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  • CLASSES

    Ophthalmological Corticosteroid and Anti-infective Combinations

    DEA CLASS

    Rx

    DESCRIPTION

    Ophthalmic suspension or ointment for inflammatory and antibacterial combination
    Used for inflammatory conditions of the eyes where there is high risk of infection or where infection coexists

    COMMON BRAND NAMES

    AK-Trol, Dexacidin, Dexasporin, Gatol, Maxitrol, Methadex, NeoPolyDex, Ocu-Trol, Poly-Dex

    HOW SUPPLIED

    AK-Trol/Dexacidin/Dexamethasone, Neomycin, Polymyxin B/Dexasporin/Gatol/Maxitrol/Methadex/NeoPolyDex/Ocu-Trol/Poly-Dex Ophthalmic Susp: 1mL, 0.1-3.5-10000U
    AK-Trol/Dexamethasone, Neomycin, Polymyxin B/Maxitrol/NeoPolyDex/Ocu-Trol/Poly-Dex Ophthalmic Ointment: 1g, 0.1-3.5-10000U

    DOSAGE & INDICATIONS

    For steroid-responsive inflammatory ocular inflammation conditions (e.g., uveitis, bacterial conjunctivitis, corneal abrasion) for which a corticosteroid is indicated and where bacterial infection or a risk of bacterial ocular infection exists.
    NOTE: Ocular steroids are indicated in inflammatory conditions of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the globe where the inherent risk of steroid use in certain infective conjunctivitides is accepted to obtain a diminution in edema and inflammation. They are also indicated in chronic anterior uveitis and corneal injury from chemical, radiation or thermal burns; or penetration of foreign bodies.
    Ophthalmic dosage (ophthalmic suspension)
    Adults

    For treatment of severe disease, instill 1 to 2 drops topically into the conjunctival sac of the affected eye(s) every hour; in mild disease, instill 1 to 2 drops every 4 to 6 hours. Re-evaluate patient if signs and symptoms do not improve after 48 hours of treatment. Withdrawal therapy gradually by tapering to discontinuation as inflammation subsides. Prescribe no more than a total of 20 mL initially; examination by physician is recommended prior to renewal of medication.

    Children and Adolescents 2 to 17 years

    For treatment of severe disease, instill 1 to 2 drops topically into the conjunctival sac of the affected eye(s) every hour; in mild disease, instill 1 to 2 drops every 4 to 6 hours. Re-evaluate patient if signs and symptoms do not improve after 48 hours of treatment. Withdrawal therapy gradually by tapering to discontinuation as inflammation subsides. Prescribe no more than a total of 20 mL initially; examination by physician is recommended prior to renewal of medication.

    Ophthalmic dosage (ophthalmic ointment)
    Adults

    Apply 1/2 inch ribbon of ointment topically into the conjunctival sac of the affected eye(s) 3 to 4 times daily. If used adjunctively with suspension formulation, apply 1/2 inch ribbon of ointment topically at bedtime. Prescribe no more than a total of 8 g initially; examination by physician is recommended prior to renewal of medication.

    Children and Adolescents 2 to 17 years†

    Safety and efficacy have not been established. However, the ointment is commonly used off-label when needed in clinical practice at doses similar to adults, and pediatric use is described in European product literature.

    MAXIMUM DOSAGE

    Adults

    48 drops/day per affected eye of the suspension (dispense no more than 20 mL without re-evaluation); 1/2 inch ointment per affected eye up to four times daily (dispense no more than 8 grams without re-evaluation).

    Geriatric

    48 drops/day per affected eye of the suspension (dispense no more than 20 mL without re-evaluation); 1/2 inch ointment per affected eye up to four times daily (dispense no more than 8 grams without re-evaluation).

    Adolescents

    48 drops/day per affected eye of the suspension (dispense no more than 20 mL without re-evaluation); 1/2 inch ointment per affected eye up to four times daily (dispense no more than 8 grams without re-evaluation).

    Children

    2 years and older: 48 drops/day per affected eye of the suspension (dispense no more than 20 mL without re-evaluation); 1/2 inch ointment per affected eye up to four times daily (dispense no more than 8 grams without re-evaluation).
    less than 2 years: Safety and efficacy have not been established.

    Infants

    Safety and efficacy have not been established.

    Neonates

    Safety and efficacy have not been established.

    DOSING CONSIDERATIONS

    Hepatic Impairment

    No dosage adjustments are needed.

    Renal Impairment

    No dosage adjustments are needed.

    ADMINISTRATION

    Ophthalmic Administration

    Ophthalmic Suspension:
    Neomycin; polymyxin B; dexamethasone suspension is indicated for topical administration to the eye; do NOT administer parenterally.
    Instruct patient on proper instillation of eye solution and suspension.
    Wash hands before and after use.
    Do not touch the tip of the dropper to the eye, fingertips, or other surface to prevent contamination.
    Shake suspension well prior to each use.
    Tilt the head back slightly and pull the lower eyelid down with the index finger to form a pouch. Squeeze the prescribed number of drops into the pouch. Close eyes to spread drops. To avoid excessive systemic absorption, apply finger pressure on the lacrimal sac for 1 to 2 minutes following application to the eye.
    To avoid contamination or the spread of infection, do not use dropper for more than one person.
     
    Ophthalmic Ointment:
    Instruct patient on proper application of eye ointment.
    Do not touch the tip of the tube to the eye, fingertips, or other surface to prevent contamination.
    Wash hands before and after use.
    Tilt the head back slightly and pull the lower eyelid down with the index finger to form a pouch. Place a small amount (about one-half of an inch) of the ointment into the pouch. Look downward before closing eyes.
    To avoid contamination or the spread of infection, do not use tube for more than one person.

    STORAGE

    AK-Trol:
    - Store at controlled room temperature (between 68 and 77 degrees F)
    Dexacidin:
    - Store at room temperature (between 59 to 86 degrees F)
    Dexasporin:
    - Store at room temperature (between 59 to 86 degrees F)
    Gatol:
    - Store at room temperature (between 59 to 86 degrees F)
    Maxitrol:
    - Store between 36 to 77 degrees F
    Methadex :
    - Store at room temperature (between 59 to 86 degrees F)
    NeoPolyDex:
    - Store at controlled room temperature (between 68 and 77 degrees F)
    Ocu-Trol:
    - Store at controlled room temperature (between 68 and 77 degrees F)
    Poly-Dex:
    - Store at controlled room temperature (between 68 and 77 degrees F)

    CONTRAINDICATIONS / PRECAUTIONS

    General Information

    NOTE: This monograph discusses the use of neomycin, polymyxin B, dexamethasone in combination for inflammatory conditions of the eyes. Clinicians may wish to consult the individual monographs for more information about specific contraindications and precautions of each agent.

    Fungal infection, herpes simplex keratitis (dendritic keratitis), mycobacterial infection, varicella, viral infection

    Neomycin; polymyxin B; dexamethasone ophthalmic products are only indicated for the treatment of ocular inflammatory conditions in the presence of, or with the possible risk of, superficial bacterial infection. These products are contraindicated in patients with an ocular viral infection such as epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, and varicella. In addition, neomycin; polymyxin B; dexamethasone is contraindicated in the presence of an ocular fungal infection or mycobacterial infection.

    Aminoglycoside hypersensitivity, corticosteroid hypersensitivity, neomycin hypersensitivity, polymyxin hypersensitivity

    Avoid neomycin; polymyxin B; dexamethasone in patients with a known or suspected allergy to any component of the medication. This precaution includes patients with corticosteroid hypersensitivity, aminoglycoside hypersensitivity (including neomycin hypersensitivity), and/or polymyxin hypersensitivity. According to the manufacturer, allergies to the antibiotic components occur with greater frequency than other components within the formulation. Instruct patients to discontinue treatment if signs of hypersensitivity occur. Cross-hypersensitivity to other aminoglycosides can occur; therefore, patients who become sensitized to topical neomycin may also be sensitive to other topical and/or systemic aminoglycosides.

    Cataracts, glaucoma, herpes infection, increased intraocular pressure, ocular infection, ocular surgery, visual disturbance

    It is recommended to monitor intraocular pressure frequently in patients at risk for increased ocular pressure from corticosteroid use. Use caution when administering neomycin; polymyxin B; dexamethasone to patients with preexisting glaucoma as prolonged use may result in an increased intraocular pressure. Prolonged use of neomycin; polymyxin B; dexamethasone in any patient may lead to optic nerve damage, visual disturbance, and the development of posterior subcapsular cataracts. Topically applied corticosteroids, such as dexamethasone, have caused corneal and scleral thinning; thus, patients with preexisting thin corneal or scleral tissue may experience perforation following treatment with neomycin; polymyxin B; dexamethasone. Neomycin; polymyxin B; dexamethasone could delay healing in patients undergoing an ocular surgery and may increase the risk of developing a secondary ocular infection; administer this medication with great caution in patients with a herpes infection history. Acute purulent or parasitic infections of the eye may be masked or activity may be enhanced by the presence of corticosteroids.

    Abrupt discontinuation, corticosteroid withdrawal

    Avoid abrupt discontinuation of neomycin; polymyxin B; dexamethasone to prevent corticosteroid withdrawal and rebound inflammation. Discontinuation of therapy is achieved by gradual tapering as the inflammation subsides.

    Intramuscular administration, intravenous administration

    Neomycin; polymyxin B; dexamethasone products are only indicated for topical administration to the eyes. Take measures to prevent intravenous administration and intramuscular administration.

    Children, infants, neonates

    The safety and efficacy of neomycin; polymyxin B; dexamethasone ophthalmic products have not been established in neonates, infants, or children less than 2 years of age.

    Pregnancy

    No adequate studies in pregnant women are available with neomycin; polymyxin B; dexamethasone. In animal studies, ophthalmic administration of corticosteroids, such as dexamethasone, have been shown to be teratogenic in rabbits and mice. In mice, corticosteroids resulted in fetal resorption and an increased incidence of cleft palate; rabbits receiving corticosteroids experienced fetal resorption and abnormalities involving the head, ears, limbs, and palate. Administer neomycin; polymyxin B; dexamethasone during pregnancy only when the benefits clearly outweigh the potential risk to the fetus. Consider monitoring for signs of hypoadrenalism in infants born to mothers who received substantial doses during pregnancy.

    Breast-feeding

    Neomycin; polymyxin B; dexamethasone ophthalmic formulations may be used with caution during breast-feeding. According to the manufacturer, it is not known if ophthalmic administered dexamethasone is detectable in human milk; however, systemically administered corticosteroids do appear in human milk and may suppress infant growth and endogenous corticosteroid production. Topically applied dexamethasone to the eye in the mother is unlikely to cause significant concern to the infant with limited dosage and duration of use. Neomycin and polymyxin B are both poorly absorbed orally, so whatever minor systemic exposure may occur maternally would be unlikely to cause infant harm during nursing. Short term use of usual moderate ocular doses for milder eye conditions probably poses little risk to the nursing infant. Consider the benefits of breast-feeding, the risk of potential infant drug exposure, and the risk of an untreated or inadequately treated condition. If a breast-feeding infant experiences an adverse effect related to maternally administered neomycin; polymyxin B; dexamethasone, health care providers are encouraged to report the adverse effect to the FDA.

    Contact lenses

    Patients with signs and symptoms of a bacterial ocular infection should not wear contact lenses.

    ADVERSE REACTIONS

    Severe

    ocular hypertension / Delayed / 0-1.0
    keratitis / Delayed / Incidence not known
    Stevens-Johnson syndrome / Delayed / Incidence not known
    anaphylactoid reactions / Rapid / Incidence not known

    Moderate

    cataracts / Delayed / Incidence not known
    conjunctivitis / Delayed / Incidence not known
    conjunctival hyperemia / Early / Incidence not known
    impaired wound healing / Delayed / Incidence not known
    superinfection / Delayed / Incidence not known
    ocular infection / Delayed / Incidence not known
    bullous rash / Early / Incidence not known
    erythema / Early / Incidence not known
    Cushing's syndrome / Delayed / Incidence not known

    Mild

    ocular pruritus / Rapid / Incidence not known
    ocular irritation / Rapid / Incidence not known
    pruritus / Rapid / Incidence not known
    urticaria / Rapid / Incidence not known
    rash / Early / Incidence not known
    headache / Early / Incidence not known

    DRUG INTERACTIONS

    There are no drug interactions associated with Neomycin; Polymyxin B; Dexamethasone products.

    PREGNANCY AND LACTATION

    Pregnancy

    No adequate studies in pregnant women are available with neomycin; polymyxin B; dexamethasone. In animal studies, ophthalmic administration of corticosteroids, such as dexamethasone, have been shown to be teratogenic in rabbits and mice. In mice, corticosteroids resulted in fetal resorption and an increased incidence of cleft palate; rabbits receiving corticosteroids experienced fetal resorption and abnormalities involving the head, ears, limbs, and palate. Administer neomycin; polymyxin B; dexamethasone during pregnancy only when the benefits clearly outweigh the potential risk to the fetus. Consider monitoring for signs of hypoadrenalism in infants born to mothers who received substantial doses during pregnancy.

    Neomycin; polymyxin B; dexamethasone ophthalmic formulations may be used with caution during breast-feeding. According to the manufacturer, it is not known if ophthalmic administered dexamethasone is detectable in human milk; however, systemically administered corticosteroids do appear in human milk and may suppress infant growth and endogenous corticosteroid production. Topically applied dexamethasone to the eye in the mother is unlikely to cause significant concern to the infant with limited dosage and duration of use. Neomycin and polymyxin B are both poorly absorbed orally, so whatever minor systemic exposure may occur maternally would be unlikely to cause infant harm during nursing. Short term use of usual moderate ocular doses for milder eye conditions probably poses little risk to the nursing infant. Consider the benefits of breast-feeding, the risk of potential infant drug exposure, and the risk of an untreated or inadequately treated condition. If a breast-feeding infant experiences an adverse effect related to maternally administered neomycin; polymyxin B; dexamethasone, health care providers are encouraged to report the adverse effect to the FDA.

    MECHANISM OF ACTION

    Neomycin; polymyxin B; dexamethasone is indicated for the treatment of inflammatory ocular conditions where a risk of superficial bacterial infection exists. Clinicians may wish to consult the individual monographs for more information about each component.
    Neomycin: Neomycin is bacteriocidal. It is actively transported into the bacterial cell where it binds to receptors present on the 30S ribosomal subunit of susceptible bacteria. This binding interferes with the initiation complex between the messenger RNA (mRNA) and the subunit. As a result, abnormal, nonfunctional proteins are formed due to misreading of the bacterial mRNA. Eventually, susceptible bacteria die because of the lack of functional proteins.
    Polymyxin B: Polymyxin B binds to gram-negative bacterial cell membrane phospholipids. This binding destroys bacterial membranes with a surface detergent-like mechanism and increases the permeability of the cell membrane, which results in loss of metabolites essential to bacterial existence. Polymyxin B is bactericidal against most gram-negative bacilli. Polymyxin B has no in vitro activity against gram-positive organisms.
    Dexamethasone: Dexamethasone is a corticosteroid with anti-inflammatory action. Corticosteroids are naturally occurring hormones that bind to specific protein receptors on targeted tissues. This binding induces a response by modifying transcription and, ultimately, protein synthesis to achieve the steroid's intended action. The anti-inflammatory action of dexamethasone results from the inhibition of leukocyte infiltration at the site of inflammation, interference in the function of mediators of inflammatory response, and suppression of humoral immune responses. The end result of treatment with dexamethasone includes reduction in edema or scar tissue as well as a general suppression of the immune response.

    PHARMACOKINETICS

    Neomycin; polymyxin B; dexamethasone is administered topically to the eyes. No pharmacokinetic information is available from the manufacturers of the combination ophthalmic products. See individual drug monographs for additional information.