroids are used, ranging from euphoria, insomnia, mood swings, personality changes, and severe depression, to frank psychosis. Use dexamethasone with caution in patients with a seizure disorder; systemic steroids can lower the seizure threshold.
Hyperthyroidism, hypothyroidism, thyroid disease
Metabolic clearance of corticosteroids is decreased in hypothyroidism and increased in hyperthyroidism. Changes in thyroid disease status of a patient may necessitate an adjustment in systemic dexamethasone dosage.
Diverticulitis, GI perforation, hepatic disease, peptic ulcer disease, ulcerative colitis
Systemic corticosteroids should be used with caution in patients with active or latent peptic ulcer disease, diverticulitis, fresh intestinal anastomoses, and nonspecific ulcerative colitis, since steroids may increase the risk of a gastrointestinal (GI) perforation. Signs of peritoneal irritation following GI perforation in patients receiving corticosteroids may be minimal or absent. Corticosteroids should not be used in patients where there is a possibility of impending GI perforation, abscess, or pyogenic infection. There is an enhanced effect due to decreased metabolism of systemic corticosteroids in patients with severe hepatic disease with cirrhosis.
Impaired wound healing
Systemic corticosteroids, like dexamethasone, may cause impaired wound healing. Ophthalmic and ocular dosage forms may cause impairment of wound healing within or near the site of application.
Cataracts, corneal abrasion, glaucoma, increased intraocular pressure, myopia, rupture of posterior ocular lens capsule, visual disturbance
Prolonged use of corticosteroids including dexamethasone may result in glaucoma with damage to the optic nerve, defects in visual acuity and fields of vision. Corticosteroids can cause cataracts and exacerbate pre-existing glaucoma. Periodically assess patients receiving corticosteroids chronically for cataract formation, visual disturbance, or increased intraocular pressure. Consider referring patients who develop ocular symptoms or use systemic corticosteroid-containing products for more than 6 weeks to an ophthalmologist for evaluation. Ophthalmic dexamethasone is more likely than other ophthalmic agents to increase intraocular pressure, so intraocular pressure should be measured every 2 to 4 weeks for the first 2 months of therapy, and every 1 to 2 months thereafter. Ophthalmic dexamethasone therapy should be undertaken with caution in patients with a history of open-angle glaucoma, myopia, Krukenberg's spindle, or diabetes because these patients have an increased risk of developing ocular hypertension during therapy. The dexamethasone intravitreal implant is contraindicated in patients with glaucoma who have cup to disc ratio more than 0.8. Ophthalmic dexamethasone should be used with caution in patients with corneal abrasion. Â Dexamethasone intravitreal implant is also contraindicated in patients who have a tear or a rupture of posterior ocular lens capsule; these patients with an absent or torn posterior capsule of the lens are at increased risk of migration of the intravitreal implant into the anterior chamber. Laser posterior capsulotomy in pseudophakic patients is not a contraindication for the dexamethasone intravitreal implant. The initial prescription and renewal of the medication order of dexamethasone intravitreal implant should be made only after examination of the patient with the aid of magnification, such as slit lamp biomicroscopy, and, where appropriate, fluorescein staining. If signs and symptoms fail to improve after 2 days, re-evaluate the patient. The safety and efficacy of dexamethasone intravitreal implant, ophthalmic injection suspension, and ophthalmic insert have not been established in pediatric patients.
Vaccination
Corticosteroid therapy usually does not contraindicate vaccination with live-virus vaccines when such therapy is of short-term (less than 2 weeks); low to moderate dose; long-term alternate-day treatment with short-acting preparations; maintenance physiologic doses (replacement therapy); ophthalmic administration, or by intra-articular, bursal or tendon injection. The immunosuppressive effects of steroid treatment differ, but many clinicians consider a dose equivalent to either 2 mg/kg/day or 20 mg/day of prednisone as sufficiently immunosuppressive to raise a concern about the safety of immunization with live-virus vaccines. In general, patients with severe immunosuppression due to large doses of corticosteroids should not receive vaccination with live-virus vaccines. When cancer chemotherapy or immunosuppressive therapy is being considered (e.g., for patients with Hodgkin's disease or organ transplantation), vaccination should precede the initiation of chemotherapy or immunotherapy by 2 or more weeks. Patients vaccinated while on immunosuppressive therapy or in the 2 weeks prior to starting therapy should be considered unimmunized and should be revaccinated at least 3 months after discontinuation of therapy. In patients who have received high-dose, systemic corticosteroids for 2Â or more weeks, it is recommended to wait at least 3 months after discontinuation of therapy before administering a live-virus vaccine.
Pregnancy
There are no adequate, well-controlled studies for the use of dexamethasone in pregnant women; therefore, the manufacturers recommend that the drug be used during pregnancy only if the potential benefit to the mother outweighs the potential risk to the fetus. For COVID-19, the National Institutes of Health (NIH) recommends use of the drug in pregnant patients, if indicated, as the potential benefit of decreased maternal mortality justifies the low risk of fetal adverse effects with the short course of therapy. Corticosteroids have been shown to be teratogenic in many species when given in systemic doses equivalent to the human dose. Animal studies in which corticosteroids have been given to pregnant mice, rats, and rabbits have yielded an increased incidence of cleft palate in the offspring. In addition, dexamethasone has been shown to be teratogenic in mice and rabbits following topical ophthalmic application in multiples of the therapeutic dose. Topical ocular administration of dexamethasone to pregnant mice and rabbits during organogenesis produced embryofetal lethality, cleft palate and multiple visceral malformations. Topical and otic corticosteroids should not be used in large amounts, on large areas, or for prolonged periods of time in pregnant women. Dexamethasone injections have been used medically later in pregnancy to induce fetal lung maturation in patients at risk for pre-term delivery; use is for select circumstances and for a limited duration of time. An infant who is born to a woman receiving large doses of systemic corticosteroids during pregnancy should be monitored for signs of adrenal insufficiency, and appropriate therapy should be initiated, if necessary.
Breast-feeding
Systemic use of dexamethasone has not been studied during breast-feeding; corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects. Caution is warranted, and some manufacturers recommend discontinuing breast-feeding if systemic dexamethasone treatment is needed. However, experts generally consider inhaled corticosteroids and oral corticosteroids (e.g., prednisone and prednisolone), acceptable to use during breast-feeding. There is no information regarding dexamethasone effects on breastfed infants or milk production or its presence in human milk following placement of the intravitreal implant or intracanalicular insert to inform risk to an infant during lactation. However, the systemic concentration of dexamethasone following administration of the intracanalicular insert is low. It is not known whether topical ophthalmic administration of dexamethasone could result in sufficient systemic absorption to produce detectable quantities in breast milk. For COVID-19, the National Institutes of Health (NIH) recommends dexamethasone be offered to lactating mothers who qualify for therapy without interruption of breast-feeding. Consider the benefits of breast-feeding, the risk of potential infant drug exposure, and the risk of an untreated or inadequately treated condition.
Neonates, premature neonates
The routine use of high-dose (greater than 0.5 mg/kg/day) dexamethasone for either the prevention or treatment of chronic lung disease in premature neonates is not recommended by the American Academy of Pediatrics (AAP) due to a lack of survival benefit and concern about long-term adverse outcomes, particularly increased rates of cerebral palsy. Studies utilizing lower doses of dexamethasone (less than 0.2 mg/kg/day) have not reported increased rates of adverse neurodevelopmental effects; however, due to the small number of patients included in these studies, the AAP states that there is insufficient evidence to recommend the use of low-dose dexamethasone and further study is warranted. In a geographical cohort study of 148 extremely premature pediatric patients (born less than 28 weeks gestation), 55 (27%) received postnatal dexamethasone (mean cumulative dose 7.7 mg/kg) during the neonatal period. Patients receiving dexamethasone had smaller total brain tissue volume (mean difference -3.6%, p value = 0.04) and smaller white matter, thalami, and basal ganglia volumes (p is less than 0.05 for all) when compared with participants who did not receive postnatal dexamethasone. There was also a trend of smaller total brain and white matter volumes with an increased dose of postnatal dexamethasone. Avoid the use of dexamethasone injectable formulations containing benzyl alcohol in premature neonates and neonates. Administration of benzyl alcohol to neonates can result in 'gasping syndrome,' which is a potentially fatal condition characterized by metabolic acidosis and CNS, respiratory, circulatory, and renal dysfunction; it is also characterized by high concentrations of benzyl alcohol and its metabolites in the blood and urine. While the minimum amount of benzyl alcohol at which toxicity may occur is not known, 'gasping syndrome' has been associated with daily benzyl alcohol exposure above 99 mg/kg/day in neonates and low-birth-weight neonates. Additional symptoms may include gradual neurological deterioration, seizures, intracranial hemorrhage, hematologic abnormalities, skin breakdown, hepatic failure, renal failure, hypotension, bradycardia, and cardiovascular collapse. Rare cases of death, primarily in premature neonates, have been reported. Further, an increased incidence of kernicterus, especially in small, premature neonates has been reported. Practitioners administering this and other medications containing benzyl alcohol should consider the combined daily metabolic load of benzyl alcohol from all sources. Premature neonates, neonates with low birth weight, and patients who receive a high dose may be more likely to develop toxicity.
Geriatric
Use systemic corticosteroids with caution in the geriatric patient; the risks and benefits of therapy should be considered for any individual patient. Geriatric and debilitated patients are especially susceptible to corticosteroid-induced decreases in bone mineral density and resultant fractures. Detrimental effects on bone metabolism, such as osteoporosis, are a risk with chronic, systemically-administered corticosteroids. According to the Beers Criteria, systemic corticosteroids are considered potentially inappropriate medications (PIMs) for use in geriatric patients with delirium or at high risk for delirium and should be avoided in these patient populations due to the possibility of new-onset delirium or exacerbation of the current condition. The Beers expert panel notes that oral and parenteral corticosteroids may be required for conditions such as exacerbation of chronic obstructive pulmonary disease (COPD) but should be prescribed in the lowest effective dose and for the shortest possible duration. The federal Omnibus Budget Reconciliation Act (OBRA) regulates medication use in residents of long-term care facilities (LTCFs); the need for continued use of a systemic glucocorticoid should be documented, along with monitoring for adverse consequences with intermediate or longer-term use.
Benzyl alcohol hypersensitivity, sulfite hypersensitivity
Some commercially available formulations of dexamethasone injection or ophthalmic solution may contain sulfites; some parenteral products also contain benzyl alcohol. Sulfites and benzyl alcohol may cause allergic reactions in some people. They should be used with caution in patients with known sulfite hypersensitivity or benzyl alcohol hypersensitivity. Patients who have asthma are more likely to experience a sulfite sensitivity reaction than non-asthmatic patients.
Tympanic membrane perforation
Dexamethasone ophthalmic solutions are sometimes used off-label in the ear for otic conditions. Otic dexamethasone use is contraindicated for use in patients with tympanic membrane perforation.
ADVERSE REACTIONS
Severe
ocular hemorrhage / Delayed / 6.0-23.0
exfoliative dermatitis / Delayed / Incidence not known
increased intracranial pressure / Early / Incidence not known
papilledema / Delayed / Incidence not known
avascular necrosis / Delayed / Incidence not known
tendon rupture / Delayed / Incidence not known
bone fractures / Delayed / Incidence not known
GI bleeding / Delayed / Incidence not known
esophageal ulceration / Delayed / Incidence not known
pancreatitis / Delayed / Incidence not known
GI perforation / Delayed / Incidence not known
peptic ulcer / Delayed / Incidence not known
anaphylactoid reactions / Rapid / Incidence not known
skin atrophy / Delayed / Incidence not known
angioedema / Rapid / Incidence not known
heart failure / Delayed / Incidence not known
seizures / Delayed / Incidence not known
stroke / Early / Incidence not known
arachnoiditis / Early / Incidence not known
visual impairment / Early / Incidence not known
macular edema / Delayed / Incidence not known
corneal erosion / Delayed / Incidence not known
retinopathy / Delayed / Incidence not known
ocular hypertension / Delayed / Incidence not known
keratoconjunctivitis / Early / Incidence not known
endophthalmitis / Delayed / Incidence not known
optic neuritis / Delayed / Incidence not known
retinal detachment / Delayed / Incidence not known
keratitis / Delayed / Incidence not known
bradycardia / Rapid / Incidence not known
vasculitis / Delayed / Incidence not known
myocardial infarction / Delayed / Incidence not known
thrombosis / Delayed / Incidence not known
thromboembolism / Delayed / Incidence not known
pulmonary edema / Early / Incidence not known
cardiomyopathy / Delayed / Incidence not known
cardiac arrest / Early / Incidence not known
arrhythmia exacerbation / Early / Incidence not known
Moderate
iritis / Delayed / 5.0-15.0
conjunctival hyperemia / Early / 1.0-7.0
photophobia / Early / 0-1.0
hyperemia / Delayed / 0-1.0
corneal edema / Early / 1.0-1.0
hyperglycemia / Delayed / 10.0
hypotension / Rapid / Incidence not known
physiological dependence / Delayed / Incidence not known
pseudotumor cerebri / Delayed / Incidence not known
withdrawal / Early / Incidence not known
adrenocortical insufficiency / Delayed / Incidence not known
hypothalamic-pituitary-adrenal (HPA) suppression / Delayed / Incidence not known
Cushing's syndrome / Delayed / Incidence not known
diabetes mellitus / Delayed / Incidence not known
glycosuria / Early / Incidence not known
osteoporosis / Delayed / Incidence not known
growth inhibition / Delayed / Incidence not known
myopathy / Delayed / Incidence not known
osteopenia / Delayed / Incidence not known
myasthenia / Delayed / Incidence not known
gastritis / Delayed / Incidence not known
esophagitis / Delayed / Incidence not known
immunosuppression / Delayed / Incidence not known
candidiasis / Delayed / Incidence not known
erythema / Early / Incidence not known
skin ulcer / Delayed / Incidence not known
impaired wound healing / Delayed / Incidence not known
sodium retention / Delayed / Incidence not known
fluid retention / Delayed / Incidence not known
hypokalemia / Delayed / Incidence not known
hypernatremia / Delayed / Incidence not known
edema / Delayed / Incidence not known
hypertension / Early / Incidence not known
hypocalcemia / Delayed / Incidence not known
metabolic alkalosis / Delayed / Incidence not known
euphoria / Early / Incidence not known
delirium / Early / Incidence not known
neuritis / Delayed / Incidence not known
EEG changes / Delayed / Incidence not known
impaired cognition / Early / Incidence not known
depression / Delayed / Incidence not known
mania / Early / Incidence not known
meningitis / Delayed / Incidence not known
peripheral neuropathy / Delayed / Incidence not known
amnesia / Delayed / Incidence not known
paresis / Delayed / Incidence not known
psychosis / Early / Incidence not known
hallucinations / Early / Incidence not known
memory impairment / Delayed / Incidence not known
conjunctivitis / Delayed / Incidence not known
exophthalmos / Delayed / Incidence not known
ocular inflammation / Early / Incidence not known
cataracts / Delayed / Incidence not known
ocular infection / Delayed / Incidence not known
blurred vision / Early / Incidence not known
palpitations / Early / Incidence not known
sinus tachycardia / Rapid / Incidence not known
angina / Early / Incidence not known
hypercholesterolemia / Delayed / Incidence not known
phlebitis / Rapid / Incidence not known
hepatomegaly / Delayed / Incidence not known
elevated hepatic enzymes / Delayed / Incidence not known
Mild
ocular pain / Early / 1.0-8.0
xerophthalmia / Early / 5.0-5.0
headache / Early / 1.0-4.0
ptosis / Delayed / 2.0-2.0
ocular discharge / Delayed / 1.0-1.0
lacrimation / Early / 1.0-1.0
malaise / Early / Incidence not known
fever / Early / Incidence not known
lethargy / Early / Incidence not known
menstrual irregularity / Delayed / Incidence not known
hirsutism / Delayed / Incidence not known
hypertrichosis / Delayed / Incidence not known
myalgia / Early / Incidence not known
weakness / Early / Incidence not known
arthropathy / Delayed / Incidence not known
arthralgia / Delayed / Incidence not known
nausea / Early / Incidence not known
abdominal pain / Early / Incidence not known
hiccups / Early / Incidence not known
weight gain / Delayed / Incidence not known
appetite stimulation / Delayed / Incidence not known
vomiting / Early / Incidence not known
leukocytosis / Delayed / Incidence not known
infection / Delayed / Incidence not known
rash / Early / Incidence not known
urticaria / Rapid / Incidence not known
pruritus / Rapid / Incidence not known
alopecia / Delayed / Incidence not known
skin hyperpigmentation / Delayed / Incidence not known
hyperhidrosis / Delayed / Incidence not known
striae / Delayed / Incidence not known
perineal pain / Early / Incidence not known
acneiform rash / Delayed / Incidence not known
purpura / Delayed / Incidence not known
injection site reaction / Rapid / Incidence not known
skin hypopigmentation / Delayed / Incidence not known
ecchymosis / Delayed / Incidence not known
telangiectasia / Delayed / Incidence not known
petechiae / Delayed / Incidence not known
xerosis / Delayed / Incidence not known
acne vulgaris / Delayed / Incidence not known
irritability / Delayed / Incidence not known
insomnia / Early / Incidence not known
paresthesias / Delayed / Incidence not known
anxiety / Delayed / Incidence not known
dizziness / Early / Incidence not known
restlessness / Early / Incidence not known
emotional lability / Early / Incidence not known
vertigo / Early / Incidence not known
ocular hypotonia / Delayed / Incidence not known
ocular irritation / Rapid / Incidence not known
foreign body sensation / Rapid / Incidence not known
ocular pruritus / Rapid / Incidence not known
mydriasis / Early / Incidence not known
syncope / Early / Incidence not known
DRUG INTERACTIONS
Abatacept: (Moderate) Concomitant use of immunosuppressives, as well as long-term corticosteroids, may potentially increase the risk of serious infection in abatacept treated patients. Advise patients taking abatacept to seek immediate medical advice if they develop signs and symptoms suggestive of infection.
Abemaciclib: (Major) Avoid coadministration of dexamethasone with abemaciclib due to decreased exposure to abemaciclib and its active metabolites, which may lead to reduced efficacy. Consider alternative treatments. Abemaciclib is a CYP3A4 substrate and dexamethasone is a moderate CYP3A4 inducer. Coadministration with moderate CYP3A4 inducers is predicted to decrease the relative potency adjusted unbound AUC of abemaciclib plus its active metabolites (M2, M18, and M20) by 53%, 41%, and 29% respectively.
Acetaminophen; Aspirin, ASA; Caffeine: (Moderate) Monitor for gastrointestinal toxicity during concurrent corticosteroid and salicylate use. Concomitant use increases the risk of GI bleeding. In patients receiving concomitant corticosteroids and chronic use of salicylates, withdrawal of corticosteroids may result in salicylism because corticosteroids enhance renal clearance of salicylates and their withdrawal is followed by return to normal rates of renal clearance.
Acetaminophen; Aspirin: (Moderate) Monitor for gastrointestinal toxicity during concurrent corticosteroid and salicylate use. Concomitant use increases the risk of GI bleeding. In patients receiving concomitant corticosteroids and chronic use of salicylates, withdrawal of corticosteroids may result in salicylism because corticosteroids enhance renal clearance of salicylates and their withdrawal is followed by return to normal rates of renal clearance.
Acetaminophen; Aspirin; Diphenhydramine: (Moderate) Monitor for gastrointestinal toxicity during concurrent corticosteroid and salicylate use. Concomitant use increases the risk of GI bleeding. In patients receiving concomitant corticosteroids and chronic use of salicylates, withdrawal of corticosteroids may result in salicylism because corticosteroids enhance renal clearance of salicylates and their withdrawal is followed by return to normal rates of renal clearance.
Acetaminophen; Caffeine; Dihydrocodeine: (Moderate) Concomitant use of dihydrocodeine with dexamethasone can decrease dihydrocodeine levels, resulting in less metabolism by CYP2D6 and decreased dihydromorphine concentrations; this may result in decreased efficacy or onset of a withdrawal syndrome in patients who have developed physical dependence. If coadministration is necessary, monitor for reduced efficacy of dihydrocodeine and signs of opioid withdrawal; consider increasing the dose of dihydrocodeine as needed. If dexamethasone is discontinued, consider a dose reduction of dihydrocodeine and frequently monitor for signs or respiratory depression and sedation. Dexamethasone is a moderate inducer of CYP3A4, an isoenzyme partially responsible for the metabolism of dihydrocodeine.
Acetaminophen; Chlorpheniramine; Dextromethorphan; Phenylephrine: (Moderate) The therapeutic effect of phenylephrine may be increased in patient receiving corticosteroids, such as hydrocortisone. Monitor patients for increased pressor effect if these agents are administered concomitantly.
Acetaminophen; Chlorpheniramine; Phenylephrine : (Moderate) The therapeutic effect of phenylephrine may be increased in patient receiving corticosteroids, such as hydrocortisone. Monitor patients for increased pressor effect if these agents are administered concomitantly.
Acetaminophen; Codeine: (Moderate) Concomitant use of codeine with dexamethasone can decrease codeine levels, resulting in less metabolism by CYP2D6 and decreased morphine concentrations; this may result in decreased efficacy or onset of a withdrawal syndrome in patients who have developed physical dependence. It is recommended to avoid this combination when codeine is being used for cough. If coadministration is necessary, monitor for reduced efficacy of codeine and signs of opioid withdrawal; consider increasing the dose of codeine as needed. If dexamethasone is discontinued, consider a dose reduction of codeine and frequently monitor for signs or respiratory depression and sedation. Codeine is primarily metabolized by CYP2D6 to morphine, and by CYP3A4 to norcodeine; norcodeine does not have analgesic properties. Dexamethasone is a moderate CYP3A4 inducer.
Acetaminophen; Dextromethorphan; Guaifenesin; Phenylephrine: (Moderate) The therapeutic effect of phenylephrine may be increased in patient receiving corticosteroids, such as hydrocortisone. Monitor patients for increased pressor effect if these agents are administered concomitantly.
Acetaminophen; Dextromethorphan; Phenylephrine: (Moderate) The therapeutic effect of phenylephrine may be increased in patient receiving corticosteroids, such as hydrocortisone. Monitor patients for increased pressor effect if these agents are administered concomitantly.
Acetaminophen; Guaifenesin; Phenylephrine: (Moderate) The therapeutic effect of phenylephrine may be increased in patient receiving corticosteroids, such as hydrocortisone. Monitor patients for increased pressor effect if these agents are administered concomitantly.
Acetaminophen; Hydrocodone: (Moderate) Concomitant use of hydrocodone with dexamethasone can decrease hydrocodone levels; this may result in decreased efficacy or onset of a withdrawal syndrome in patients who have developed physical dependence. It is recommended to avoid this combination when hydrocodone is being used for cough. If coadministration is necessary, monitor for reduced efficacy of hydrocodone and signs of opioid withdrawal; consider increasing the dose of hydrocodone as needed. If dexamethasone is discontinued, consider a dose reduction of hydrocodone and frequently monitor for signs or respiratory depression and sedation. Hydrocodone is a CYP3A4 substrate and dexamethasone is a moderate CYP3A4 inducer.
Acetaminophen; Oxycodone: (Moderate) Monitor for reduced efficacy of oxycodone and signs of opioid withdrawal if coadministration with dexamethasone is necessary; consider increasing the dose of oxycodone as needed. If dexamethasone is discontinued, consider a dose reduction of oxycodone and frequently monitor for signs of respiratory depression and sedation. Oxycodone is a CYP3A4 substrate and dexamethasone is a moderate CYP3A4 inducer. Concomitant use with CYP3A4 inducers can decrease oxycodone concentrations; this may result in decreased efficacy or onset of a withdrawal syndrome in patients who have developed physical dependence.
Acetazolamide: (Moderate) Corticosteroids may increase the risk of hypokalemia if used concurrently with acetazolamide. Hypokalemia may be especially severe with prolonged use of corticotropin, ACTH. Monitor serum potassium levels to determine the need for potassium supplementation and/or alteration in drug therapy.
Acetohexamide: (Moderate) Monitor blood glucose during concomitant corticosteroid and sulfonylurea use; a sulfonylurea dose adjustment may be necessary. Corticosteroids may increase blood glucose concentrations. Risk factors for impaired glucose tolerance due to corticosteroids include the corticosteroid dose and duration of treatment. Corticosteroids stimulate hepatic glucose production and inhibit peripheral glucose uptake into muscle and fatty tissues, producing insulin resistance. Decreased insulin production may occur in the pancreas due to a direct effect on pancreatic beta cells.
Adagrasib: (Moderate) Monitor for steroid-related adverse reactions if coadministration of adagrasib with dexamethasone is necessary, due to increased dexamethasone exposure; Cushing's syndrome and adrenal suppression could potentially occur with long-term use. Consider the use of corticosteroids such as beclomethasone and prednisolone, whose concentrations are less affected by strong CYP3A inhibitors, especially for long-term use. Adagrasib is a strong CYP3A inhibitor and dexamethasone is primarily metabolized by CYP3A. Another strong CYP3A inhibitor has been reported to decrease the metabolism of certain corticosteroids by up to 60%, leading to increased risk of corticosteroid side effects.
Albendazole: (Minor) Concomitant administration of albendazole with dexamethasone increases the plasma concentration of albendazole sulfoxide, presumably via reduction in albendazole sulfoxide clearance.
Albiglutide: (Moderate) Monitor blood glucose during concomitant corticosteroid and incretin mimetic use; an incretin mimetic dose adjustment may be necessary. Corticosteroids may increase blood glucose concentrations. Risk factors for impaired glucose tolerance due to corticosteroids include the corticosteroid dose and duration of treatment. Corticosteroids stimulate hepatic glucose production and inhibit peripheral glucose uptake into muscle and fatty tissues, producing insulin resistance. Decreased insulin production may occur in the pancreas due to a direct effect on pancreatic beta cells.
Aldesleukin, IL-2: (Minor) Because systemically administered corticosteroids exhibit immunosuppressive effects when given in high doses and/or for extended periods, additive effects may be seen with other immunosuppressives or antineoplastic agents.
Alemtuzumab: (Moderate) Concomitant use of alemtuzumab with immunosuppressant doses of corticosteroids may increase the risk of immunosuppression. Monitor patients carefully for signs and symptoms of infection.
Aliskiren; Hydrochlorothiazide, HCTZ: (Moderate) Monitor potassium concentrations during concomitant corticosteroid and thiazide diuretic use due to risk for additive hypokalemia; potassium supplementation may be necessary. Both corticosteroids and thiazide diuretics cause increased renal potassium loss.
Alogliptin; Metformin: (Moderate) Monitor blood glucose during concomitant corticosteroid and metformin use; a metformin dose adjustment may be necessary. Corticosteroids may increase blood glucose concentrations. Risk factors for impaired glucose tolerance due to corticosteroids include the corticosteroid dose and duration of treatment. Corticosteroids stimulate hepatic glucose production and inhibit peripheral glucose uptake into muscle and fatty tissues, producing insulin resistance. Decreased insulin production may occur in the pancreas due to a direct effect on pancreatic beta cells.
Alosetron: (Minor) Dexamethasone can induce the activity of CYP3A4 and increase the metabolism of alosetron by increasing the metabolism of the drug, thus potentially reducing the effect of alosetron.
Alpha-glucosidase Inhibitors: (Moderate) Monitor patients receiving antidiabetic agents closely for worsening glycemic control when corticosteroids are instituted and for signs of hypoglycemia when corticosteroids are discontinued. Systemic and inhaled corticosteroids are known to increase blood glucose and worsen glycemic control in patients taking antidiabetic agents. The main risk factors for impaired glucose tolerance due to corticosteroids are the dose of steroid and duration of treatment. Corticosteroids stimulate hepatic glucose production and inhibit peripheral glucose uptake into muscle and fatty tissues, producing insulin resistance. Decreased insulin production may occur in the pancreas due to a direct effect on pancreatic beta cells.
Altretamine: (Minor) Concurrent use of altretamine with other agents which cause bone marrow or immune suppression such as corticosteroids may result in additive effects.
Ambenonium Chloride: (Moderate) Concomitant use of anticholinesterase agents, such as ambenonium chloride, and corticosteroids may produce severe weakness in patients with myasthenia gravis. If possible, anticholinesterase agents used to treat myasthenia should be withdrawn at least 24 hours before initiating corticosteroid therapy.
Amifampridine: (Moderate) Carefully consider the need for concomitant treatment with systemic corticosteroids and amifampridine, as coadministration may increase the risk of seizures. If coadministration occurs, closely monitor patients for seizure activity. Seizures have been observed in patients without a history of seizures taking amifampridine at recommended doses. Systemic corticosteroids may increase the risk of seizures in some patients.
Amiloride; Hydrochlorothiazide, HCTZ: (Moderate) Monitor potassium concentrations during concomitant corticosteroid and thiazide diuretic use due to risk for additive hypokalemia; potassium supplementation may be necessary. Both corticosteroids and thiazide diuretics cause increased renal potassium loss.
Aminolevulinic Acid: (Minor) Corticosteroids administered prior to or concomitantly with photosensitizing agents used in photodynamic therapy may decrease the efficacy of the treatment.
Aminosalicylate sodium, Aminosalicylic acid: (Moderate) Monitor for gastrointestinal toxicity during concurrent corticosteroid and salicylate use. Concomitant use increases the risk of GI bleeding. In patients receiving concomitant corticosteroids and chronic use of salicylates, withdrawal of corticosteroids may result in salicylism because corticosteroids enhance renal clearance of salicylates and their withdrawal is followed by return to normal rates of renal clearance.
Amiodarone: (Major) Use caution when coadministering amiodarone with drugs which may induce hypokalemia and, or hypomagnesemia, including corticosteroids. Since antiarrhythmic drugs may be ineffective or may be arrhythmogenic in patients with hypokalemia, any potassium or magnesium deficiency should be corrected before instituting and during amiodarone therapy.
Amlodipine: (Minor) Coadministration of CYP3A4 inducers with amlodipine can theoretically increase the hepatic metabolism of amlodipine (a CYP3A4 substrate). Caution should be used when CYP3A4 inducers, such as dexamethasone, are coadministered with amlodipine. Monitor therapeutic response; the dosage requirements of amlodipine may be increased.
Amlodipine; Atorvastatin: (Minor) Coadministration of CYP3A4 inducers with amlodipine can theoretically increase the hepatic metabolism of amlodipine (a CYP3A4 substrate). Caution should be used when CYP3A4 inducers, such as dexamethasone, are coadministered with amlodipine. Monitor therapeutic response; the dosage requirements of amlodipine may be increased.
Amlodipine; Benazepril: (Minor) Coadministration of CYP3A4 inducers with amlodipine can theoretically increase the hepatic metabolism of amlodipine (a CYP3A4 substrate). Caution should be used when CYP3A4 inducers, such as dexamethasone, are coadministered with amlodipine. Monitor therapeutic response; the dosage requirements of amlodipine may be increased.
Amlodipine; Celecoxib: (Minor) Coadministration of CYP3A4 inducers with amlodipine can theoretically increase the hepatic metabolism of amlodipine (a CYP3A4 substrate). Caution should be used when CYP3A4 inducers, such as dexamethasone, are coadministered with amlodipine. Monitor therapeutic response; the dosage requirements of amlodipine may be increased.
Amlodipine; Olmesartan: (Minor) Coadministration of CYP3A4 inducers with amlodipine can theoretically increase the hepatic metabolism of amlodipine (a CYP3A4 substrate). Caution should be used when CYP3A4 inducers, such as dexamethasone, are coadministered with amlodipine. Monitor therapeutic response; the dosage requirements of amlodipine may be increased.
Amlodipine; Valsartan: (Minor) Coadministration of CYP3A4 inducers with amlodipine can theoretically increase the hepatic metabolism of amlodipine (a CYP3A4 substrate). Caution should be used when CYP3A4 inducers, such as dexamethasone, are coadministered with amlodipine. Monitor therapeutic response; the dosage requirements of amlodipine may be increased.
Amlodipine; Valsartan; Hydrochlorothiazide, HCTZ: (Moderate) Monitor potassium concentrations during concomitant corticosteroid and thiazide diuretic use due to risk for additive hypokalemia; potassium supplementation may be necessary. Both corticosteroids and thiazide diuretics cause increased renal potassium loss. (Minor) Coadministration of CYP3A4 inducers with amlodipine can theoretically increase the hepatic metabolism of amlodipine (a CYP3A4 substrate). Caution should be used when CYP3A4 inducers, such as dexamethasone, are coadministered with amlodipine. Monitor therapeutic response; the dosage requirements of amlodipine may be increased.
Amoxicillin; Clarithromycin; Omeprazole: (Major) Coadministration of dexamethasone and clarithromycin may decrease clarithromycin serum concentrations due to CYP3A4 enzyme induction. While the 14-OH-clarithromycin active metabolite concentrations are increased, this metabolite has different antimicrobial activity compared to clarithromycin. The intended therapeutic effect of clarithromycin could be decreased. It is not clear if clarithromycin activity against other organisms would be reduced, but reduced efficacy is possible. Alternatives to clarithromycin should be considered in patients who are taking CYP3A4 inducers. Additionally, clarithromycin inhibits CYP3A4 and has the potential to result in increased plasma concentrations of dexamethasone. Increased blood concentrations and physiologic activity may necessitate a decrease in corticosteroid dosage. (Moderate) Monitor for decreased efficacy of omeprazole if coadministration with dexamethasone is necessary. Omeprazole is metabolized by CYP2C19 and CYP3A4. Dexamethasone is a moderate CYP3A4 inducer. The manufacturer of omeprazole recommends avoidance with strong inducers because decreased exposure of omeprazole can occur. Recommendations are not available for concomitant use with moderate inducers of CYP3A4.
Amphotericin B lipid complex (ABLC): (Moderate) The potassium-wasting effects of corticosteroid therapy can be exacerbated by concomitant administration of other potassium-depleting drugs including amphotericin B. Serum potassium levels should be monitored in patients receiving these drugs concomitantly.
Amphotericin B liposomal (LAmB): (Moderate) The potassium-wasting effects of corticosteroid therapy can be exacerbated by concomitant administration of other potassium-depleting drugs including amphotericin B. Serum potassium levels should be monitored in patients receiving these drugs concomitantly.
Amphotericin B: (Moderate) The potassium-wasting effects of corticosteroid therapy can be exacerbated by concomitant administration of other potassium-depleting drugs including amphotericin B. Serum potassium levels should be monitored in patients receiving these drugs concomitantly.
Antithymocyte Globulin: (Moderate) Because systemically administered corticosteroids exhibit immunosuppressive effects when given in high doses and/or for extended periods, additive effects may be seen with other immunosuppressives or antineoplastic agents.
Apalutamide: (Moderate) Monitor for decreased efficacy of dexamethasone if coadministration with apalutamide is necessary; consider increasing the dose of dexamethasone if clinically appropriate. Dexamethasone is a CYP3A4 substrate and apalutamide is a strong CYP3A4 inducer.
Aprepitant, Fosaprepitant: (Minor) Aprepitant, fosaprepitant is indicated for the treatment of chemotherapy-induced nausea/vomiting (CINV) in combination with dexamethasone and a 5HT3 antagonist; the pharmacokinetic interactions discussed here are accounted for in the recommended dosing for this indication. No dosage adjustment is needed when dexamethasone is used in combination with a single 40-mg dose of oral aprepitant. Dexamethasone is a CYP3A4 substrate. Aprepitant, when administered as a 3-day oral regimen (125 mg/80 mg/80 mg), is a moderate CYP3A4 inhibitor and inducer. The AUC of dexamethasone (8 mg PO on days 1, 2, and 3) was increased by approximately 2-fold on days 1 and 2 when given with a single 150-mg dose of IV fosaprepitant. After a 5-day regimen of oral aprepitant (125 mg/80 mg/80 mg/80 mg/80 mg), the AUC of dexamethasone increased 2.2-fold on days 1 and 5. A single dose of aprepitant 40 mg increased the AUC of dexamethasone by 1.45-fold, which was not considered clinically significant.
Aripiprazole: (Moderate) Because aripiprazole is metabolized by CYP3A4, concurrent use of CYP3A4 inducers such as dexamethasone may result in decreased plasma concentrations of aripiprazole. If these agents are used in combination, the patient should be carefully monitored for a decrease in aripiprazole efficacy. An increase in aripiprazole dosage may be clinically warranted in some patients. Avoid concurrent use of Abilify Maintena with a CYP3A4 inducer when the combined treatment period exceeds 14 days because aripiprazole blood concentrations decline and may become suboptimal. There are no dosing recommendations for Aristada or Aristada Initio during concurrent use of a mild or moderate CYP3A4 inducer.
Armodafinil: (Minor) Armodafinil is partially metabolized via CYP3A4/5 isoenzymes. CYP3A4 inducers, such as dexamethasone, may potentially increase the metabolism of armodafinil. Decreased serum levels of armodafinil could potentially result in decreased efficacy of the drug.
Arsenic Trioxide: (Moderate) Caution is advisable during concurrent use of arsenic trioxide and corticosteroids as electrolyte imbalance caused by corticosteroids may increase the risk of QT prolongation with arsenic trioxide.
Artemether; Lumefantrine: (Major) Dexamethasone is a substrate/inducer and both components of artemether; lumefantrine are substrates of the CYP3A4 isoenzyme; therefore, coadministration may lead to decreased artemether; lumefantrine concentrations. Concomitant use warrants caution due to a possible reduction in antimalarial activity.
Articaine; Epinephrine: (Moderate) Monitor potassium concentrations during concomitant corticosteroid and epinephrine use due to risk for additive hypokalemia; potassium supplementation may be necessary. Corticosteroids may potentiate the hypokalemic effects of epinephrine.
Asparaginase Erwinia chrysanthemi: (Moderate) Concomitant use of L-asparaginase with corticosteroids can result in additive hyperglycemia. L-Asparaginase transiently inhibits insulin production contributing to hyperglycemia seen during concurrent corticosteroid therapy. Insulin therapy may be required in some cases. Administration of L-asparaginase after rather than before corticosteroids reportedly has produced fewer hypersensitivity reactions.
Aspirin, ASA: (Moderate) Monitor for gastrointestinal toxicity during concurrent corticosteroid and salicylate use. Concomitant use increases the risk of GI bleeding. In patients receiving concomitant corticosteroids and chronic use of salicylates, withdrawal of corticosteroids may result in salicylism because corticosteroids enhance renal clearance of salicylates and their withdrawal is followed by return to normal rates of renal clearance.
Aspirin, ASA; Butalbital; Caffeine: (Moderate) Coadministration may result in decreased exposure to dexamethasone. Butalbital is a CYP3A4 inducer; dexamethasone is a CYP3A4 substrate. Monitor for decreased response to dexamethasone during concurrent use. (Moderate) Monitor for gastrointestinal toxicity during concurrent corticosteroid and salicylate use. Concomitant use increases the risk of GI bleeding. In patients receiving concomitant corticosteroids and chronic use of salicylates, withdrawal of corticosteroids may result in salicylism because corticosteroids enhance renal clearance of salicylates and their withdrawal is followed by return to normal rates of renal clearance.
Aspirin, ASA; Caffeine: (Moderate) Monitor for gastrointestinal toxicity during concurrent corticosteroid and salicylate use. Concomitant use increases the risk of GI bleeding. In patients receiving concomitant corticosteroids and chronic use of salicylates, withdrawal of corticosteroids may result in salicylism because corticosteroids enhance renal clearance of salicylates and their withdrawal is followed by return to normal rates of renal clearance.
Aspirin, ASA; Caffeine; Orphenadrine: (Moderate) Monitor for gastrointestinal toxicity during concurrent corticosteroid and salicylate use. Concomitant use increases the risk of GI bleeding. In patients receiving concomitant corticosteroids and chronic use of salicylates, withdrawal of corticosteroids may result in salicylism because corticosteroids enhance renal clearance of salicylates and their withdrawal is followed by return to normal rates of renal clearance.
Aspirin, ASA; Carisoprodol: (Moderate) Monitor for gastrointestinal toxicity during concurrent corticosteroid and salicylate use. Concomitant use increases the risk of GI bleeding. In patients receiving concomitant corticosteroids and chronic use of salicylates, withdrawal of corticosteroids may result in salicylism because corticosteroids enhance renal clearance of salicylates and their withdrawal is followed by return to normal rates of renal clearance.
Aspirin, ASA; Carisoprodol; Codeine: (Moderate) Concomitant use of codeine with dexamethasone can decrease codeine levels, resulting in less metabolism by CYP2D6 and decreased morphine concentrations; this may result in decreased efficacy or onset of a withdrawal syndrome in patients who have developed physical dependence. It is recommended to avoid this combination when codeine is being used for cough. If coadministration is necessary, monitor for reduced efficacy of codeine and signs of opioid withdrawal; consider increasing the dose of codeine as needed. If dexamethasone is discontinued, consider a dose reduction of codeine and frequently monitor for signs or respiratory depression and sedation. Codeine is primarily metabolized by CYP2D6 to morphine, and by CYP3A4 to norcodeine; norcodeine does not have analgesic properties. Dexamethasone is a moderate CYP3A4 inducer. (Moderate) Monitor for gastrointestinal toxicity during concurrent corticosteroid and salicylate use. Concomitant use increases the risk of GI bleeding. In patients receiving concomitant corticosteroids and chronic use of salicylates, withdrawal of corticosteroids may result in salicylism because corticosteroids enhance renal clearance of salicylates and their withdrawal is followed by return to normal rates of renal clearance.
Aspirin, ASA; Citric Acid; Sodium Bicarbonate: (Moderate) Monitor for gastrointestinal toxicity during concurrent corticosteroid and salicylate use. Concomitant use increases the risk of GI bleeding. In patients receiving concomitant corticosteroids and chronic use of salicylates, withdrawal of corticosteroids may result in salicylism because corticosteroids enhance renal clearance of salicylates and their withdrawal is followed by return to normal rates of renal clearance.
Aspirin, ASA; Dipyridamole: (Moderate) Monitor for gastrointestinal toxicity during concurrent corticosteroid and salicylate use. Concomitant use increases the risk of GI bleeding. In patients receiving concomitant corticosteroids and chronic use of salicylates, withdrawal of corticosteroids may result in salicylism because corticosteroids enhance renal clearance of salicylates and their withdrawal is followed by return to normal rates of renal clearance.
Aspirin, ASA; Omeprazole: (Moderate) Monitor for decreased efficacy of omeprazole if coadministration with dexamethasone is necessary. Omeprazole is metabolized by CYP2C19 and CYP3A4. Dexamethasone is a moderate CYP3A4 inducer. The manufacturer of omeprazole recommends avoidance with strong inducers because decreased exposure of omeprazole can occur. Recommendations are not available for concomitant use with moderate inducers of CYP3A4. (Moderate) Monitor for gastrointestinal toxicity during concurrent corticosteroid and salicylate use. Concomitant use increases the risk of GI bleeding. In patients receiving concomitant corticosteroids and chronic use of salicylates, withdrawal of corticosteroids may result in salicylism because corticosteroids enhance renal clearance of salicylates and their withdrawal is followed by return to normal rates of renal clearance.
Aspirin, ASA; Oxycodone: (Moderate) Monitor for gastrointestinal toxicity during concurrent corticosteroid and salicylate use. Concomitant use increases the risk of GI bleeding. In patients receiving concomitant corticosteroids and chronic use of salicylates, withdrawal of corticosteroids may result in salicylism because corticosteroids enhance renal clearance of salicylates and their withdrawal is followed by return to normal rates of renal clearance. (Moderate) Monitor for reduced efficacy of oxycodone and signs of opioid withdrawal if coadministration with dexamethasone is necessary; consider increasing the dose of oxycodone as needed. If dexamethasone is discontinued, consider a dose reduction of oxycodone and frequently monitor for signs of respiratory depression and sedation. Oxycodone is a CYP3A4 substrate and dexamethasone is a moderate CYP3A4 inducer. Concomitant use with CYP3A4 inducers can decrease oxycodone concentrations; this may result in decreased efficacy or onset of a withdrawal syndrome in patients who have developed physical dependence.
Aspirin, ASA; Pravastatin: (Moderate) Monitor for gastrointestinal toxicity during concurrent corticosteroid and salicylate use. Concomitant use increases the risk of GI bleeding. In patients receiving concomitant corticosteroids and chronic use of salicylates, withdrawal of corticosteroids may result in salicylism because corticosteroids enhance renal clearance of salicylates and their withdrawal is followed by return to normal rates of renal clearance.
Atazanavir: (Major) Avoid concurrent use of dexamethasone with atazanavir. Coadministration may result in a reduction of antiretroviral efficacy and the potential development of viral resistance to atazanavir; consider use of an alternative corticosteroid. In addition, serum concentrations of dexamethasone may be increased, potentially resulting in Cushing's syndrome and adrenal suppression. Dexamethasone is a CYP3A4 substrate and inducer; atazanavir is a substrate of this enzyme as well as a strong CYP3A inhibitor. Corticosteroids, such as beclomethasone and prednisolone) whose concentrations are less affected by strong CYP3A4 inhibitors, should be considered, especially for long-term use.
Atazanavir; Cobicistat: (Major) Avoid concurrent use of dexamethasone with atazanavir. Coadministration may result in a reduction of antiretroviral efficacy and the potential development of viral resistance to atazanavir; consider use of an alternative corticosteroid. In addition, serum concentrations of dexamethasone may be increased, potentially resulting in Cushing's syndrome and adrenal suppression. Dexamethasone is a CYP3A4 substrate and inducer; atazanavir is a substrate of this enzyme as well as a strong CYP3A inhibitor. Corticosteroids, such as beclomethasone and prednisolone) whose concentrations are less affected by strong CYP3A4 inhibitors, should be considered, especially for long-term use. (Major) Avoid concurrent use of dexamethasone with cobicistat containing regimens. Coadministration may result in a reduction of antiretroviral efficacy and the potential development of viral resistance. In addition, serum concentrations of dexamethasone may be increased, potentially resulting in Cushing's syndrome and adrenal suppression. Dexamethasone is a CYP3A4 substrate and inducer; cobicistat is a substrate of this enzyme as well as a strong CYP3A inhibitor. Corticosteroids, such as beclomethasone and prednisolone, whose concentrations are less affected by strong CYP3A4 inhibitors, should be considered, especially for long-term use.
Atenolol; Chlorthalidone: (Moderate) Monitor potassium concentrations during concomitant corticosteroid and thiazide diuretic use due to risk for additive hypokalemia; potassium supplementation may be necessary. Both corticosteroids and thiazide diuretics cause increased renal potassium loss.
Atogepant: (Major) Avoid use of atogepant and dexamethasone when atogepant is used for chronic migraine. Use an atogepant dose of 30 or 60 mg PO once daily for episodic migraine if coadministered with dexamethasone. Concurrent use may decrease atogepant exposure and reduce efficacy. Atogepant is a CYP3A substrate and dexamethasone is a moderate CYP3A inducer.
Atracurium: (Moderate) Limit the period of use of neuromuscular blockers and corticosteroids and only use when the specific advantages of the drugs outweigh the risks for acute myopathy. An acute myopathy has been observed with the use of high doses of corticosteroids in patients receiving concomitant long-term therapy with neuromuscular blockers. Clinical improvement or recovery after stopping therapy may require weeks to years.
Atropine; Benzoic Acid; Hyoscyamine; Methenamine; Methylene Blue; Phenyl Salicylate: (Moderate) Monitor for gastrointestinal toxicity during concurrent corticosteroid and salicylate use. Concomitant use increases the risk of GI bleeding. In patients receiving concomitant corticosteroids and chronic use of salicylates, withdrawal of corticosteroids may result in salicylism because corticosteroids enhance renal clearance of salicylates and their withdrawal is followed by return to normal rates of renal clearance.
Avacopan: (Major) Avoid concomitant use of avacopan and dexamethasone due to the risk of decreased avacopan exposure which may reduce its efficacy. Avacopan is a CYP3A substrate and dexamethasone is a moderate CYP3A inducer.
Avanafil: (Minor) Avanafil is primarily metabolized by CYP3A4, and although no studies have been performed, concomitant administration of CYP3A4 inducers, such as dexamethasone, may decrease avanafil plasma levels. Concomitant use is not recommended.
Avapritinib: (Major) Avoid coadministration of avapritinib with dexamethasone due to the risk of decreased avapritinib efficacy. Avapritinib is a CYP3A4 substrate and dexamethasone is a moderate CYP3A4 inducer. Coadministration with another moderate CYP3A4 inducer is predicted to decrease the AUC and Cmax of avapritinib by 62% and 55%, respectively.
Axitinib: (Major) Avoid coadministration of axitinib with dexamethasone due to the risk of decreased efficacy of axitinib. Selection of a concomitant medication with no or minimal CYP3A4 induction potential is recommended. Axitinib is a CYP3A4/5 substrate and dexamethasone is a CYP3A4 inducer. Coadministration with a strong CYP3A4/5 inducer significantly decreased the plasma exposure of axitinib in healthy volunteers.
Azathioprine: (Minor) Because systemically administered corticosteroids exhibit immunosuppressive effects when given in high doses and/or for extended periods, additive effects may be seen with other immunosuppressives or antineoplastic agents.
Azilsartan; Chlorthalidone: (Moderate) Monitor potassium concentrations during concomitant corticosteroid and thiazide diuretic use due to risk for additive hypokalemia; potassium supplementation may be necessary. Both corticosteroids and thiazide diuretics cause increased renal potassium loss.
Basiliximab: (Minor) Because systemically administered corticosteroids have immunosuppressive effects when given in high doses and/or for extended periods, additive effects may be seen with other immunosuppressives.
Bedaquiline: (Major) Avoid concurrent use of dexamethasone with bedaquiline. Dexamethasone is a CYP3A4 inducer, which may result in decreased bedaquiline systemic exposure (AUC) and possibly reduced therapeutic effect.
Benazepril; Hydrochlorothiazide, HCTZ: (Moderate) Monitor potassium concentrations during concomitant corticosteroid and thiazide diuretic use due to risk for additive hypokalemia; potassium supplementation may be necessary. Both corticosteroids and thiazide diuretics cause increased renal potassium loss.
Bendroflumethiazide; Nadolol: (Moderate) Monitor potassium concentrations during concomitant corticosteroid and thiazide diuretic use due to risk for additive hypokalemia; potassium supplementation may be necessary. Both corticosteroids and thiazide diuretics cause increased renal potassium loss.
Benzhydrocodone; Acetaminophen: (Moderate) Concurrent use of benzhydrocodone with dexamethasone may decrease hydrocodone plasma concentrations, decrease opioid efficacy, and potentially lead to a withdrawal syndrome in those with physical dependence to opioid agonists. If concomitant use is necessary, consider increasing the benzhydrocodone dosage until stable drug effects are achieved. Monitor for signs of opioid withdrawal. Discontinuation of dexamethasone may increase the risk of increased opioid-related adverse reactions, such as fatal respiratory depression. If dexamethasone is discontinued, consider a benzhydrocodone dosage reduction and monitor patients for respiratory depression and sedation at frequent intervals. Benzhydrocodone is a prodrug of hydrocodone. Dexamethasone is an inducer of CYP3A4, an isoenzyme partially responsible for the metabolism of hydrocodone.
Benzoic Acid; Hyoscyamine; Methenamine; Methylene Blue; Phenyl Salicylate: (Moderate) Monitor for gastrointestinal toxicity during concurrent corticosteroid and salicylate use. Concomitant use increases the risk of GI bleeding. In patients receiving concomitant corticosteroids and chronic use of salicylates, withdrawal of corticosteroids may result in salicylism because corticosteroids enhance renal clearance of salicylates and their withdrawal is followed by return to normal rates of renal clearance.
Bexarotene: (Minor) Because systemically administered corticosteroids exhibit immunosuppressive effects when given in high doses and/or for extended periods, additive effects may be seen with other immunosuppressives or antineoplastic agents, such as bexarotene.
Bismuth Subsalicylate: (Moderate) Monitor for gastrointestinal toxicity during concurrent corticosteroid and salicylate use. Concomitant use increases the risk of GI bleeding. In patients receiving concomitant corticosteroids and chronic use of salicylates, withdrawal of corticosteroids may result in salicylism because corticosteroids enhance renal clearance of salicylates and their withdrawal is followed by return to normal rates of renal clearance.
Bismuth Subsalicylate; Metronidazole; Tetracycline: (Moderate) Monitor for gastrointestinal toxicity during concurrent corticosteroid and salicylate use. Concomitant use increases the risk of GI bleeding. In patients receiving concomitant corticosteroids and chronic use of salicylates, withdrawal of corticosteroids may result in salicylism because corticosteroids enhance renal clearance of salicylates and their withdrawal is followed by return to normal rates of renal clearance.
Bisoprolol; Hydrochlorothiazide, HCTZ: (Moderate) Monitor potassium concentrations during concomitant corticosteroid and thiazide diuretic use due to risk for additive hypokalemia; potassium supplementation may be necessary. Both corticosteroids and thiazide diuretics cause increased renal potassium loss.
Bortezomib: (Minor) Because systemically administered corticosteroids exhibit immunosuppressive effects when given in high doses and/or for extended periods, additive effects may be seen with other immunosuppressives or antineoplastic agents.
Brentuximab vedotin: (Moderate) Concomitant administration of brentuximab vedotin and dexamethasone may decrease the exposure of monomethyl auristatin E (MMAE), one of the 3 components released from brentuximab vedotin. MMAE is a CYP3A4 substrate and dexamethasone is a potent CYP3A4 inducer; therefore, the efficacy of brentuximab may be reduced.
Brexpiprazole: (Moderate) Because brexpiprazole is partially metabolized by CYP3A4, concurrent use of CYP3A4 inducers such as dexamethasone may result in decreased plasma concentrations of brexpiprazole. If these agents are used in combination, the patient should be carefully monitored for a decrease in brexpiprazole efficacy. An increase in brexpiprazole dosage may be clinically warranted in some patients.
Brigatinib: (Moderate) Avoid coadministration of brigatinib with dexamethasone due to decreased plasma exposure to brigatinib which may result in decreased efficacy. If concomitant use is unavoidable, after 7 days of concomitant treatment with dexamethasone, increase the dose of brigatinib as tolerated in 30 mg increments to a maximum of twice the original brigatinib dose. After discontinuation of dexamethasone, resume the brigatinib dose that was tolerated prior to initiation of dexamethasone. Brigatinib is a CYP3A4 substrate and dexamethasone is a moderate CYP3A4 inducer. Coadministration with a moderate CYP3A inducer is predicted to decrease the AUC of brigatinib by approximately 50%.
Bromocriptine: (Moderate) Caution and close monitoring are advised if bromocriptine and dexamethasone are used together. Concurrent use may decrease the plasma concentrations of bromocriptine resulting in loss of efficacy. Bromocriptine is extensively metabolized by the liver via CYP3A4; dexamethasone is a moderate inducer of CYP3A4.
Brompheniramine; Dextromethorphan; Phenylephrine: (Moderate) The therapeutic effect of phenylephrine may be increased in patient receiving corticosteroids, such as hydrocortisone. Monitor patients for increased pressor effect if these agents are administered concomitantly.
Brompheniramine; Phenylephrine: (Moderate) The therapeutic effect of phenylephrine may be increased in patient receiving corticosteroids, such as hydrocortisone. Monitor patients for increased pressor effect if these agents are administered concomitantly.
Budesonide: (Moderate) Theoretically, induction of the cytochrome P450 (CYP) 3A4 isoenzyme may result in a lowering of budesonide plasma concentrations, reducing the clinical effect. Drugs known to induce the 3A4 isoenzyme include dexamethasone.
Budesonide; Formoterol: (Moderate) Theoretically, induction of the cytochrome P450 (CYP) 3A4 isoenzyme may result in a lowering of budesonide plasma concentrations, reducing the clinical effect. Drugs known to induce the 3A4 isoenzyme include dexamethasone.
Budesonide; Glycopyrrolate; Formoterol: (Moderate) Theoretically, induction of the cytochrome P450 (CYP) 3A4 isoenzyme may result in a lowering of budesonide plasma concentrations, reducing the clinical effect. Drugs known to induce the 3A4 isoenzyme include dexamethasone.
Bupivacaine; Epinephrine: (Moderate) Monitor potassium concentrations during concomitant corticosteroid and epinephrine use due to risk for additive hypokalemia; potassium supplementation may be necessary. Corticosteroids may potentiate the hypokalemic effects of epinephrine.
Bupivacaine; Lidocaine: (Moderate) Concomitant use of systemic lidocaine and dexamethasone may decrease lidocaine plasma concentrations. Higher lidocaine doses may be required; titrate to effect. Lidocaine is a CYP3A4 and CYP1A2 substrate; dexamethasone induces CYP3A4.
Bupropion: (Moderate) Monitor for seizure activity during concomitant bupropion and corticosteroid use. Bupropion is associated with a dose-related seizure risk; concomitant use of other medications that lower the seizure threshold, such as systemic corticosteroids, increases the seizure risk.
Bupropion; Naltrexone: (Moderate) Monitor for seizure activity during concomitant bupropion and corticosteroid use. Bupropion is associated with a dose-related seizure risk; concomitant use of other medications that lower the seizure threshold, such as systemic corticosteroids, increases the seizure risk.
Buspirone: (Moderate) Potent inducers of hepatic cytochrome P450 3A4, such as dexamethasone, may increase the rate of buspirone metabolism.
Butabarbital: (Moderate) Coadministration may result in decreased exposure to dexamethasone. Butabarbital is a CYP3A4 inducer; dexamethasone is a CYP3A4 substrate. Monitor for decreased response to dexamethasone during concurrent use.
Butalbital; Acetaminophen: (Moderate) Coadministration may result in decreased exposure to dexamethasone. Butalbital is a CYP3A4 inducer; dexamethasone is a CYP3A4 substrate. Monitor for decreased response to dexamethasone during concurrent use.
Butalbital; Acetaminophen; Caffeine: (Moderate) Coadministration may result in decreased exposure to dexamethasone. Butalbital is a CYP3A4 inducer; dexamethasone is a CYP3A4 substrate. Monitor for decreased response to dexamethasone during concurrent use.
Butalbital; Acetaminophen; Caffeine; Codeine: (Moderate) Coadministration may result in decreased exposure to dexamethasone. Butalbital is a CYP3A4 inducer; dexamethasone is a CYP3A4 substrate. Monitor for decreased response to dexamethasone during concurrent use. (Moderate) Concomitant use of codeine with dexamethasone can decrease codeine levels, resulting in less metabolism by CYP2D6 and decreased morphine concentrations; this may result in decreased efficacy or onset of a withdrawal syndrome in patients who have developed physical dependence. It is recommended to avoid this combination when codeine is being used for cough. If coadministration is necessary, monitor for reduced efficacy of codeine and signs of opioid withdrawal; consider increasing the dose of codeine as needed. If dexamethasone is discontinued, consider a dose reduction of codeine and frequently monitor for signs or respiratory depression and sedation. Codeine is primarily metabolized by CYP2D6 to morphine, and by CYP3A4 to norcodeine; norcodeine does not have analgesic properties. Dexamethasone is a moderate CYP3A4 inducer.
Butalbital; Aspirin; Caffeine; Codeine: (Moderate) Coadministration may result in decreased exposure to dexamethasone. Butalbital is a CYP3A4 inducer; dexamethasone is a CYP3A4 substrate. Monitor for decreased response to dexamethasone during concurrent use. (Moderate) Concomitant use of codeine with dexamethasone can decrease codeine levels, resulting in less metabolism by CYP2D6 and decreased morphine concentrations; this may result in decreased efficacy or onset of a withdrawal syndrome in patients who have developed physical dependence. It is recommended to avoid this combination when codeine is being used for cough. If coadministration is necessary, monitor for reduced efficacy of codeine and signs of opioid withdrawal; consider increasing the dose of codeine as needed. If dexamethasone is discontinued, consider a dose reduction of codeine and frequently monitor for signs or respiratory depression and sedation. Codeine is primarily metabolized by CYP2D6 to morphine, and by CYP3A4 to norcodeine; norcodeine does not have analgesic properties. Dexamethasone is a moderate CYP3A4 inducer. (Moderate) Monitor for gastrointestinal toxicity during concurrent corticosteroid and salicylate use. Concomitant use increases the risk of GI bleeding. In patients receiving concomitant corticosteroids and chronic use of salicylates, withdrawal of corticosteroids may result in salicylism because corticosteroids enhance renal clearance of salicylates and their withdrawal is followed by return to normal rates of renal clearance.
Cabotegravir; Rilpivirine: (Contraindicated) Concurrent use of dexamethasone (more than 1 dose) and rilpivirine is contraindicated. When these drugs are coadministered, there is a potential for treatment failure and/or the development of rilpivirine or NNRTI resistance. Dexamethasone is an inducer of CYP3A4, which is primarily responsible for the metabolism of rilpivirine. Coadministration may result in decreased rilpivirine serum concentrations, which could cause impaired virologic response to rilpivirine.
Cabozantinib: (Minor) Monitor for an increase in dexamethasone-related adverse reactions if coadministration with cabozantinib is necessary. Dexamethasone is a P-glycoprotein (P-gp) substrate. Cabozantinib is a P-gp inhibitor and has the potential to increase plasma concentrations of P-gp substrates; however, the clinical relevance of this finding is unknown.
Caffeine; Sodium Benzoate: (Moderate) Corticosteroids may cause protein breakdown, which could lead to elevated blood ammonia concentrations, especially in patients with an impaired ability to form urea. Corticosteroids should be used with caution in patients receiving treatment for hyperammonemia.
Calcium Carbonate: (Moderate) Calcium absorption is reduced when calcium carbonate is taken concomitantly with systemic corticosteroids. Systemic corticosteroids induce a negative calcium balance by inhibiting intestinal calcium absorption as well as by increasing renal calcium losses. The mechanism by which these drugs inhibit calcium absorption in the intestine is likely to involve a direct inhibition of absorptive cell function.
Calcium Carbonate; Famotidine; Magnesium Hydroxide: (Moderate) Calcium absorption is reduced when calcium carbonate is taken concomitantly with systemic corticosteroids. Systemic corticosteroids induce a negative calcium balance by inhibiting intestinal calcium absorption as well as by increasing renal calcium losses. The mechanism by which these drugs inhibit calcium absorption in the intestine is likely to involve a direct inhibition of absorptive cell function.
Calcium Carbonate; Magnesium Hydroxide: (Moderate) Calcium absorption is reduced when calcium carbonate is taken concomitantly with systemic corticosteroids. Systemic corticosteroids induce a negative calcium balance by inhibiting intestinal calcium absorption as well as by increasing renal calcium losses. The mechanism by which these drugs inhibit calcium absorption in the intestine is likely to involve a direct inhibition of absorptive cell function.
Calcium Carbonate; Magnesium Hydroxide; Simethicone: (Moderate) Calcium absorption is reduced when calcium carbonate is taken concomitantly with systemic corticosteroids. Systemic corticosteroids induce a negative calcium balance by inhibiting intestinal calcium absorption as well as by increasing renal calcium losses. The mechanism by which these drugs inhibit calcium absorption in the intestine is likely to involve a direct inhibition of absorptive cell function.
Calcium Carbonate; Risedronate: (Moderate) Calcium absorption is reduced when calcium carbonate is taken concomitantly with systemic corticosteroids. Systemic corticosteroids induce a negative calcium balance by inhibiting intestinal calcium absorption as well as by increasing renal calcium losses. The mechanism by which these drugs inhibit calcium absorption in the intestine is likely to involve a direct inhibition of absorptive cell function.
Calcium Carbonate; Simethicone: (Moderate) Calcium absorption is reduced when calcium carbonate is taken concomitantly with systemic corticosteroids. Systemic corticosteroids induce a negative calcium balance by inhibiting intestinal calcium absorption as well as by increasing renal calcium losses. The mechanism by which these drugs inhibit calcium absorption in the intestine is likely to involve a direct inhibition of absorptive cell function.
Calcium; Vitamin D: (Moderate) Calcium absorption is reduced when calcium carbonate is taken concomitantly with systemic corticosteroids. Systemic corticosteroids induce a negative calcium balance by inhibiting intestinal calcium absorption as well as by increasing renal calcium losses. The mechanism by which these drugs inhibit calcium absorption in the intestine is likely to involve a direct inhibition of absorptive cell function.
Canagliflozin: (Moderate) Monitor blood glucose during concomitant corticosteroid and SGLT2 inhibitor use; a SGLT2 inhibitor dose adjustment may be necessary. Corticosteroids may increase blood glucose concentrations. Risk factors for impaired glucose tolerance due to corticosteroids include the corticosteroid dose and duration of treatment. Corticosteroids stimulate hepatic glucose production and inhibit peripheral glucose uptake into muscle and fatty tissues, producing insulin resistance. Decreased insulin production may occur in the pancreas due to a direct effect on pancreatic beta cells.
Canagliflozin; Metformin: (Moderate) Monitor blood glucose during concomitant corticosteroid and metformin use; a metformin dose adjustment may be necessary. Corticosteroids may increase blood glucose concentrations. Risk factors for impaired glucose tolerance due to corticosteroids include the corticosteroid dose and duration of treatment. Corticosteroids stimulate hepatic glucose production and inhibit peripheral glucose uptake into muscle and fatty tissues, producing insulin resistance. Decreased insulin production may occur in the pancreas due to a direct effect on pancreatic beta cells. (Moderate) Monitor blood glucose during concomitant corticosteroid and SGLT2 inhibitor use; a SGLT2 inhibitor dose adjustment may be necessary. Corticosteroids may increase blood glucose concentrations. Risk factors for impaired glucose tolerance due to corticosteroids include the corticosteroid dose and duration of treatment. Corticosteroids stimulate hepatic glucose production and inhibit peripheral glucose uptake into muscle and fatty tissues, producing insulin resistance. Decreased insulin production may occur in the pancreas due to a direct effect on pancreatic beta cells.
Candesartan; Hydrochlorothiazide, HCTZ: (Moderate) Monitor potassium concentrations during concomitant corticosteroid and thiazide diuretic use due to risk for additive hypokalemia; potassium supplementation may be necessary. Both corticosteroids and thiazide diuretics cause increased renal potassium loss.
Capmatinib: (Major) Avoid coadministration of capmatinib and dexamethasone due to the risk of decreased capmatinib exposure, which may reduce its efficacy. Capmatinib is a CYP3A substrate and dexamethasone is a moderate CYP3A4 inducer. Coadministration with another moderate CYP3A4 inducer decreased capmatinib exposure by 44%.
Captopril; Hydrochlorothiazide, HCTZ: (Moderate) Monitor potassium concentrations during concomitant corticosteroid and thiazide diuretic use due to risk for additive hypokalemia; potassium supplementation may be necessary. Both corticosteroids and thiazide diuretics cause increased renal potassium loss.
Carbamazepine: (Moderate) Hepatic microsomal enzyme inducers, including carbamazepine, can increase the metabolism of dexamethasone. Dosage adjustments may be necessary, and closer monitoring of clinical and/or adverse effects is warranted when carbamazepine is used with dexamethasone.
Carbinoxamine; Phenylephrine: (Moderate) The therapeutic effect of phenylephrine may be increased in patient receiving corticosteroids, such as hydrocortisone. Monitor patients for increased pressor effect if these agents are administered concomitantly.
Cariprazine: (Major) Cariprazine and its active metabolites are extensively metabolized by CYP3A4. Concurrent use of cariprazine with CYP3A4 inducers, such as dexamethasone, has not been evaluated and is not recommended because the net effect on active drug and metabolites is unclear.
Carmustine, BCNU: (Minor) Because systemically administered corticosteroids exhibit immunosuppressive effects when given in high doses and/or for extended periods, additive effects may be seen with other immunosuppressives or antineoplastic agents.
Carvedilol: (Minor) Increased concentrations of dexamethasone may occur if it is coadministered with carvedilol; exercise caution. Carvedilol is a P-glycoprotein (P-gp) inhibitor and dexamethasone is a P-gp substrate.
Caspofungin: (Major) Data suggest that coadministration of inducers or mixed inducers/inhibitors of hepatic drug clearance along with caspofungin may result in reduced caspofungin blood concentrations. The reductions may be clinically significant. It is not known how caspofungin drug clearance is induced. Drugs that may lead to reductions in caspofungin concentrations include dexamethasone. For adult patients receiving dexamethasone, an increase in the caspofungin dose to 70 mg/day should be considered. For pediatric patients receiving dexamethasone, a daily dosage of 70 mg/m2, not to exceed 70 mg, should be considered.
Cenobamate: (Minor) A dose adjustment of systemic dexamethasone may be necessary if cenobamate is initiated or withdrawn during therapy. Cenobamate may increase the metabolism of dexamethasone resulting in decreased exposure. Cenobamate is a moderate inducer of CYP3A4; dexamethasone is a CYP3A4 substrate.
Ceritinib: (Moderate) Monitor for steroid-related adverse reactions if coadministration of ceritinib with dexamethasone is necessary, due to increased dexamethasone exposure; Cushings syndrome and adrenal suppression could potentially occur with long-term use. Consider the use of corticosteroids such as beclomethasone and prednisolone, whose concentrations are less affected by strong CYP3A4 inhibitors, especially for long-term use. Ceritinib is a strong CYP3A4 inhibitor and dexamethasone is primarily metabolized by CYP3A4. Another strong CYP3A4 inhibitor has been reported to decrease the metabolism of certain corticosteroids by up to 60%, leading to increased risk of corticosteroid side effects.
Certolizumab pegol: (Moderate) The safety and efficacy of certolizumab in patients with immunosuppression have not been evaluated. Patients receiving immunosuppressives along with certolizumab may be at a greater risk of developing an infection. Many of the serious infections occurred in patients on immunosuppressive therapy who received certolizumab.
Chlorambucil: (Minor) Because systemically administered corticosteroids exhibit immunosuppressive effects when given in high doses and/or for extended periods, additive effects may be seen with other immunosuppressives or antineoplastic agents.
Chlorothiazide: (Moderate) Monitor potassium concentrations during concomitant corticosteroid and thiazide diuretic use due to risk for additive hypokalemia; potassium supplementation may be necessary. Both corticosteroids and thiazide diuretics cause increased renal potassium loss.
Chlorpheniramine; Codeine: (Moderate) Concomitant use of codeine with dexamethasone can decrease codeine levels, resulting in less metabolism by CYP2D6 and decreased morphine concentrations; this may result in decreased efficacy or onset of a withdrawal syndrome in patients who have developed physical dependence. It is recommended to avoid this combination when codeine is being used for cough. If coadministration is necessary, monitor for reduced efficacy of codeine and signs of opioid withdrawal; consider increasing the dose of codeine as needed. If dexamethasone is discontinued, consider a dose reduction of codeine and frequently monitor for signs or respiratory depression and sedation. Codeine is primarily metabolized by CYP2D6 to morphine, and by CYP3A4 to norcodeine; norcodeine does not have analgesic properties. Dexamethasone is a moderate CYP3A4 inducer.
Chlorpheniramine; Dextromethorphan; Phenylephrine: (Moderate) The therapeutic effect of phenylephrine may be increased in patient receiving corticosteroids, such as hydrocortisone. Monitor patients for increased pressor effect if these agents are administered concomitantly.
Chlorpheniramine; Dihydrocodeine; Phenylephrine: (Moderate) Concomitant use of dihydrocodeine with dexamethasone can decrease dihydrocodeine levels, resulting in less metabolism by CYP2D6 and decreased dihydromorphine concentrations; this may result in decreased efficacy or onset of a withdrawal syndrome in patients who have developed physical dependence. If coadministration is necessary, monitor for reduced efficacy of dihydrocodeine and signs of opioid withdrawal; consider increasing the dose of dihydrocodeine as needed. If dexamethasone is discontinued, consider a dose reduction of dihydrocodeine and frequently monitor for signs or respiratory depression and sedation. Dexamethasone is a moderate inducer of CYP3A4, an isoenzyme partially responsible for the metabolism of dihydrocodeine. (Moderate) The therapeutic effect of phenylephrine may be increased in patient receiving corticosteroids, such as hydrocortisone. Monitor patients for increased pressor effect if these agents are administered concomitantly.
Chlorpheniramine; Hydrocodone: (Moderate) Concomitant use of hydrocodone with dexamethasone can decrease hydrocodone levels; this may result in decreased efficacy or onset of a withdrawal syndrome in patients who have developed physical dependence. It is recommended to avoid this combination when hydrocodone is being used for cough. If coadministration is necessary, monitor for reduced efficacy of hydrocodone and signs of opioid withdrawal; consider increasing the dose of hydrocodone as needed. If dexamethasone is discontinued, consider a dose reduction of hydrocodone and frequently monitor for signs or respiratory depression and sedation. Hydrocodone is a CYP3A4 substrate and dexamethasone is a moderate CYP3A4 inducer.
Chlorpheniramine; Phenylephrine: (Moderate) The therapeutic effect of phenylephrine may be increased in patient receiving corticosteroids, such as hydrocortisone. Monitor patients for increased pressor effect if these agents are administered concomitantly.
Chlorpropamide: (Moderate) Monitor blood glucose during concomitant corticosteroid and sulfonylurea use; a sulfonylurea dose adjustment may be necessary. Corticosteroids may increase blood glucose concentrations. Risk factors for impaired glucose tolerance due to corticosteroids include the corticosteroid dose and duration of treatment. Corticosteroids stimulate hepatic glucose production and inhibit peripheral glucose uptake into muscle and fatty tissues, producing insulin resistance. Decreased insulin production may occur in the pancreas due to a direct effect on pancreatic beta cells.
Chlorthalidone: (Moderate) Monitor potassium concentrations during concomitant corticosteroid and thiazide diuretic use due to risk for additive hypokalemia; potassium supplementation may be necessary. Both corticosteroids and thiazide diuretics cause increased renal potassium loss.
Chlorthalidone; Clonidine: (Moderate) Monitor potassium concentrations during concomitant corticosteroid and thiazide diuretic use due to risk for additive hypokalemia; potassium supplementation may be necessary. Both corticosteroids and thiazide diuretics cause increased renal potassium loss.
Cholestyramine: (Moderate) Cholestyramine may increase the clearance of corticosteroids.
Choline Salicylate; Magnesium Salicylate: (Moderate) Monitor for gastrointestinal toxicity during concurrent corticosteroid and salicylate use. Concomitant use increases the risk of GI bleeding. In patients receiving concomitant corticosteroids and chronic use of salicylates, withdrawal of corticosteroids may result in salicylism because corticosteroids enhance renal clearance of salicylates and their withdrawal is followed by return to normal rates of renal clearance.
Cisapride: (Moderate) Cisapride is metabolized by the hepatic cytochrome P450 enzyme system, specifically the CYP3A4 isoenzyme. Inducers of CYP3A4, such as dexamethasone, may increase the clearance of cisapride.
Cisatracurium: (Moderate) Limit the period of use of neuromuscular blockers and corticosteroids and only use when the specific advantages of the drugs outweigh the risks for acute myopathy. An acute myopathy has been observed with the use of high doses of corticosteroids in patients receiving concomitant long-term therapy with neuromuscular blockers. Clinical improvement or recovery after stopping therapy may require weeks to years.
Clarithromycin: (Major) Coadministration of dexamethasone and clarithromycin may decrease clarithromycin serum concentrations due to CYP3A4 enzyme induction. While the 14-OH-clarithromycin active metabolite concentrations are increased, this metabolite has different antimicrobial activity compared to clarithromycin. The intended therapeutic effect of clarithromycin could be decreased. It is not clear if clarithromycin activity against other organisms would be reduced, but reduced efficacy is possible. Alternatives to clarithromycin should be considered in patients who are taking CYP3A4 inducers. Additionally, clarithromycin inhibits CYP3A4 and has the potential to result in increased plasma concentrations of dexamethasone. Increased blood concentrations and physiologic activity may necessitate a decrease in corticosteroid dosage.
Clofarabine: (Minor) Because systemically administered corticosteroids exhibit immunosuppressive effects when given in high doses and/or for extended periods, additive effects may be seen with other immunosuppressives or antineoplastic agents.
Clozapine: (Moderate) Caution is advisable during concurrent use of dexamethasone and clozapine. Dexamethasone is an inducer of CYP3A4, one of the isoenzymes responsible for the metabolism of clozapine. According to the manufacturer, patients receiving clozapine in combination with a weak to moderate CYP3A4 inducer should be monitored for loss of effectiveness. Consideration should be given to increasing the clozapine dose if necessary. Concurrent use with strong CYP3A4 inducers is not recommended. Topical corticosteroids are not likely to interact.
Cobicistat: (Major) Avoid concurrent use of dexamethasone with cobicistat containing regimens. Coadministration may result in a reduction of antiretroviral efficacy and the potential development of viral resistance. In addition, serum concentrations of dexamethasone may be increased, potentially resulting in Cushing's syndrome and adrenal suppression. Dexamethasone is a CYP3A4 substrate and inducer; cobicistat is a substrate of this enzyme as well as a strong CYP3A inhibitor. Corticosteroids, such as beclomethasone and prednisolone, whose concentrations are less affected by strong CYP3A4 inhibitors, should be considered, especially for long-term use.
Cobimetinib: (Major) Avoid the concurrent use of cobimetinib with dexamethasone due to decreased cobimetinib efficacy. Cobimetinib is a CYP3A substrate in vitro, and dexamethasone is a moderate inducer of CYP3A. Based on simulations, cobimetinib exposure would decrease by 73% when coadministered with a moderate CYP3A inducer.
Codeine: (Moderate) Concomitant use of codeine with dexamethasone can decrease codeine levels, resulting in less metabolism by CYP2D6 and decreased morphine concentrations; this may result in decreased efficacy or onset of a withdrawal syndrome in patients who have developed physical dependence. It is recommended to avoid this combination when codeine is being used for cough. If coadministration is necessary, monitor for reduced efficacy of codeine and signs of opioid withdrawal; consider increasing the dose of codeine as needed. If dexamethasone is discontinued, consider a dose reduction of codeine and frequently monitor for signs or respiratory depression and sedation. Codeine is primarily metabolized by CYP2D6 to morphine, and by CYP3A4 to norcodeine; norcodeine does not have analgesic properties. Dexamethasone is a moderate CYP3A4 inducer.
Codeine; Guaifenesin: (Moderate) Concomitant use of codeine with dexamethasone can decrease codeine levels, resulting in less metabolism by CYP2D6 and decreased morphine concentrations; this may result in decreased efficacy or onset of a withdrawal syndrome in patients who have developed physical dependence. It is recommended to avoid this combination when codeine is being used for cough. If coadministration is necessary, monitor for reduced efficacy of codeine and signs of opioid withdrawal; consider increasing the dose of codeine as needed. If dexamethasone is discontinued, consider a dose reduction of codeine and frequently monitor for signs or respiratory depression and sedation. Codeine is primarily metabolized by CYP2D6 to morphine, and by CYP3A4 to norcodeine; norcodeine does not have analgesic properties. Dexamethasone is a moderate CYP3A4 inducer.
Codeine; Guaifenesin; Pseudoephedrine: (Moderate) Concomitant use of codeine with dexamethasone can decrease codeine levels, resulting in less metabolism by CYP2D6 and decreased morphine concentrations; this may result in decreased efficacy or onset of a withdrawal syndrome in patients who have developed physical dependence. It is recommended to avoid this combination when codeine is being used for cough. If coadministration is necessary, monitor for reduced efficacy of codeine and signs of opioid withdrawal; consider increasing the dose of codeine as needed. If dexamethasone is discontinued, consider a dose reduction of codeine and frequently monitor for signs or respiratory depression and sedation. Codeine is primarily metabolized by CYP2D6 to morphine, and by CYP3A4 to norcodeine; norcodeine does not have analgesic properties. Dexamethasone is a moderate CYP3A4 inducer.
Codeine; Phenylephrine; Promethazine: (Moderate) Concomitant use of codeine with dexamethasone can decrease codeine levels, resulting in less metabolism by CYP2D6 and decreased morphine concentrations; this may result in decreased efficacy or onset of a withdrawal syndrome in patients who have developed physical dependence. It is recommended to avoid this combination when codeine is being used for cough. If coadministration is necessary, monitor for reduced efficacy of codeine and signs of opioid withdrawal; consider increasing the dose of codeine as needed. If dexamethasone is discontinued, consider a dose reduction of codeine and frequently monitor for signs or respiratory depression and sedation. Codeine is primarily metabolized by CYP2D6 to morphine, and by CYP3A4 to norcodeine; norcodeine does not have analgesic properties. Dexamethasone is a moderate CYP3A4 inducer. (Moderate) The therapeutic effect of phenylephrine may be increased in patient receiving corticosteroids, such as hydrocortisone. Monitor patients for increased pressor effect if these agents are administered concomitantly.
Codeine; Promethazine: (Moderate) Concomitant use of codeine with dexamethasone can decrease codeine levels, resulting in less metabolism by CYP2D6 and decreased morphine concentrations; this may result in decreased efficacy or onset of a withdrawal syndrome in patients who have developed physical dependence. It is recommended to avoid this combination when codeine is being used for cough. If coadministration is necessary, monitor for reduced efficacy of codeine and signs of opioid withdrawal; consider increasing the dose of codeine as needed. If dexamethasone is discontinued, consider a dose reduction of codeine and frequently monitor for signs or respiratory depression and sedation. Codeine is primarily metabolized by CYP2D6 to morphine, and by CYP3A4 to norcodeine; norcodeine does not have analgesic properties. Dexamethasone is a moderate CYP3A4 inducer.
Corticorelin, Ovine: (Major) Patients pretreated with dexamethasone have demonstrated an inhibited or blunted response to corticotropin, ovine. Patients receiving corticotropin, ovine should not be pretreated with dexamethasone; no specific guidelines are available.
Cyclosporine: (Moderate) Convulsions have been reported during concurrent use of cyclosporine and other corticosteroids. In addition, mutual inhibition of metabolism occurs with concurrent use of cyclosporine and dexamethasone; therefore, the potential for adverse events associated with either drug may be increased. Coadministration should be approached with caution.
Dabrafenib: (Major) Use dabrafenib and dexamethasone together with caution; concentrations of either agent may be decreased. Use an alternate agent in place of dexamethasone if possible. If concomitant use cannot be avoided, monitor patients for loss of dexamethasone efficacy. Dexamethasone and dabrafenib are both CYP3A4 substrates and moderate CYP3A4 inducers.
Daclatasvir: (Major) The dose of daclatasvir, a CYP3A4 substrate, must be increased to 90 mg PO once daily when administered in combination with moderate CYP3A4 inducers, such as dexamethasone. Taking these drugs together may decrease daclatasvir serum concentrations, potentially resulting in reduced antiviral efficacy and antimicrobial resistance. Conversely, the therapeutic effects of dexamethasone, a P-glycoprotein (P-gp) substrate, may be increased by daclatasvir, a P-gp inhibitor.
Dapagliflozin: (Moderate) Monitor blood glucose during concomitant corticosteroid and SGLT2 inhibitor use; a SGLT2 inhibitor dose adjustment may be necessary. Corticosteroids may increase blood glucose concentrations. Risk factors for impaired glucose tolerance due to corticosteroids include the corticosteroid dose and duration of treatment. Corticosteroids stimulate hepatic glucose production and inhibit peripheral glucose uptake into muscle and fatty tissues, producing insulin resistance. Decreased insulin production may occur in the pancreas due to a direct effect on pancreatic beta cells.
Dapagliflozin; Metformin: (Moderate) Monitor blood glucose during concomitant corticosteroid and metformin use; a metformin dose adjustment may be necessary. Corticosteroids may increase blood glucose concentrations. Risk factors for impaired glucose tolerance due to corticosteroids include the corticosteroid dose and duration of treatment. Corticosteroids stimulate hepatic glucose production and inhibit peripheral glucose uptake into muscle and fatty tissues, producing insulin resistance. Decreased insulin production may occur in the pancreas due to a direct effect on pancreatic beta cells. (Moderate) Monitor blood glucose during concomitant corticosteroid and SGLT2 inhibitor use; a SGLT2 inhibitor dose adjustment may be necessary. Corticosteroids may increase blood glucose concentrations. Risk factors for impaired glucose tolerance due to corticosteroids include the corticosteroid dose and duration of treatment. Corticosteroids stimulate hepatic glucose production and inhibit peripheral glucose uptake into muscle and fatty tissues, producing insulin resistance. Decreased insulin production may occur in the pancreas due to a direct effect on pancreatic beta cells.
Dapagliflozin; Saxagliptin: (Moderate) Monitor blood glucose during concomitant corticosteroid and SGLT2 inhibitor use; a SGLT2 inhibitor dose adjustment may be necessary. Corticosteroids may increase blood glucose concentrations. Risk factors for impaired glucose tolerance due to corticosteroids include the corticosteroid dose and duration of treatment. Corticosteroids stimulate hepatic glucose production and inhibit peripheral glucose uptake into muscle and fatty tissues, producing insulin resistance. Decreased insulin production may occur in the pancreas due to a direct effect on pancreatic beta cells.
Dapsone: (Moderate) Closely monitor for a reduction in dapsone efficacy and signs of hemolytic anemia if coadministration with dexamethasone is necessary. Dapsone is a CYP3A4 substrate and dexamethasone is a moderate CYP3A4 inducer. Coadministration may decrease plasma concentrations of dapsone and increase the formation of dapsone hydroxylamine (a metabolite associated with hemolysis).
Daridorexant: (Major) Avoid concomitant use of daridorexant and dexamethasone. Coadministration may decrease daridorexant exposure which may reduce its efficacy. Daridorexant is a CYP3A substrate and dexamethasone is a moderate CYP3A inducer. Concomitant use of another moderate CYP3A inducer decreased daridorexant overall exposure by over 50%.
Darunavir: (Major) Avoid concurrent use of darunavir with dexamethasone. Coadministration may result in a reduction of antiretroviral efficacy and the potential development of viral resistance to darunavir; consider use of an alternative corticosteroid. In addition, serum concentrations of dexamethasone may be increased, potentially resulting in Cushing's syndrome and adrenal suppression. Dexamethasone is a CYP3A4 substrate and inducer; darunavir is a substrate of this enzyme as well as a strong CYP3A inhibitor. Corticosteroids, such as beclomethasone and prednisolone, whose concentrations are less affected by strong CYP3A4 inhibitors, should be considered, especially for long-term use.
Darunavir; Cobicistat: (Major) Avoid concurrent use of darunavir with dexamethasone. Coadministration may result in a reduction of antiretroviral efficacy and the potential development of viral resistance to darunavir; consider use of an alternative corticosteroid. In addition, serum concentrations of dexamethasone may be increased, potentially resulting in Cushing's syndrome and adrenal suppression. Dexamethasone is a CYP3A4 substrate and inducer; darunavir is a substrate of this enzyme as well as a strong CYP3A inhibitor. Corticosteroids, such as beclomethasone and prednisolone, whose concentrations are less affected by strong CYP3A4 inhibitors, should be considered, especially for long-term use. (Major) Avoid concurrent use of dexamethasone with cobicistat containing regimens. Coadministration may result in a reduction of antiretroviral efficacy and the potential development of viral resistance. In addition, serum concentrations of dexamethasone may be increased, potentially resulting in Cushing's syndrome and adrenal suppression. Dexamethasone is a CYP3A4 substrate and inducer; cobicistat is a substrate of this enzyme as well as a strong CYP3A inhibitor. Corticosteroids, such as beclomethasone and prednisolone, whose concentrations are less affected by strong CYP3A4 inhibitors, should be considered, especially for long-term use.
Darunavir; Cobicistat; Emtricitabine; Tenofovir alafenamide: (Major) Avoid concurrent use of darunavir with dexamethasone. Coadministration may result in a reduction of antiretroviral efficacy and the potential development of viral resistance to darunavir; consider use of an alternative corticosteroid. In addition, serum concentrations of dexamethasone may be increased, potentially resulting in Cushing's syndrome and adrenal suppression. Dexamethasone is a CYP3A4 substrate and inducer; darunavir is a substrate of this enzyme as well as a strong CYP3A inhibitor. Corticosteroids, such as beclomethasone and prednisolone, whose concentrations are less affected by strong CYP3A4 inhibitors, should be considered, especially for long-term use. (Major) Avoid concurrent use of dexamethasone with cobicistat containing regimens. Coadministration may result in a reduction of antiretroviral efficacy and the potential development of viral resistance. In addition, serum concentrations of dexamethasone may be increased, potentially resulting in Cushing's syndrome and adrenal suppression. Dexamethasone is a CYP3A4 substrate and inducer; cobicistat is a substrate of this enzyme as well as a strong CYP3A inhibitor. Corticosteroids, such as beclomethasone and prednisolone, whose concentrations are less affected by strong CYP3A4 inhibitors, should be considered, especially for long-term use.
Dasabuvir; Ombitasvir; Paritaprevir; Ritonavir: (Contraindicated) Concurrent administration of dexamethasone with dasabuvir; ombitasvir; paritaprevir; ritonavir is contraindicated. Taking these drugs together could result in elevated dexamethasone plasma concentrations and decreased concentrations of dasabuvir, paritaprevir, and ritonavir. Antiviral efficacy could be affected. Dexamethasone is a P-glycoprotein (P-gp) substrate and a CYP3A4 substrate/inducer. Ritonavir is a P-gp inhibitor and a CYP3A4 substrate/potent inhibitor. Both paritaprevir and dasabuvir (minor) are CYP3A4 substrates. (Contraindicated) Concurrent administration of dexamethasone with dasabuvir; ombitasvir; paritaprevir; ritonavir or ombitasvir; paritaprevir; ritonavir is contraindicated. Taking these drugs together could result in elevated dexamethasone plasma concentrations and decreased concentrations of dasabuvir, paritaprevir, and ritonavir. Antiviral efficacy could be affected. Dexamethasone is a P-glycoprotein (P-gp) substrate and a CYP3A4 substrate/inducer. Ritonavir is a P-gp inhibitor and a CYP3A4 substrate/potent inhibitor. Both paritaprevir and dasabuvir (minor) are CYP3A4 substrates. (Moderate) Close monitoring of therapeutic and adverse effects is required when dexamethasone is coadministered with ritonavir. Ritonavir inhibits CYP3A4 and dexamethasone is a CYP3A4 substrate.
Deferasirox: (Moderate) Because gastric ulceration and GI bleeding have been reported in patients taking deferasirox, use caution when coadministering with other drugs known to increase the risk of peptic ulcers or gastric hemorrhage including corticosteroids.
Deflazacort: (Major) Avoid concomitant use of deflazacort and dexamethasone. Concurrent use may significantly decrease concentrations of 21-desDFZ, the active metabolite of deflazacort, resulting in loss of efficacy. Deflazacort is a CYP3A4 substrate; dexamethasone is a moderate inducer of CYP3A4. Administration of deflazacort with multiple doses of rifampin (a strong CYP3A4 inducer) resulted in geometric mean exposures that were approximately 95% lower compared to administration alone.
Delavirdine: (Minor) Since dexamethasone may induce metabolism of delavirdine, concomitant use of these agents should be done with caution. Delavirdine therapy may be less effective due to decreased plasma levels in patients taking these drugs concomitantly.
Denileukin Diftitox: (Minor) Because systemically administered corticosteroids exhibit immunosuppressive effects when given in high doses and/or for extended periods, additive effects may be seen with other immunosuppressives or antineoplastic agents.
Denosumab: (Moderate) The safety and efficacy of denosumab use in patients with immunosuppression have not been evaluated. Patients receiving immunosuppressives along with denosumab may be at a greater risk of developing an infection.
Desmopressin: (Major) Desmopressin is contraindicated with concomitant inhaled or systemic corticosteroid use due to an increased risk of hyponatremia. Desmopressin can be started or resumed 3 days or 5 half-lives after the corticosteroid is discontinued, whichever is longer.
Dextromethorphan; Bupropion: (Moderate) Monitor for seizure activity during concomitant bupropion and corticosteroid use. Bupropion is associated with a dose-related seizure risk; concomitant use of other medications that lower the seizure threshold, such as systemic corticosteroids, increases the seizure risk.
Dextromethorphan; Diphenhydramine; Phenylephrine: (Moderate) The therapeutic effect of phenylephrine may be increased in patient receiving corticosteroids, such as hydrocortisone. Monitor patients for increased pressor effect if these agents are administered concomitantly.
Dextromethorphan; Guaifenesin; Phenylephrine: (Moderate) The therapeutic effect of phenylephrine may be increased in patient receiving corticosteroids, such as hydrocortisone. Monitor patients for increased pressor effect if these agents are administered concomitantly.
Dextromethorphan; Quinidine: (Moderate) Quinidine is a substrate of the CYP3A4 isoenzyme. Inducers of CYP3A4 such as dexamethasone may increase hepatic elimination of quinidine with the potential for reduced efficacy of quinidine.
Dipeptidyl Peptidase-4 Inhibitors: (Moderate) Monitor blood glucose during concomitant corticosteroid and dipeptidyl peptidase-4 (DPP-4) inhibitor use; a DPP-4 dose adjustment may be necessary. Corticosteroids may increase blood glucose concentrations. Risk factors for impaired glucose tolerance due to corticosteroids include the corticosteroid dose and duration of treatment. Corticosteroids stimulate hepatic glucose production and inhibit peripheral glucose uptake into muscle and fatty tissues, producing insulin resistance. Decreased insulin production may occur in the pancreas due to a direct effect on pancreatic beta cells.
Diphenhydramine; Phenylephrine: (Moderate) The therapeutic effect of phenylephrine may be increased in patient receiving corticosteroids, such as hydrocortisone. Monitor patients for increased pressor effect if these agents are administered concomitantly.
Dofetilide: (Major) Corticosteroids can cause increases in blood pressure, sodium and water retention, and hypokalemia, predisposing patients to interactions with certain other medications. Corticosteroid-induced hypokalemia could also enhance the proarrhythmic effects of dofetilide.
Dolutegravir; Rilpivirine: (Contraindicated) Concurrent use of dexamethasone (more than 1 dose) and rilpivirine is contraindicated. When these drugs are coadministered, there is a potential for treatment failure and/or the development of rilpivirine or NNRTI resistance. Dexamethasone is an inducer of CYP3A4, which is primarily responsible for the metabolism of rilpivirine. Coadministration may result in decreased rilpivirine serum concentrations, which could cause impaired virologic response to rilpivirine.
Doravirine: (Moderate) Concurrent administration of doravirine and dexamethasone may result in decreased doravirine exposure, resulting in potential loss of virologic control. Doravirine is a CYP3A4 substrate; dexamethasone is a moderate CYP3A4 inducer.
Doravirine; Lamivudine; Tenofovir disoproxil fumarate: (Moderate) Concurrent administration of doravirine and dexamethasone may result in decreased doravirine exposure, resulting in potential loss of virologic control. Doravirine is a CYP3A4 substrate; dexamethasone is a moderate CYP3A4 inducer.
Doxacurium: (Moderate) Limit the period of use of neuromuscular blockers and corticosteroids and only use when the specific advantages of the drugs outweigh the risks for acute myopathy. An acute myopathy has been observed with the use of high doses of corticosteroids in patients receiving concomitant long-term therapy with neuromuscular blockers. Clinical improvement or recovery after stopping therapy may require weeks to years.
Dronabinol: (Moderate) Use caution if coadministration of dronabinol with dexamethasone is necessary, and monitor for a decrease in the efficacy of dronabinol. Dronabinol is a CYP2C9 and 3A4 substrate; dexamethasone is a moderate inducer of CYP3A4. Concomitant use may result in decreased plasma concentrations of dronabinol.
Dronedarone: (Major) The concomitant use of dronedarone and CYP3A4 inducers should be avoided. Dronedarone is metabolized by CYP3A and is an inhibitor of CYP3A and P-gp. Dexamethasone induces CYP3A4 and is a substrate for CYP3A4 and P-gp. Coadministration of CYP3A4 inducers, such as dexamethasone, with dronedarone may result in reduced plasma concentration and subsequent reduced effectiveness of dronedarone therapy; the plasma concentrations of dexamethasone may also be increased.
Droperidol: (Moderate) Caution is advised when using droperidol in combination with corticosteroids which may lead to electrolyte abnormalities, especially hypokalemia or hypomagnesemia, as such abnormalities may increase the risk for QT prolongation or cardiac arrhythmias.
Dulaglutide: (Moderate) Monitor blood glucose during concomitant corticosteroid and incretin mimetic use; an incretin mimetic dose adjustment may be necessary. Corticosteroids may increase blood glucose concentrations. Risk factors for impaired glucose tolerance due to corticosteroids include the corticosteroid dose and duration of treatment. Corticosteroids stimulate hepatic glucose production and inhibit peripheral glucose uptake into muscle and fatty tissues, producing insulin resistance. Decreased insulin production may occur in the pancreas due to a direct effect on pancreatic beta cells.
Duvelisib: (Major) Avoid concomitant use of duvelisib with dexamethasone. Coadministration may decrease the exposure of duvelisib, which may reduce the efficacy of duvelisib. If concomitant use is necessary, increase the dose of duvelisib on day 12 of coadministration from 25 mg PO twice daily to 40 mg PO twice daily; or from 15 mg PO twice daily to 25 mg PO twice daily. When dexamethasone has been discontinued for at least 14 days, resume duvelisib at the dose taken prior to initiating treatment with dexamethasone. Duvelisib is a CYP3A substrate; dexamethasone is a moderate CYP3A inducer. Coadministration of duvelisib with another moderate CYP3A inducer for 12 days decreased duvelisib exposure by 35%.
Echinacea: (Moderate) Echinacea possesses immunostimulatory activity and may theoretically reduce the response to immunosuppressant drugs like corticosteroids. For some patients who are using corticosteroids for serious illness, such as cancer or organ transplant, this potential interaction may result in the preferable avoidance of Echinacea. Although documentation is lacking, coadministration of echinacea with immunosuppressants is not recommended by some resources.
Econazole: (Minor) In vitro studies indicate that corticosteroids inhibit the antifungal activity of econazole against C. albicans in a concentration-dependent manner. When the concentration of the corticosteroid was equal to or greater than that of econazole on a weight basis, the antifungal activity of econazole was substantially inhibited. When the corticosteroid concentration was one-tenth that of econazole, no inhibition of antifungal activity was observed.
Elacestrant: (Major) Avoid concurrent use of elacestrant and dexamethasone due to the risk of decreased elacestrant exposure which may reduce its efficacy. Elacestrant is a CYP3A substrate and dexamethasone is a moderate CYP3A inducer. Concomitant use with another moderate CYP3A inducer reduced elacestrant overall exposure by 55% to 73%.
Elagolix: (Moderate) Monitor for decreased efficacy of dexamethasone if coadministration with elagolix is necessary; consider increasing the dose of dexamethasone if clinically appropriate. Dexamethasone is a CYP3A4 substrate and elagolix is a weak to moderate CYP3A4 inducer.
Elagolix; Estradiol; Norethindrone acetate: (Moderate) Monitor for decreased efficacy of dexamethasone if coadministration with elagolix is necessary; consider increasing the dose of dexamethasone if clinically appropriate. Dexamethasone is a CYP3A4 substrate and elagolix is a weak to moderate CYP3A4 inducer.
Elbasvir; Grazoprevir: (Major) If possible, avoid concurrent administration of elbasvir with dexamethasone. Dexamethasone is a moderate CYP3A inducer, while elbasvir is a substrate of CYP3A. Use of these drugs together is expected to decrease the plasma concentrations of elbasvir, and may result in decreased virologic response. (Major) If possible, avoid concurrent administration of grazoprevir with dexamethasone. Dexamethasone is a moderate CYP3A inducer, while grazoprevir is a substrate of CYP3A. Use of these drugs together is expected to decrease the plasma concentrations of grazoprevir, and may result in decreased virologic response. Conversely, concentrations of dexamethasone (also a CYP3A substrate) may be increased when given with grazoprevir (a weak CYP3A inhibitor).
Eliglustat: (Moderate) Coadministration of dexamethasone and eliglustat may result in increased plasma concentrations of dexamethasone. Monitor patients closely for corticosteroid-related adverse effects; if appropriate, consider reducing the dexamethasone dosage and titrating to clinical effect. Dexamethasone is a P-glycoprotein (P-gp) substrate; eliglustat is a P-gp inhibitor.
Elvitegravir; Cobicistat; Emtricitabine; Tenofovir Alafenamide: (Major) Avoid concurrent use of dexamethasone with cobicistat containing regimens. Coadministration may result in a reduction of antiretroviral efficacy and the potential development of viral resistance. In addition, serum concentrations of dexamethasone may be increased, potentially resulting in Cushing's syndrome and adrenal suppression. Dexamethasone is a CYP3A4 substrate and inducer; cobicistat is a substrate of this enzyme as well as a strong CYP3A inhibitor. Corticosteroids, such as beclomethasone and prednisolone, whose concentrations are less affected by strong CYP3A4 inhibitors, should be considered, especially for long-term use. (Major) Avoid concurrent use of dexamethasone with elvitegravir. Coadministration may result in a reduction of antiretroviral efficacy and the potential development of viral resistance to elvitegravir; consider use of an alternative corticosteroid, such as beclomethasone and prednisolone. Dexamethasone induces CYP3A4, and elvitegravir is a substrate of this enzyme.
Elvitegravir; Cobicistat; Emtricitabine; Tenofovir Disoproxil Fumarate: (Major) Avoid concurrent use of dexamethasone with cobicistat containing regimens. Coadministration may result in a reduction of antiretroviral efficacy and the potential development of viral resistance. In addition, serum concentrations of dexamethasone may be increased, potentially resulting in Cushing's syndrome and adrenal suppression. Dexamethasone is a CYP3A4 substrate and inducer; cobicistat is a substrate of this enzyme as well as a strong CYP3A inhibitor. Corticosteroids, such as beclomethasone and prednisolone, whose concentrations are less affected by strong CYP3A4 inhibitors, should be considered, especially for long-term use. (Major) Avoid concurrent use of dexamethasone with elvitegravir. Coadministration may result in a reduction of antiretroviral efficacy and the potential development of viral resistance to elvitegravir; consider use of an alternative corticosteroid, such as beclomethasone and prednisolone. Dexamethasone induces CYP3A4, and elvitegravir is a substrate of this enzyme.
Empagliflozin: (Moderate) Monitor blood glucose during concomitant corticosteroid and SGLT2 inhibitor use; a SGLT2 inhibitor dose adjustment may be necessary. Corticosteroids may increase blood glucose concentrations. Risk factors for impaired glucose tolerance due to corticosteroids include the corticosteroid dose and duration of treatment. Corticosteroids stimulate hepatic glucose production and inhibit peripheral glucose uptake into muscle and fatty tissues, producing insulin resistance. Decreased insulin production may occur in the pancreas due to a direct effect on pancreatic beta cells.
Empagliflozin; Linagliptin: (Moderate) Monitor blood glucose during concomitant corticosteroid and SGLT2 inhibitor use; a SGLT2 inhibitor dose adjustment may be necessary. Corticosteroids may increase blood glucose concentrations. Risk factors for impaired glucose tolerance due to corticosteroids include the corticosteroid dose and duration of treatment. Corticosteroids stimulate hepatic glucose production and inhibit peripheral glucose uptake into muscle and fatty tissues, producing insulin resistance. Decreased insulin production may occur in the pancreas due to a direct effect on pancreatic beta cells.
Empagliflozin; Linagliptin; Metformin: (Moderate) Monitor blood glucose during concomitant corticosteroid and metformin use; a metformin dose adjustment may be necessary. Corticosteroids may increase blood glucose concentrations. Risk factors for impaired glucose tolerance due to corticosteroids include the corticosteroid dose and duration of treatment. Corticosteroids stimulate hepatic glucose production and inhibit peripheral glucose uptake into muscle and fatty tissues, producing insulin resistance. Decreased insulin production may occur in the pancreas due to a direct effect on pancreatic beta cells. (Moderate) Monitor blood glucose during concomitant corticosteroid and SGLT2 inhibitor use; a SGLT2 inhibitor dose adjustment may be necessary. Corticosteroids may increase blood glucose concentrations. Risk factors for impaired glucose tolerance due to corticosteroids include the corticosteroid dose and duration of treatment. Corticosteroids stimulate hepatic glucose production and inhibit peripheral glucose uptake into muscle and fatty tissues, producing insulin resistance. Decreased insulin production may occur in the pancreas due to a direct effect on pancreatic beta cells.
Empagliflozin; Metformin: (Moderate) Monitor blood glucose during concomitant corticosteroid and metformin use; a metformin dose adjustment may be necessary. Corticosteroids may increase blood glucose concentrations. Risk factors for impaired glucose tolerance due to corticosteroids include the corticosteroid dose and duration of treatment. Corticosteroids stimulate hepatic glucose production and inhibit peripheral glucose uptake into muscle and fatty tissues, producing insulin resistance. Decreased insulin production may occur in the pancreas due to a direct effect on pancreatic beta cells. (Moderate) Monitor blood glucose during concomitant corticosteroid and SGLT2 inhibitor use; a SGLT2 inhibitor dose adjustment may be necessary. Corticosteroids may increase blood glucose concentrations. Risk factors for impaired glucose tolerance due to corticosteroids include the corticosteroid dose and duration of treatment. Corticosteroids stimulate hepatic glucose production and inhibit peripheral glucose uptake into muscle and fatty tissues, producing insulin resistance. Decreased insulin production may occur in the pancreas due to a direct effect on pancreatic beta cells.
Emtricitabine; Rilpivirine; Tenofovir alafenamide: (Contraindicated) Concurrent use of dexamethasone (more than 1 dose) and rilpivirine is contraindicated. When these drugs are coadministered, there is a potential for treatment failure and/or the development of rilpivirine or NNRTI resistance. Dexamethasone is an inducer of CYP3A4, which is primarily responsible for the metabolism of rilpivirine. Coadministration may result in decreased rilpivirine serum concentrations, which could cause impaired virologic response to rilpivirine.
Emtricitabine; Rilpivirine; Tenofovir Disoproxil Fumarate: (Contraindicated) Concurrent use of dexamethasone (more than 1 dose) and rilpivirine is contraindicated. When these drugs are coadministered, there is a potential for treatment failure and/or the development of rilpivirine or NNRTI resistance. Dexamethasone is an inducer of CYP3A4, which is primarily responsible for the metabolism of rilpivirine. Coadministration may result in decreased rilpivirine serum concentrations, which could cause impaired virologic response to rilpivirine.
Enalapril; Hydrochlorothiazide, HCTZ: (Moderate) Monitor potassium concentrations during concomitant corticosteroid and thiazide diuretic use due to risk for additive hypokalemia; potassium supplementation may be necessary. Both corticosteroids and thiazide diuretics cause increased renal potassium loss.
Encorafenib: (Major) Avoid coadministration of encorafenib and dexamethasone due to decreased encorafenib exposure and potential loss of efficacy. Encorafenib is a CYP3A4 substrate; dexamethasone is a moderate CYP3A4 inducer. Coadministration with CYP3A4 inducers has not been studied with encorafenib; however, in clinical trials, steady-state encorafenib exposures were lower than encorafenib exposures after the first dose, suggesting CYP3A4 auto-induction.
Entrectinib: (Major) Avoid coadministration of entrectinib with dexamethasone due to decreased entrectinib exposure and risk of decreased efficacy. Entrectinib is a CYP3A4 substrate; dexamethasone is a moderate CYP3A4 inducer. Coadministration of a moderate CYP3A4 inducer is predicted to reduce the entrectinib AUC by 56%.
Enzalutamide: (Moderate) Monitor for decreased efficacy of dexamethasone if coadministration with enzalutamide is necessary; consider increasing the dose of dexamethasone if clinically appropriate. Dexamethasone is a CYP3A4 substrate and enzalutamide is a strong CYP3A4 inducer.
Ephedrine: (Moderate) Ephedrine may enhance the metabolic clearance of corticosteroids. Decreased blood concentrations and lessened physiologic activity may necessitate an increase in corticosteroid dosage.
Ephedrine; Guaifenesin: (Moderate) Ephedrine may enhance the metabolic clearance of corticosteroids. Decreased blood concentrations and lessened physiologic activity may necessitate an increase in corticosteroid dosage.
Epinephrine: (Moderate) Monitor potassium concentrations during concomitant corticosteroid and epinephrine use due to risk for additive hypokalemia; potassium supplementation may be necessary. Corticosteroids may potentiate the hypokalemic effects of epinephrine.
Eprosartan; Hydrochlorothiazide, HCTZ: (Moderate) Monitor potassium concentrations during concomitant corticosteroid and thiazide diuretic use due to risk for additive hypokalemia; potassium supplementation may be necessary. Both corticosteroids and thiazide diuretics cause increased renal potassium loss.
Erdafitinib: (Major) If coadministration of erdafitinib and dexamethasone is necessary at the initiation of erdafitinib therapy, administer the dose of erdafitinib as recommended (8 mg once daily with potential to increase the dose to 9 mg on days 14 to 21 based on phosphate levels and tolerability). If dexamethasone must be added to erdafitinib therapy after the initial dose inc