Dosing & Uses
Dosage Forms & Strengths
powder for injection
- 1g/vial
Tuberculosis
1 g qDay (not to exceed 20 mg/kg/day), given IM or by IV infusion for 60-120 days
Maintenance dose: 1 g IM or IV infusion 2 or 3 times weekly; maintain therapy for tuberculosis for 12 to 24 months; 20 mg/kg/day maximum
Dosage Forms & Strengths
powder for injection
- 1g/vial
Tuberculosis (Off-label)
Per CTC/IDSA/ATS/AAP recommendation
<15 years old and <40 kg: 15-30 mg/kg IV/IM qDay; maximum 1 g/day for 2-4 months followed by 15-30 mg/kg given twice weekly; maximum 1 g/day
>15 years old and >40 kg: 15 mg/kg IV/IM; maximum 1 g/day for 2-4 months followed by 15 mg/kg 2-3 times/week; maximum 1 g/dose
Always used in conjunction with other antitubercular agents
Monitor: Renal function qWeek, serum potassium
Interactions
Interaction Checker
No Results
Contraindicated
Serious - Use Alternative
Significant - Monitor Closely
Minor
Adverse Effects
>10%
Nephrotoxicity, incr BUN (36%)
Hearing loss (11% subclinical; 3% clinical)
1-10%
Eosinophilia (dose related, >5%)
<1%
Incr LFTs
Inj site pain/induration
Leukopenia
Maculopapular rash
Urticaria
Warnings
Black Box Warnings
Use great caution in patients with renal insufficiency and pre-existing auditory impairment. Weigh the risk of additional cranial nerve VIII impairment or renal injury against the benefits of the therapy. Simulatneous administration with parenteral nonantituberculous agents with ototoxic potential (e.g., polymixin A sulfate, colisitin sulfate, amikacin, gentamicin, tobramycin, vancompycin, kanamycin, and neomycin) is not recommended.
Coadministration with antituberculous agents like streptomycin is also not recommended since they have similar and sometimes irreversible effects in cranial nerve VIII.
Safety in pregnancy has not been determined.
Effectiveness in pediatric patients has not been established.
Contraindications
Hypersensitivity
Pregnancy
Cautions
Renal impairment, auditory impairment, history of allergic rxns
Risk of hypokalemia
Risk of rare but potentially fatal toxic nephritis
Pregnancy & Lactation
Pregnancy Category: C
Lactation: excretion in milk unknown; use with caution
Pregnancy Categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk. C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done. D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk. X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist. NA: Information not available.Pharmacology
Half-life: 4-6 hr, prolonged in renal impairment
Peak Plasma Time: 1-2 hr
Excretion: urine
Mechanism of Action
Polypeptide antibiotic complex of 4 microbiologically active components, bacteriostatic
Administration
IV Preparation
Dissolve 1 g powder with 2, 2.15, 2.63, 3.3, or 4.3 mL of NS or SWI
Allow 2-3 min to dissolve
IV/IM Administration
IM: deep IM into large muscle mass
IV: dilute with 100 mL NS & infuse over 1 hr
Storage
Reconstituted soln may be stored at 2-8°C for 24 hr
Darkening or pale straw color development may occur over time, does NOT indicate loss of potency
Images
Patient Handout
Formulary
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