Garamycin

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Garamycin

Classes

Aminoglycoside Antibiotics
Ophthalmological Anti-infectives
Topical Aminoglycosides, Plain or in Combination

Administration
Injectable Administration

Visually inspect parenteral products for particulate matter and discoloration prior to administration whenever solution and container permit.

Intravenous Administration

Intermittent IV Infusion
Dilution/Preparation
Vials for Injection
Concentrated solutions (10 mg/mL and 40 mg/mL) may be diluted in 0.9% Sodium Chloride Injection or 5% Dextrose Injection prior to IV infusion.
Adults: Dilute in 50 to 200 mL.[41185] [65278]
Pediatric patients: Dilute to a convenient volume (usually 1 mg/mL or less).
 
Premixed IV Solution
Administer as a secondary medication unit.
Check for leaks by squeezing bag firmly. Do not add supplementary medication.
Adjustments may be made to premixed containers to either add or remove contents to provide an appropriate dose.
Attach to administration set. Do not introduce additives to the solution
Do not use plastic containers in series connections as this could result in an embolism due to residual air being drawn from the primary container before administration of the fluid from the secondary container is complete.[34041]
 
Intermittent IV Infusion Administration
Infuse IV over 30 minutes to 2 hours; usual infusion time is 30 to 60 minutes.
Do not physically premix with other drugs.[34041] [41185]
 
Intermittent IV Push†
NOTE: Gentamicin is not approved by the FDA for IV push administration.[41185]
Dilution
A report included 1,941 doses of gentamicin administered by IV push in an outpatient parenteral antibiotic (OPAT) setting.[65267]
Doses less than 800 mg were diluted with 0.9% Sodium Chloride Injection to a total volume of 20 mL.
Doses 800 mg or larger were administered undiluted as the 40 mg/mL solution as supplied by the manufacturer.
A study included 36 adult patients who received gentamicin by IV push.
A dose of 120 mg was administered to 26 patients (overall dose range: 60 mg to 120 mg). Doses were diluted in 50 mL of 5% Dextrose Injection or 0.9% Sodium Chloride Injection.
A study included 5 adult patients who received gentamicin by IV push.
A dose of 80 mg was administered. Doses were prediluted in 2 mL of 0.9% Sodium Chloride Injection (40 mg/mL).
A study included 21 adult patients who received gentamicin by IV push.
Doses of 6 mg/kg/day in divided doses (n = 19) or a single dose of 2 mg/kg (n = 2) were used. Doses were diluted with 0.9% Sodium Chloride Injection to a total volume of 20 mL.
Storage:
In one study, gentamicin (40 mg/mL) stored propylene glycol syringes retained potency for 30 days when stored at 4 degrees C and 25 degrees C.
Another study showed gentamicin (40 mg/mL) stored in plastic syringes had an average potency loss of 16% at 30 days at both 4 degrees C and 25 degrees C. Gentamicin (40 mg/mL) stored in glass syringes had an average potency loss of 7% at 30 days at both 4 degrees C and 25 degrees C. In both instances, a brown precipitate formed.
 
Intermittent IV Push Administration
Adults: The most common IV push rate is 3 to 5 minutes; however, a range of less than 10 seconds to 5 minutes has been reported.[65274]
Pediatrics: An IV push rate of 3 to 5 minutes has been reported in pediatric patients.[65267] However, IV push administration is generally not recommended in pediatric patients.

Intramuscular Administration

Do not use solutions prepared from commercially available premixed solutions for IM administration.
Withdraw appropriate dose directly from the vial of solution for injection. No dilution necessary. Inject deeply into a large muscle mass.

Topical Administration Cream/Ointment/Lotion Formulations

Topical Cream or Ointment
Rub cream or ointment gently into cleansed affected area. Care should be taken to avoid further contamination of the infected skin.
Treated area may be covered with sterile gauze if desired.
Crusts from impetigo should be removed before application to permit maximum contact between the antibiotic and the infection.
Use of topical gentamicin under gelatin packing may be used for infected stasis ulcers.

Inhalation Administration

NOTE: Gentamicin is not FDA-approved for inhalation administration.
 
Reconstitution
0.9% Sodium Chloride Injection has been used as a diluent.
80 mg of gentamicin diluted to achieve a total volume of 4 mL has been described.
 
Nebulization†
Consider pretreating with a bronchodilator.
Various nebulizers have been used.
The dose should be nebulized and inhaled over 10 minutes.

Ophthalmic Administration

Ophthalmic Solution or Ointment
Apply ophthalmic solution or ointment topically to the eye.
Instruct patient on appropriate installation 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 one individual, do not share among patients.

Adverse Reactions
Severe

oliguria / Early / Incidence not known
proteinuria / Delayed / Incidence not known
azotemia / Delayed / Incidence not known
nephrotoxicity / Delayed / Incidence not known
renal tubular acidosis (RTA) / Delayed / Incidence not known
ototoxicity / Delayed / Incidence not known
hearing loss / Delayed / Incidence not known
increased intracranial pressure / Early / Incidence not known
pulmonary fibrosis / Delayed / Incidence not known
anaphylactoid reactions / Rapid / Incidence not known
laryngeal edema / Rapid / Incidence not known
agranulocytosis / Delayed / Incidence not known
C. difficile-associated diarrhea / Delayed / Incidence not known

Moderate

pyuria / Delayed / Incidence not known
myasthenia / Delayed / Incidence not known
encephalopathy / Delayed / Incidence not known
peripheral neuropathy / Delayed / Incidence not known
tetany / Early / Incidence not known
neurotoxicity / Early / Incidence not known
phlebitis / Rapid / Incidence not known
confusion / Early / Incidence not known
hallucinations / Early / Incidence not known
pseudotumor cerebri / Delayed / Incidence not known
depression / Delayed / Incidence not known
conjunctival hyperemia / Early / Incidence not known
conjunctivitis / Delayed / Incidence not known
impaired wound healing / Delayed / Incidence not known
erythema / Early / Incidence not known
stomatitis / Delayed / Incidence not known
respiratory depression / Rapid / Incidence not known
hepatomegaly / Delayed / Incidence not known
elevated hepatic enzymes / Delayed / Incidence not known
hyperbilirubinemia / Delayed / Incidence not known
splenomegaly / Delayed / Incidence not known
hypotension / Rapid / Incidence not known
hypertension / Early / Incidence not known
hypocalcemia / Delayed / Incidence not known
hyponatremia / Delayed / Incidence not known
hypokalemia / Delayed / Incidence not known
hypomagnesemia / Delayed / Incidence not known
leukopenia / Delayed / Incidence not known
thrombocytopenia / Delayed / Incidence not known
anemia / Delayed / Incidence not known
eosinophilia / Delayed / Incidence not known
vitamin B12 deficiency / Delayed / Incidence not known
pseudomembranous colitis / Delayed / Incidence not known
superinfection / Delayed / Incidence not known

Mild

ocular irritation / Rapid / 1.0-10.0
cylindruria / Delayed / Incidence not known
vertigo / Early / Incidence not known
dizziness / Early / Incidence not known
tinnitus / Delayed / Incidence not known
paresthesias / Delayed / Incidence not known
weakness / Early / Incidence not known
injection site reaction / Rapid / Incidence not known
headache / Early / Incidence not known
lethargy / Early / Incidence not known
skin irritation / Early / Incidence not known
rash / Early / Incidence not known
purpura / Delayed / Incidence not known
photosensitivity / Delayed / Incidence not known
pruritus / Rapid / Incidence not known
alopecia / Delayed / Incidence not known
urticaria / Rapid / Incidence not known
hypersalivation / Early / Incidence not known
vomiting / Early / Incidence not known
nausea / Early / Incidence not known
weight loss / Delayed / Incidence not known
arthralgia / Delayed / Incidence not known
fever / Early / Incidence not known
vitamin B6 deficiency / Delayed / Incidence not known

Boxed Warning
Dehydration, nephrotoxicity, renal disease, renal failure, renal impairment

Patients receiving systemic aminoglycosides, such as gentamicin, should be closely monitored for nephrotoxicity. Aminoglycosides are associated with major toxic effects on the renal tubules. The risks of severe nephrotoxic adverse reactions are increased in patients with pre-existing renal disease, renal impairment, renal failure, or in those with normal renal function who receive high doses or prolonged therapy. Nephrotoxicity can manifest as decreased creatinine clearance, the presence of cells or casts, oliguria, proteinuria, decreased urine specific gravity, or evidence of increasing nitrogen retention (increasing BUN, NPN, or serum creatinine). When monitoring gentamicin serum concentrations during the use of conventional dose regimens, the manufacturer states that prolonged peak concentrations above 12 mcg/mL should be avoided and trough concentrations above 2 mcg/mL should be avoided. However, single-daily dosing schemes that produce higher peak serum concentrations have been used without additional toxicity noted. Renal function should be closely monitored. Evidence of nephrotoxicity requires dosage adjustment or discontinuance of therapy. Hemodialysis may aid in gentamicin removal in the event of overdose or toxic reactions, especially if renal function is or becomes impaired. In rare cases, nephrotoxicity may not be evident until soon after completion of therapy. Aminoglycoside-induced nephrotoxicity usually is reversible. Avoid concurrent and/or sequential coadministration of aminoglycosides with other drugs that are potentially nephrotoxic and/or neurotoxic because toxicity may be additive. Patients of advanced age and patients with dehydration are at increased risk of developing toxicity. In the event of toxicity in newborns, exchange transfusions may be considered. Intravenous diuretics may also alter aminoglycoside concentrations in serum and tissue and thereby enhance aminoglycoside toxicity.

Hearing impairment, neurotoxicity, ototoxicity, tinnitus

Monitor patients receiving systemic and inhaled aminoglycosides, such as gentamicin, for neurotoxicity, including ototoxicity and hearing impairment. Use aminoglycosides with caution in patients with preexisting hearing impairment, especially eighth-cranial-nerve impairment. Consider serial audiograms for high-risk patients. The risk of hearing loss increases with the degree of exposure (high or prolonged therapy), pre-existing renal impairment, concomitant or sequential nephrotoxic or ototoxic agents, dehydration, and advanced age. Patients with certain variants in the mitochondrially encoded 12S rRNA gene (MT-RNR1), particularly the m.1555A>G variant, may develop ototoxicity even when aminoglycoside serum concentrations are within the recommended range. These variants are present in less than 1% of the general US population, and the proportion of the variant carriers who may develop ototoxicity, including severe cases, is unknown. If there is a known maternal history of ototoxicity due to aminoglycosides or a known mitochondrial DNA variant, consider alternative treatments unless the severity of the infection and lack of alternatives outweighs the risk of permanent hearing loss. Discontinue therapy if there is evidence of auditory or vestibular toxicity. In the event of toxicity in newborns, exchange transfusions may be considered. When monitoring gentamicin serum concentrations during use of conventional dose regimens, avoid prolonged gentamicin peak concentrations above 12 mcg/mL and trough concentrations above 2 mcg/mL. However, single-daily dosing schemes that produce higher peak serum concentrations have been used without additional toxicity noted. Aminoglycosides are associated with major toxic effects on the auditory and vestibular branches of the eighth nerve. Auditory changes are irreversible, usually bilateral, and may be partial or total. Symptoms of ototoxicity can include dizziness, vertigo, tinnitus, roaring in the ears, and hearing loss and may manifest during therapy or after discontinuation. High-frequency hearing loss usually occurs before there is noticeable clinical hearing loss; clinical symptoms may not be present to warn of developing cochlear damage. Other manifestations of neurotoxicity may include numbness, skin tingling, muscle twitching, and convulsions.

Pregnancy

Systemic exposure to gentamicin may cause fetal harm during human pregnancy. Use gentamicin during pregnancy only if the potential benefit justifies the potential risk to the fetus. There have been reports of total irreversible bilateral congenital deafness (eighth cranial nerve toxicity) in children whose mothers received a related aminoglycoside, streptomycin, during pregnancy. Serious side effects to the fetus, newborn, or mother have not been reported in the treatment of pregnant women with other aminoglycosides. Animal reproduction studies conducted on rats and rabbits did not reveal evidence of impaired fertility or harm to the fetus due to gentamicin sulfate. However, it is not known whether gentamicin sulfate can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Gentamicin rapidly crosses the placenta into fetal circulation and amniotic fluid, with peak cord serum concentrations averaging 34% to 44% of maternal serum concentrations after administration to women in labor. One reported case of potential congenital defects occurred after a 10-day maternal antibiotic course including gentamicin around gestational week 7. At birth, the infant had impaired renal function and small kidneys, and at 4.5 years of age, he was diagnosed with renal cystic dysplasia. It is unknown if fetal gentamicin exposure contributed to the renal problems. In a study of pregnant patients treated for pyelonephritis, the clinical and pregnancy outcomes of 62 patients who received ampicillin plus gentamicin did not differ from patients who received either cefazolin or ceftriaxone monotherapy. A case-control surveillance study (n = 38) in women who received gentamicin showed no risk for teratogenicity with gentamicin. The ophthalmic and topical preparations of gentamicin do not appear likely to result in fetal harm when used as directed for limited exposure/treatment durations; however, gentamicin has been shown to depress body weights, kidney weights, and median glomerular counts in newborn rats when administered systemically to pregnant rats in daily doses approximately 500 times the maximum recommended ophthalmic human dose.

Common Brand Names

Garamycin, Genoptic, Genoptic SOP, Gentacidin, Gentafair, Gentak, Gentasol, Ocu-Mycin

Dea Class

Rx

Description

Aminoglycoside antibiotic
Used for a variety of gram-negative bacterial infections as well as synergistically for gram-positive bacterial infections, such as endocarditis
Major toxicities include nephrotoxicity, ototoxicity, neurotoxicity; careful patient monitoring is suggested. Available in a variety of dosage forms to be used topically, via ophthalmic route, and as systemic parenteral therapy.

Dosage And Indications
For the treatment of lower respiratory tract infections (LRTIs), including community-acquired pneumonia (CAP) and nosocomial pneumonia.
NOTE: Use lean body mass to calculate the gentamicin dose. Adjust dose based on serum gentamicin concentrations.
For the treatment of nonspecific LRTIs. Intravenous or Intramuscular dosage (extended-interval dosing)† Adults

5 to 7 mg/kg/dose IV or IM every 24 hours.[34172] [34173] [34175] [34186]

Infants, Children, and Adolescents

5 to 7.5 mg/kg/dose IV or IM every 24 hours. A study in pediatric patients 3 months to 18 years (n = 114) suggested daily (i.e., every 24 hours) age-specific doses of 9.5 mg/kg/dose (3 to 23 months), 8.5 mg/kg/dose (2 to 7 years), and 7 mg/kg/dose (8 to 18 years) may be more appropriate to achieve goal gentamicin concentrations.

Neonates 35 weeks gestation and older and 8 days and older

5 mg/kg/dose IV or IM every 24 hours.

Neonates 35 weeks gestation and older and 0 to 7 days

4 mg/kg/dose IV or IM every 24 hours.

Neonates 30 to 34 weeks gestation and 11 days and older

5 mg/kg/dose IV or IM every 24 hours.

Neonates 30 to 34 weeks gestation and 0 to 10 days

5 mg/kg/dose IV or IM every 36 hours.

Neonates younger than 30 weeks gestation and 15 days and older

5 mg/kg/dose IV or IM every 36 hours.

Neonates younger than 30 weeks gestation and 0 to 14 days

5 mg/kg/dose IV or IM every 48 hours.

Intravenous or Intramuscular dosage (conventional dosing) Adults

3 mg/kg/day IV or IM divided every 8 hours; doses up to 5 mg/kg/day IV or IM divided every 6 to 8 hours may be required in life-threatening infections.[34041]

Children and Adolescents

2 to 2.5 mg/kg/dose IV or IM every 8 hours.

Infants

2.5 mg/kg/dose IV or IM every 8 hours.

Premature Infants 30 days and older weighing less than 1.2 kg

2.5 mg/kg/dose IV or IM every 18 hours. The FDA-approved dose is 2.5 mg/kg/dose IV or IM every 8 hours. This dosing does not account for gestational age or birthweight.

Neonates 8 to 29 days weighing more than 2 kg

2.5 mg/kg/dose IV or IM every 8 hours. Extend the interval to 18 to 24 hours for neonates on ECMO. Individualize subsequent dosing by monitoring serum drug concentrations. When ECMO is discontinued, dosage adjustment may be required.

Neonates 8 to 29 days weighing 1.2 to 2 kg

2.5 mg/kg/dose IV or IM every 12 hours. The FDA-approved dose is 2.5 mg/kg/dose IV or IM every 8 hours.

Neonates 8 to 29 days weighing less than 1.2 kg

2.5 mg/kg/dose IV or IM every 18 to 24 hours.[51918] [53249] The FDA-approved dose is 2.5 mg/kg/dose IV or IM every 8 hours. This dosing does not account for gestational age or birthweight.[41185]

Neonates 0 to 7 days weighing more than 2 kg

2.5 mg/kg/dose IV or IM every 12 hours.[41185] [51918] Extend the interval to 18 to 24 hours for neonates on ECMO. Individualize subsequent dosing by monitoring serum drug concentrations. When ECMO is discontinued, dosage adjustment may be required.[51916] [51917] [51954]

Neonates 0 to 7 days weighing 1.2 to 2 kg

2.5 mg/kg/dose IV or IM every 18 hours. The FDA-approved dose is 2.5 mg/kg/dose IV or IM every 12 hours.

Neonates 0 to 7 days weighing less than 1.2 kg

2.5 mg/kg/dose IV or IM every 18 to 24 hours. The FDA-approved dose is 2.5 mg/kg/dose IV or IM every 12 hours. This dosing does not account for gestational age or birthweight.

For the treatment of nosocomial pneumonia. Intravenous dosage (extended-interval dosing)† Adults

5 to 7 mg/kg/dose IV every 24 hours for 7 days as part of combination therapy.[34172] [34173] [34175] [34186]

For the treatment of community-acquired pneumonia (CAP). Intravenous dosage (extended-interval dosing)† Adults living with HIV

5 to 7 mg/kg/dose IV every 24 hours for 5 to 7 days as an alternative as part of combination therapy.[34172] [34173] [34175] [34186]

Adolescents living with HIV

5 to 7.5 mg/kg/dose IV every 24 hours for 5 to 7 days as an alternative as part of combination therapy. A single study in pediatric patients 3 months to 18 years (n = 114) suggested daily (i.e., every 24 hours) age-specific doses of 9.5 mg/kg/dose (3 to 23 months), 8.5 mg/kg/dose (2 to 7 years), and 7 mg/kg/dose (8 to 18 years) may be more appropriate to achieve goal gentamicin concentrations.

Intravenous dosage (conventional dosing) Adults living with HIV

3 mg/kg/day IV divided every 8 hours for 5 to 7 days as an alternative as part of combination therapy. Doses up to 5 mg/kg/day IV divided every 6 to 8 hours may be required in life-threatening infections.[34041]

Adolescents living with HIV

2 to 2.5 mg/kg/dose IV every 8 hours for 5 to 7 days as an alternative as part of combination therapy.

For the treatment of infective endocarditis.
NOTE: Base aminoglycoside dosage on an estimate of lean body mass. Adjust dose based on serum gentamicin concentrations.
For the treatment of native valve endocarditis due to viridans group streptococci† and nonenterococcal group D streptococci relatively resistant to penicillin. Intravenous or Intramuscular dosage Adults

3 mg/kg/day IV or IM every 24 hours, or alternately, divided every 8 hours for 2 weeks plus penicillin G, ampicillin, or ceftriaxone for 4 weeks.

Children and Adolescents

1 to 2 mg/kg/dose IV every 8 hours for 2 weeks plus penicillin G, ampicillin, or ceftriaxone for 4 weeks. The FDA-approved dosage is 2 to 2.5 mg/kg/dose IV or IM every 8 hours.

Infants

2.5 mg/kg/dose IV or IM every 8 hours for 2 weeks plus penicillin G, ampicillin, or ceftriaxone for 4 weeks.

Premature infants 30 days and older weighing less than 1.2 kg

2.5 mg/kg/dose IV or IM every 18 hours for 2 weeks plus penicillin G, ampicillin, or ceftriaxone for 4 weeks. The FDA-approved dosage is 2.5 mg/kg/dose IV or IM every 8 hours; however, this dosing does not account for gestational age or birthweight.

Neonates 8 to 29 days weighing more than 2 kg

2.5 mg/kg/dose IV or IM every 8 hours for 2 weeks plus penicillin G, ampicillin, or ceftriaxone for 4 weeks.

Neonates 8 to 29 days weighing 1.2 to 2 kg

2.5 mg/kg/dose IV or IM every 12 hours for 2 weeks plus penicillin G, ampicillin, or ceftriaxone for 4 weeks. The FDA-approved dosage is 2.5 mg/kg/dose IV or IM every 8 hours.

Neonates 8 to 29 days weighing less than 1.2 kg

2.5 mg/kg/dose IV or IM every 18 to 24 hours for 2 weeks plus penicillin G, ampicillin, or ceftriaxone for 4 weeks. The FDA-approved dosage is 2.5 mg/kg/dose IV or IM every 8 hours; however, this dosing does not account for gestational age or birthweight.

Neonates 0 to 7 days weighing more than 2 kg

2.5 mg/kg/dose IV or IM every 12 hours for 2 weeks plus penicillin G, ampicillin, or ceftriaxone for 4 weeks.

Neonates 0 to 7 days weighing 1.2 to 2 kg

2.5 mg/kg/dose IV or IM every 18 hours for 2 weeks plus penicillin G, ampicillin, or ceftriaxone for 4 weeks. The FDA-approved dosage is 2.5 mg/kg/dose IV or IM every 12 hours.

Neonates 0 to 7 days weighing less than 1.2 kg

2.5 mg/kg/dose IV or IM every 18 to 24 hours for 2 weeks plus penicillin G, ampicillin, or ceftriaxone for 4 weeks. The FDA-approved dosage is 2.5 mg/kg/dose IV or IM every 12 hours; however, this dosing does not account for gestational age or birthweight.

For the treatment of endocarditis due to group B, C, F, and G streptococci†. Intravenous or Intramuscular dosage Adults

3 mg/kg/day IV or IM once daily, or alternately, divided every 8 hours for at least 2 weeks with penicillin G or ceftriaxone for 4 to 6 weeks.

Children and Adolescents

1 to 2 mg/kg/dose IV every 8 hours for 2 weeks plus penicillin G, ampicillin, or ceftriaxone for 4 to 6 weeks.

Infants

2.5 mg/kg/dose IV or IM every 8 hours for 2 weeks plus penicillin G, ampicillin, or ceftriaxone for 4 to 6 weeks.

Premature infants 30 days and older weighing less than 1.2 kg

2.5 mg/kg/dose IV or IM every 18 hours for 2 weeks plus penicillin G, ampicillin, or ceftriaxone for 4 to 6 weeks.

Neonates 8 to 29 days weighing more than 2 kg

2.5 mg/kg/dose IV or IM every 8 hours for 2 weeks plus penicillin G, ampicillin, or ceftriaxone for 4 to 6 weeks.

Neonates 8 to 29 days weighing 1.2 to 2 kg

2.5 mg/kg/dose IV or IM every 12 hours for 2 weeks plus penicillin G, ampicillin, or ceftriaxone for 4 to 6 weeks.

Neonates 8 to 29 days weighing less than 1.2 kg

2.5 mg/kg/dose IV or IM every 18 to 24 hours for 2 weeks plus penicillin G, ampicillin, or ceftriaxone for 4 to 6 weeks.

Neonates 0 to 7 days weighing more than 2 kg

2.5 mg/kg/dose IV or IM every 12 hours for 2 weeks plus penicillin G, ampicillin, or ceftriaxone for 4 to 6 weeks.

Neonates 0 to 7 days weighing 1.2 to 2 kg

2.5 mg/kg/dose IV or IM every 18 hours for 2 weeks plus penicillin G, ampicillin, or ceftriaxone for 4 to 6 weeks.

Neonates 0 to 7 days weighing less than 1.2 kg

2.5 mg/kg/dose IV or IM every 18 to 24 hours for 2 weeks plus penicillin G, ampicillin, or ceftriaxone for 4 to 6 weeks.

For the treatment of prosthetic valve endocarditis due to viridans group streptococci† and nonenterococcal group D streptococci relatively resistant to penicillin. Intravenous or Intramuscular dosage Adults

3 mg/kg/day IV or IM once daily, or alternately, divided every 8 hours for 6 weeks plus penicillin G or ceftriaxone.

Children and Adolescents

1 to 2 mg/kg/dose IV every 8 hours for 2 weeks plus penicillin G, ampicillin, or ceftriaxone for 6 weeks. The FDA-approved dosage is 2 to 2.5 mg/kg/dose IV or IM every 8 hours.

Infants

2.5 mg/kg/dose IV or IM every 8 hours for 2 weeks plus penicillin G, ampicillin, or ceftriaxone for 6 weeks.

Premature infants 30 days and older weighing less than 1.2 kg

2.5 mg/kg/dose IV or IM every 18 hours for 2 weeks plus penicillin G, ampicillin, or ceftriaxone for 6 weeks. The FDA-approved dosage is 2.5 mg/kg/dose IV or IM every 8 hours; however, this dosing does not account for gestational age or birthweight.

Neonates 8 to 29 days weighing more than 2 kg

2.5 mg/kg/dose IV or IM every 8 hours for 2 weeks plus penicillin G, ampicillin, or ceftriaxone for 6 weeks.

Neonates 8 to 29 days weighing 1.2 to 2 kg

2.5 mg/kg/dose IV or IM every 12 hours for 2 weeks plus penicillin G, ampicillin, or ceftriaxone for 6 weeks. The FDA-approved dosage is 2.5 mg/kg/dose IV or IM every 8 hours.

Neonates 8 to 29 days weighing less than 1.2 kg

2.5 mg/kg/dose IV or IM every 18 to 24 hours for 2 weeks plus penicillin G, ampicillin, or ceftriaxone for 6 weeks. The FDA-approved dosage is 2.5 mg/kg/dose IV or IM every 8 hours; however, this dosing does not account for gestational age or birthweight.

Neonates 0 to 7 days weighing more than 2 kg

2.5 mg/kg/dose IV or IM every 12 hours for 2 weeks plus penicillin G, ampicillin, or ceftriaxone for 6 weeks.

Neonates 0 to 7 days weighing 1.2 to 2 kg

2.5 mg/kg/dose IV or IM every 18 hours for 2 weeks plus penicillin G, ampicillin, or ceftriaxone for 6 weeks. The FDA-approved dosage is 2.5 mg/kg/dose IV or IM every 12 hours.

Neonates 0 to 7 days weighing less than 1.2 kg

2.5 mg/kg/dose IV or IM every 18 to 24 hours for 2 weeks plus penicillin G, ampicillin, or ceftriaxone for 6 weeks. The FDA-approved dosage is 2.5 mg/kg/dose IV or IM every 12 hours; however, this dosing does not account for gestational age or birthweight.

For the treatment of native valve endocarditis due to Staphylococcus sp.. Intravenous or Intramuscular dosage Children and Adolescents

1 to 2 mg/kg/dose IV every 8 hours for 3 to 5 days plus nafcillin/oxacillin or vancomycin for 4 to 6 weeks. The FDA-approved dosage is 2 to 2.5 mg/kg/dose IV or IM every 8 hours.

Infants

2.5 mg/kg/dose IV or IM every 8 hours for 3 to 5 days plus nafcillin/oxacillin or vancomycin for 4 to 6 weeks.

Premature infants 30 days and older weighing less than 1.2 kg

2.5 mg/kg/dose IV or IM every 18 hours for 3 to 5 days plus nafcillin/oxacillin or vancomycin for 4 to 6 weeks. The FDA-approved dosage is 2.5 mg/kg/dose IV or IM every 8 hours; however, this dosing does not account for gestational age or birthweight.

Neonates 8 to 29 days weighing more than 2 kg

2.5 mg/kg/dose IV or IM every 8 hours for 3 to 5 days plus nafcillin/oxacillin or vancomycin for 4 to 6 weeks.

Neonates 8 to 29 days weighing 1.2 to 2 kg

2.5 mg/kg/dose IV or IM every 12 hours for 3 to 5 days plus nafcillin/oxacillin or vancomycin for 4 to 6 weeks. The FDA-approved dosage is 2.5 mg/kg/dose IV or IM every 8 hours.

Neonates 8 to 29 days weighing less than 1.2 kg

2.5 mg/kg/dose IV or IM every 18 to 24 hours for 3 to 5 days plus nafcillin/oxacillin or vancomycin for 4 to 6 weeks. The FDA-approved dosage is 2.5 mg/kg/dose IV or IM every 8 hours; however, this dosing does not account for gestational age or birthweight.

Neonates 0 to 7 days weighing more than 2 kg

2.5 mg/kg/dose IV or IM every 12 hours for 3 to 5 days plus nafcillin/oxacillin or vancomycin for 4 to 6 weeks.

Neonates 0 to 7 days weighing 1.2 to 2 kg

2.5 mg/kg/dose IV or IM every 18 hours for 3 to 5 days plus nafcillin/oxacillin or vancomycin for 4 to 6 weeks. The FDA-approved dosage is 2.5 mg/kg/dose IV or IM every 12 hours.

Neonates 0 to 7 days weighing less than 1.2 kg

2.5 mg/kg/dose IV or IM every 18 to 24 hours for 3 to 5 days plus nafcillin/oxacillin or vancomycin for 4 to 6 weeks. The FDA-approved dosage is 2.5 mg/kg/dose IV or IM every 12 hours; however, this dosing does not account for gestational age or birthweight.

For the treatment of prosthetic valve endocarditis due to Staphylococcus sp.. Intravenous or Intramuscular dosage Adults

3 mg/kg/day IV or IM every 24 hours, or alternately, divided every 8 to 12 hours for 2 weeks plus nafcillin/oxacillin or vancomycin and rifampin for at least 6 weeks.

Children and Adolescents

1 to 2 mg/kg/dose IV every 8 hours for 2 weeks plus nafcillin/oxacillin, vancomycin, or daptomycin plus rifampin for at least 6 weeks. The FDA-approved dosage is 2 to 2.5 mg/kg/dose IV or IM every 8 hours.

Infants

2.5 mg/kg/dose IV or IM every 8 hours for 2 weeks plus nafcillin/oxacillin, vancomycin, or daptomycin plus rifampin for at least 6 weeks.

Premature infants 30 days and older weighing less than 1.2 kg

2.5 mg/kg/dose IV or IM every 18 hours for 2 weeks plus nafcillin/oxacillin, vancomycin, or daptomycin plus rifampin for at least 6 weeks. The FDA-approved dosage is 2.5 mg/kg/dose IV or IM every 8 hours; however, this dosing does not account for gestational age or birthweight.

Neonates 8 to 29 days weighing more than 2 kg

2.5 mg/kg/dose IV or IM every 8 hours for 2 weeks plus nafcillin/oxacillin, vancomycin, or daptomycin plus rifampin for at least 6 weeks.

Neonates 8 to 29 days weighing 1.2 to 2 kg

2.5 mg/kg/dose IV or IM every 12 hours for 2 weeks plus nafcillin/oxacillin, vancomycin, or daptomycin plus rifampin for at least 6 weeks. The FDA-approved dosage is 2.5 mg/kg/dose IV or IM every 8 hours.

Neonates 8 to 29 days weighing less than 1.2 kg

2.5 mg/kg/dose IV or IM every 18 to 24 hours for 2 weeks plus nafcillin/oxacillin, vancomycin, or daptomycin plus rifampin for at least 6 weeks. The FDA-approved dosage is 2.5 mg/kg/dose IV or IM every 8 hours; however, this dosing does not account for gestational age or birthweight.

Neonates 0 to 7 days weighing more than 2 kg

2.5 mg/kg/dose IV or IM every 12 hours for 2 weeks plus nafcillin/oxacillin, vancomycin, or daptomycin plus rifampin for at least 6 weeks.

Neonates 0 to 7 days weighing 1.2 to 2 kg

2.5 mg/kg/dose IV or IM every 18 hours for 2 weeks plus nafcillin/oxacillin, vancomycin, or daptomycin plus rifampin for at least 6 weeks. The FDA-approved dosage is 2.5 mg/kg/dose IV or IM every 12 hours.

Neonates 0 to 7 days weighing less than 1.2 kg

2.5 mg/kg/dose IV or IM every 18 to 24 hours for 2 weeks plus nafcillin/oxacillin, vancomycin, or daptomycin plus rifampin for at least 6 weeks. The FDA-approved dosage is 2.5 mg/kg/dose IV or IM every 12 hours; however, this dosing does not account for gestational age or birthweight.

For the treatment of native or prosthetic valve endocarditis due to penicillin-susceptible Enterococcus sp.. Intravenous or Intramuscular dosage Adults

3 mg/kg/day IV or IM divided every 8 to 12 hours for 2 to 3 weeks plus penicillin G or ampicillin for 4 to 6 weeks.

Children and Adolescents

1 to 2 mg/kg/dose IV every 8 hours for 4 to 6 weeks plus penicillin G or ampicillin. The FDA-approved dosage is 2 to 2.5 mg/kg/dose IV or IM every 8 hours.

Infants

2.5 mg/kg/dose IV or IM every 8 hours for 4 to 6 weeks plus penicillin G or ampicillin.

Premature infants 30 days and older weighing less than 1.2 kg

2.5 mg/kg/dose IV or IM every 18 hours for 4 to 6 weeks plus penicillin G or ampicillin. The FDA-approved dosage is 2.5 mg/kg/dose IV or IM every 8 hours; however, this dosing does not account for gestational age or birthweight.

Neonates 8 to 29 days weighing more than 2 kg

2.5 mg/kg/dose IV or IM every 8 hours for 4 to 6 weeks plus penicillin G or ampicillin.

Neonates 8 to 29 days weighing 1.2 to 2 kg

2.5 mg/kg/dose IV or IM every 12 hours for 4 to 6 weeks plus penicillin G or ampicillin. The FDA-approved dosage is 2.5 mg/kg/dose IV or IM every 8 hours.

Neonates 8 to 29 days weighing less than 1.2 kg

2.5 mg/kg/dose IV or IM every 18 to 24 hours for 4 to 6 weeks plus penicillin G or ampicillin. The FDA-approved dosage is 2.5 mg/kg/dose IV or IM every 8 hours; however, this dosing does not account for gestational age or birthweight.

Neonates 0 to 7 days weighing more than 2 kg

2.5 mg/kg/dose IV or IM every 12 hours for 4 to 6 weeks plus penicillin G or ampicillin.

Neonates 0 to 7 days weighing 1.2 to 2 kg

2.5 mg/kg/dose IV or IM every 18 hours for 4 to 6 weeks plus penicillin G or ampicillin. The FDA-approved dosage is 2.5 mg/kg/dose IV or IM every 12 hours.

Neonates 0 to 7 days weighing less than 1.2 kg

2.5 mg/kg/dose IV or IM every 18 to 24 hours for 4 to 6 weeks plus penicillin G or ampicillin. The FDA-approved dosage is 2.5 mg/kg/dose IV or IM every 12 hours; however, this dosing does not account for gestational age or birthweight.

For the treatment of native valve endocarditis due to penicillin-resistant Enterococcus sp.† or in patients unable to tolerate beta-lactams. Intravenous or Intramuscular dosage Adults

3 mg/kg/day IV or IM divided every 8 hours for 6 weeks plus vancomycin.

Children and Adolescents

1 to 2 mg/kg/dose IV every 8 hours for 6 weeks plus vancomycin.

Infants

2.5 mg/kg/dose IV or IM every 8 hours for 6 weeks plus vancomycin.

Premature infants 30 days and older weighing less than 1.2 kg

2.5 mg/kg/dose IV or IM every 18 hours for 6 weeks plus vancomycin.

Neonates 8 to 29 days weighing more than 2 kg

2.5 mg/kg/dose IV or IM every 8 hours for 6 weeks plus vancomycin.

Neonates 8 to 29 days weighing 1.2 to 2 kg

2.5 mg/kg/dose IV or IM every 12 hours for 6 weeks plus vancomycin.

Neonates 8 to 29 days weighing less than 1.2 kg

2.5 mg/kg/dose IV or IM every 18 to 24 hours for 6 weeks plus vancomycin.

Neonates 0 to 7 days weighing more than 2 kg

2.5 mg/kg/dose IV or IM every 12 hours for 6 weeks plus vancomycin.

Neonates 0 to 7 days weighing 1.2 to 2 kg

2.5 mg/kg/dose IV or IM every 18 hours for 6 weeks plus vancomycin.

Neonates 0 to 7 days weighing less than 1.2 kg

2.5 mg/kg/dose IV or IM every 18 to 24 hours for 6 weeks plus vancomycin.

For the treatment of prosthetic valve endocarditis due to penicillin-resistant Enterococcus sp.† or in patients unable to tolerate beta-lactams. Intravenous or Intramuscular dosage Adults

3 mg/kg/day IV or IM divided every 8 hours for at least 6 weeks plus vancomycin.

Children and Adolescents

1 to 2 mg/kg/dose IV every 8 hours for at least 6 weeks plus vancomycin.

Infants

2.5 mg/kg/dose IV or IM every 8 hours for at least 6 weeks plus vancomycin.

Premature infants 30 days and older weighing less than 1.2 kg

2.5 mg/kg/dose IV or IM every 18 hours for at least 6 weeks plus vancomycin.

Neonates 8 to 29 days weighing more than 2 kg

2.5 mg/kg/dose IV or IM every 8 hours for at least 6 weeks plus vancomycin.

Neonates 8 to 29 days weighing 1.2 to 2 kg

2.5 mg/kg/dose IV or IM every 12 hours for at least 6 weeks plus vancomycin.

Neonates 8 to 29 days weighing less than 1.2 kg

2.5 mg/kg/dose IV or IM every 18 to 24 hours for at least 6 weeks plus vancomycin.

Neonates 0 to 7 days weighing more than 2 kg

2.5 mg/kg/dose IV or IM every 12 hours for at least 6 weeks plus vancomycin.

Neonates 0 to 7 days weighing 1.2 to 2 kg

2.5 mg/kg/dose IV or IM every 18 hours for at least 6 weeks plus vancomycin.

Neonates 0 to 7 days weighing less than 1.2 kg

2.5 mg/kg/dose IV or IM every 18 to 24 hours for at least 6 weeks plus vancomycin.

For the treatment of native or prosthetic valve endocarditis due to enteric gram-negative microorganisms. Intravenous or Intramuscular dosage Adults

3 mg/kg/day IV or IM divided every 8 hours for 6 weeks plus a beta-lactam.

Children and Adolescents

1 to 2 mg/kg/dose IV every 8 hours for at least 6 weeks plus a beta-lactam. The FDA-approved dosage is 2 to 2.5 mg/kg/dose IV or IM every 8 hours.

Infants

2.5 mg/kg/dose IV or IM every 8 hours for at least 6 weeks plus a beta-lactam.

Premature infants 30 days and older weighing less than 1.2 kg

2.5 mg/kg/dose IV or IM every 18 hours for at least 6 weeks plus a beta-lactam. The FDA-approved dosage is 2.5 mg/kg/dose IV or IM every 8 hours; however, this dosing does not account for gestational age or birthweight.

Neonates 8 to 29 days weighing more than 2 kg

2.5 mg/kg/dose IV or IM every 8 hours for at least 6 weeks plus a beta-lactam.

Neonates 8 to 29 days weighing 1.2 to 2 kg

2.5 mg/kg/dose IV or IM every 12 hours for at least 6 weeks plus a beta-lactam. The FDA-approved dosage is 2.5 mg/kg/dose IV or IM every 8 hours.

Neonates 8 to 29 days weighing less than 1.2 kg

2.5 mg/kg/dose IV or IM every 18 to 24 hours for at least 6 weeks plus a beta-lactam. The FDA-approved dosage is 2.5 mg/kg/dose IV or IM every 8 hours; however, this dosing does not account for gestational age or birthweight.

Neonates 0 to 7 days weighing more than 2 kg

2.5 mg/kg/dose IV or IM every 12 hours for at least 6 weeks plus a beta-lactam.

Neonates 0 to 7 days weighing 1.2 to 2 kg

2.5 mg/kg/dose IV or IM every 18 hours for at least 6 weeks plus a beta-lactam. The FDA-approved dosage is 2.5 mg/kg/dose IV or IM every 12 hours.

Neonates 0 to 7 days weighing less than 1.2 kg

2.5 mg/kg/dose IV or IM every 18 to 24 hours for at least 6 weeks plus a beta-lactam. The FDA-approved dosage is 2.5 mg/kg/dose IV or IM every 12 hours; however, this dosing does not account for gestational age or birthweight.

For the treatment of early (1 year or less after surgery) culture-negative prosthetic valve endocarditis. Intravenous or Intramuscular dosage Adults

3 mg/kg/day IV or IM divided every 8 hours for at least 2 weeks plus vancomycin, cefepime, and rifampin for at least 4 to 6 weeks.

Children and Adolescents

1 to 2 mg/kg/dose IV every 8 hours for 2 weeks plus vancomycin, cefepime, and rifampin for 6 weeks. The FDA-approved dosage is 2 to 2.5 mg/kg/dose IV or IM every 8 hours.

Infants

2.5 mg/kg/dose IV or IM every 8 hours for 2 weeks plus vancomycin, cefepime, and rifampin for 6 weeks.

Premature infants 30 days and older weighing less than 1.2 kg

2.5 mg/kg/dose IV or IM every 18 hours for 2 weeks plus vancomycin, cefepime, and rifampin for 6 weeks. The FDA-approved dosage is 2.5 mg/kg/dose IV or IM every 8 hours; however, this dosing does not account for gestational age or birthweight.

Neonates 8 to 29 days weighing more than 2 kg

2.5 mg/kg/dose IV or IM every 8 hours for 2 weeks plus vancomycin, cefepime, and rifampin for 6 weeks.

Neonates 8 to 29 days weighing 1.2 to 2 kg

2.5 mg/kg/dose IV or IM every 12 hours for 2 weeks plus vancomycin, cefepime, and rifampin for 6 weeks. The FDA-approved dosage is 2.5 mg/kg/dose IV or IM every 8 hours.

Neonates 8 to 29 days weighing less than 1.2 kg

2.5 mg/kg/dose IV or IM every 18 to 24 hours for 2 weeks plus vancomycin, cefepime, and rifampin for 6 weeks. The FDA-approved dosage is 2.5 mg/kg/dose IV or IM every 8 hours; however, this dosing does not account for gestational age or birthweight.

Neonates 0 to 7 days weighing more than 2 kg

2.5 mg/kg/dose IV or IM every 12 hours for 2 weeks plus vancomycin, cefepime, and rifampin for 6 weeks.

Neonates 0 to 7 days weighing 1.2 to 2 kg

2.5 mg/kg/dose IV or IM every 18 hours for 2 weeks plus vancomycin, cefepime, and rifampin for 6 weeks. The FDA-approved dosage is 2.5 mg/kg/dose IV or IM every 12 hours.

Neonates 0 to 7 days weighing less than 1.2 kg

2.5 mg/kg/dose IV or IM every 18 to 24 hours for 2 weeks plus vancomycin, cefepime, and rifampin for 6 weeks. The FDA-approved dosage is 2.5 mg/kg/dose IV or IM every 12 hours; however, this dosing does not account for gestational age or birthweight.

For the treatment of suspected Bartonella endocarditis† (culture-negative). Intravenous or Intramuscular dosage Adults

3 mg/kg/day IV divided every 8 hours for 2 weeks plus ceftriaxone with or without doxycycline for 6 weeks.

Children and Adolescents

3 mg/kg/day IV or IM divided every 8 hours for 2 weeks plus ceftriaxone with or without doxycycline for 6 weeks.

Infants

2.5 mg/kg/dose IV or IM every 8 hours for 2 weeks plus ceftriaxone for 6 weeks.

Premature infants 30 days and older weighing less than 1.2 kg

2.5 mg/kg/dose IV or IM every 18 hours for 2 weeks plus ceftriaxone for 6 weeks.

Neonates 8 to 29 days weighing more than 2 kg

2.5 mg/kg/dose IV or IM every 8 hours for 2 weeks plus ceftriaxone for 6 weeks.

Neonates 8 to 29 days weighing 1.2 to 2 kg

2.5 mg/kg/dose IV or IM every 12 hours for 2 weeks plus ceftriaxone for 6 weeks.

Neonates 8 to 29 days weighing less than 1.2 kg

2.5 mg/kg/dose IV or IM every 18 to 24 hours for 2 weeks plus ceftriaxone for 6 weeks.

Neonates 0 to 7 days weighing more than 2 kg

2.5 mg/kg/dose IV or IM every 12 hours for 2 weeks plus ceftriaxone for 6 weeks.

Neonates 0 to 7 days weighing 1.2 to 2 kg

2.5 mg/kg/dose IV or IM every 18 hours for 2 weeks plus ceftriaxone for 6 weeks.

Neonates 0 to 7 days weighing less than 1.2 kg

2.5 mg/kg/dose IV or IM every 18 to 24 hours for 2 weeks plus ceftriaxone for 6 weeks.

For the treatment of documented Bartonella endocarditis†. Intravenous or Intramuscular dosage Adults

3 mg/kg/day IV divided every 8 hours for 2 weeks plus doxycycline for at least 6 weeks.

Children and Adolescents

3 mg/kg/day IV or IM divided every 8 hours for 2 weeks plus doxycycline for at least 6 weeks.

For the treatment of native or prosthetic valve endocarditis due to HACEK microorganisms†. Intravenous or Intramuscular dosage Children and Adolescents

1 to 2 mg/kg/dose IV every 8 hours for 4 weeks plus ampicillin.

Infants

2.5 mg/kg/dose IV or IM every 8 hours for 4 weeks plus ampicillin.

Premature infants 30 days and older weighing less than 1.2 kg

2.5 mg/kg/dose IV or IM every 18 hours for 4 weeks plus ampicillin.

Neonates 8 to 29 days weighing more than 2 kg

2.5 mg/kg/dose IV or IM every 8 hours for 4 weeks plus ampicillin.

Neonates 8 to 29 days weighing 1.2 to 2 kg

2.5 mg/kg/dose IV or IM every 12 hours for 4 weeks plus ampicillin.

Neonates 8 to 29 days weighing less than 1.2 kg

2.5 mg/kg/dose IV or IM every 18 to 24 hours for 4 weeks plus ampicillin.

Neonates 0 to 7 days weighing more than 2 kg

2.5 mg/kg/dose IV or IM every 12 hours for 4 weeks plus ampicillin.

Neonates 0 to 7 days weighing 1.2 to 2 kg

2.5 mg/kg/dose IV or IM every 18 hours for 4 weeks plus ampicillin.

Neonates 0 to 7 days weighing less than 1.2 kg

2.5 mg/kg/dose IV or IM every 18 to 24 hours for 4 weeks plus ampicillin.

For the treatment of native valve culture-negative endocarditis. Intravenous or Intramuscular dosage Children and Adolescents

1 to 2 mg/kg/dose IV every 8 hours for 4 to 6 weeks plus ampicillin; sulbactam or vancomycin with ciprofloxacin. The FDA-approved dosage is 2 to 2.5 mg/kg/dose IV or IM every 8 hours.

Infants

2.5 mg/kg/dose IV or IM every 8 hours for 4 to 6 weeks plus ampicillin; sulbactam.

Premature infants 30 days and older weighing less than 1.2 kg

2.5 mg/kg/dose IV or IM every 18 hours for 4 to 6 weeks plus ampicillin; sulbactam. The FDA-approved dosage is 2.5 mg/kg/dose IV or IM every 8 hours; however, this dosing does not account for gestational age or birthweight.

Neonates 8 to 29 days weighing more than 2 kg

2.5 mg/kg/dose IV or IM every 8 hours for 4 to 6 weeks plus ampicillin; sulbactam.

Neonates 8 to 29 days weighing 1.2 to 2 kg

2.5 mg/kg/dose IV or IM every 12 hours for 4 to 6 weeks plus ampicillin; sulbactam. The FDA-approved dosage is 2.5 mg/kg/dose IV or IM every 8 hours.

Neonates 8 to 29 days weighing less than 1.2 kg

2.5 mg/kg/dose IV or IM every 18 to 24 hours for 4 to 6 weeks plus ampicillin; sulbactam. The FDA-approved dosage is 2.5 mg/kg/dose IV or IM every 8 hours; however, this dosing does not account for gestational age or birthweight.

Neonates 0 to 7 days weighing more than 2 kg

2.5 mg/kg/dose IV or IM every 12 hours for 4 to 6 weeks plus ampicillin; sulbactam.

Neonates 0 to 7 days weighing 1.2 to 2 kg

2.5 mg/kg/dose IV or IM every 18 hours for 4 to 6 weeks plus ampicillin; sulbactam. The FDA-approved dosage is 2.5 mg/kg/dose IV or IM every 12 hours.

Neonates 0 to 7 days weighing less than 1.2 kg

2.5 mg/kg/dose IV or IM every 18 to 24 hours for 4 to 6 weeks plus ampicillin; sulbactam. The FDA-approved dosage is 2.5 mg/kg/dose IV or IM every 12 hours; however, this dosing does not account for gestational age or birthweight.

For the treatment of native valve endocarditis due to highly penicillin-susceptible viridans group streptococci† and nonenterococcal group D streptococci. Intravenous or Intramuscular dosage Adults

3 mg/kg/day IV or IM every 24 hours, or alternately, divided every 8 hours for 2 weeks plus penicillin G, ampicillin, or ceftriaxone for 2 to 4 weeks.

For the treatment of prosthetic valve endocarditis due to highly penicillin-susceptible viridans group streptococci† and nonenterococcal group D streptococci. Intravenous or Intramuscular dosage Adults

3 mg/kg/day IV or IM every 24 hours, or alternately, divided every 8 hours for 2 weeks plus penicillin G or ceftriaxone for 6 weeks.

For the treatment of skin and skin structure infections, including burn wound infection, necrotizing infections, and diabetic foot ulcer as well as minor skin infections, including folliculitis, furunculosis, impetigo, eczema, pyoderma gangrenosum, sycosis barbae, infectious eczematoid dermatitis, pustular acne, pustular psoriasis, infected seborrheic dermatitis, infected contact dermatitis, and infected excoriations.
NOTE: Base aminoglycoside dosage on an estimate of lean body mass. Adjust dose based on serum gentamicin concentrations.
For the treatment of minor bacterial skin infection including, folliculitis, furunculosis, impetigo, eczema, pyoderma gangrenosum, sycosis barbae, infectious eczematoid dermatitis, pustular acne, pustular psoriasis, infected seborrheic dermatitis, infected contact dermatitis, and infected excoriations. Topical dosage Adults

Apply a thin layer topically to the affected area(s) 3 to 4 times daily.

Children and Adolescents

Apply a thin layer topically to the affected area(s) 3 to 4 times daily.

For the treatment of unspecified skin and skin structure infections. Intravenous or Intramuscular dosage (extended-interval dosing)† Adults

5 to 7 mg/kg/dose IV or IM every 24 hours.[34172] [34173] [34175] [34186]

Infants, Children, and Adolescents

5 to 7.5 mg/kg/dose IV or IM every 24 hours. A study in pediatric patients 3 months to 18 years (n = 114) suggested daily (i.e., every 24 hours) age-specific doses of 9.5 mg/kg/dose (3 to 23 months), 8.5 mg/kg/dose (2 to 7 years), and 7 mg/kg/dose (8 to 18 years) may be more appropriate to achieve goal gentamicin concentrations.

Neonates 35 weeks gestation and older and 8 days and older

5 mg/kg/dose IV or IM every 24 hours.

Neonates 35 weeks gestation and older and 0 to 7 days

4 mg/kg/dose IV or IM every 24 hours.

Neonates 30 to 34 weeks gestation and 11 days and older

5 mg/kg/dose IV or IM every 24 hours.

Neonates 30 to 34 weeks gestation and 0 to 10 days

5 mg/kg/dose IV or IM every 36 hours.

Neonates younger than 30 weeks gestation and 15 days and older

5 mg/kg/dose IV or IM every 36 hours.

Neonates younger than 30 weeks gestation and 0 to 14 days

5 mg/kg/dose IV or IM every 48 hours.

Intravenous or Intramuscular dosage (conventional dosing) Adults

3 mg/kg/day IV or IM divided every 8 hours; doses up to 5 mg/kg/day IV or IM divided every 6 to 8 hours may be required in life-threatening infections.[34041]

Children and Adolescents

2 to 2.5 mg/kg/dose IV or IM every 8 hours.

Infants

2.5 mg/kg/dose IV or IM every 8 hours.

Premature Infants 30 days and older weighing less than 1.2 kg

2.5 mg/kg/dose IV or IM every 18 hours. The FDA-approved dosage is 2.5 mg/kg/dose IV or IM every 8 hours; however, this dosing does not account for gestational age or birthweight.

Neonates 8 to 29 days weighing more than 2 kg

2.5 mg/kg/dose IV or IM every 8 hours. Extend the interval to 18 to 24 hours for neonates on ECMO. Individualize subsequent dosing by monitoring serum drug concentrations. When ECMO is discontinued, dosage adjustment may be required.

Neonates 8 to 29 days weighing 1.2 to 2 kg

2.5 mg/kg/dose IV or IM every 12 hours. The FDA-approved dosage is 2.5 mg/kg/dose IV or IM every 8 hours.

Neonates 8 to 29 days weighing less than 1.2 kg

2.5 mg/kg/dose IV or IM every 18 to 24 hours.[51918] [53249] The FDA-approved dosage is 2.5 mg/kg/dose IV or IM every 8 hours; however, this dosing does not account for gestational age or birthweight.[41185]

Neonates 0 to 7 days weighing more than 2 kg

2.5 mg/kg/dose IV or IM every 12 hours. Extend the interval to 18 to 24 hours for neonates on ECMO. Individualize subsequent dosing by monitoring serum drug concentrations. When ECMO is discontinued, dosage adjustment may be required.

Neonates 0 to 7 days weighing 1.2 to 2 kg

2.5 mg/kg/dose IV or IM every 18 hours. The FDA-approved dosage is 2.5 mg/kg/dose IV or IM every 12 hours.

Neonates 0 to 7 days weighing less than 1.2 kg

2.5 mg/kg/dose IV or IM every 18 to 24 hours. The FDA-approved dosage is 2.5 mg/kg/dose IV or IM every 12 hours; however, this dosing does not account for gestational age or birthweight.

For the treatment of necrotizing infections of the skin, fascia, and muscle. Intravenous or Intramuscular dosage (extended-interval dosing)† Adults

5 to 7 mg/kg/dose IV or IM every 24 hours until further debridement is not necessary, the patient has improved clinically, and fever has been absent for 48 to 72 hours plus clindamycin or metronidazole for mixed necrotizing infections.[34172] [34173] [34175] [34186]

Infants, Children, and Adolescents

5 to 7.5 mg/kg/dose IV or IM every 24 hours until further debridement is not necessary, the patient has improved clinically, and fever has been absent for 48 to 72 hours plus clindamycin or metronidazole for mixed necrotizing infections. A study in pediatric patients 3 months to 18 years (n = 114) suggested daily (i.e., every 24 hours) age-specific doses of 9.5 mg/kg/dose (3 to 23 months), 8.5 mg/kg/dose (2 to 7 years), and 7 mg/kg/dose (8 to 18 years) may be more appropriate to achieve goal gentamicin concentrations.

Neonates 35 weeks gestation and older and 8 days and older

5 mg/kg/dose IV or IM every 24 hours until further debridement is not necessary, the patient has improved clinically, and fever has been absent for 48 to 72 hours plus clindamycin or metronidazole for mixed necrotizing infections.

Neonates 35 weeks gestation and older and 0 to 7 days

4 mg/kg/dose IV or IM every 24 hours until further debridement is not necessary, the patient has improved clinically, and fever has been absent for 48 to 72 hours plus clindamycin or metronidazole for mixed necrotizing infections.

Neonates 30 to 34 weeks gestation and 11 days and older

5 mg/kg/dose IV or IM every 24 hours until further debridement is not necessary, the patient has improved clinically, and fever has been absent for 48 to 72 hours plus clindamycin or metronidazole for mixed necrotizing infections.

Neonates 30 to 34 weeks gestation and 0 to 10 days

5 mg/kg/dose IV or IM every 36 hours until further debridement is not necessary, the patient has improved clinically, and fever has been absent for 48 to 72 hours plus clindamycin or metronidazole for mixed necrotizing infections.

Neonates younger than 30 weeks gestation and 15 days and older

5 mg/kg/dose IV or IM every 36 hours until further debridement is not necessary, the patient has improved clinically, and fever has been absent for 48 to 72 hours plus clindamycin or metronidazole for mixed necrotizing infections.

Neonates younger than 30 weeks gestation and 0 to 14 days

5 mg/kg/dose IV or IM every 48 hours until further debridement is not necessary, the patient has improved clinic

ally, and fever has been absent for 48 to 72 hours plus clindamycin or metronidazole for mixed necrotizing infections.

Intravenous or Intramuscular dosage (conventional dosing) Adults

5 mg/kg/day IV or IM divided every 6 to 8 hours until further debridement is not necessary, the patient has improved clinically, and fever has been absent for 48 to 72 hours plus clindamycin or metronidazole for mixed necrotizing infections.[34041]

Children and Adolescents

2 to 2.5 mg/kg/dose IV or IM every 8 hours until further debridement is not necessary, the patient has improved clinically, and fever has been absent for 48 to 72 hours plus clindamycin or metronidazole for mixed necrotizing infections.

Infants

2.5 mg/kg/dose IV or IM every 8 hours until further debridement is not necessary, the patient has improved clinically, and fever has been absent for 48 to 72 hours plus clindamycin or metronidazole for mixed necrotizing infections.

Premature Infants 30 days and older weighing less than 1.2 kg

2.5 mg/kg/dose IV or IM every 18 hours until further debridement is not necessary, the patient has improved clinically, and fever has been absent for 48 to 72 hours plus clindamycin or metronidazole for mixed necrotizing infections. The FDA-approved dosage is 2.5 mg/kg/dose IV or IM every 8 hours; however, this dosing does not account for gestational age or birthweight.

Neonates 8 to 29 days weighing more than 2 kg

2.5 mg/kg/dose IV or IM every 8 hours. Extend the interval to 18 to 24 hours for neonates on ECMO. Individualize subsequent dosing by monitoring serum drug concentrations. When ECMO is discontinued, dosage adjustment may be required. Treat until further debridement is not necessary, the patient has improved clinically, and fever has been absent for 48 to 72 hours plus clindamycin or metronidazole for mixed necrotizing infections.

Neonates 8 to 29 days weighing 1.2 to 2 kg

2.5 mg/kg/dose IV or IM every 12 hours until further debridement is not necessary, the patient has improved clinically, and fever has been absent for 48 to 72 hours plus clindamycin or metronidazole for mixed necrotizing infections. The FDA-approved dosage is 2.5 mg/kg/dose IV or IM every 8 hours.

Neonates 8 to 29 days weighing less than 1.2 kg

2.5 mg/kg/dose IV or IM every 18 to 24 hours until further debridement is not necessary, the patient has improved clinically, and fever has been absent for 48 to 72 hours plus clindamycin or metronidazole for mixed necrotizing infections. The FDA-approved dosage is 2.5 mg/kg/dose IV or IM every 8 hours; however, this dosing does not account for gestational age or birthweight.

Neonates 0 to 7 days weighing more than 2 kg

2.5 mg/kg/dose IV or IM every 12 hours. Extend the interval to 18 to 24 hours for neonates on ECMO. Individualize subsequent dosing by monitoring serum drug concentrations. When ECMO is discontinued, dosage adjustment may be required. Treat until further debridement is not necessary, the patient has improved clinically, and fever has been absent for 48 to 72 hours plus clindamycin or metronidazole for mixed necrotizing infections.

Neonates 0 to 7 days weighing 1.2 to 2 kg

2.5 mg/kg/dose IV or IM every 18 hours until further debridement is not necessary, the patient has improved clinically, and fever has been absent for 48 to 72 hours plus clindamycin or metronidazole for mixed necrotizing infections. The FDA-approved dosage is 2.5 mg/kg/dose IV or IM every 12 hours.

Neonates 0 to 7 days weighing less than 1.2 kg

2.5 mg/kg/dose IV or IM every 18 to 24 hours until further debridement is not necessary, the patient has improved clinically, and fever has been absent for 48 to 72 hours plus clindamycin or metronidazole for mixed necrotizing infections. The FDA-approved dosage is 2.5 mg/kg/dose IV or IM every 12 hours; however, this dosing does not account for gestational age or birthweight.

For the treatment of diabetic foot ulcer. Intravenous or Intramuscular dosage (extended-interval dosing)† Adults

5 to 7 mg/kg/dose IV or IM every 24 hours for 7 to 14 days for moderate or severe infections as part of combination therapy. Continue treatment for up to 28 days if infection is improving but is extensive and resolving slower than expected or if patient has severe peripheral artery disease.

Intravenous or Intramuscular dosage (conventional dosing) Adults

3 mg/kg/day IV or IM divided every 8 hours; doses up to 5 mg/kg/day IV or IM divided every 6 to 8 hours may be required in life-threatening infections.[34041] Treat for 7 to 14 days for moderate or severe infections as part of combination therapy. Continue treatment for up to 28 days if infection is improving but is extensive and resolving slower than expected or if patient has severe peripheral artery disease.

For the treatment of blepharitis, blepharoconjunctivitis, bacterial conjunctivitis, corneal ulcer, dacryocystitis, keratitis, keratoconjunctivitis, and acute meibomianitis. Ophthalmic dosage (0.3% ophthalmic ointment) Adults

0.5 inch ribbon in the affected eye(s) 2 to 3 times daily.

Infants, Children, and Adolescents

0.5 inch ribbon in the affected eye(s) 2 to 3 times daily.

Ophthalmic dosage (0.3% ophthalmic solution) Adults

1 to 2 drops in the affected eye(s) every 4 hours; up to 2 drops in the affected eye(s) every hour for severe infections.

Infants, Children, and Adolescents

1 to 2 drops in the affected eye(s) every 4 hours; up to 2 drops in the affected eye(s) every hour for severe infections.

For the treatment of bacteremia and sepsis, including infections with difficult-to-treat resistance.
NOTE: Serum concentrations should be used to guide dosage adjustments. In most patients, dosage of aminoglycosides should be based on an estimate of lean body mass.
For the treatment of unspecified bacteremia and sepsis, including infections with difficult-to-treat resistance. Intravenous or Intramuscular dosage (extended-interval dosing)† Adults

5 to 7 mg/kg/dose IV or IM every 24 hours. Start within 1 hour for septic shock or within 3 hours for possible sepsis without shock. Duration of therapy is not well-defined and dependent on patient- and infection-specific factors. Assess patient daily for deescalation of antimicrobial therapy based on pathogen identification and/or adequate clinical response.

Infants, Children, and Adolescents

5 to 7.5 mg/kg/dose IV or IM every 24 hours.[51899] [51920] [51922] [51960] A study in pediatric patients 3 months to 18 years (n = 114) suggested daily (i.e., every 24 hours) age-specific doses of 9.5 mg/kg/dose (3 months to younger than 2 years), 8.5 mg/kg/dose (2 to 7 years), and 7 mg/kg/dose (8 to 18 years) may be more appropriate to achieve goal gentamicin concentrations.[51959] Start within 1 hour for septic shock or within 3 hours for sepsis-associated organ dysfunction without shock. Duration of therapy is not well-defined and dependent on patient- and infection-specific factors. Assess patient daily for de-escalation of antimicrobial therapy based on pathogen identification and/or adequate clinical response.[64985]

Neonates 35 weeks gestation and older and 8 days and older

5 mg/kg/dose IV or IM every 24 hours. In neonates with hypoxic ischemic encephalopathy (HIE) receiving hypothermia, a gentamicin dosing interval of 36 hours has been recommended due to a lower gentamicin clearance in these patients.[55215] Start within 1 hour for septic shock or within 3 hours for sepsis-associated organ dysfunction without shock. Duration of therapy is not well-defined and dependent on patient- and infection-specific factors. Assess patient daily for de-escalation of antimicrobial therapy based on pathogen identification and/or adequate clinical response. Neonates younger than 37 weeks gestational age were excluded from the scope of the Surviving Sepsis Campaign guidelines.[64985]

Neonates 35 weeks gestation and older and 0 to 7 days

4 mg/kg/dose IV or IM every 24 hours. In neonates with hypoxic ischemic encephalopathy (HIE) receiving hypothermia, a gentamicin dosing interval of 36 hours has been recommended due to a lower gentamicin clearance in these patients.[55215] Start within 1 hour for septic shock or within 3 hours for sepsis-associated organ dysfunction without shock. Duration of therapy is not well-defined and dependent on patient- and infection-specific factors. Assess patient daily for de-escalation of antimicrobial therapy based on pathogen identification and/or adequate clinical response. Neonates younger than 37 weeks gestational age were excluded from the scope of the Surviving Sepsis Campaign guidelines.[64985]

Neonates 30 to 34 weeks gestation and 11 days and older

5 mg/kg/dose IV or IM every 24 hours.

Neonates 30 to 34 weeks gestation and 0 to 10 days

5 mg/kg/dose IV or IM every 36 hours.

Neonates younger than 30 weeks gestation and 15 days and older

5 mg/kg/dose IV or IM every 36 hours.

Neonates younger than 30 weeks gestation and 0 to 14 days

5 mg/kg/dose IV or IM every 48 hours.

Intravenous or Intramuscular dosage (conventional dosing) Adults

3 mg/kg/day IV or IM divided every 8 hours; doses up to 5 mg/kg/day IV or IM divided every 6 to 8 hours may be required in life-threatening infections. Start within 1 hour for septic shock or within 3 hours for possible sepsis without shock. Duration of therapy is not well-defined and dependent on patient- and infection-specific factors. Assess patient daily for deescalation of antimicrobial therapy based on pathogen identification and/or adequate clinical response.

Children and Adolescents

2 to 2.5 mg/kg/dose IV or IM every 8 hours.[41185] Start within 1 hour for septic shock or within 3 hours for sepsis-associated organ dysfunction without shock. Duration of therapy is not well-defined and dependent on patient- and infection-specific factors. Assess patient daily for de-escalation of antimicrobial therapy based on pathogen identification and/or adequate clinical response.[64985]

Infants

2.5 mg/kg/dose IV or IM every 8 hours.[41185] Start within 1 hour for septic shock or within 3 hours for sepsis-associated organ dysfunction without shock. Duration of therapy is not well-defined and dependent on patient- and infection-specific factors. Assess patient daily for de-escalation of antimicrobial therapy based on pathogen identification and/or adequate clinical response.[64985]

Premature infants 30 days and older weighing less than 1.2 kg

2.5 mg/kg/dose IV or IM every 18 hours. The FDA-approved dose is 2.5 mg/kg/dose IV or IM every 8 hours; however, this dosing does not account for gestational age or birthweight.

Neonates 8 to 29 days weighing more than 2 kg

2.5 mg/kg/dose IV or IM every 8 hours.[41185] [51918] Extend the interval to 18 to 24 hours for neonates on ECMO. Individualize subsequent dosing by monitoring serum drug concentrations. When ECMO is discontinued, dosage adjustment may be required.[51916] [51917] [51954] Start within 1 hour for septic shock or within 3 hours for sepsis-associated organ dysfunction without shock. Duration of therapy is not well-defined and dependent on patient- and infection-specific factors. Assess patient daily for de-escalation of antimicrobial therapy based on pathogen identification and/or adequate clinical response. Neonates younger than 37 weeks gestational age were excluded from the scope of the Surviving Sepsis Campaign guidelines.[64985]

Neonates 8 to 29 days weighing 1.2 to 2 kg

2.5 mg/kg/dose IV or IM every 12 hours.[51918] The FDA-approved dose is 2.5 mg/kg/dose IV or IM every 8 hours.[41185] Start within 1 hour for septic shock or within 3 hours for sepsis-associated organ dysfunction without shock. Duration of therapy is not well-defined and dependent on patient- and infection-specific factors. Assess patient daily for de-escalation of antimicrobial therapy based on pathogen identification and/or adequate clinical response. Neonates younger than 37 weeks gestational age were excluded from the scope of the Surviving Sepsis Campaign guidelines.[64985]

Neonates 8 to 29 days weighing less than 1.2 kg

2.5 mg/kg/dose IV or IM every 18 to 24 hours. The FDA-approved dose is 2.5 mg/kg/dose IV or IM every 8 hours; however, this dosing does not account for gestational age or birthweight.

Neonates 0 to 7 days weighing more than 2 kg

2.5 mg/kg/dose IV or IM every 12 hours.[41185] [51918] Extend the interval to 18 to 24 hours for neonates on ECMO. Individualize subsequent dosing by monitoring serum drug concentrations. When ECMO is discontinued, dosage adjustment may be required.[51916] [51917] [51954] Start within 1 hour for septic shock or within 3 hours for sepsis-associated organ dysfunction without shock. Duration of therapy is not well-defined and dependent on patient- and infection-specific factors. Assess patient daily for de-escalation of antimicrobial therapy based on pathogen identification and/or adequate clinical response. Neonates younger than 37 weeks gestational age were excluded from the scope of the Surviving Sepsis Campaign guidelines.[64985]

Neonates 0 to 7 days weighing 1.2 to 2 kg

2.5 mg/kg/dose IV or IM every 18 hours.[51918] The FDA-approved dose is 2.5 mg/kg/dose IV or IM every 12 hours.[41185] Start within 1 hour for septic shock or within 3 hours for sepsis-associated organ dysfunction without shock. Duration of therapy is not well-defined and dependent on patient- and infection-specific factors. Assess patient daily for de-escalation of antimicrobial therapy based on pathogen identification and/or adequate clinical response. Neonates younger than 37 weeks gestational age were excluded from the scope of the Surviving Sepsis Campaign guidelines.[64985]

Neonates 0 to 7 days weighing less than 1.2 kg

2.5 mg/kg/dose IV or IM every 18 to 24 hours. The FDA-approved dose is 2.5 mg/kg/dose IV or IM every 12 hours; however, this dosing does not account for gestational age or birthweight.

For the treatment of persistent methicillin-resistant S. aureus (MRSA) bacteremia and vancomycin failure. Intravenous dosage (conventional dosing) Adults

1 mg/kg/dose IV every 8 hours plus high dose daptomycin for 2 weeks. Routine use of gentamicin for MRSA bacteremia is not recommended.

For the treatment of intraabdominal infections (i.e., appendicitis, peritonitis, necrotizing enterocolitis).
NOTE: Serum concentrations should be used to guide dosage adjustments. In most patients, dosage of aminoglycosides should be based on an estimate of lean body mass.[41185]
For peritoneal dialysis-associated peritonitis† in patients with end-stage renal disease. Intraperitoneal† dosage Adults

Intraperitoneal (IP) gentamicin can be administered continuously in each dialysate exchange bag with a loading dose of 8 mg/L initially and then a maintenance dose of 4 mg/L. Alternatively, for intermittent dosing, administer 0.6 mg/kg/dose IP for anuric patients and 0.75 mg/kg/dose IP for non-anuric patients once daily during the long-dwell periods. Treat for 2 to 3 weeks depending on infecting organism and the patient's clinical status.[54203]

Infants, Children, and Adolescents

Intraperitoneal (IP) gentamicin can be administered continuously in each dialysate exchange bag with a loading dose of 8 mg/L initially and then a maintenance dose of 4 mg/L. Alternatively, for intermittent dosing, administer 0.6 mg/kg/dose IP for anuric patients and 0.75 mg/kg/dose IP for non-anuric patients once daily during the long-dwell periods. Treat for 2 to 3 weeks depending on infecting organism and the patient's clinical status.[53190]

Intravenous or Intramuscular dosage (extended-interval dosing)† Adults

5 to 7 mg/kg/dose IV or IM. Initial dosing intervals are often determined using a nomogram and then are adjusted based on a random concentration drawn 8 to 12 hours after the first dose; dosing intervals of 24, 36, and, in some cases, 48 to 72 hours, may be necessary.[34172] [34173] [34175] [34186] Routine use of an aminoglycoside is not recommended in adults with community-acquired intra-abdominal infections. An aminoglycoside may be necessary for healthcare-associated intra-abdominal infection depending on culture and susceptibility results. Treatment is recommended for 4 to 7 days.[49816]

Infants, Children, and Adolescents

5 to 7.5 mg/kg/dose IV or IM every 24 hours. One study in pediatric patients 3 months to 18 years (n = 114) suggested daily (i.e., every 24 hours) age-specific doses of 9.5 mg/kg/dose (3 months to younger than 2 years), 8.5 mg/kg/dose (2 to 7 years), and 7 mg/kg/dose (8 to 18 years) may be more appropriate to achieve goal gentamicin concentrations. Guidelines recommend gentamicin, in combination with other appropriate antimicrobial agents (typically ampicillin and clindamycin/metronidazole), for complicated, community-acquired intra-abdominal infections. Treat for 4 to 7 days.

Neonates 35 weeks gestation and older and 8 days and older

5 mg/kg/dose IV or IM every 24 hours. Guidelines recommend gentamicin in combination with ampicillin and metronidazole for necrotizing enterocolitis in neonates.

Neonates 35 weeks gestation and older and 0 to 7 days

4 mg/kg/dose IV or IM every 24 hours. Guidelines recommend gentamicin in combination with ampicillin and metronidazole for necrotizing enterocolitis in neonates.

Neonates 30 to 34 weeks gestation and 11 days and older

5 mg/kg/dose IV or IM every 24 hours. Guidelines recommend gentamicin in combination with ampicillin and metronidazole for necrotizing enterocolitis in neonates.

Neonates 30 to 34 weeks gestation and 0 to 10 days

5 mg/kg/dose IV or IM every 36 hours. Guidelines recommend gentamicin in combination with ampicillin and metronidazole for necrotizing enterocolitis in neonates.

Neonates younger than 30 weeks gestation and 15 days and older

5 mg/kg/dose IV or IM every 36 hours. Guidelines recommend gentamicin in combination with ampicillin and metronidazole for necrotizing enterocolitis in neonates.

Neonates younger than 30 weeks gestation and 0 to 14 days

5 mg/kg/dose IV or IM every 48 hours. Guidelines recommend gentamicin in combination with ampicillin and metronidazole for necrotizing enterocolitis in neonates.

Intravenous or Intramuscular dosage (conventional dosing) Adults

3 mg/kg/day IV or IM divided every 8 hours; doses up to 5 mg/kg/day IV or IM divided every 6 to 8 hours may be required in life-threatening infections.[34041] Routine use of an aminoglycoside is not recommended in adults with community-acquired intra-abdominal infections. An aminoglycoside may be necessary for healthcare-associated intra-abdominal infection depending on culture and susceptibility results. Treatment is recommended for 4 to 7 days.[49816]

Children and Adolescents

2 to 2.5 mg/kg/dose IV or IM every 8 hours. Guidelines recommend gentamicin, in combination with other appropriate antimicrobial agents (typically ampicillin and clindamycin/metronidazole), for complicated, community-acquired intra-abdominal infections. Treat for 4 to 7 days.

Infants

2.5 mg/kg/dose IV or IM every 8 hours. Guidelines recommend gentamicin, in combination with other appropriate antimicrobial agents (typically ampicillin and clindamycin/metronidazole), for complicated, community-acquired intra-abdominal infections. Treat for 4 to 7 days.

Premature infants 30 days and older weighing less than 1.2 kg

2.5 mg/kg/dose IV or IM every 18 hours. The FDA-approved dosage is 2.5 mg/kg/dose IV or IM every 8 hours; however, this dosing does not account for gestational age or birthweight. In general, IM administration of antibiotics in very low birth weight neonates is not practical due to small muscle mass and unreliable absorption. Guidelines recommend gentamicin in combination with ampicillin and metronidazole for necrotizing enterocolitis in neonates.

Neonates 8 to 29 days weighing more than 2 kg

2.5 mg/kg/dose IV or IM every 8 hours. Extend the interval to 18 to 24 hours for neonates on ECMO. Individualize subsequent dosing by monitoring serum drug concentrations. When ECMO is discontinued, dosage adjustment may be required. Guidelines recommend gentamicin in combination with ampicillin and metronidazole for necrotizing enterocolitis in neonates.

Neonates 8 to 29 days weighing 1.2 to 2 kg

2.5 mg/kg/dose IV or IM every 12 hours. The FDA-approved dosage is 2.5 mg/kg/dose IV or IM every 8 hours. Guidelines recommend gentamicin in combination with ampicillin and metronidazole for necrotizing enterocolitis in neonates.

Neonates 8 to 29 days weighing less than 1.2 kg

2.5 mg/kg/dose IV or IM every 18 to 24 hours. The FDA-approved dosage is 2.5 mg/kg/dose IV or IM every 8 hours; however, this dosing does not account for gestational age or birthweight. In general, IM administration of antibiotics in very low birth weight neonates is not practical due to small muscle mass and unreliable absorption. Guidelines recommend gentamicin in combination with ampicillin and metronidazole for necrotizing enterocolitis in neonates.

Neonates 0 to 7 days weighing more than 2 kg

2.5 mg/kg/dose IV or IM every 12 hours. Extend the interval to 18 to 24 hours for neonates on ECMO. Individualize subsequent dosing by monitoring serum drug concentrations. When ECMO is discontinued, dosage adjustment may be required. Guidelines recommend gentamicin in combination with ampicillin and metronidazole for necrotizing enterocolitis in neonates.

Neonates 0 to 7 days weighing 1.2 to 2 kg

2.5 mg/kg/dose IV or IM every 18 hours. The FDA-approved dosage is 2.5 mg/kg/dose IV or IM every 12 hours. Guidelines recommend gentamicin in combination with ampicillin and metronidazole for necrotizing enterocolitis in neonates.

Neonates 0 to 7 days weighing less than 1.2 kg

2.5 mg/kg/dose IV or IM every 18 to 24 hours. The FDA-approved dosage is 2.5 mg/kg/dose IV or IM every 12 hours; however, this dosing does not account for gestational age or birthweight. In general, IM administration of antibiotics in very low birth weight neonates is not practical due to small muscle mass and unreliable absorption. Guidelines recommend gentamicin in combination with ampicillin and metronidazole for necrotizing enterocolitis in neonates.

For the treatment of bone and joint infections, including osteomyelitis and infectious arthritis.
NOTE: Use lean body mass to calculate the gentamicin dose. Adjust dose based on serum gentamicin concentrations.[41185]
For the treatment of osteomyelitis. Intravenous dosage (extended-interval dosing)† Adults

5 to 7 mg/kg/dose IV every 24 hours for 4 to 6 weeks.

Infants, Children, and Adolescents 3 months to 17 years

5 to 7.5 mg/kg/dose IV every 24 hours. One study in pediatric patients 3 months to 18 years (n = 114) suggested daily (i.e., every 24 hours) age-specific doses of 9.5 mg/kg/dose (3 months to younger than 2 years), 8.5 mg/kg/dose (2 to 7 years), and 7 mg/kg/dose (8 to 18 years) may be more appropriate to achieve goal gentamicin concentrations. Treat for 2 to 4 days or until clinically improved, followed by oral step-down therapy for a total duration of 3 to 4 weeks for uncomplicated cases. A longer course (i.e., 4 to 6 weeks or longer) may be needed for severe or complicated infections.

Infants 1 to 2 months

5 to 7.5 mg/kg/dose IV every 24 hours. Treat for 14 to 21 days or until clinically improved, followed by oral step-down therapy for a total duration of 4 to 6 weeks. A longer course (several months) may be needed for severe or complicated infections.

Neonates 35 weeks gestation and older and 8 days and older

5 mg/kg/dose IV every 24 hours. Treat for 14 to 21 days or until clinically improved, followed by oral step-down therapy for a total duration of 4 to 6 weeks. A longer course (several months) may be needed for severe or complicated infections.

Neonates 35 weeks gestation and older and 0 to 7 days

4 mg/kg/dose IV every 24 hours. Treat for 14 to 21 days or until clinically improved, followed by oral step-down therapy for a total duration of 4 to 6 weeks. A longer course (several months) may be needed for severe or complicated infections.

Neonates 30 to 34 weeks gestation and 11 days and older

5 mg/kg/dose IV every 24 hours. Treat for 14 to 21 days or until clinically improved, followed by oral step-down therapy for a total duration of 4 to 6 weeks. A longer course (several months) may be needed for severe or complicated infections.

Neonates 30 to 34 weeks gestation and 0 to 10 days

5 mg/kg/dose IV every 36 hours. Treat for 14 to 21 days or until clinically improved, followed by oral step-down therapy for a total duration of 4 to 6 weeks. A longer course (several months) may be needed for severe or complicated infections.

Neonates younger than 30 weeks gestation and 15 days and older

5 mg/kg/dose IV every 36 hours. Treat for 14 to 21 days or until clinically improved, followed by oral step-down therapy for a total duration of 4 to 6 weeks. A longer course (several months) may be needed for severe or complicated infections.

Neonates younger than 30 weeks gestation and 0 to 14 days

5 mg/kg/dose IV every 48 hours. Treat for 14 to 21 days or until clinically improved, followed by oral step-down therapy for a total duration of 4 to 6 weeks. A longer course (several months) may be needed for severe or complicated infections.

Intravenous dosage (conventional dosing) Adults

3 mg/kg/day IV divided every 8 hours for 4 to 6 weeks; doses up to 5 mg/kg/day IV divided every 6 to 8 hours may be required in life-threatening infections.

Children and Adolescents

2 to 2.5 mg/kg/dose IV every 8 hours. Treat for 2 to 4 days or until clinically improved, followed by oral step-down therapy for a total duration of 3 to 4 weeks for uncomplicated cases. A longer course (i.e., 4 to 6 weeks or longer) may be needed for severe or complicated infections.

Infants 3 to 11 months

2.5 mg/kg/dose IV every 8 hours. Treat for 2 to 4 days or until clinically improved, followed by oral step-down therapy for a total duration of 3 to 4 weeks for uncomplicated cases. A longer course (i.e., 4 to 6 weeks or longer) may be needed for severe or complicated infections.

Infants 1 to 2 months

2.5 mg/kg/dose IV every 8 hours. Treat for 14 to 21 days or until clinically improved, followed by oral step-down therapy for a total duration of 4 to 6 weeks. A longer course (several months) may be needed for severe or complicated infections.

Premature infants 30 days and older weighing less than 1.2 kg

2.5 mg/kg/dose IV every 18 hours. Treat for 14 to 21 days or until clinically improved, followed by oral step-down therapy for a total duration of 4 to 6 weeks. A longer course (several months) may be needed for severe or complicated infections. The FDA-approved dosage is 2.5 mg/kg/dose IV every 8 hours; however, this dosing does not account for gestational age or birthweight.

Neonates 8 to 29 days weighing more than 2 kg

2.5 mg/kg/dose IV every 8 hours. Extend the interval to 18 to 24 hours for neonates on ECMO. Individualize subsequent dosing by monitoring serum drug concentrations. When ECMO is discontinued, dosage adjustment may be required. Treat for 14 to 21 days or until clinically improved, followed by oral step-down therapy for a total duration of 4 to 6 weeks. A longer course (several months) may be needed for severe or complicated infections.

Neonates 8 to 29 days weighing 1.2 to 2 kg

2.5 mg/kg/dose IV every 12 hours. Treat for 14 to 21 days or until clinically improved, followed by oral step-down therapy for a total duration of 4 to 6 weeks. A longer course (several months) may be needed for severe or complicated infections. The FDA-approved dosage is 2.5 mg/kg/dose IV every 8 hours.

Neonates 8 to 29 days weighing less than 1.2 kg

2.5 mg/kg/dose IV every 18 to 24 hours. Treat for 14 to 21 days or until clinically improved, followed by oral step-down therapy for a total duration of 4 to 6 weeks. A longer course (several months) may be needed for severe or complicated infections. The FDA-approved dosage is 2.5 mg/kg/dose IV every 8 hours; however, this dosing does not account for gestational age or birthweight.

Neonates 0 to 7 days weighing more than 2 kg

2.5 mg/kg/dose IV every 12 hours. Extend the interval to 18 to 24 hours for neonates on ECMO. Individualize subsequent dosing by monitoring serum drug concentrations. When ECMO is discontinued, dosage adjustment may be required. Treat for 14 to 21 days or until clinically improved, followed by oral step-down therapy for a total duration of 4 to 6 weeks. A longer course (several months) may be needed for severe or complicated infections.

Neonates 0 to 7 days weighing 1.2 to 2 kg

2.5 mg/kg/dose IV every 18 hours. Treat for 14 to 21 days or until clinically improved, followed by oral step-down therapy for a total duration of 4 to 6 weeks. A longer course (several months) may be needed for severe or complicated infections. The FDA-approved dosage is 2.5 mg/kg/dose IV every 12 hours.

Neonates 0 to 7 days weighing less than 1.2 kg

2.5 mg/kg/dose IV every 18 to 24 hours. Treat for 14 to 21 days or until clinically improved, followed by oral step-down therapy for a total duration of 4 to 6 weeks. A longer course (several months) may be needed for severe or complicated infections. The FDA-approved dosage is 2.5 mg/kg/dose IV every 12 hours; however, this dosing does not account for gestational age or birthweight.

For the treatment of infectious arthritis. Intravenous dosage (extended-interval dosing)† Adults

5 to 7 mg/kg/dose IV every 24 hours. Treat for 1 to 2 weeks or until clinically improved, followed by oral step-down therapy for 2 to 4 weeks.

Infants, Children, and Adolescents 3 months to 17 years

5 to 7.5 mg/kg/dose IV every 24 hours. One study in pediatric patients 3 months to 18 years (n = 114) suggested daily (i.e., every 24 hours) age-specific doses of 9.5 mg/kg/dose (3 months to younger than 2 years), 8.5 mg/kg/dose (2 to 7 years), and 7 mg/kg/dose (8 to 18 years) may be more appropriate to achieve goal gentamicin concentrations. Treat for 2 to 4 days or until clinically improved, followed by oral step-down therapy for a total duration of 2 to 3 weeks for uncomplicated cases. A longer course (i.e., 4 to 6 weeks or longer) may be needed for septic hip arthritis or severe or complicated infections.

Infants 1 to 2 months

5 to 7.5 mg/kg/dose IV every 24 hours. Treat for 14 to 21 days or until clinically improved, followed by oral step-down therapy for a total duration of 4 to 6 weeks. A longer course (several months) may be needed for severe or complicated infections.

Neonates 35 weeks gestation and older and 8 days and older

5 mg/kg/dose IV every 24 hours. Treat for 14 to 21 days or until clinically improved, followed by oral step-down therapy for a total duration of 4 to 6 weeks. A longer course (several months) may be needed for severe or complicated infections.

Neonates 35 weeks gestation and older and 0 to 7 days

4 mg/kg/dose IV every 24 hours. Treat for 14 to 21 days or until clinically improved, followed by oral step-down therapy for a total duration of 4 to 6 weeks. A longer course (several months) may be needed for severe or complicated infections.

Neonates 30 to 34 weeks gestation and 11 days and older

5 mg/kg/dose IV every 24 hours. Treat for 14 to 21 days or until clinically improved, followed by oral step-down therapy for a total duration of 4 to 6 weeks. A longer course (several months) may be needed for severe or complicated infections.

Neonates 30 to 34 weeks gestation and 0 to 10 days

5 mg/kg/dose IV every 36 hours. Treat for 14 to 21 days or until clinically improved, followed by oral step-down therapy for a total duration of 4 to 6 weeks. A longer course (several months) may be needed for severe or complicated infections.

Neonates younger than 30 weeks gestation and 15 days and older

5 mg/kg/dose IV every 36 hours. Treat for 14 to 21 days or until clinically improved, followed by oral step-down therapy for a total duration of 4 to 6 weeks. A longer course (several months) may be needed for severe or complicated infections.

Neonates younger than 30 weeks gestation and 0 to 14 days

5 mg/kg/dose IV every 48 hours. Treat for 14 to 21 days or until clinically improved, followed by oral step-down therapy for a total duration of 4 to 6 weeks. A longer course (several months) may be needed for severe or complicated infections.

Intravenous dosage (conventional dosing) Adults

3 mg/kg/day IV divided every 8 hours; doses up to 5 mg/kg/day IV divided every 6 to 8 hours may be required in life-threatening infections. Treat for 1 to 2 weeks or until clinically improved, followed by oral step-down therapy for 2 to 4 weeks.

Children and Adolescents

2 to 2.5 mg/kg/dose IV every 8 hours. Treat for 2 to 4 days or until clinically improved, followed by oral step-down therapy for a total duration of 2 to 3 weeks for uncomplicated cases. A longer course (i.e., 4 to 6 weeks or longer) may be needed for septic hip arthritis or severe or complicated infections.

Infants 3 to 11 months

2.5 mg/kg/dose IV every 8 hours. Treat for 2 to 4 days or until clinically improved, followed by oral step-down therapy for a total duration of 2 to 3 weeks for uncomplicated cases. A longer course (i.e., 4 to 6 weeks or longer) may be needed for septic hip arthritis or severe or complicated infections.

Infants 1 to 2 months

2.5 mg/kg/dose IV every 8 hours. Treat for 14 to 21 days or until clinically improved, followed by oral step-down therapy for a total duration of 4 to 6 weeks. A longer course (several months) may be needed for severe or complicated infections.

Premature infants 30 days and older weighing less than 1.2 kg

2.5 mg/kg/dose IV every 18 hours. Treat for 14 to 21 days or until clinically improved, followed by oral step-down therapy for a total duration of 4 to 6 weeks. A longer course (several months) may be needed for severe or complicated infections. The FDA-approved dosage is 2.5 mg/kg/dose IV every 8 hours; however, this dosing does not account for gestational age or birthweight.

Neonates 8 to 29 days weighing more than 2 kg

2.5 mg/kg/dose IV every 8 hours. Extend the interval to 18 to 24 hours for neonates on ECMO. Individualize subsequent dosing by monitoring serum drug concentrations. When ECMO is discontinued, dosage adjustment may be required. Treat for 14 to 21 days or until clinically improved, followed by oral step-down therapy for a total duration of 4 to 6 weeks. A longer course (several months) may be needed for severe or complicated infections.

Neonates 8 to 29 days weighing 1.2 to 2 kg

2.5 mg/kg/dose IV every 12 hours. Treat for 14 to 21 days or until clinically improved, followed by oral step-down therapy for a total duration of 4 to 6 weeks. A longer course (several months) may be needed for severe or complicated infections. The FDA-approved dosage is 2.5 mg/kg/dose IV every 8 hours. 

Neonates 8 to 29 days weighing less than 1.2 kg

2.5 mg/kg/dose IV every 18 to 24 hours. Treat for 14 to 21 days or until clinically improved, followed by oral step-down therapy for a total duration of 4 to 6 weeks. A longer course (several months) may be needed for severe or complicated infections. The FDA-approved dosage is 2.5 mg/kg/dose IV every 8 hours; however, this dosing does not account for gestational age or birthweight.

Neonates 0 to 7 days weighing more than 2 kg

2.5 mg/kg/dose IV every 12 hours. Extend the interval to 18 to 24 hours for neonates on ECMO. Individualize subsequent dosing by monitoring serum drug concentrations. When ECMO is discontinued, dosage adjustment may be required. Treat for 14 to 21 days or until clinically improved, followed by oral step-down therapy for a total duration of 4 to 6 weeks. A longer course (several months) may be needed for severe or complicated infections.

Neonates 0 to 7 days weighing 1.2 to 2 kg

2.5 mg/kg/dose IV every 18 hours. Treat for 14 to 21 days or until clinically improved, followed by oral step-down therapy for a total duration of 4 to 6 weeks. A longer course (several months) may be needed for severe or complicated infections. The FDA-approved dosage is 2.5 mg/kg/dose IV every 12 hours. 

Neonates 0 to 7 days weighing less than 1.2 kg

2.5 mg/kg/dose IV every 18 to 24 hours. Treat for 14 to 21 days or until clinically improved, followed by oral step-down therapy for a total duration of 4 to 6 weeks. A longer course (several months) may be needed for severe or complicated infections. The FDA-approved dosage is 2.5 mg/kg/dose IV every 12 hours; however, this dosing does not account for gestational age or birthweight.

For the treatment of meningitis and ventriculitis†.
NOTE: Serum concentrations should be used to guide dosage adjustments. In most patients, dosage of aminoglycosides should be based on an estimate of lean body mass.
For the treatment of meningitis due to L. monocytogenes†. Intravenous or Intramuscular dosage (extended-interval dosing)† Adults

5 to 7 mg/kg/dose IV or IM every 24 hours for at least 21 days as adjunct therapy.[32690] [34172] [34173] [34175] [34186]

Infants, Children, and Adolescents

5 to 7.5 mg/kg/dose IV or IM every 24 hours for at least 21 days as adjunct therapy. A study in pediatric patients 3 months to 18 years (n = 114) suggested daily (i.e., every 24 hours) age-specific doses of 9.5 mg/kg/dose (3 to 23 months), 8.5 mg/kg/dose (2 to 7 years), and 7 mg/kg/dose (8 to 18 years) may be more appropriate to achieve goal gentamicin concentrations.

Neonates 35 weeks gestation and older and 8 days and older

5 mg/kg/dose IV or IM every 24 hours for at least 21 days as adjunct therapy.

Neonates 35 weeks gestation and older and 0 to 7 days

4 mg/kg/dose IV or IM every 24 hours for at least 21 days as adjunct therapy.

Neonates 30 to 34 weeks gestation and 11 days and older

5 mg/kg/dose IV or IM every 24 hours for at least 21 days as adjunct therapy.

Neonates 30 to 34 weeks gestation and 0 to 10 days

5 mg/kg/dose IV or IM every 36 hours for at least 21 days as adjunct therapy.

Neonates younger than 30 weeks gestation and 15 days and older

5 mg/kg/dose IV or IM every 36 hours for at least 21 days as adjunct therapy.

Neonates younger than 30 weeks gestation and 0 to 14 days

5 mg/kg/dose IV or IM every 48 hours for at least 21 days as adjunct therapy.

Intravenous or Intramuscular dosage (conventional dosing) Adults

5 mg/kg/day IV or IM divided every 8 hours for at least 21 days as adjunct therapy.

Infants, Children, and Adolescents

2.5 mg/kg/dose IV or IM every 8 hours for at least 21 days as adjunct therapy.

Premature Infants 30 days and older weighing less than 1.2 kg

2.5 mg/kg/dose IV or IM every 18 hours for at least 21 days as adjunct therapy.

Neonates 8 to 29 days weighing more than 2 kg

2.5 mg/kg/dose IV or IM every 8 hours for at least 21 days as adjunct therapy. Extend the interval to 18 to 24 hours for neonates on ECMO. Individualize subsequent dosing by monitoring serum drug concentrations. When ECMO is discontinued, dosage adjustment may be required.

Neonates 8 to 29 days weighing 1.2 to 2 kg

2.5 mg/kg/dose IV or IM every 12 hours for at least 21 days as adjunct therapy.

Neonates 8 to 29 days weighing less than 1.2 kg

2.5 mg/kg/dose IV or IM every 18 to 24 hours for at least 21 days as adjunct therapy.

Neonates 0 to 7 days weighing more than 2 kg

2.5 mg/kg/dose IV or IM every 12 hours for at least 21 days as adjunct therapy. Extend the interval to 18 to 24 hours for neonates on ECMO. Individualize subsequent dosing by monitoring serum drug concentrations. When ECMO is discontinued, dosage adjustment may be required.[51916] [51917] [51954]

Neonates 0 to 7 days weighing 1.2 to 2 kg

2.5 mg/kg/dose IV or IM every 18 hours for at least 21 days as adjunct therapy.

Neonates 0 to 7 days weighing less than 1.2 kg

2.5 mg/kg/dose IV or IM every 18 to 24 hours for at least 21 days as adjunct therapy.

For the treatment of group B streptococcal meningitis†. Intravenous or Intramuscular dosage (extended-interval dosing) Adults

5 to 7 mg/kg/dose IV or IM every 24 hours for 14 to 21 days as adjunct therapy.[32690] [34172] [34173] [34175] [34186]

Infants, Children, and Adolescents

5 to 7.5 mg/kg/dose IV or IM every 24 hours for 14 to 21 days as adjunct therapy. A study in pediatric patients 3 months to 18 years (n = 114) suggested daily (i.e., every 24 hours) age-specific doses of 9.5 mg/kg/dose (3 to 23 months), 8.5 mg/kg/dose (2 to 7 years), and 7 mg/kg/dose (8 to 18 years) may be more appropriate to achieve goal gentamicin concentrations.

Neonates 35 weeks gestation and older and 8 days and older

5 mg/kg/dose IV or IM every 24 hours for 14 to 21 days as adjunct therapy.

Neonates 35 weeks gestation and older and 0 to 7 days

4 mg/kg/dose IV or IM every 24 hours for 14 to 21 days as adjunct therapy.

Neonates 30 to 34 weeks gestation and 11 days and older

5 mg/kg/dose IV or IM every 24 hours for 14 to 21 days as adjunct therapy.

Neonates 30 to 34 weeks gestation and 0 to 10 days

5 mg/kg/dose IV or IM every 36 hours for 14 to 21 days as adjunct therapy.

Neonates younger than 30 weeks gestation and 15 days and older

5 mg/kg/dose IV or IM every 36 hours for 14 to 21 days as adjunct therapy.

Neonates younger than 30 weeks gestation and 0 to 14 days

5 mg/kg/dose IV or IM every 48 hours for 14 to 21 days as adjunct therapy.

Intravenous or Intramuscular dosage (conventional dosing) Adults

5 mg/kg/day IV or IM divided every 8 hours for 14 to 21 days as adjunct therapy.

Infants, Children, and Adolescents

2.5 mg/kg/dose IV or IM every 8 hours for 14 to 21 days as adjunct therapy.

Premature Infants 30 days and older weighing less than 1.2 kg

2.5 mg/kg/dose IV or IM every 18 hours for 14 to 21 days as adjunct therapy.

Neonates 8 to 29 days weighing more than 2 kg

2.5 mg/kg/dose IV or IM every 8 hours for 14 to 21 days as adjunct therapy. Extend the interval to 18 to 24 hours for neonates on ECMO. Individualize subsequent dosing by monitoring serum drug concentrations. When ECMO is discontinued, dosage adjustment may be required.

Neonates 8 to 29 days weighing 1.2 to 2 kg

2.5 mg/kg/dose IV or IM every 12 hours for 14 to 21 days as adjunct therapy.

Neonates 8 to 29 days weighing less than 1.2 kg

2.5 mg/kg/dose IV or IM every 18 to 24 hours for 14 to 21 days as adjunct therapy.

Neonates 0 to 7 days weighing more than 2 kg

2.5 mg/kg/dose IV or IM every 12 hours for 14 to 21 days as adjunct therapy. Extend the interval to 18 to 24 hours for neonates on ECMO. Individualize subsequent dosing by monitoring serum drug concentrations. When ECMO is discontinued, dosage adjustment may be required.

Neonates 0 to 7 days weighing 1.2 to 2 kg

2.5 mg/kg/dose IV or IM every 18 hours for 14 to 21 days as adjunct therapy.

Neonates 0 to 7 days weighing less than 1.2 kg

2.5 mg/kg/dose IV or IM every 18 to 24 hours for 14 to 21 days as adjunct therapy.

For the treatment of enterococcal meningitis†. Intravenous or Intramuscular dosage (extended-interval dosing) Adults

5 to 7 mg/kg/dose IV or IM every 24 hours for 14 to 21 days as adjunct therapy.

Infants, Children, and Adolescents

5 to 7.5 mg/kg/dose IV or IM every 24 hours for 14 to 21 days as adjunct therapy. A study in pediatric patients 3 months to 18 years (n = 114) suggested daily (i.e., every 24 hours) age-specific doses of 9.5 mg/kg/dose (3 to 23 months), 8.5 mg/kg/dose (2 to 7 years), and 7 mg/kg/dose (8 to 18 years) may be more appropriate to achieve goal gentamicin concentrations.

Neonates 35 weeks gestation and older and 8 days and older

5 mg/kg/dose IV or IM every 24 hours for 14 to 21 days as adjunct therapy.

Neonates 35 weeks gestation and older and 0 to 7 days

4 mg/kg/dose IV or IM every 24 hours for 14 to 21 days as adjunct therapy.

Neonates 30 to 34 weeks gestation and 11 days and older

5 mg/kg/dose IV or IM every 24 hours for 14 to 21 days as adjunct therapy.

Neonates 30 to 34 weeks gestation and 0 to 10 days

5 mg/kg/dose IV or IM every 36 hours for 14 to 21 days as adjunct therapy.

Neonates younger than 30 weeks gestation and 15 days and older

5 mg/kg/dose IV or IM every 36 hours for 14 to 21 days as adjunct therapy.

Neonates younger than 30 weeks gestation and 0 to 14 days

5 mg/kg/dose IV or IM every 48 hours for 14 to 21 days as adjunct therapy.

Intravenous or Intramuscular dosage (conventional dosing) Adults

5 mg/kg/day IV or IM divided every 8 hours for 14 to 21 days as adjunct therapy.

Infants, Children, and Adolescents

2.5 mg/kg/dose IV or IM every 8 hours for 14 to 21 days as adjunct therapy.

Premature Infants 30 days and older weighing less than 1.2 kg

2.5 mg/kg/dose IV or IM every 18 hours for 14 to 21 days as adjunct therapy.

Neonates 8 to 29 days weighing more than 2 kg >

2.5 mg/kg/dose IV or IM every 8 hours for 14 to 21 days as adjunct therapy. Extend the interval to 18 to 24 hours for neonates on ECMO. Individualize subsequent dosing by monitoring serum drug concentrations. When ECMO is discontinued, dosage adjustment may be required.

Neonates 8 to 29 days weighing 1.2 to 2 kg

2.5 mg/kg/dose IV or IM every 12 hours for 14 to 21 days as adjunct therapy.

Neonates 8 to 29 days weighing less than 1.2 kg

2.5 mg/kg/dose IV or IM every 18 to 24 hours for 14 to 21 days as adjunct therapy.

Neonates 0 to 7 days weighing more than 2 kg

2.5 mg/kg/dose IV or IM every 12 hours for 14 to 21 days as adjunct therapy. Extend the interval to 18 to 24 hours for neonates on ECMO. Individualize subsequent dosing by monitoring serum drug concentrations. When ECMO is discontinued, dosage adjustment may be required.

Neonates 0 to 7 days weighing 1.2 to 2 kg

2.5 mg/kg/dose IV or IM every 18 hours for 14 to 21 days as adjunct therapy.

Neonates 0 to 7 days weighing less than 1.2 kg

2.5 mg/kg/dose IV or IM every 18 to 24 hours for 14 to 21 days as adjunct therapy.

For the treatment of meningitis or ventriculitis† due to gram-negative organisms. Intravenous or Intramuscular dosage (extended-interval dosing)† Adults

5 to 7 mg/kg/dose IV or IM every 24 hours for 10 to 21 days as adjunct therapy.

Infants, Children, and Adolescents

5 to 7.5 mg/kg/dose IV or IM every 24 hours for 10 to 21 days as adjunct therapy. A study in pediatric patients 3 months to 18 years (n = 114) suggested daily (i.e., every 24 hours) age-specific doses of 9.5 mg/kg/dose (3 to 23 months), 8.5 mg/kg/dose (2 to 7 years), and 7 mg/kg/dose (8 to 18 years) may be more appropriate to achieve goal gentamicin concentrations.

Neonates 35 weeks gestation and older and 8 days and older

5 mg/kg/dose IV or IM every 24 hours for 2 weeks beyond the first sterile CSF culture or at least 21 days, whichever is longer, as adjunct therapy.

Neonates 35 weeks gestation and older and 0 to 7 days

4 mg/kg/dose IV or IM every 24 hours for 2 weeks beyond the first sterile CSF culture or at least 21 days, whichever is longer, as adjunct therapy.

Neonates 30 to 34 weeks gestation and 11 days and older

5 mg/kg/dose IV or IM every 24 hours for 2 weeks beyond the first sterile CSF culture or at least 21 days, whichever is longer, as adjunct therapy.

Neonates 30 to 34 weeks gestation and 0 to 10 days

5 mg/kg/dose IV or IM every 36 hours for 2 weeks beyond the first sterile CSF culture or at least 21 days, whichever is longer, as adjunct therapy.

Neonates younger than 30 weeks gestation and 15 days and older

5 mg/kg/dose IV or IM every 36 hours for 2 weeks beyond the first sterile CSF culture or at least 21 days, whichever is longer, as adjunct therapy.

Neonates younger than 30 weeks gestation and 0 to 14 days

5 mg/kg/dose IV or IM every 48 hours for 2 weeks beyond the first sterile CSF culture or at least 21 days, whichever is longer, as adjunct therapy.

Intravenous or Intramuscular dosage (conventional dosing) Adults

5 mg/kg/day IV or IM divided every 8 hours for 10 to 21 days as adjunct therapy.

Children and Adolescents

2 to 2.5 mg/kg/dose IV or IM every 8 hours for 10 to 21 days as adjunct therapy.

Infants

2.5 mg/kg/dose IV or IM every 8 hours for 10 to 21 days as adjunct therapy.

Premature Infants 30 days and older weighing less than 1.2 kg

2.5 mg/kg/dose IV or IM every 18 hours for 2 weeks beyond the first sterile CSF culture or at least 21 days, whichever is longer, as adjunct therapy. The FDA-approved dosage is 2.5 mg/kg/dose IV or IM every 8 hours. This dosing does not account for gestational age or birthweight.

Neonates 8 to 29 days weighing more than 2 kg

2.5 mg/kg/dose IV or IM every 8 hours for 2 weeks beyond the first sterile CSF culture or at least 21 days, whichever is longer, as adjunct therapy. Extend the interval to 18 to 24 hours for neonates on ECMO. Individualize subsequent dosing by monitoring serum drug concentrations. When ECMO is discontinued, dosage adjustment may be required.

Neonates 8 to 29 days weighing 1.2 to 2 kg

2.5 mg/kg/dose IV or IM every 12 hours for 2 weeks beyond the first sterile CSF culture or at least 21 days, whichever is longer, as adjunct therapy. The FDA-approved dosage is 2.5 mg/kg/dose IV or IM every 8 hours. This dosing does not account for gestational age or birthweight.

Neonates 8 to 29 days weighing less than 1.2 kg

2.5 mg/kg/dose IV or IM every 18 to 24 hours for 2 weeks beyond the first sterile CSF culture or at least 21 days, whichever is longer, as adjunct therapy. The FDA-approved dosage is 2.5 mg/kg/dose IV or IM every 8 hours. This dosing does not account for gestational age or birthweight.

Neonates 0 to 7 days weighing more than 2 kg

2.5 mg/kg/dose IV or IM every 12 hours for 2 weeks beyond the first sterile CSF culture or at least 21 days, whichever is longer, as adjunct therapy. Extend the interval to 18 to 24 hours for neonates on ECMO. Individualize subsequent dosing by monitoring serum drug concentrations. When ECMO is discontinued, dosage adjustment may be required.

Neonates 0 to 7 days weighing 1.2 to 2 kg

2.5 mg/kg/dose IV or IM every 18 hours for 2 weeks beyond the first sterile CSF culture or at least 21 days, whichever is longer, as adjunct therapy. The FDA-approved dosage is 2.5 mg/kg/dose IV or IM every 12 hours. This dosing does not account for gestational age or birthweight.

Neonates 0 to 7 days weighing less than 1.2 kg

2.5 mg/kg/dose IV or IM every 18 to 24 hours for 2 weeks beyond the first sterile CSF culture or at least 21 days, whichever is longer, as adjunct therapy. The FDA-approved dosage is 2.5 mg/kg/dose IV or IM every 12 hours. This dosing does not account for gestational age or birthweight.

For the intrathecal† treatment of meningitis or ventriculitis. Intrathecal dosage (preservative-free solution) Adults

4 to 8 mg intrathecally once daily. Use in addition to systemic therapy. Adjust dose as necessary based on gentamicin CSF concentrations and MIC of the organism.

Infants, Children, and Adolescents

1 to 2 mg intrathecally once daily. Use in addition to systemic therapy. Adjust dose as necessary based on gentamicin CSF concentrations and MIC of the organism.

For the intraventricular† treatment of meningitis or ventriculitis with slit ventricles with external ventricular drain output of less than 50 mL/24 hours. Intraventricular dosage (preservative-free solution) Adults

2 mg intraventricularly every third day. Use in addition to systemic therapy. Adjust dose as necessary based on gentamicin CSF concentrations and MIC of the organism.

For the intraventricular† treatment of meningitis or ventriculitis with slit ventricles with external ventricular drain output of 50 to 100 mL/24 hours. Intraventricular dosage (preservative-free solution) Adults

2 mg intraventricularly every second day. Use in addition to systemic therapy. Adjust dose as necessary based on gentamicin CSF concentrations and MIC of the organism.

For the intraventricular† treatment of meningitis or ventriculitis with slit ventricles with external ventricular drain output of 100 to 150 mL/24 hours. Intraventricular dosage (preservative-free solution) Adults

2 mg intraventricularly once daily. Use in addition to systemic therapy. Adjust dose as necessary based on gentamicin CSF concentrations and MIC of the organism.

For the intraventricular† treatment of meningitis or ventriculitis with slit ventricles with external ventricular drain output of 150 to 200 mL/24 hours. Intraventricular dosage (preservative-free solution) Adults

3 mg intraventricularly once daily. Use in addition to systemic therapy. Adjust dose as necessary based on gentamicin CSF concentrations and MIC of the organism.

For the intraventricular† treatment of meningitis or ventriculitis with slit ventricles with external ventricular drain output of 200 to 250 mL/24 hours. Intraventricular dosage (preservative-free solution) Adults

4 mg intraventricularly once daily. Use in addition to systemic therapy. Adjust dose as necessary based on gentamicin CSF concentrations and MIC of the organism.

For the intraventricular† treatment of meningitis or ventriculitis with normal size ventricles with external ventricular drain output of less than 50 mL/24 hours. Intraventricular dosage (preservative-free solution) Adults

3 mg intraventricularly every third day. Use in addition to systemic therapy. Adjust dose as necessary based on gentamicin CSF concentrations and MIC of the organism.

For the intraventricular† treatment of meningitis or ventriculitis with normal size ventricles with external ventricular drain output of 50 to 100 mL/24 hours. Intraventricular dosage (preservative-free solution) Adults

3 mg intraventricularly every second day. Use in addition to systemic therapy. Adjust dose as necessary based on gentamicin CSF concentrations and MIC of the organism.

For the intraventricular† treatment of meningitis or ventriculitis with normal size ventricles with external ventricular drain output of 100 to 150 mL/24 hours. Intraventricular dosage (preservative-free solution) Adults

3 mg intraventricularly once daily. Use in addition to systemic therapy. Adjust dose as necessary based on gentamicin CSF concentrations and MIC of the organism.

For the intraventricular† treatment of meningitis or ventriculitis with normal size ventricles with external ventricular drain output of 150 to 200 mL/24 hours. Intraventricular dosage (preservative-free solution) Adults

4 mg intraventricularly once daily. Use in addition to systemic therapy. Adjust dose as necessary based on gentamicin CSF concentrations and MIC of the organism.

For the intraventricular† treatment of meningitis or ventriculitis with normal size ventricles with external ventricular drain output of 200 to 250 mL/24 hours. Intraventricular dosage (preservative-free solution) Adults

5 mg intraventricularly once daily. Use in addition to systemic therapy. Adjust dose as necessary based on gentamicin CSF concentrations and MIC of the organism.

For the intraventricular† treatment of meningitis or ventriculitis with enlarged ventricles with external ventricular drain output of less than 50 mL/24 hours. Intraventricular dosage (preservative-free solution) Adults

4 to 5 mg intraventricularly every third day. Use in addition to systemic therapy. Adjust dose as necessary based on gentamicin CSF concentrations and MIC of the organism.

For the intraventricular† treatment of meningitis or ventriculitis with enlarged ventricles with external ventricular drain output of 50 to 100 mL/24 hours. Intraventricular dosage (preservative-free solution) Adults

4 to 5 mg intraventricularly every second day. Use in addition to systemic therapy. Adjust dose as necessary based on gentamicin CSF concentrations and MIC of the organism.

For the intraventricular† treatment of meningitis or ventriculitis with enlarged ventricles with external ventricular drain output of 100 to 150 mL/24 hours. Intraventricular dosage (preservative-free solution) Adults

4 to 5 mg intraventricularly once daily. Use in addition to systemic therapy. Adjust dose as necessary based on gentamicin CSF concentrations and MIC of the organism.

For the intraventricular† treatment of meningitis or ventriculitis with enlarged ventricles with external ventricular drain output of 150 to 200 mL/24 hours. Intraventricular dosage (preservative-free solution) Adults

5 to 6 mg intraventricularly once daily. Use in addition to systemic therapy. Adjust dose as necessary based on gentamicin CSF concentrations and MIC of the organism.

For the intraventricular† treatment of meningitis or ventriculitis with enlarged ventricles with external ventricular drain output of 200 to 250 mL/24 hours. Intraventricular dosage (preservative-free solution) Adults

6 to 7 mg intraventricularly once daily. Use in addition to systemic therapy. Adjust dose as necessary based on gentamicin CSF concentrations and MIC of the organism.

For the intraventricular† treatment of meningitis or ventriculitis with unspecified ventricle size or drainage output. Intraventricular dosage (preservative-free solution) Adults

4 to 8 mg intraventricularly once daily. Use in addition to systemic therapy. Adjust dose as necessary based on gentamicin CSF concentrations and MIC of the organism.

Infants, Children, and Adolescents

1 to 2 mg intraventricularly once daily. Use in addition to systemic therapy. Adjust dose as necessary based on gentamicin CSF concentrations and MIC of the organism.

For the treatment of gynecologic infections†, including postpartum endometritis† and pelvic inflammatory disease (PID)†, with or without associated tubo-ovarian abscess†. For the treatment of postpartum endometritis†. Intravenous dosage (extended-interval dosing) Adults

5 mg/kg/dose IV every 24 hours as part of combination therapy. Continue treatment until clinical improvement and afebrile for 24 to 48 hours.

For the treatment of pelvic inflammatory disease (PID)†, with or without associated tubo-ovarian abscess†. Intravenous or Intramuscular dosage (extended-interval dosing) Adults

3 to 5 mg/kg/dose IV or IM every 24 hours in combination with clindamycin IV as an alternative. Parenteral therapy should be continued for at least 24 to 48 hours after clinical improvement, and then stepdown to oral clindamycin or doxycycline for total of 14 days of therapy. When tubo-ovarian abscess is present, oral clindamycin or metronidazole plus doxycycline should be used for a total of 14 days of therapy.

Adolescents

3 to 5 mg/kg/dose IV or IM every 24 hours in combination with clindamycin IV as an alternative. Parenteral therapy should be continued for at least 24 to 48 hours after clinical improvement, and then stepdown to oral clindamycin or doxycycline for total of 14 days of therapy. When tubo-ovarian abscess is present, oral clindamycin or metronidazole plus doxycycline should be used for a total of 14 days of therapy.

Intravenous or Intramuscular dosage (conventional dosing) Adults

2 mg/kg/dose IV or IM loading dose, then 1.5 mg/kg/dose IV or IM every 8 hours in combination with clindamycin IV as an alternative. Parenteral therapy should be continued for at least 24 to 48 hours after clinical improvement, and then stepdown to oral clindamycin or doxycycline for total of 14 days of therapy. When tubo-ovarian abscess is present, oral clindamycin or metronidazole plus doxycycline should be used for a total of 14 days of therapy.

Adolescents

2 mg/kg/dose IV or IM loading dose, then 1.5 mg/kg/dose IV or IM every 8 hours in combination with clindamycin IV as an alternative. Parenteral therapy should be continued for at least 24 to 48 hours after clinical improvement, and then stepdown to oral clindamycin or doxycycline for total of 14 days of therapy. When tubo-ovarian abscess is present, oral clindamycin or metronidazole plus doxycycline should be used for a total of 14 days of therapy.

For the treatment of plague† infection. For the treatment of bubonic or pharyngeal plague†. Intravenous or Intramuscular dosage Adults

5 mg/kg/dose IV or IM every 24 hours for 10 to 14 days as first-line therapy. Monotherapy is recommended for stable patients with naturally occurring plague, although dual therapy can be considered for patients with large buboes. Use dual therapy with 2 distinct classes of antimicrobials for initial treatment of naturally occurring plague in pregnant patients and patients infected after intentional release of Y. pestis.

Infants, Children, and Adolescents

4.5 to 7.5 mg/kg/dose IV or IM every 24 hours for 10 to 14 days as first-line therapy. Monotherapy is recommended for stable patients with naturally occurring plague, although dual therapy can be considered for patients with large buboes. Use dual therapy with 2 distinct classes of antimicrobials for initial treatment in patients infected after intentional release of Y. pestis.

Neonates 8 days and older

5 mg/kg/dose IV or IM every 24 hours for 10 to 14 days as first-line therapy. Use dual therapy with 2 distinct classes of antimicrobials for initial treatment in patients infected after intentional release of Y. pestis.

Neonates 0 to 7 days

4 mg/kg/dose IV or IM every 24 hours for 10 to 14 days as first-line therapy. Use dual therapy with 2 distinct classes of antimicrobials for initial treatment in patients infected after intentional release of Y. pestis.

For the treatment of pneumonic or septicemic plague†. Intravenous or Intramuscular dosage Adults

5 mg/kg/dose IV or IM every 24 hours for 10 to 14 days as first-line therapy. Monotherapy can be considered for mild-to-moderate disease in patients with naturally occurring plague. Use dual therapy with 2 distinct classes of antimicrobials for initial treatment of naturally occurring plague in pregnant patients, patients with severe disease, and patients infected after intentional release of Y. pestis.

Infants, Children, and Adolescents

4.5 to 7.5 mg/kg/dose IV or IM every 24 hours for 10 to 14 days as first-line therapy. Monotherapy can be considered for mild-to-moderate disease in patients with naturally occurring plague. Use dual therapy with 2 distinct classes of antimicrobials for initial treatment in patients with severe disease and patients infected after intentional release of Y. pestis.

Neonates 8 days and older

5 mg/kg/dose IV or IM every 24 hours for 10 to 14 days as first-line therapy. Use dual therapy with 2 distinct classes of antimicrobials for initial treatment in patients with severe disease and patients infected after intentional release of Y. pestis.

Neonates 0 to 7 days

4 mg/kg/dose IV or IM every 24 hours for 10 to 14 days as first-line therapy. Use dual therapy with 2 distinct classes of antimicrobials for initial treatment in patients with severe disease and patients infected after intentional release of Y. pestis.

For the treatment of tularemia† infection due to exposure to Francisella tularensis in an individual patient or in a contained casualty setting.
NOTE: Streptomycin is the drug of choice to treat tularemia in most patients, however, because gentamicin is more widely available it is an acceptable alternative. Gentamicin is the preferred agent in pregnant women; if gentamicin is contraindicated, streptomycin should be used.
Intravenous or Intramuscular dosage Adults

5 mg/kg/dose IV or IM every 24 hours for 10 days. Alternatively, 2 mg/kg IV or IM loading dose, followed by 1.7 mg/kg/dose IV or IM every 8 hours for 10 days could be used. IV doxycycline, chloramphenicol, or ciprofloxacin could be used as third-line alternatives.

Infants, Children, and Adolescents

2.5 mg/kg/dose IV or IM every 8 hours for 10 days. IV doxycycline, chloramphenicol, or ciprofloxacin could be used as third-line alternatives.

For surgical infection prophylaxis†. Intravenous dosage Adults

5 mg/kg/dose IV as a single dose within 60 minutes prior to the surgical incision; no intraoperative redosing is necessary. Guidelines recommend gentamicin in combination with another appropriate antimicrobial (i.e., vancomycin, clindamycin, or metronidazole depending on procedure) as an alternate therapy for patients with beta-lactam allergy undergoing gastrointestinal, biliary tract, uncomplicated appendectomy, colorectal, urogynecology, or transplant procedures.

Infants, Children, and Adolescents

2.5 mg/kg/dose IV as a single dose within 60 minutes prior to the surgical incision; no intraoperative redosing is necessary. Guidelines recommend gentamicin, in combination with another appropriate antimicrobial (i.e., vancomycin, clindamycin, or metronidazole depending on procedure), as an alternate therapy for patients with beta-lactam allergy undergoing gastrointestinal, biliary tract, uncomplicated appendectomy, colorectal, urologic, or transplant procedures.

For the treatment of bartonellosis†, including bacteremia†, trench fever†, and atypical hepatosplenic cat scratch disease†.
NOTE: See endocarditis for treatment of endocarditis.
For the treatment of Bartonella bacteremia† or trench fever†. Intravenous dosage Adults

3 mg/kg/dose IV every 24 hours for 2 weeks plus doxycycline for 4 weeks.

For the treatment of atypical hepatosplenic cat scratch disease†. Intravenous dosage Adults

3 mg/kg/dose IV every 24 hours for 4 to 6 weeks plus rifampin.

For the treatment of uncomplicated gonorrhea†, including cervicitis†, urethritis†, and proctitis†. Intramuscular dosage Adults

240 mg IM as a single dose plus azithromycin as an alternative in patients with a cephalosporin allergy or when ceftriaxone is not available.

Children weighing more than 45 kg and Adolescents

240 mg IM as a single dose plus azithromycin as an alternative in patients with a cephalosporin allergy or when ceftriaxone is not available.

For the treatment of complicated urinary tract infection (UTI), pyelonephritis, and cystitis† due to infections with difficult-to-treat resistance as well as catheter-associated urinary tract infection. For the treatment of complicated UTI and pyelonephritis, including infections with difficult-to-treat resistance. Intravenous or Intramuscular dosage (extended-interval dosing)† Adults

5 to 7 mg/kg/dose IV or IM every 24 hours for 7 to 14 days alone or as combination therapy. A single dose prior to oral therapy may be used in persons not requiring hospitalization.

Infants, Children, and Adolescents 2 months to 17 years

5 to 7.5 mg/kg/dose IV or IM every 24 hours. A study in pediatric patients age 3 months to 18 years (n = 114) suggested daily (i.e., every 24 hours) age-specific doses of 9.5 mg/kg/dose (3 months to younger than 2 years), 8.5 mg/kg/dose (2 to 7 years), and 7 mg/kg/dose (8 to 18 years) may be more appropriate to achieve goal gentamicin concentrations. Treat for 24 to 48 hours or until patient is clinically stable and afebrile, followed by oral antibiotics for a total duration of 7 to 14 days.

Infants 1 month

5 to 7.5 mg/kg/dose IV or IM every 24 hours. Infants younger than 2 to 3 months are at risk for systemic infection and rapid change in their clinical condition. Treat UTIs as presumed pyelonephritis in these patients.

Neonates 35 weeks gestation and older and 8 days and older

5 mg/kg/dose IV or IM every 24 hours. Neonates are at risk for systemic infection and rapid change in their clinical condition. Treat UTIs as presumed pyelonephritis in these patients.

Neonates 35 weeks gestation and older and 0 to 7 days

4 mg/kg/dose IV or IM every 24 hours. Neonates are at risk for systemic infection and rapid change in their clinical condition. Treat UTIs as presumed pyelonephritis in these patients.

Neonates 30 to 34 weeks gestation and 11 days and older

5 mg/kg/dose IV or IM every 24 hours. Neonates are at risk for systemic infection and rapid change in their clinical condition. Treat UTIs as presumed pyelonephritis in these patients.

Neonates 30 to 34 weeks gestation and 0 to 10 days

5 mg/kg/dose IV or IM every 36 hours. Neonates are at risk for systemic infection and rapid change in their clinical condition. Treat UTIs as presumed pyelonephritis in these patients.

Neonates younger than 30 weeks gestation and 15 days and older

5 mg/kg/dose IV or IM every 36 hours. Neonates are at risk for systemic infection and rapid change in their clinical condition. Treat UTIs as presumed pyelonephritis in these patients.

Neonates younger than 30 weeks gestation and 0 to 14 days

5 mg/kg/dose IV or IM every 48 hours. Neonates are at risk for systemic infection and rapid change in their clinical condition. Treat UTIs as presumed pyelonephritis in these patients.

Intravenous or Intramuscular dosage (conventional dosing) Adults

3 mg/kg/day IV or IM divided every 8 hours; doses up to 5 mg/kg/day IV or IM divided every 6 to 8 hours may be required in life-threatening infections.

Children and Adolescents

2 to 2.5 mg/kg/dose IV or IM every 8 hours. Treat for 24 to 48 hours or until patient is clinically stable and afebrile, followed by oral antibiotics for a total duration of 7 to 14 days.

Infants 2 to 11 months

2.5 mg/kg/dose IV or IM every 8 hours. Treat for 24 to 48 hours or until patient is clinically stable and afebrile, followed by oral antibiotics for a total duration of 7 to 14 days.

Infants 1 month

2.5 mg/kg/dose IV or IM every 8 hours. Infants younger than 2 to 3 months are at risk for systemic infection and rapid change in their clinical condition. Treat UTIs as presumed pyelonephritis in these patients.

Premature Infants 30 days and older weighing less than 1.2 kg

2.5 mg/kg/dose IV or IM every 18 hours. The FDA-approved dosage is 2.5 mg/kg/dose IV or IM every 8 hours; however, this dosing does not account for gestational age or birthweight. Neonates are at risk for systemic infection and rapid change in their clinical condition. Treat UTIs as presumed pyelonephritis in these patients.

Neonates 8 to 29 days weighing more than 2 kg

2.5 mg/kg/dose IV or IM every 8 hours.[41185] [51918] Extend the interval to 18 to 24 hours for neonates on ECMO. Individualize subsequent dosing by monitoring serum drug concentrations. When ECMO is discontinued, dosage adjustment may be required.[51916] [51917] [51954] Neonates are at risk for systemic infection and rapid change in their clinical condition. Treat UTIs as presumed pyelonephritis in these patients.

Neonates 8 to 29 days weighing 1.2 to 2 kg

2.5 mg/kg/dose IV or IM every 12 hours. The FDA-approved dosage is 2.5 mg/kg/dose IV or IM every 8 hours. Neonates are at risk for systemic infection and rapid change in their clinical condition. Treat UTIs as presumed pyelonephritis in these patients.

Neonates 8 to 29 days weighing less than 1.2 kg

2.5 mg/kg/dose IV or IM every 18 to 24 hours. The FDA-approved dosage is 2.5 mg/kg/dose every 8 hours; however, this dosing does not account for gestational age or birthweight. Neonates are at risk for systemic infection and rapid change in their clinical condition. Treat UTIs as presumed pyelonephritis in these patients.

Neonates 0 to 7 days weighing more than 2 kg

2.5 mg/kg/dose IV or IM every 12 hours.[41185] [51918] Extend the interval to 18 to 24 hours for neonates on ECMO. Individualize subsequent dosing by monitoring serum drug concentrations. When ECMO is discontinued, dosage adjustment may be required.[51916] [51917] [51954] Neonates are at risk for systemic infection and rapid change in their clinical condition. Treat UTIs as presumed pyelonephritis in these patients.

Neonates 0 to 7 days weighing 1.2 to 2 kg

2.5 mg/kg/dose IV or IM every 18 hours. The FDA-approved dosage is 2.5 mg/kg/dose IV or IM every 12 hours. Neonates are at risk for systemic infection and rapid change in their clinical condition. Treat UTIs as presumed pyelonephritis in these patients.

Neonates 0 to 7 days weighing less than 1.2 kg

2.5 mg/kg/dose IV or IM every 18 to 24 hours. The FDA-approved dosage is 2.5 mg/kg/dose IV or IM every 12 hours; however, this dosing does not account for gestational age or birthweight. Neonates are at risk for systemic infection and rapid change in their clinical condition. Treat UTIs as presumed pyelonephritis in these patients.

For the treatment of cystitis† due to infections with difficult-to-treat resistance. Intravenous dosage (extended-interval dosing) Adults

5 mg/kg/dose IV as a single dose.

For the treatment of catheter-associated UTI. Intravenous or Intramuscular dosage (extended-interval dosing)† Adults

5 to 7 mg/kg/dose IV or IM every 24 hours for 7 to 14 days with or without ampicillin. A single dose prior to oral therapy may be used in persons not requiring hospitalization.

Infants, Children, and Adolescents 2 months to 17 years

5 to 7.5 mg/kg/dose IV or IM every 24 hours for 7 to 14 days. A study in pediatric patients age 3 months to 18 years (n = 114) suggested daily (i.e., every 24 hours) age-specific doses of 9.5 mg/kg/dose (3 months to younger than 2 years), 8.5 mg/kg/dose (2 to 7 years), and 7 mg/kg/dose (8 to 18 years) may be more appropriate to achieve goal gentamicin concentrations.

Infants 1 month

5 to 7.5 mg/kg/dose IV or IM every 24 hours for 7 to 14 days.

Intravenous or Intramuscular dosage (conventional dosing) Adults

3 mg/kg/day IV or IM divided every 8 hours; doses up to 5 mg/kg/day IV or IM divided every 6 to 8 hours may be required in life-threatening infections.

Children and Adolescents

2 to 2.5 mg/kg/dose IV or IM every 8 hours.

Infants 2 to 11 months

2.5 mg/kg/dose IV or IM every 8 hours.

Infants 1 month

2.5 mg/kg/dose IV or IM every 8 hours. Infants younger than 2 to 3 months are at risk for systemic infection and rapid change in their clinical condition. Treat UTIs as presumed pyelonephritis in these patients.

For the empiric treatment of febrile neutropenia†.
NOTE: Serum concentrations should be used to guide dosage adjustments. In most patients, dosage of aminoglycosides should be based on an estimate of lean body mass.
For the treatment of febrile neutropenia in adults. Intravenous dosage (extended-interval dosing) Adults

Studies of once daily or 'pulse' dosing have typically used doses of 5 to 7 mg/kg IV. Initial dosing intervals are often determined using a nomogram and then are adjusted based on a random level drawn 8 to 12 hours after the first dose; dosing intervals of 24, 36, and in some cases, 48 to 72 hours, may be necessary. Aminoglycosides are recommended as an option in for febrile neutropenia in combination with an antipseudomonal beta-lactam in patients with complications or those with suspected or documented resistance.

Intravenous dosage (conventional dosing) Adults

The manufacturer recommends up to 5 mg/kg/day IV or IM in 3 to 4 divided dose for life-threatening infections. Studies in patients with febrile neutropenia have used initial doses of either 80 mg IV or 1.5 mg/kg IV every 8 hours with dose adjustments to maintain peak concentrations of 4 to 8 mcg/ml. Aminoglycosides are recommended as an option in combination with an antipseudomonal beta-lactam in patients with complications or those with suspected or documented resistance.

For the treatment of febrile neutropenia in pediatric patients. Intravenous dosage (extended-interval dosing) Infants, Children, and Adolescents

7 to 8 mg/kg/dose IV every 24 hours. In a pharmacokinetic analysis of data from a retrospective study in pediatric patients with febrile neutropenia, age-specific initial doses of 10.5 mg/kg/dose IV (1 year to less than 6 years), 9.5 mg/kg/dose IV (girls 6 years and older), and 7.5 mg/kg/dose IV (boys 6 years and older) given every 24 hours were recommended to achieve target serum gentamicin peak concentrations. The efficacy of once daily gentamicin for febrile neutropenia has been established in several studies in pediatric patients. Gentamicin, in combination with an antipseudomonal penicillin or cephalosporin, has been successfully used for the empiric treatment of febrile neutropenia in children. Guidelines for the management of fever and neutropenia in cancer patients recommend monotherapy with an antipseudomonal beta-lactam or a carbapenem as empiric treatment in high-risk patients; addition of a second gram-negative antimicrobial agent (i.e., aminoglycoside, aztreonam) is recommended for patients who are clinically unstable, when a resistant infection is suspected, or for centers with high rates of resistant pathogens.

Intravenous dosage (conventional dosing) Infants, Children, and Adolescents

2 to 2.5 mg/kg/dose IV every 8 hours. Gentamicin, in combination with an antipseudomonal penicillin or cephalosporin, has been successfully used for the empiric treatment of febrile neutropenia in children. Guidelines for the management of fever and neutropenia in cancer patients recommend monotherapy with an antipseudomonal beta-lactam or a carbapenem as empiric treatment in high-risk patients; addition of a second gram-negative antimicrobial agent (i.e., aminoglycoside, aztreonam) is recommended for patients who are clinically unstable, when a resistant infection is suspected, or for centers with high rates of resistant pathogens.

For the treatment of pulmonary exacerbations in patients with cystic fibrosis (CF)†. Intravenous dosage Adults

10 mg/kg/dose IV every 24 hours (Max: 660 mg/dose) initially, and then adjust dosage based on serum concentrations. Aminoglycosides have traditionally been administered as a three-times daily regimen such as 3.3 mg/kg/dose IV every 8 hours; however, high dose once-daily aminoglycoside regimens are now preferred. Of note, tobramycin is usually the preferred aminoglycoside for CF exacerbations because of its increased activity against Pseudomonas aeruginosa. Additionally, gentamicin has been associated with an increased risk of precipitating acute renal failure in CF patients compared with tobramycin.

Infants, Children, and Adolescents

10 mg/kg/dose IV every 24 hours (Max: 660 mg/dose) initially, and then adjust dosage based on serum concentrations. Aminoglycosides have traditionally been administered as a three-times daily regimen such as 3.3 mg/kg/dose IV every 8 hours; however, high dose once-daily aminoglycoside regimens are now preferred. Of note, tobramycin is usually the preferred aminoglycoside for CF exacerbations because of its increased activity against Pseudomonas aeruginosa. Additionally, gentamicin has been associated with an increased risk of precipitating acute renal failure in CF patients compared with tobramycin.

For postexposure plague prophylaxis†. Intravenous or Intramuscular dosage Neonates 8 days and older

5 mg/kg/dose IV or IM every 24 hours for 7 days as an alternative therapy.

Neonates 0 to 7 days

4 mg/kg/dose IV or IM every 24 hours for 7 days as an alternative therapy.

For the treatment of invasive vibriosis†. Intravenous or Intramuscular dosage (extended-interval dosing) Infants, Children, and Adolescents

5 to 7.5 mg/kg/dose IV or IM every 24 hours in combination with sulfamethoxazole; trimethoprim for 7 to 14 days.

Intravenous or Intramuscular dosage (conventional dosing) Infants, Children, and Adolescents

2 to 2.5 mg/kg/dose IV or IM every 8 hours in combination with sulfamethoxazole; trimethoprim for 7 to 14 days.

For the treatment of chorioamnionitis† or intraamniotic infection†. Intravenous dosage (extended-interval dosing) Adults

5 mg/kg/dose IV every 24 hours during the intrapartum period as part of combination therapy. Give 1 additional dose after cesarean delivery; an additional dose is generally not needed after vaginal delivery. Other risk factors such as bacteremia or persistent postpartum fever may require additional therapy.

Adolescents

5 mg/kg/dose IV every 24 hours during the intrapartum period as part of combination therapy. Give 1 additional dose after cesarean delivery; an additional dose is generally not needed after vaginal delivery. Other risk factors such as bacteremia or persistent postpartum fever may require additional therapy.

Intravenous dosage (conventional dosing) Adults

2 mg/kg/dose IV loading dose, followed by 1.5 mg/kg/dose IV every 8 hours during the intrapartum period as part of combination therapy. Give 1 additional dose after cesarean delivery; an additional dose is generally not needed after vaginal delivery. Other risk factors such as bacteremia or persistent postpartum fever may require additional therapy.

Adolescents

2 mg/kg/dose IV loading dose, followed by 1.5 mg/kg/dose IV every 8 hours during the intrapartum period as part of combination therapy. Give 1 additional dose after cesarean delivery; an additional dose is generally not needed after vaginal delivery. Other risk factors such as bacteremia or persistent postpartum fever may require additional therapy.

For the treatment of bronchiectasis†. For the treatment of acute exacerbations of bronchiectasis†. Intravenous dosage (extended-interval dosing) Adults

5 to 7 mg/kg/dose IV every 24 hours for a total duration of 14 days as part of combination therapy.

Infants, Children, and Adolescents

5 to 7.5 mg/kg/dose IV every 24 hours for 14 days as part of combination therapy.

For long-term treatment of bronchiectasis† to reduce exacerbations in patients with recurrent exacerbations. Respiratory (Inhalation) dosage (Solution for inhalation) Adults

80 mg nebulized every 12 hours based on limited data.

Children and Adolescents

80 mg nebulized every 12 hours based on limited data.

For the eradication of first or new isolates of Pseudomonas aeruginosa in patients with bronchiectasis†. Intravenous dosage (extended-interval dosing) Adults

5 to 7 mg/kg/dose IV every 24 hours for a total duration of 14 days as part of combination therapy, followed by inhaled antibiotics for 4 to 12 weeks.

Infants, Children, and Adolescents

5 to 7.5 mg/kg/dose IV every 24 hours for 14 days as part of combination therapy, followed by inhaled antibiotics for 4 to 12 weeks.

Respiratory (Inhalation) dosage (Solution for inhalation) Adults

80 mg inhaled by nebulizer twice daily; may be used in combination with initial systemic therapy for 14 days; treat for 4 to 12 weeks following systemic therapy.

Children and Adolescents

80 mg inhaled by nebulizer twice daily; may be used in combination with initial systemic therapy for 14 days; treat for 4 to 12 weeks following systemic therapy.

For the treatment of invasive listeriosis† with bacteremia as adjunct therapy.
NOTE: For CNS disease, see meningitis indication.
NOTE: Serum concentrations should be used to guide dosage adjustments. In most patients, dosage of aminoglycosides should be based on an estimate of lean body mass.
Intravenous or Intramuscular dosage (extended-interval dosing) Adults

5 to 7 mg/kg/dose IV or IM every 24 hours until clinical improvement for up to 14 days.

Infants, Children, and Adolescents

5 to 7.5 mg/kg/dose IV or IM every 24 hours until clinical improvement for up to 14 days. A study in pediatric patients 3 months to 18 years (n = 114) suggested daily (i.e., every 24 hours) age-specific doses of 9.5 mg/kg/dose (3 to 23 months), 8.5 mg/kg/dose (2 to 7 years), and 7 mg/kg/dose (8 to 18 years) may be more appropriate to achieve goal gentamicin concentrations.

Neonates 35 weeks gestation and older and 8 days and older

5 mg/kg/dose IV or IM every 24 hours until clinical improvement for up to 14 days.

Neonates 35 weeks gestation and older and 0 to 7 days

4 mg/kg/dose IV or IM every 24 hours until clinical improvement for up to 14 days.

Neonates 30 to 34 weeks gestation and 11 days and older

5 mg/kg/dose IV or IM every 24 hours until clinical improvement for up to 14 days.

Neonates 30 to 34 weeks gestation and 0 to 10 days

5 mg/kg/dose IV or IM every 36 hours until clinical improvement for up to 14 days.

Neonates younger than 30 weeks gestation and 15 days and older

5 mg/kg/dose IV or IM every 36 hours until clinical improvement for up to 14 days.

Neonates younger than 30 weeks gestation and 0 to 14 days

5 mg/kg/dose IV or IM every 48 hours until clinical improvement for up to 14 days.

Intravenous or Intramuscular dosage (conventional dosing) Adults

1 to 2.5 mg/kg/dose IV or IM every 8 hours until clinical improvement for up to 14 days.

Infants, Children and Adolescents

2 to 2.5 mg/kg/dose IV or IM every 8 hours until clinical improvement for up to 14 days.

Premature Infants 30 days and older weighing less than 1.2 kg

2.5 mg/kg/dose IV or IM every 18 hours until clinical improvement for up to 14 days.

Neonates 8 to 29 days weighing more than 2 kg

2.5 mg/kg/dose IV or IM every 8 hours until clinical improvement for up to 14 days. Extend the interval to 18 to 24 hours for neonates on ECMO. Individualize subsequent dosing by monitoring serum drug concentrations. When ECMO is discontinued, dosage adjustment may be required.

Neonates 8 to 29 days weighing 1.2 to 2 kg

2.5 mg/kg/dose IV or IM every 12 hours until clinical improvement for up to 14 days.

Neonates 8 to 29 days weighing less than 1.2 kg

2.5 mg/kg/dose IV or IM every 18 to 24 hours until clinical improvement for up to 14 days.

Neonates 0 to 7 days weighing more than 2 kg

2.5 mg/kg/dose IV or IM every 12 hours until clinical improvement for up to 14 days. Extend the interval to 18 to 24 hours for neonates on ECMO. Individualize subsequent dosing by monitoring serum drug concentrations. When ECMO is discontinued, dosage adjustment may be required.

Neonates 0 to 7 days weighing 1.2 to 2 kg

2.5 mg/kg/dose IV or IM every 18 hours until clinical improvement for up to 14 days.

Neonates 0 to 7 days weighing less than 1.2 kg

2.5 mg/kg/dose IV or IM every 18 to 24 hours until clinical improvement for up to 14 days.

†Indicates off-label use

Dosing Considerations
Hepatic Impairment

Gentamicin does not undergo hepatic metabolism. Specific guidelines for dosage adjustment in hepatic impairment are not available; it appears that no dosage adjustments are needed.

Renal Impairment

Conventional dosing:
The manufacturer recommends either maintaining the standard dose and increasing the interval between doses or decreasing the dose while maintaining an every 8 hour dosing interval. To increase the dosing interval, the manufacturer recommends multiplying the patient's serum creatinine (mg/100 mL) by 8 to determine the dosing interval (i.e. serum creatinine of 2 mg/100 mL would yield a dosing interval of 16 hours). To decrease the dose, the manufacturer recommends dividing the patient's standard dose by the serum creatinine (mg/100 mL) to determine the lower recommended dose. For example, if a patient was receiving a standard dose of 60 mg IV every 8 hours and had a serum creatinine of 2 mg/100 mL, the dose would be adjusted to 30 mg IV every 8 hours. The manufacturer does suggest measuring gentamicin serum concentrations and adjusting the dose accordingly. Additionally, renal function status may change throughout the course of therapy. Several dosing regimens and nomograms designed to maintain traditional gentamicin serum concentrations have been published in the literature for dosing gentamicin in patients with renal impairment. However, these predictive dosage regimens and nomograms may result in gentamicin serum concentrations outside the targeted range; therefore, doses should be adjusted based on patient-specific serum concentrations. Factors such as site of infection and organism susceptibility may alter the goals of therapy; thereby altering dosing in patients with renal impairment. The initial dosing interval should be individualized based on specific patient and disease-state characteristics, serum concentrations goals, site of infection, organism susceptibility, weight, age, and degree and stability of renal impairment (acute vs. chronic). Further dosing should be guided by serum gentamicin concentrations.
 
Interval adjustment of extended-interval dosing of 5 or 7 mg/kg† :
CrCl 60 mL/minute or more: No dosage adjustment is needed. Adjust doses based on serum concentrations and organism MIC.
CrCl 40 to 59 mL/minute: 5 or 7 mg/kg IV every 36 hours. Adjust doses based on serum concentrations and organism MIC.
CrCl 20 to 39 mL/minute: 5 or 7 mg/kg IV every 48 hours. Adjust doses based on serum concentrations and organism MIC.
CrCl less than 20 mL/minute: 5 or 7 mg/kg IV once, then follow serial concentrations to determine time of next dose (serum concentration less than 1 mcg/mL). Adjust doses based on serum concentrations and organism MIC.
 
Dose adjustment of extended-interval dosing of 5 mg/kg† :
CrCl more than 80 mL/minute: No dosage adjustment is needed. Adjust doses based on serum concentrations and organism MIC.
CrCl 60 to 79 mL/minute: 4 mg/kg IV every 24 hours. Adjust doses based on serum concentrations and organism MIC.
CrCl 50 mL/minute: 3.5 mg/kg IV every 24 hours. Adjust doses based on serum concentrations and organism MIC.
CrCl 40 mL/minute: 2.5 mg/kg IV every 24 hours. Adjust doses based on serum concentrations and organism MIC.
CrCl less than 30 mL/minute: Use traditional dosing. Adjust doses based on serum concentrations and organism MIC.
 
Intermittent hemodialysis
Adults: The manufacturer recommends 1 to 1.7 mg/kg IV or IM after the initial hemodialysis session. Doses should be guided by serum gentamicin concentrations. Factors such as patient size, site of infection, and organism susceptibility should also be considered. Pre-dialysis dosing has been studied in patients receiving hemodialysis and generally requires larger gentamicin doses. Pre-dialysis dosing may also produce higher target peak serum concentrations with minimal accumulation. Other recommendations suggest giving half of a full dose after dialysis.
Infants, Children, and Adolescents: The manufacturer recommends 2 mg/kg IV or IM after the initial hemodialysis session. Subsequent doses should be guided by serum gentamicin concentrations. Factors such as patient size, site of infection, and organism susceptibility should also be considered.
 
Continuous ambulatory peritoneal dialysis (CAPD)
The International Society for Peritoneal Dialysis (ISPD) states that intraperitoneal (IP) gentamicin can administered continuously in each dialysate exchange bag with a loading dose of 8 mg/L and a maintenance dose of 4 mg/L. Alternatively, an IP dose of 0.6 mg/kg can be administered in 1 exchange bag per day.

Drug Interactions

Acetaminophen; Aspirin, ASA; Caffeine: (Minor) Due to the inhibition of renal prostaglandins by salicylates, concurrent use of salicylates and other nephrotoxic agents like the aminoglycosides may lead to additive nephrotoxicity.
Acetaminophen; Aspirin: (Minor) Due to the inhibition of renal prostaglandins by salicylates, concurrent use of salicylates and other nephrotoxic agents like the aminoglycosides may lead to additive nephrotoxicity.
Acetaminophen; Aspirin; Diphenhydramine: (Minor) Diphenhydramine may mask vestibular symptoms (e.g., dizziness, tinnitus, or vertigo) that are associated with ototoxicity induced by aminoglycosides. Antiemetics block the histamine or acetylcholine response that causes nausea due to vestibular emetic stimuli such as motion. (Minor) Due to the inhibition of renal prostaglandins by salicylates, concurrent use of salicylates and other nephrotoxic agents like the aminoglycosides may lead to additive nephrotoxicity.
Acetaminophen; Chlorpheniramine: (Minor) Chlorpheniramine may effectively mask vestibular symptoms (e.g., dizziness, tinnitus, or vertigo) that are associated with ototoxicity induced by aminoglycosides. Antiemetics block the histamine or acetylcholine response that causes nausea due to vestibular emetic stimuli such as motion.
Acetaminophen; Chlorpheniramine; Dextromethorphan: (Minor) Chlorpheniramine may effectively mask vestibular symptoms (e.g., dizziness, tinnitus, or vertigo) that are associated with ototoxicity induced by aminoglycosides. Antiemetics block the histamine or acetylcholine response that causes nausea due to vestibular emetic stimuli such as motion.
Acetaminophen; Chlorpheniramine; Dextromethorphan; Phenylephrine: (Minor) Chlorpheniramine may effectively mask vestibular symptoms (e.g., dizziness, tinnitus, or vertigo) that are associated with ototoxicity induced by aminoglycosides. Antiemetics block the histamine or acetylcholine response that causes nausea due to vestibular emetic stimuli such as motion.
Acetaminophen; Chlorpheniramine; Dextromethorphan; Pseudoephedrine: (Minor) Chlorpheniramine may effectively mask vestibular symptoms (e.g., dizziness, tinnitus, or vertigo) that are associated with ototoxicity induced by aminoglycosides. Antiemetics block the histamine or acetylcholine response that causes nausea due to vestibular emetic stimuli such as motion.
Acetaminophen; Chlorpheniramine; Phenylephrine : (Minor) Chlorpheniramine may effectively mask vestibular symptoms (e.g., dizziness, tinnitus, or vertigo) that are associated with ototoxicity induced by aminoglycosides. Antiemetics block the histamine or acetylcholine response that causes nausea due to vestibular emetic stimuli such as motion.
Acetaminophen; Diphenhydramine: (Minor) Diphenhydramine may mask vestibular symptoms (e.g., dizziness, tinnitus, or vertigo) that are associated with ototoxicity induced by aminoglycosides. Antiemetics block the histamine or acetylcholine response that causes nausea due to vestibular emetic stimuli such as motion.
Acyclovir: (Moderate) Additive nephrotoxicity is possible if systemic aminoglycosides are used with acyclovir. Carefully monitor renal function during concomitant therapy.
Adefovir: (Moderate) Chronic coadministration of adefovir with nephrotoxic drugs, such as aminoglycosides, may increase the risk of developing nephrotoxicity, even in patients who have normal renal function.
Aldesleukin, IL-2: (Moderate) Aldesleukin, IL 2 may cause nephrotoxicity. Concurrent administration of drugs possessing nephrotoxic effects, such as the aminoglycosides, with Aldesleukin, IL 2 may increase the risk of kidney dysfunction. In addition, reduced kidney function secondary to Aldesleukin, IL 2 treatment may delay elimination of concomitant medications and increase the risk of adverse events from those drugs.
Aminosalicylate sodium, Aminosalicylic acid: (Minor) Due to the inhibition of renal prostaglandins by salicylates, concurrent use of salicylates and other nephrotoxic agents like the aminoglycosides may lead to additive nephrotoxicity.
Amphotericin B lipid complex (ABLC): (Major) Additive nephrotoxicity can occur if amphotericin B is given concomitantly with aminoglycosides (e.g., gentamicin, tobramycin, or amikacin). Intensive monitoring of renal function is recommended. Amphotericin B dosage reduction may be necessary if renal impairment occurs.
Amphotericin B liposomal (LAmB): (Major) Additive nephrotoxicity can occur if amphotericin B is given concomitantly with aminoglycosides (e.g., gentamicin, tobramycin, or amikacin). Intensive monitoring of renal function is recommended. Amphotericin B dosage reduction may be necessary if renal impairment occurs.
Amphotericin B: (Major) Additive nephrotoxicity can occur if amphotericin B is given concomitantly with aminoglycosides (e.g., gentamicin, tobramycin, or amikacin). Intensive monitoring of renal function is recommended. Amphotericin B dosage reduction may be necessary if renal impairment occurs.
Aprotinin: (Moderate) The manufacturer recommends using aprotinin cautiously in patients that are receiving drugs that can affect renal function, such as the aminoglycosides, as the risk of renal impairment may be increased.
Aspirin, ASA: (Minor) Due to the inhibition of renal prostaglandins by salicylates, concurrent use of salicylates and other nephrotoxic agents like the aminoglycosides may lead to additive nephrotoxicity.
Aspirin, ASA; Butalbital; Caffeine: (Minor) Due to the inhibition of renal prostaglandins by salicylates, concurrent use of salicylates and other nephrotoxic agents like the aminoglycosides may lead to additive nephrotoxicity.
Aspirin, ASA; Caffeine: (Minor) Due to the inhibition of renal prostaglandins by salicylates, concurrent use of salicylates and other nephrotoxic agents like the aminoglycosides may lead to additive nephrotoxicity.
Aspirin, ASA; Caffeine; Orphenadrine: (Minor) Due to the inhibition of renal prostaglandins by salicylates, concurrent use of salicylates and other nephrotoxic agents like the aminoglycosides may lead to additive nephrotoxicity.
Aspirin, ASA; Carisoprodol: (Minor) Due to the inhibition of renal prostaglandins by salicylates, concurrent use of salicylates and other nephrotoxic agents like the aminoglycosides may lead to additive nephrotoxicity.
Aspirin, ASA; Carisoprodol; Codeine: (Minor) Due to the inhibition of renal prostaglandins by salicylates, concurrent use of salicylates and other nephrotoxic agents like the aminoglycosides may lead to additive nephrotoxicity.
Aspirin, ASA; Citric Acid; Sodium Bicarbonate: (Minor) Due to the inhibition of renal prostaglandins by salicylates, concurrent use of salicylates and other nephrotoxic agents like the aminoglycosides may lead to additive nephrotoxicity.
Aspirin, ASA; Dipyridamole: (Minor) Due to the inhibition of renal prostaglandins by salicylates, concurrent use of salicylates and other nephrotoxic agents like the aminoglycosides may lead to additive nephrotoxicity.
Aspirin, ASA; Omeprazole: (Minor) Due to the inhibition of renal prostaglandins by salicylates, concurrent use of salicylates and other nephrotoxic agents like the aminoglycosides may lead to additive nephrotoxicity.
Aspirin, ASA; Oxycodone: (Minor) Due to the inhibition of renal prostaglandins by salicylates, concurrent use of salicylates and other nephrotoxic agents like the aminoglycosides may lead to additive nephrotoxicity.
Atracurium: (Moderate) Concomitant use of neuromuscular blockers and systemic aminoglycosides may prolong neuromuscular blockade. The use of a peripheral nerve stimulator is strongly recommended to evaluate the level of neuromuscular blockade, to assess the need for additional doses of neuromuscular blocker, and to determine whether adjustments need to be made to the dose with subsequent administration.
Bacillus Calmette-Guerin Vaccine, BCG: (Major) Urinary concentrations of gentamicin could interfere with the therapeutic effectiveness of BCG. Postpone instillation of BCG if the patient is receiving antibiotics.
Bacitracin: (Minor) Additive nephrotoxicity may occur with concurrent use of bacitracin and other nephrotoxic agents. When possible, avoid concomitant administration of systemic bacitracin and other nephrotoxic drugs such as aminoglycosides (particularly kanamycin, streptomycin, and neomycin). Use of topically administrated preparations containing bacitracin, especially when applied to large surface areas, with aminoglycosides may have additive nephrotoxic potential.
Benzoic Acid; Hyoscyamine; Methenamine; Methylene Blue; Phenyl Salicylate: (Minor) Due to the inhibition of renal prostaglandins by salicylates, concurrent use of salicylates and other nephrotoxic agents like the aminoglycosides may lead to additive nephrotoxicity.
Bictegravir; Emtricitabine; Tenofovir Alafenamide: (Moderate) Monitor for changes in serum creatinine and adverse reactions, such as lactic acidosis or hepatotoxicity if emtricitabine is administered in combination with nephrotoxic agents, such as aminoglycosides. Consider the potential for drug interaction prior to and during concurrent use of these medications. Both emtricitabine and aminoglycosides are excreted via the kidneys by a combination of glomerular filtration and active tubular secretion. While no drug interactions due to competition for renal excretion have been observed, coadministration of these medications may increase concentrations of both drugs.
Bismuth Subsalicylate: (Minor) Due to the inhibition of renal prostaglandins by salicylates, concurrent use of salicylates and other nephrotoxic agents like the aminoglycosides may lead to additive nephrotoxicity.
Bismuth Subsalicylate; Metronidazole; Tetracycline: (Minor) Due to the inhibition of renal prostaglandins by salicylates, concurrent use of salicylates and other nephrotoxic agents like the aminoglycosides may lead to additive nephrotoxicity.
Bleomycin: (Moderate) Previous treatment with nephrotoxic agents, like aminoglycosides, may result in decreased clearance of bleomycin if renal function has been impaired.
Botulinum Toxins: (Moderate) The effects of botulinum toxin can be potentiated by systemic aminoglycosides or other drugs that interfere with neuromuscular transmission. Monitor aminoglycoside concentrations, and monitor for evidence of neurotoxicity including systemic neuromuscular blockade.
Bumetanide: (Moderate) The risk of ototoxicity or nephrotoxicity secondary to aminoglycosides may be increased by the addition of concomitant therapies with similar side effects, including loop diuretics. If loop diuretics and aminoglycosides are used together, it would be prudent to monitor renal function parameters, serum electrolytes, and serum aminoglycoside concentrations during therapy. Audiologic monitoring may be advisable during high dose therapy or therapy of long duration, when hearing loss is suspected, or in selected risk groups (e.g., neonates).
Butalbital; Aspirin; Caffeine; Codeine: (Minor) Due to the inhibition of renal prostaglandins by salicylates, concurrent use of salicylates and other nephrotoxic agents like the aminoglycosides may lead to additive nephrotoxicity.
Capreomycin: (Major) The concomitant use of capreomycin and aminoglycosides may increase the risk of nephrotoxicity and neurotoxicity. Since capreomycin is eliminated by the kidney, coadministration of capreomycin with other potentially nephrotoxic drugs, including aminoglycosides may increase serum concentrations of either capreomycin or aminoglycosides. Theoretically, coadministration may increase the risk of developing nephrotoxicity, even in patients who have normal renal function. Monitor patients for changes in renal function if these drugs are coadministered. Additionally, neuromuscular blockade has been associated with capreomycin resulting from administration of large doses or rapid intravenous infusion. Aminoglycosides have also been reported to interfere with nerve transmission at the neuromuscular junction. Concomitant administration of capreomycin with aminoglycosides should be avoided if possible; however, if they must be coadministered, use extreme caution.
Carboplatin: (Moderate) Patients previously or currently treated with other potentially nephrotoxic agents, such as systemic aminoglycosides, can have a greater risk of developing carboplatin-induced nephrotoxicity. These patients may benefit from hydration prior to carboplatin therapy to lessen the incidence of nephrotoxicity. Monitor renal function closely.
Cefepime: (Minor) Cefepime's product label states that cephalosporins may potentiate the adverse renal effects of nephrotoxic agents, such as aminoglycosides and loop diuretics. Carefully monitor renal function, especially during prolonged therapy or use of high aminoglycoside doses. The majority of reported cases involve the combination of aminoglycosides and cephalothin or cephaloridine, which are associated with dose-related nephrotoxicity as singular agents. Limited but conflicting data with other cephalosporins have been noted.
Cefotaxime: (Minor) Cefotaxime's product label states that cephalosporins may potentiate the adverse renal effects of nephrotoxic agents, such as aminoglycosides and loop diuretics. Carefully monitor renal function, especially during prolonged therapy or use of high aminoglycoside doses. The majority of reported cases involve the combination of aminoglycosides and cephalothin or cephaloridine, which are associated with dose-related nephrotoxicity as singular agents. Limited but conflicting data with other cephalosporins have been noted.
Cefotetan: (Minor) Cefotetan's product label states that cephalosporins may potentiate the adverse renal effects of nephrotoxic agents, such as aminoglycosides. Carefully monitor renal function, especially during prolonged therapy or use of high aminoglycoside doses. The majority of reported cases involve the combination of aminoglycosides and cephalothin or cephaloridine, which are associated with dose-related nephrotoxicity as singular agents. Limited but conflicting data with other cephalosporins have been noted.
Cefoxitin: (Minor) Cefoxitin's product label states that cephalosporins may potentiate the adverse renal effects of nephrotoxic agents, such as aminoglycosides. Carefully monitor renal function, especially during prolonged therapy or use of high aminoglycoside doses. The majority of reported cases involve the combination of aminoglycosides and cephalothin or cephaloridine, which are associated with dose-related nephrotoxicity as singular agents. Limited but conflicting data with other cephalosporins have been noted.
Cefprozil: (Minor) Cefprozil's product label states that cephalosporins may potentiate the adverse renal effects of nephrotoxic agents, such as aminoglycosides and loop diuretics. Carefully monitor renal function, especially during prolonged therapy or use of high aminoglycoside doses. The majority of reported cases involve the combination of aminoglycosides and cephalothin or cephaloridine, which are associated with dose-related nephrotoxicity as singular agents. Limited but conflicting data with other cephalosporins have been noted.
Ceftazidime: (Minor) Ceftazidime's product label states that cephalosporins may potentiate the adverse renal effects of nephrotoxic agents, such as aminoglycosides and loop diuretics. Carefully monitor renal function, especially during prolonged therapy or use of high aminoglycoside doses. The majority of reported cases involve the combination of aminoglycosides and cephalothin or cephaloridine, which are associated with dose-related nephrotoxicity as singular agents. Limited but conflicting data with other cephalosporins have been noted.
Ceftazidime; Avibactam: (Minor) Ceftazidime's product label states that cephalosporins may potentiate the adverse renal effects of nephrotoxic agents, such as aminoglycosides and loop diuretics. Carefully monitor renal function, especially during prolonged therapy or use of high aminoglycoside doses. The majority of reported cases involve the combination of aminoglycosides and cephalothin or cephaloridine, which are associated with dose-related nephrotoxicity as singular agents. Limited but conflicting data with other cephalosporins have been noted.
Cefuroxime: (Minor) Cefuroxime's product label states that cephalosporins may potentiate the adverse renal effects of nephrotoxic agents, such as aminoglycosides and loop diuretics. Carefully monitor renal function, especially during prolonged therapy or use of high aminoglycoside doses. The majority of reported cases involve the combination of aminoglycosides and cephalothin or cephaloridine, which are associated with dose-related nephrotoxicity as singular agents. Limited but conflicting data with other cephalosporins have been noted.
Chlorpheniramine: (Minor) Chlorpheniramine may effectively mask vestibular symptoms (e.g., dizziness, tinnitus, or vertigo) that are associated with ototoxicity induced by aminoglycosides. Antiemetics block the histamine or acetylcholine response that causes nausea due to vestibular emetic stimuli such as motion.
Chlorpheniramine; Codeine: (Minor) Chlorpheniramine may effectively mask vestibular symptoms (e.g., dizziness, tinnitus, or vertigo) that are associated with ototoxicity induced by aminoglycosides. Antiemetics block the histamine or acetylcholine response that causes nausea due to vestibular emetic stimuli such as motion.
Chlorpheniramine; Dextromethorphan: (Minor) Chlorpheniramine may effectively mask vestibular symptoms (e.g., dizziness, tinnitus, or vertigo) that are associated with ototoxicity induced by aminoglycosides. Antiemetics block the histamine or acetylcholine response that causes nausea due to vestibular emetic stimuli such as motion.
Chlorpheniramine; Dextromethorphan; Phenylephrine: (Minor) Chlorpheniramine may effectively mask vestibular symptoms (e.g., dizziness, tinnitus, or vertigo) that are associated with ototoxicity induced by aminoglycosides. Antiemetics block the histamine or acetylcholine response that causes nausea due to vestibular emetic stimuli such as motion.
Chlorpheniramine; Dextromethorphan; Pseudoephedrine: (Minor) Chlorpheniramine may effectively mask vestibular symptoms (e.g., dizziness, tinnitus, or vertigo) that are associated with ototoxicity induced by aminoglycosides. Antiemetics block the histamine or acetylcholine response that causes nausea due to vestibular emetic stimuli such as motion.
Chlorpheniramine; Dihydrocodeine; Phenylephrine: (Minor) Chlorpheniramine may effectively mask vestibular symptoms (e.g., dizziness, tinnitus, or vertigo) that are associated with ototoxicity induced by aminoglycosides. Antiemetics block the histamine or acetylcholine response that causes nausea due to vestibular emetic stimuli such as motion.
Chlorpheniramine; Hydrocodone: (Minor) Chlorpheniramine may effectively mask vestibular symptoms (e.g., dizziness, tinnitus, or vertigo) that are associated with ototoxicity induced by aminoglycosides. Antiemetics block the histamine or acetylcholine response that causes nausea due to vestibular emetic stimuli such as motion.
Chlorpheniramine; Ibuprofen; Pseudoephedrine: (Minor) Chlorpheniramine may effectively mask vestibular symptoms (e.g., dizziness, tinnitus, or vertigo) that are associated with ototoxicity induced by aminoglycosides. Antiemetics block the histamine or acetylcholine response that causes nausea due to vestibular emetic stimuli such as motion.
Chlorpheniramine; Phenylephrine: (Minor) Chlorpheniramine may effectively mask vestibular symptoms (e.g., dizziness, tinnitus, or vertigo) that are associated with ototoxicity induced by aminoglycosides. Antiemetics block the histamine or acetylcholine response that causes nausea due to vestibular emetic stimuli such as motion.
Chlorpheniramine; Pseudoephedrine: (Minor) Chlorpheniramine may effectively mask vestibular symptoms (e.g., dizziness, tinnitus, or vertigo) that are associated with ototoxicity induced by aminoglycosides. Antiemetics block the histamine or acetylcholine response that causes nausea due to vestibular emetic stimuli such as motion.
Chlorpromazine: (Minor) When used for the treatment of nausea and vomiting, antiemetic phenothiazines may effectively mask symptoms that are associated with ototoxicity induced by the aminoglycosides.
Choline Salicylate; Magnesium Salicylate: (Minor) Due to the inhibition of renal prostaglandins by salicylates, concurrent use of salicylates and other nephrotoxic agents like the aminoglycosides may lead to additive nephrotoxicity.
Cidofovir: (Contraindicated) The administration of cidofovir with other potentially nephrotoxic agents, such as aminoglycosides, is contraindicated. These agents should be discontinued at least 7 days prior to beginning cidofovir.
Cisatracurium: (Moderate) Concomitant use of neuromuscular blockers and systemic aminoglycosides may prolong neuromuscular blockade. The use of a peripheral nerve stimulator is strongly recommended to evaluate the level of neuromuscular blockade, to assess the need for additional doses of neuromuscular blocker, and to determine whether adjustments need to be made to the dose with subsequent administration.
Cisplatin: (Moderate) Closely monitor renal function and hearing ability if concomitant use with cisplatin and aminoglycosides is necessary. Both cisplatin and aminoglycosides can cause nephrotoxicity and ototoxicity, which may be exacerbated with the use of other nephrotoxic and ototoxic drugs.
Clindamycin: (Moderate) Concomitant use of aminoglycosides and clindamycin may result in additive nephrotoxicity. Monitor for renal toxicity if concomitant use is required.
Clofarabine: (Major) Avoid the concurrent and/or sequential use of gentamicin and other nephrotoxic drugs such as clofarabine; coadministration may result in additive nephrotoxicity.
Codeine; Phenylephrine; Promethazine: (Minor) Antiemetics, like promethazine, should be used carefully with aminoglycosides because they can mask symptoms of ototoxicity (e.g., nausea secondary to vertigo). These agents block the histamine or acetylcholine response that causes nausea due to vestibular (inner ear) emetic stimuli such as motion.
Codeine; Promethazine: (Minor) Antiemetics, like promethazine, should be used carefully with aminoglycosides because they can mask symptoms of ototoxicity (e.g., nausea secondary to vertigo). These agents block the histamine or acetylcholine response that causes nausea due to vestibular (inner ear) emetic stimuli such as motion.
Colistin: (Major) The concomitant use of colistimethate sodium with systemic aminoglycosides may increase the risk of nephrotoxicity, ototoxicity, and neurotoxicity. Since polymyxins and aminoglycosides are both eliminated by the kidney, coadministration may increase serum concentrations of either drug class. If these drugs are used in combination, monitor renal function and patients for increased adverse effects. Additionally, neuromuscular blockade has been associated with both polymyxins and aminoglycosides, and is more likely to occur in patients with renal dysfunction.
Cyclizine: (Minor) Cyclizine may effectively mask vestibular symptoms (e.g., dizziness, tinnitus, or vertigo) that are associated with ototoxicity induced by aminoglycosides. Antiemetics block the histamine or acetylcholine response that causes nausea due to vestibular emetic stimuli such as motion.
Cyclosporine: (Major) Additive nephrotoxicity can occur if cyclosporine is administered with other nephrotoxic drugs such as aminoglycosides.
Cytarabine, ARA-C: (Minor) Cytarabine may reduce the efficacy of gentamicin in certain infections. The lack of a prompt therapeutic response may indicate the need for reevaluation of antibacterial therapy.
Darunavir; Cobicistat; Emtricitabine; Tenofovir alafenamide: (Moderate) Monitor for changes in serum creatinine and adverse reactions, such as lactic acidosis or hepatotoxicity if emtricitabine is administered in combination with nephrotoxic agents, such as aminoglycosides. Consider the potential for drug interaction prior to and during concurrent use of these medications. Both emtricitabine and aminoglycosides are excreted via the kidneys by a combination of glomerular filtration and active tubular secretion. While no drug interactions due to competition for renal excretion have been observed, coadministration of these medications may increase concentrations of both drugs.
Deferasirox: (Moderate) Acute renal failure has been reported during treatment with deferasirox. Coadministration of deferasirox with other potentially nephrotoxic drugs, including aminoglycosides, may increase the risk of this toxicity. Monitor serum creatinine and/or creatinine clearance in patients who are receiving deferasirox and aminoglycosides concomitantly.
Dextromethorphan; Diphenhydramine; Phenylephrine: (Minor) Diphenhydramine may mask vestibular symptoms (e.g., dizziness, tinnitus, or vertigo) that are associated with ototoxicity induced by aminoglycosides. Antiemetics block the histamine or acetylcholine response that causes nausea due to vestibular emetic stimuli such as motion.
Digoxin: (Major) The coadministration of gentamicin and digoxin resulted in a 129-212% increase in the serum concentration of digoxin. Measure serum digoxin concentrations before initiating gentamicin. Reduce digoxin concentrations by decreasing the digoxin dose by approximately 30-50% or by modifying the dosing frequency and continue monitoring.
Dimenhydrinate: (Minor) Dimenhydrinate and other antiemetics should be used carefully with aminoglycosides because they can mask symptoms of ototoxicity, including nausea secondary to vertigo.
Diphenhydramine: (Minor) Diphenhydramine may mask vestibular symptoms (e.g., dizziness, tinnitus, or vertigo) that are associated with ototoxicity induced by aminoglycosides. Antiemetics block the histamine or acetylcholine response that causes nausea due to vestibular emetic stimuli such as motion.
Diphenhydramine; Ibuprofen: (Minor) Diphenhydramine may mask vestibular symptoms (e.g., dizziness, tinnitus, or vertigo) that are associated with ototoxicity induced by aminoglycosides. Antiemetics block the histamine or acetylcholine response that causes nausea due to vestibular emetic stimuli such as motion.
Diphenhydramine; Naproxen: (Minor) Diphenhydramine may mask vestibular symptoms (e.g., dizziness, tinnitus, or vertigo) that are associated with ototoxicity induced by aminoglycosides. Antiemetics block the histamine or acetylcholine response that causes nausea due to vestibular emetic stimuli such as motion.
Diphenhydramine; Phenylephrine: (Minor) Diphenhydramine may mask vestibular symptoms (e.g., dizziness, tinnitus, or vertigo) that are associated with ototoxicity induced by aminoglycosides. Antiemetics block the histamine or acetylcholine response that causes nausea due to vestibular emetic stimuli such as motion.
Doravirine; Lamivudine; Tenofovir disoproxil fumarate: (Moderate) Renal impairment, which may include hypophosphatemia, has been reported with the use of tenofovir with a majority of the cases occurring in patients who have underlying systemic or renal disease or who are concurrently taking nephrotoxic agents. Tenofovir should be avoided with concurrent or recent use of a nephrotoxic agent; patients receiving concomitant nephrotoxic agents should be carefully monitored for changes in serum creatinine and phosphorus.
Efavirenz; Emtricitabine; Tenofovir Disoproxil Fumarate: (Moderate) Monitor for changes in serum creatinine and adverse reactions, such as lactic acidosis or hepatotoxicity if emtricitabine is administered in combination with nephrotoxic agents, such as aminoglycosides. Consider the potential for drug interaction prior to and during concurrent use of these medications. Both emtricitabine and aminoglycosides are excreted via the kidneys by a combination of glomerular filtration and active tubular secretion. While no drug interactions due to competition for renal excretion have been observed, coadministration of these medications may increase concentrations of both drugs. (Moderate) Renal impairment, which may include hypophosphatemia, has been reported with the use of tenofovir with a majority of the cases occurring in patients who have underlying systemic or renal disease or who are concurrently taking nephrotoxic agents. Tenofovir should be avoided with concurrent or recent use of a nephrotoxic agent; patients receiving concomitant nephrotoxic agents should be carefully monitored for changes in serum creatinine and phosphorus.
Efavirenz; Lamivudine; Tenofovir Disoproxil Fumarate: (Moderate) Renal impairment, which may include hypophosphatemia, has been reported with the use of tenofovir with a majority of the cases occurring in patients who have underlying systemic or renal disease or who are concurrently taking nephrotoxic agents. Tenofovir should be avoided with concurrent or recent use of a nephrotoxic agent; patients receiving concomitant nephrotoxic agents should be carefully monitored for changes in serum creatinine and phosphorus.
Elvitegravir; Cobicistat; Emtricitabine; Tenofovir Alafenamide: (Moderate) Monitor for changes in serum creatinine and adverse reactions, such as lactic acidosis or hepatotoxicity if emtricitabine is administered in combination with nephrotoxic agents, such as aminoglycosides. Consider the potential for drug interaction prior to and during concurrent use of these medications. Both emtricitabine and aminoglycosides are excreted via the kidneys by a combination of glomerular filtration and active tubular secretion. While no drug interactions due to competition for renal excretion have been observed, coadministration of these medications may increase concentrations of both drugs.
Elvitegravir; Cobicistat; Emtricitabine; Tenofovir Disoproxil Fumarate: (Moderate) Monitor for changes in serum creatinine and adverse reactions, such as lactic acidosis or hepatotoxicity if emtricitabine is administered in combination with nephrotoxic agents, such as aminoglycosides. Consider the potential for drug interaction prior to and during concurrent use of these medications. Both emtricitabine and aminoglycosides are excreted via the kidneys by a combination of glomerular filtration and active tubular secretion. While no drug interactions due to competition for renal excretion have been observed, coadministration of these medications may increase concentrations of both drugs. (Moderate) Renal impairment, which may include hypophosphatemia, has been reported with the use of tenofovir with a majority of the cases occurring in patients who have underlying systemic or renal disease or who are concurrently taking nephrotoxic agents. Tenofovir should be avoided with concurrent or recent use of a nephrotoxic agent; patients receiving concomitant nephrotoxic agents should be carefully monitored for changes in serum creatinine and phosphorus.
Emtricitabine: (Moderate) Monitor for changes in serum creatinine and adverse reactions, such as lactic acidosis or hepatotoxicity if emtricitabine is administered in combination with nephrotoxic agents, such as aminoglycosides. Consider the potential for drug interaction prior to and during concurrent use of these medications. Both emtricitabine and aminoglycosides are excreted via the kidneys by a combination of glomerular filtration and active tubular secretion. While no drug interactions due to competition for renal excretion have been observed, coadministration of these medications may increase concentrations of both drugs.
Emtricitabine; Rilpivirine; Tenofovir alafenamide: (Moderate) Monitor for changes in serum creatinine and adverse reactions, such as lactic acidosis or hepatotoxicity if emtricitabine is administered in combination with nephrotoxic agents, such as aminoglycosides. Consider the potential for drug interaction prior to and during concurrent use of these medications. Both emtricitabine and aminoglycosides are excreted via the kidneys by a combination of glomerular filtration and active tubular secretion. While no drug interactions due to competition for renal excretion have been observed, coadministration of these medications may increase concentrations of both drugs.
Emtricitabine; Rilpivirine; Tenofovir Disoproxil Fumarate: (Moderate) Monitor for changes in serum creatinine and adverse reactions, such as lactic acidosis or hepatotoxicity if emtricitabine is administered in combination with nephrotoxic agents, such as aminoglycosides. Consider the potential for drug interaction prior to and during concurrent use of these medications. Both emtricitabine and aminoglycosides are excreted via the kidneys by a combination of glomerular filtration and active tubular secretion. While no drug interactions due to competition for renal excretion have been observed, coadministration of these medications may increase concentrations of both drugs. (Moderate) Renal impairment, which may include hypophosphatemia, has been reported with the use of tenofovir with a majority of the cases occurring in patients who have underlying systemic or renal disease or who are concurrently taking nephrotoxic agents. Tenofovir should be avoided with concurrent or recent use of a nephrotoxic agent; patients receiving concomitant nephrotoxic agents should be carefully monitored for changes in serum creatinine and phosphorus.
Emtricitabine; Tenofovir alafenamide: (Moderate) Monitor for changes in serum creatinine and adverse reactions, such as lactic acidosis or hepatotoxicity if emtricitabine is administered in combination with nephrotoxic agents, such as aminoglycosides. Consider the potential for drug interaction prior to and during concurrent use of these medications. Both emtricitabine and aminoglycosides are excreted via the kidneys by a combination of glomerular filtration and active tubular secretion. While no drug interactions due to competition for renal excretion have been observed, coadministration of these medications may increase concentrations of both drugs.
Emtricitabine; Tenofovir Disoproxil Fumarate: (Moderate) Monitor for changes in serum creatinine and adverse reactions, such as lactic acidosis or hepatotoxicity if emtricitabine is administered in combination with nephrotoxic agents, such as aminoglycosides. Consider the potential for drug interaction prior to and during concurrent use of these medications. Both emtricitabine and aminoglycosides are excreted via the kidneys by a combination of glomerular filtration and active tubular secretion. While no drug interactions due to competition for renal excretion have been observed, coadministration of these medications may increase concentrations of both drugs. (Moderate) Renal impairment, which may include hypophosphatemia, has been reported with the use of tenofovir with a majority of the cases occurring in patients who have underlying systemic or renal disease or who are concurrently taking nephrotoxic agents. Tenofovir should be avoided with concurrent or recent use of a nephrotoxic agent; patients receiving concomitant nephrotoxic agents should be carefully monitored for changes in serum creatinine and phosphorus.
Entecavir: (Moderate) Because entecavir is primarily eliminated by the kidneys and aminoglycosides can affect renal function, concurrent administration with aminoglycosides may increase the serum concentrations of entecavir and adverse events. The manufacturer of entecavir recommends monitoring for adverse effects when these drugs are coadministered.
Ethacrynic Acid: (Moderate) The risk of ototoxicity or nephrotoxicity secondary to aminoglycosides may be increased by the addition of concomitant therapies with similar side effects, including loop diuretics. If loop diuretics and aminoglycosides are used together, it would be prudent to monitor renal function parameters, serum electrolytes, and serum aminoglycoside concentrations during therapy. Audiologic monitoring may be advisable during high dose therapy or therapy of long duration, when hearing loss is suspected, or in selected risk groups (e.g., neonates).
Ethiodized Oil: (Moderate) Because the use of other nephrotoxic drugs, such as aminoglycoside antibiotics, is an additive risk factor for nephrotoxicity in patients receiving radiopaque contrast agents, concomitant use should be avoided when possible.
Etomidate: (Moderate) Patients receiving general anesthetics should be observed for exaggerated effects if they are receiving gentamicin.
Fluphenazine: (Minor) When used for the treatment of nausea and vomiting, antiemetic phenothiazines may effectively mask symptoms that are associated with ototoxicity induced by aminoglycosides.
Foscarnet: (Major) The risk of renal toxicity may be increased if foscarnet is used in conjunction with other nephrotoxic agents such as aminoglycosides.
Furosemide: (Moderate) The risk of ototoxicity or nephrotoxicity secondary to aminoglycosides may be increased by the addition of concomitant therapies with similar side effects, including loop diuretics. If loop diuretics and aminoglycosides are used together, it would be prudent to monitor renal function parameters, serum electrolytes, and serum aminoglycoside concentrations during therapy. Audiologic monitoring may be advisable during high dose therapy or therapy of long duration, when hearing loss is suspected, or in selected risk groups (e.g., neonates).
Galsulfase: (Minor) There is a possible drug interaction between galsulfase and medications which may impact lysosomal efficacy. Gentamicin slightly increases the intralysosomal pH of proximal tubular cells and decreases the activity of the lysosomal proteinases, cathepsin B and L, which are proteolytic activators of other lysosomal enzymes. Because similar interactions have occurred between gentamicin and other therapies used for a similar disease, the effectiveness of galsulfase therapy should be monitored during coadministration.
Ganciclovir: (Major) Concurrent use of nephrotoxic agents, such as the aminoglycosides, with ganciclovir should be done cautiously to avoid additive nephrotoxicity.
Ginger, Zingiber officinale: (Minor) Ginger may mask vestibular symptoms (e.g., dizziness, tinnitus, or vertigo) that are associated with ototoxicity induced by aminoglycosides. Antiemetics block the histamine or acetylcholine response that causes nausea due to vestibular emetic stimuli such as motion.
Gold: (Minor) Both aminoglycosides and gold compounds can cause nephrotoxicity. Auranofin has been reported to cause a nephrotic syndrome or glomerulonephritis with proteinuria and hematuria. Monitor renal function carefully during concurrent therapy.
Hyaluronidase, Recombinant; Immune Globulin: (Moderate) Immune globulin (IG) products have been reported to be associated with renal dysfunction, acute renal failure, osmotic nephrosis, and death. Patients predisposed to acute renal failure include patients receiving known nephrotoxic drugs like aminoglycosides. Coadminister IG products at the minimum concentration available and the minimum rate of infusion practicable. Closely monitor renal function.
Hyoscyamine; Methenamine; Methylene Blue; Phenyl Salicylate; Sodium Biphosphate: (Minor) Due to the inhibition of renal prostaglandins by salicylates, concurrent use of salicylates and other nephrotoxic agents like the aminoglycosides may lead to additive nephrotoxicity.
Ibandronate: (Moderate) Theoretically, coadministration of intravenous ibandronate with other potentially nephrotoxic drugs like the aminoglycosides may increase the risk of developing nephrotoxicity.
Ibuprofen lysine: (Moderate) Use caution in combining ibuprofen lysine with renally eliminated medications, like aminoglycosides, as ibuprofen lysine may reduce the clearance of aminoglycosides. Closely monitor renal function and adjust aminoglycoside doses based on renal function and serum aminoglycoside concentrations as clinically indicated.
Immune Globulin IV, IVIG, IGIV: (Moderate) Immune globulin (IG) products have been reported to be associated with renal dysfunction, acute renal failure, osmotic nephrosis, and death. Patients predisposed to acute renal failure include patients receiving known nephrotoxic drugs like aminoglycosides. Coadminister IG products at the minimum concentration available and the minimum rate of infusion practicable. Closely monitor renal function.
Inotersen: (Moderate) Use caution with concomitant use of inotersen and aminoglycosides due to the risk of glomerulonephritis and nephrotoxicity.
Iodixanol: (Moderate) Because the use of other nephrotoxic drugs, such as aminoglycoside antibiotics, is an additive risk factor for nephrotoxicity in patients receiving radiopaque contrast agents, concomitant use should be avoided when possible.
Iohexol: (Moderate) Because the use of other nephrotoxic drugs, such as aminoglycoside antibiotics, is an additive risk factor for nephrotoxicity in patients receiving radiopaque contrast agents, concomitant use should be avoided when possible.
Iomeprol: (Moderate) Because the use of other nephrotoxic drugs, such as aminoglycoside antibiotics, is an additive risk factor for nephrotoxicity in patients receiving radiopaque contrast agents, concomitant use should be avoided when possible.
Iopamidol: (Moderate) Because the use of other nephrotoxic drugs, such as aminoglycoside antibiotics, is an additive risk factor for nephrotoxicity in patients receiving radiopaque contrast agents, concomitant use should be avoided when possible.
Iopromide: (Moderate) Because the use of other nephrotoxic drugs, such as aminoglycoside antibiotics, is an additive risk factor for nephrotoxicity in patients receiving radiopaque contrast agents, concomitant use should be avoided when possible.
Ioversol: (Moderate) Because the use of other nephrotoxic drugs, such as aminoglycoside antibiotics, is an additive risk factor for nephrotoxicity in patients receiving radiopaque contrast agents, concomitant use should be avoided when possible.
Isoflurane: (Moderate) Halogenated anesthetics may be associated with enhanced neuromuscular blocking effects. Aminoglycosides may potentiate this effect, however, it appears this is only seen when aminoglycosides are used to irrigate the abdominal cavity during surgery, a practice which has been discouraged. It is believed that this problem is less likely to occur with parenteral aminoglycoside therapy since patients are exposed to smaller amounts of drug.
Isosulfan Blue: (Moderate) Because the use of other nephrotoxic drugs, such as aminoglycoside antibiotics, is an additive risk factor for nephrotoxicity in patients receiving radiopaque contrast agents, concomitant use should be avoided when possible.
Ketamine: (Moderate) Patients receiving general anesthetics should be observed for exaggerated effects if they are receiving gentamicin.
Lamivudine; Tenofovir Disoproxil Fumarate: (Moderate) Renal impairment, which may include hypophosphatemia, has been reported with the use of tenofovir with a majority of the cases occurring in patients who have underlying systemic or renal disease or who are concurrently taking nephrotoxic agents. Tenofovir should be avoided with concurrent or recent use of a nephrotoxic agent; patients receiving concomitant nephrotoxic agents should be carefully monitored for changes in serum creatinine and phosphorus.
Lithium: (Moderate) Moderate to significant dietary sodium changes, or changes in sodium and fluid intake, may affect lithium excretion. Systemic sodium chloride administration may result in increased lithium excretion and therefore, decreased serum lithium concentrations. In addition, high fluid intake may increase lithium excretion. For patients receiving sodium-containing intravenous fluids, symptom control and lithium concentrations should be carefully monitored. It is recommended that patients taking lithium maintain consistent dietary sodium consumption and adequate fluid intake during the initial stabilization period and throughout lithium treatment. Supplemental oral sodium and fluid should be only be administered under careful medical supervision.
Magnesium Salicylate: (Minor) Due to the inhibition of renal prostaglandins by salicylates, concurrent use of salicylates and other nephrotoxic agents like the aminoglycosides may lead to additive nephrotoxicity.
Mannitol: (Major) Avoid concomitant use of mannitol and aminoglycosides, if possible. Concomitant administration of systemic therapy may increase the risk of ototoxicity and nephrotoxicity. In addition, systemic mannitol may alter the serum and tissue concentrations of aminoglycosides and increase the risk for aminoglycoside toxicity. If use together is necessary, monitor renal function and serum aminoglycoside concentrations. Audiologic monitoring may be advisable during high dose therapy or therapy of long duration, when hearing loss is suspected, or in selected risk groups (e.g., neonates). Studies to evaluate a potential interaction between inhaled formulations of mannitol and tobramycin have not been conducted.
Meclizine: (Minor) Meclizine and other antiemetics should be used carefully with aminoglycosides because they can mask symptoms of ototoxicity (e.g., nausea secondary to vertigo).
Methenamine; Sodium Salicylate: (Minor) Due to the inhibition of renal prostaglandins by salicylates, concurrent use of salicylates and other nephrotoxic agents like the aminoglycosides may lead to additive nephrotoxicity.
Methohexital: (Moderate) Patients receiving general anesthetics should be observed for exaggerated effects if they are receiving gentamicin.
Methotrexate: (Major) Avoid concomitant use of methotrexate with gentamicin due to the risk of additive nephrotoxicity as well as an increased risk of severe methotrexate-related adverse reactions. If concomitant use is unavoidable, closely monitor for adverse reactions. Gentamicin and methotrexate are both nephrotoxic drugs; methotrexate is also renally eliminated. Coadministration of methotrexate with gentamicin may result in decreased renal function as well as increased methotrexate plasma concentrations.
Mivacurium: (Moderate) Concomitant use of neuromuscular blockers and systemic aminoglycosides may prolong neuromuscular blockade. The use of a peripheral nerve stimulator is strongly recommended to evaluate the level of neuromuscular blockade, to assess the need for additional doses of neuromuscular blocker, and to determine whether adjustments need to be made to the dose with subsequent administration.
Neuromuscular blockers: (Moderate) Concomitant use of neuromuscular blockers and systemic aminoglycosides may prolong neuromuscular blockade. The use of a peripheral nerve stimulator is strongly recommended to evaluate the level of neuromuscular blockade, to assess the need for additional doses of neuromuscular blocker, and to determine whether adjustments need to be made to the dose with subsequent administration.
Non-Ionic Contrast Media: (Moderate) Because the use of other nephrotoxic drugs, such as aminoglycoside antibiotics, is an additive risk factor for nephrotoxicity in patients receiving radiopaque contrast agents, concomitant use should be avoided when possible.
Nonsteroidal antiinflammatory drugs: (Moderate) It is possible that additive nephrotoxicity may occur in patients who receive nonsteroidal anti-inflammatory drugs (NSAIDs) concurrently with other nephrotoxic agents, such as gentamicin.
Oral Contraceptives: (Moderate) It would be prudent to recommend alternative or additional contraception when oral contraceptives (OCs) are used in conjunction with antibiotics. It was previously thought that antibiotics may decrease the effectiveness of OCs containing estrogens due to stimulation of metabolism or a reduction in enterohepatic circulation via changes in GI flora. One retrospective study reviewed the literature to determine the effects of oral antibiotics on the pharmacokinetics of contraceptive estrogens and progestins, and also examined clinical studies in which the incidence of pregnancy with OCs and antibiotics was reported. It was concluded that the antibiotics ampicillin, ciprofloxacin, clarithromycin, doxycycline, metronidazole, ofloxacin, roxithromycin, temafloxacin, and tetracycline did not alter plasma concentrations of OCs. Antituberculous drugs (e.g., rifampin) were the only agents associated with OC failure and pregnancy. Based on the study results, these authors recommended that back-up contraception may not be necessary if OCs are used reliably during oral antibiotic use. Another review concurred with these data, but noted that individual patients have been identified who experienced significant decreases in plasma concentrations of combined OC components and who appeared to ovulate; the agents most often associated with these changes were rifampin, tetracyclines, and penicillin derivatives. These authors concluded that because females most at risk for OC failure or noncompliance may not be easily identified and the true incidence of such events may be under-reported, and given the serious consequence of unwanted pregnancy, that recommending an additional method of contraception during short-term antibiotic use may be justified. During long-term antibiotic administration, the risk for drug interaction with OCs is less clear, but alternative or additional contraception may be advisable in selected circumstances. Data regarding progestin-only contraceptives or for newer combined contraceptive deliveries (e.g., patches, rings) are not available.
Pamidronate: (Moderate) Coadministration of pamidronate with other nephrotoxic drugs, such as aminoglycosides, may increase the risk of developing nephrotoxicity following pamidronate administration, even in patients who have normal renal function.
Pancuronium: (Moderate) Concomitant use of neuromuscular blockers and systemic aminoglycosides may prolong neuromuscular blockade. The use of a peripheral nerve stimulator is strongly recommended to evaluate the level of neuromuscular blockade, to assess the need for additional doses of neuromuscular blocker, and to determine whether adjustments need to be made to the dose with subsequent administration.
Pentamidine: (Major) Additive nephrotoxicity may be seen with the combination of pentamidine and other agents that cause nephrotoxicity, such as systemic aminoglycosides. Renal function and aminoglycoside concentratons should be closely monitored.
Perphenazine: (Minor) When used for the treatment of nausea and vomiting, antiemetic phenothiazines may effectively mask symptoms that are associated with ototoxicity induced by the aminoglycosides.
Perphenazine; Amitriptyline: (Minor) When used for the treatment of nausea and vomiting, antiemetic phenothiazines may effectively mask symptoms that are associated with ototoxicity induced by the aminoglycosides.
Phenobarbital; Hyoscyamine; Atropine; Scopolamine: (Minor) Antiemetics, like scopolamine, should be used carefully with amikacin because they can mask symptoms of ototoxicity (e.g., nausea secondary to vertigo). These agents block the histamine or acetylcholine response that causes nausea due to vestibular (inner ear) emetic stimuli such as motion.
Polymyxin B: (Major) The concomitant use of systemic Polymyxin B with systemic aminoglycosides increases the risk of nephrotoxicity, ototoxicity, and neurotoxicity. Since polymyxins and aminoglycosides are both eliminated by the kidney, coadministration may increase serum concentrations of either drug class. Monitor patients for changes in renal function if these drugs are coadministered. Additionally, neuromuscular blockade has been associated with both polymyxins and aminoglycosides, and is more likely to occur in patients with renal dysfunction.
Promethazine: (Minor) Antiemetics, like promethazine, should be used carefully with aminoglycosides because they can mask symptoms of ototoxicity (e.g., nausea secondary to vertigo). These agents block the histamine or acetylcholine response that causes nausea due to vestibular (inner ear) emetic stimuli such as motion.
Promethazine; Dextromethorphan: (Minor) Antiemetics, like promethazine, should be used carefully with aminoglycosides because they can mask symptoms of ototoxicity (e.g., nausea secondary to vertigo). These agents block the histamine or acetylcholine response that causes nausea due to vestibular (inner ear) emetic stimuli such as motion.
Promethazine; Phenylephrine: (Minor) Antiemetics, like promethazine, should be used carefully with aminoglycosides because they can mask symptoms of ototoxicity (e.g., nausea secondary to vertigo). These agents block the histamine or acetylcholine response that causes nausea due to vestibular (inner ear) emetic stimuli such as motion.
Propofol: (Moderate) Patients receiving general anesthetics should be observed for exaggerated effects if they are receiving gentamicin.
Pyridostigmine: (Moderate) Aminoglycosides have been associated with neuromuscular blockade when used as an abdominal irrigant intraoperatively. Although the risk of neuromuscular blockade is remote with parenteral aminoglycoside therapy, these antibiotics should be used cautiously in myasthenic patients. This represents a pharmacodynamic interaction with cholinesterase inhibitors when used to treat myasthenia gravis, rather than a pharmacokinetic interaction.
Rocuronium: (Moderate) Concomitant use of neuromuscular blockers and systemic aminoglycosides may prolong neuromuscular blockade. The use of a peripheral nerve stimulator is strongly recommended to evaluate the level of neuromuscular blockade, to assess the need for additional doses of neuromuscular blocker, and to determine whether adjustments need to be made to the dose with subsequent administration.
Salicylates: (Minor) Due to the inhibition of renal prostaglandins by salicylates, concurrent use of salicylates and other nephrotoxic agents like the aminoglycosides may lead to additive nephrotoxicity.
Salsalate: (Minor) Due to the inhibition of renal prostaglandins by salicylates, concurrent use of salicylates and other nephrotoxic agents like the aminoglycosides may lead to additive nephrotoxicity.
Scopolamine: (Minor) Antiemetics, like scopolamine, should be used carefully with amikacin because they can mask symptoms of ototoxicity (e.g., nausea secondary to vertigo). These agents block the histamine or acetylcholine response that causes nausea due to vestibular (inner ear) emetic stimuli such as motion.
Sevoflurane: (Moderate) Patients receiving general anesthetics should be observed for exaggerated effects if they are receiving gentamicin.
Sodium picosulfate; Magnesium oxide; Anhydrous citric acid: (Major) Prior or concomitant use of antibiotics with sodium picosulfate; magnesium oxide; anhydrous citric acid may reduce efficacy of the bowel preparation as conversion of sodium picosulfate to its active metabolite bis-(p-hydroxy-phenyl)-pyridyl-2-methane (BHPM) is mediated by colonic bacteria. If possible, avoid coadministration. Certain antibiotics (i.e., tetracyclines and quinolones) may chelate with the magnesium in sodium picosulfate; magnesium oxide; anhydrous citric acid solution. Therefore, these antibiotics should be taken at least 2 hours before and not less than 6 hours after the administration of sodium picosulfate; magnesium oxide; anhydrous citric acid solution.
Streptozocin: (Moderate) Because streptozocin is nephrotoxic, concurrent or subsequent administration of other nephrotoxic agents, including aminoglycosides, could exacerbate the renal insult.
Succinylcholine: (Moderate) Concomitant use of neuromuscular blockers and systemic aminoglycosides may prolong neuromuscular blockade. The use of a peripheral nerve stimulator is strongly recommended to evaluate the level of neuromuscular blockade, to assess the need for additional doses of neuromuscular blocker, and to determine whether adjustments need to be made to the dose with subsequent administration.
Sulfacetamide: (Moderate) Based on the possibility of in vitro antagonism, avoid using sulfacetamide sodium concomitantly with gentamicin sulfate.
Sulfacetamide; Sulfur: (Moderate) Based on the possibility of in vitro antagonism, avoid using sulfacetamide sodium concomitantly with gentamicin sulfate.
Surfactants: (Major) Aminoglycosides are commonly given via nebulization to the airway for the prevention and treatment of pneumonia and are known to be at risk for inactivation of their antibiotic activity, mainly due to their susceptibility for changes in pH. A reduced activity of gentamicin may occur in the presence of surfactant.
Tacrolimus: (Moderate) Additive nephrotoxicity is possible if aminoglycosides are used with tacrolimus. Care should be taken in using tacrolimus with other nephrotoxic drugs. Assessment of renal function in patients who have received tacrolimus is recommended as the tacrolimus dosage may need to be reduced.
Telavancin: (Major) Concurrent or sequential use of telavancin with other potentially nephrotoxic drugs (e.g., systemic aminoglycosides) may lead to additive nephrotoxicity. Televancin is closely related to vancomycin. In one clinical study, vancomycin coadministration, high aminoglycoside trough levels, and heart failure independently predicted acute kidney injury during aminoglycoside treatment. Closely monitor renal function and adjust telavancin doses based on creatinine clearance/renal function, and aminoglycoside doses based on renal function and serum aminoglycoside concentrations as clinically indicated.
Tenofovir Alafenamide: (Moderate) Monitor for changes in renal function if tenofovir alafenamide is administered in combination with nephrotoxic agents, such as aminoglycosides. Tenofovir is primarily excreted via the kidneys by a combination of glomerular filtration and active tubular secretion. Coadministration of tenofovir alafenamide with a drug that reduces renal function or competes for active tubular secretion may increase concentrations of tenofovir and other renally eliminated drugs; thus, increasing the risk of developing renal-related adverse reactions.
Tenofovir Disoproxil Fumarate: (Moderate) Renal impairment, which may include hypophosphatemia, has been reported with the use of tenofovir with a majority of the cases occurring in patients who have underlying systemic or renal disease or who are concurrently taking nephrotoxic agents. Tenofovir should be avoided with concurrent or recent use of a nephrotoxic agent; patients receiving concomitant nephrotoxic agents should be carefully monitored for changes in serum creatinine and phosphorus.
Thioridazine: (Minor) When used for the treatment of nausea and vomiting, antiemetic phenothiazines may effectively mask vestibular symptoms that are associated with ototoxicity induced by various medications, including the aminoglycosides.
Tolvaptan: (Moderate) Coadministration of tolvaptan and hypertonic saline (e.g., 3% NaCl injection solution) is not recommended. The use of hypertonic sodium chloride in combination with tolvaptan may result in a too rapid correction of hyponatremia and increase the risk of osmotic demyelination (i.e., central pontine myelinolysis).
Torsemide: (Moderate) The risk of ototoxicity or nephrotoxicity secondary to aminoglycosides may be increased by the addition of concomitant therapies with similar side effects, including loop diuretics. If loop diuretics and aminoglycosides are used together, it would be prudent to monitor renal function parameters, serum electrolytes, and serum aminoglycoside concentrations during therapy. Audiologic monitoring may be advisable during high dose therapy or therapy of long duration, when hearing loss is suspected, or in selected risk groups (e.g., neonates).
Tretinoin, ATRA: (Moderate) The concomitant use of systemic tretinoin, ATRA and systemic gentamicin should be done cautiously due to the potential for increased intracranial pressure and an increased risk of pseudotumor cerebri (benign intracranial hypertension). Early signs and symptoms of pseudotumor cerebri include papilledema, headache, nausea, vomiting, and visual disturbances.
Trifluoperazine: (Minor) When used for the treatment of nausea and vomiting, antiemetic phenothiazines may mask symptoms that are associated with ototoxicity induced by the aminoglycosides.
Trimethobenzamide: (Minor) Because of trimethobenzamide's antiemetic pharmacology, the drug may effectively mask dizziness, tinnitus, or vertigo that are associated with ototoxicity induced by various medications, including the aminoglycosides. Clinicians should be aware of this potential interaction and take it into consideration when monitoring for aminoglycoside-induced side effects.
Urea: (Moderate) The risk of ototoxicity or nephrotoxicity secondary to aminoglycosides may b

e increased by the addition of concomitant therapies with similar side effects, including urea. In addition, urea may alter the serum and tissue concentrations of tobramycin, thereby, increasing the risk for aminoglycoside toxicities. If possible, avoid concurrent use. If these drugs must be used together, it would be prudent to monitor renal function, serum electrolytes, and serum aminoglycoside concentrations. Audiologic monitoring may be advisable during high dose therapy or therapy of long duration, when hearing loss is suspected, or in selected risk groups (e.g., neonates).
Valacyclovir: (Moderate) Additive nephrotoxicity is possible if systemic aminoglycosides are used with valacyclovir. Carefully monitor renal function during concomitant therapy.
Valganciclovir: (Major) Concurrent use of nephrotoxic agents, such as aminoglycosides, with valganciclovir should be done cautiously to avoid additive nephrotoxicity.
Vancomycin: (Major) Concomitant use of parenteral vancomycin with other nephrotoxic drugs, such as aminoglycosides, can lead to additive nephrotoxicity. Both vancomycin and aminoglycosides may cause ototoxicity as well. In a clinical study, vancomycin coadministration, high aminoglycoside trough concentrations, and heart failure independently predicted acute kidney injury during aminoglycoside treatment. Renal function should be monitored closely, and vancomycin and aminoglycoside doses should be adjusted according to serum concentrations as clinically indicated.
Vecuronium: (Moderate) Concomitant use of neuromuscular blockers and systemic aminoglycosides may prolong neuromuscular blockade. The use of a peripheral nerve stimulator is strongly recommended to evaluate the level of neuromuscular blockade, to assess the need for additional doses of neuromuscular blocker, and to determine whether adjustments need to be made to the dose with subsequent administration.
Voclosporin: (Moderate) Concomitant use of voclosporin and aminoglycosides may result in additive nephrotoxicity. Monitor for renal toxicity if concomitant use is required.
Warfarin: (Moderate) The concomitant use of warfarin with many classes of antibiotics, including aminoglycosides, may result in an increased INR thereby potentiating the risk for bleeding. Inhibition of vitamin K synthesis due to alterations in the intestinal flora may be a mechanism; however, concurrent infection is also a potential risk factor for elevated INR. Monitor patients for signs and symptoms of bleeding. Additionally, increased monitoring of the INR, especially during initiation and upon discontinuation of the antibiotic, may be necessary.
Zoledronic Acid: (Moderate) Since zoledronic acid is eliminated by the kidney, coadministration of zoledronic acid with other potentially nephrotoxic drugs may increase serum concentrations of either zoledronic acid and/or these coadministered drugs. Theoretically, the chronic coadministration of zoledronic acid with other nephrotoxic drugs, such as aminoglycosides, may increase the risk of developing nephrotoxicity.

How Supplied

Garamycin/Genoptic SOP/Gentak/Gentamicin/Gentamicin Sulfate/Ocu-Mycin Ophthalmic Ointment: 0.3%, 1g, 3mg
Garamycin/Genoptic/Gentacidin/Gentafair/Gentak/Gentamicin/Gentamicin Sulfate/Gentasol/Ocu-Mycin Ophthalmic Sol: 0.3%
Garamycin/Gentamicin/Gentamicin Sulfate Intramuscular Inj Sol: 1mL, 10mg, 40mg
Garamycin/Gentamicin/Gentamicin Sulfate/Gentamicin Sulfate, Sodium Chloride/Gentamicin, Sodium Chloride Intravenous Inj Sol: 1mL, 10mg, 40mg, 100-0.9%, 120-0.9%, 60-0.9%, 70-0.9%, 80-0.9%, 90-0.9%
Gentamicin/Gentamicin Sulfate Topical Cream: 0.1%
Gentamicin/Gentamicin Sulfate Topical Ointment: 0.1%

Maximum Dosage
Adults

Aminoglycoside dosing is highly variable and dependent on several factors. 5 mg/kg/day IV/IM is FDA-approved maximum; however, doses of 7 mg/kg/day IV have been used in extended-interval dosing regimens. There is no maximum dose stated for ophthalmic or topical administration.

Geriatric

Aminoglycoside dosing is highly variable and dependent on several factors. 5 mg/kg/day IV/IM is FDA-approved maximum; however, doses of 7 mg/kg/day IV have been used in extended-interval dosing regimens. There is no maximum dose stated for ophthalmic or topical administration.

Adolescents

Aminoglycoside dosing is highly variable and dependent on several factors. 7.5 mg/kg/day IV/IM is FDA-approved maximum. There is no maximum dose stated for ophthalmic or topical administration.

Children

Aminoglycoside dosing is highly variable and dependent on several factors. 7.5 mg/kg/day IV/IM is FDA-approved maximum. There is no maximum dose stated for ophthalmic or topical administration.

Infants

Aminoglycoside dosing is highly variable and dependent on several factors. 7.5 mg/kg/day IV/IM is FDA-approved maximum. There is no maximum dose stated for ophthalmic administration. Safety and efficacy of topical administration have not been established.

Neonates

Aminoglycoside dosing is highly variable and dependent on several factors. 7.5 mg/kg/day IV/IM is FDA-approved maximum; however, this dose is not typically used in clinical practice. Usual maximum doses in neonates are as follows:
35 weeks gestation and older: 4 to 5 mg/kg/dose IV/IM every 24 hours.
30 to 34 weeks gestation: 5 mg/kg/dose IV/IM every 24 to 36 hours.
Younger than 30 weeks gestation: 5 mg/kg/dose IV/IM every 36 to 48 hours.

Mechanism Of Action

Gentamicin is bactericidal in action. Similar to other aminoglycosides, it works by inhibiting bacterial protein synthesis through irreversible binding to the 30 S ribosomal subunit of susceptible bacteria. Gentamicin is actively transported into the bacterial cell where it binds to receptors present on the 30 S ribosomal subunit. This binding interferes with messenger RNA (mRNA). As a result, abnormal, nonfunctional proteins are formed due to misreading of the bacterial DNA. Eventually, susceptible bacteria die because of the lack of functional proteins. One aspect essential to aminoglycoside lethality is the need to achieve intracellular concentrations in excess of extracellular. Anaerobic bacteria are not susceptible to aminoglycosides due, at least in part, to a lack of an active transport mechanism for aminoglycoside uptake. The uptake of aminoglycosides may be facilitated by the presence of inhibitors of the bacterial cell wall (i.e., beta-lactams, vancomycin).[34041] [34163] [34173] [40042] [41225]
 
Against gram-negative aerobic rods, aminoglycosides exhibit 'concentration-dependent killing' and a 'post-antibiotic effect' (PAE). 'Concentration-dependent killing' describes the principle that bactericidal effects increase as the concentration increases. PAE is where suppression of bacterial growth continues after the antibiotic concentration falls below the bacterial MIC. The post-antibiotic effect can be bacteria-specific, as well as drug-specific. The PAE of aminoglycosides is short for most gram-positive organisms (less than 2 hours) and longer for gram-negative organisms (2 to 8 hours), such as E. coli, K. pneumoniae, and P. aeruginosa. Both of these phenomena are being exploited in designing dosage regimens that employ higher doses administered at longer intervals. The major pharmacodynamic parameters that determine efficacy of aminoglycosides are the serum peak concentration to MIC ratio (peak/MIC) and the AUC to MIC ratio (AUC/MIC). Both time-kill studies as well as studies in humans have shown that a peak/MIC of more than 8 to 12/1 is associated with successful regimens. An AUC/MIC ratio of more than 125 has also been associated with a successful regimen.[23947] [24566] [34142] [34143] [34144] [34145] [34191] [34192] [41226]
 
The mechanism of renal toxicity with aminoglycosides is associated with accumulation of aminoglycosides in the renal tubule, which is a saturable process. Elevated serum trough concentrations are associated with an increased risk of toxicity.[34159] [34160] [41226]
 
The mechanism of ototoxicity relates to the aminoglycoside-induced destruction of sensory hair cells of the inner ear. The cochlear sensory cells that are most vulnerable are in the basal end, thereby leading to high-frequency hearing loss first. As ototoxicity ascends toward the apex of the cochlea, the lower frequencies are affected. Sensory cells that deal with vestibular function may also be affected. Aminoglycosides may cause free-radical damage to sensory cells and neurons. Biochemically, aminoglycosides may bind to polyphosphoinositides, which are part of the transmembrane signaling system mediating physiological effects of hormones, neurotransmitters, and neuromodulators which may interfere with essential mechanisms of cell physiology. Neural destruction without any cochlear hair cell damage has also been described. There may also be a genetic mitochondrial RNA mutation that may predispose some patients to aminoglycoside ototoxicity. Aminoglycosides enter the inner ear rapidly, but it is suggested that aminoglycoside concentrations do not correlate with the development of ototoxicity. Likely, the aminoglycoside concentrations in the inner ear dissipate slowly, which is consistent with the possibility of developing ototoxicity days to weeks after drug discontinuation.[33555] [42984] [42985] [42986]
 
The susceptibility interpretive criteria for gentamicin are delineated by pathogen. The MICs are defined for Staphylococcus sp. as susceptible at 4 mcg/mL or less, intermediate at 8 mcg/mL, and resistant at 16 mcg/mL or more (only to be used in combination with other active agents). The MICs are defined for P. aeruginosa, Acinetobacter sp., non-Enterobacterales, Y. pestis, Corynebacterium sp. and related Coryneform genera, Bacillus sp. (excluding B. anthracis) and related genera, Aeromonas sp., and Vibrio sp. as susceptible at 4 mcg/mL or less, intermediate at 8 mcg/mL, and resistant at 16 mcg/mL or more. The Clinical and Laboratory Standards Institute (CLSI) and the FDA differ on MIC interpretation for Enterobacterales (excluding Salmonella sp. and Shigella sp.). The MICs are defined for Enterobacterales by the FDA as susceptible at 4 mcg/mL or less, intermediate at 8 mcg/mL, and resistant at 16 mcg/mL or more; however, the MICs are defined for Enterobacterales by the CLSI as susceptible at 2 mcg/mL or less, intermediate at 4 mcg/mL, and resistant at 8 mcg/mL or more (based on a dosage regimen of 7 mg/kg every 24 hours). The MICs are defined for F. tularensis and Brucella sp. as susceptible at 4 mcg/mL or less. However, based on the pharmacodynamic properties of aminoglycosides, an MIC of 2 mcg/mL or more would likely lead to unacceptably low probabilities of good clinical outcomes when using reasonable dosage regimens.
 
Aminoglycoside resistance is well documented. There are a variety of resistance mechanisms employed by different pathogens. Enzymatic inhibition by gram-negative pathogens and Enterococcus sp. via aminoglycoside-modifying enzymes is achieved by modification of the aminoglycoside as it is transported across the cytoplasmic membrane. Alterations in the inner membrane porin channels by Pseudomonas aeruginosa decrease antimicrobial penetration to the site of activity within the bacterial cell. Some gram-negative organisms and Enterococcus sp. can alter the ribosomal target sites of the aminoglycosides to decrease binding, thereby decreasing antimicrobial activity. Aminoglycosides can also be actively transported out of the bacterial cells via efflux pumps.[34161] [34162] [34163] [41225]

Pharmacokinetics

Gentamicin is administered intravenously, intramuscularly, topically, and via the ophthalmic route. Gentamicin distributes into extracellular fluid. Volume of distribution approximates extracellular space; therefore, peak serum concentrations may be lower in patients with a large volume of extracellular fluid. Protein binding of gentamicin is low (0% to 30%). Gentamicin can be detected in the serum, lymph, tissues, sputum, synovial fluid, and peritoneal fluid. Concentrations in the renal cortex may be 8 times higher than in the serum. Gentamicin crosses the peritoneal wall and the placental membranes. There is poor diffusion into the subarachnoid space with systemic administration; therefore, concentrations in the cerebrospinal fluid are often low and dependent upon dose, rate of penetration, and degree of meningeal inflammation. There is minimal penetration into ocular tissues after systemic administration.
 
Gentamicin is not metabolized. Approximately >= 70% of the gentamicin dose is recovered in the urine after 24 hours. Elimination is almost exclusively via glomerular filtration. Reabsorption of a small amount of the drug by the proximal tubule results in accumulation in the renal cortex, which may be responsible for nephrotoxicity. Renal clearance of gentamicin is similar to endogenous creatinine. The endogenous creatinine clearance rate and serum creatinine concentration have a high correlation with the half-life of gentamicin. Minimal amounts are excreted into bile. Thus, elimination half-life varies according to renal function. Febrile states may be associated with decreased serum concentrations and a shorter half-life. In severely burned patients, the half-life may also be decreased. In patients with normal renal function, the serum half-life is approximately 2 hours; however, there is considerable interpatient variation.

Oral Route

Gentamicin is not absorbed when administered orally.

Intravenous Route

When administered by IV infusion over a 2-hour period, gentamicin serum concentrations are similar to those obtained by intramuscular administration.

Intramuscular Route

After intramuscular administration, gentamicin peak serum concentrations usually occur between 30 to 60 minutes and are similar to those obtained from intravenous infusion. In patients with normal renal function, peak serum concentrations are usually up to 4 times the single intramuscular dose (i.e., 1 mg/kg dose yields approximately a 4 mcg/mL peak serum concentration) with some interpatient variability. Gentamicin, administered at doses of 1 mg/kg every 8 hours for 7 to 10 days, is unlikely to accumulate in the serum in patients with normal renal function. Higher doses and/or prolonged periods of treatment may cause gentamicin accumulation. Doses of 4 mg/kg/day or higher may result in a slight, progressive rise in both peak and trough concentrations.

Topical Route

Gentamicin may be used as a topical cream or ointment. Systemic absorption from application to intact skin is negligible. However, topical gentamicin may be absorbed systemically from areas of denuded, burned or granulating areas, or via topical sinus irrigation. However, unless applied to very large areas and for long durations of time, detectable serum levels are usually well below levels associated with systemic therapy.

Other Route(s)

Ophthalmic Route
Gentamicin is administered topically to the eye as a solution or as an ointment. Systemic absorption by these routes is expected to be negligible.

Pregnancy And Lactation
Pregnancy

Systemic exposure to gentamicin may cause fetal harm during human pregnancy. Use gentamicin during pregnancy only if the potential benefit justifies the potential risk to the fetus. There have been reports of total irreversible bilateral congenital deafness (eighth cranial nerve toxicity) in children whose mothers received a related aminoglycoside, streptomycin, during pregnancy. Serious side effects to the fetus, newborn, or mother have not been reported in the treatment of pregnant women with other aminoglycosides. Animal reproduction studies conducted on rats and rabbits did not reveal evidence of impaired fertility or harm to the fetus due to gentamicin sulfate. However, it is not known whether gentamicin sulfate can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Gentamicin rapidly crosses the placenta into fetal circulation and amniotic fluid, with peak cord serum concentrations averaging 34% to 44% of maternal serum concentrations after administration to women in labor. One reported case of potential congenital defects occurred after a 10-day maternal antibiotic course including gentamicin around gestational week 7. At birth, the infant had impaired renal function and small kidneys, and at 4.5 years of age, he was diagnosed with renal cystic dysplasia. It is unknown if fetal gentamicin exposure contributed to the renal problems. In a study of pregnant patients treated for pyelonephritis, the clinical and pregnancy outcomes of 62 patients who received ampicillin plus gentamicin did not differ from patients who received either cefazolin or ceftriaxone monotherapy. A case-control surveillance study (n = 38) in women who received gentamicin showed no risk for teratogenicity with gentamicin. The ophthalmic and topical preparations of gentamicin do not appear likely to result in fetal harm when used as directed for limited exposure/treatment durations; however, gentamicin has been shown to depress body weights, kidney weights, and median glomerular counts in newborn rats when administered systemically to pregnant rats in daily doses approximately 500 times the maximum recommended ophthalmic human dose.

Although the manufacturer does not give recommendations for gentamicin use during breast feeding, gentamicin use appears compatible with breast-feeding. Small amounts of gentamicin are excreted into breast milk. In a study of 10 women who received systemic gentamicin prophylaxis (80 mg IM every 8 hours) for 5 days, mean maternal gentamicin serum concentrations on day four obtained 1 and 7 hours after a dose were 3.95 mcg/mL and 1.02 mcg/mL, respectively. Corresponding mean milk concentrations at 1, 3, 5, and 7 hours after the dose were 0.42 mcg/mL, 0.48 mcg/mL, 0.49 mcg/mL, and 0.41 mcg/mL, respectively. Gentamicin also has extremely poor oral bioavailability, and therefore, significant absorption of ingested drug by the breast-fed infant is not expected. 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 a maternally administered drug, health care providers are encouraged to report the adverse effect to the FDA.