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ALERT: U.S. Boxed Warning
The FDA-approved labeling includes a boxed warning. See Warnings/Precautions section and/or refer to product labeling for additional detail.
Medication Safety Issues
Sound-alike/look-alike issues:
Capastat® may be confused with Cepastat®
Pronunciation
(kap ree oh MYE sin)
U.S. Brand Names
Index Terms
Generic Available
No
Pharmacologic Category
Pharmacologic Category Synonyms
Use: Labeled Indications
Treatment of tuberculosis in conjunction with at least one other antituberculosis agent
Pregnancy Risk Factor
C
Pregnancy Considerations
Capreomycin has been shown to be teratogenic in animal studies. [U.S. Boxed Warning]: Safety has not been established in pregnant women; use during pregnancy only if the potential benefit to the mother outweighs the possible risk to the fetus.
Lactation
Excretion in breast milk unknown/use caution
Contraindications
Hypersensitivity to capreomycin sulfate or any component of the formulation
Warnings/Precautions
Boxed warnings:
• Auditory impairment: See “Disease-related concerns and Concurrent drug therapy issues” below.
• Pediatrics: See “Special populations” below.
• Pregnancy: See “Special populations” below.
• Renal impairment: See “Disease-related concerns and Concurrent drug therapy issues” below.
Concerns related to adverse effects:
• Superinfection: Prolonged use may result in fungal or bacterial superinfection, including C. difficile-associated diarrhea (CDAD) and pseudomembranous colitis; CDAD has been observed >2 months postantibiotic treatment.
Disease-related concerns:
• Auditory impairment: [U.S. Boxed Warning]: Use in patients with pre-existing auditory impairment must be undertaken with great caution, and the risk of additional eighth nerve impairment should be weighed against the benefits to be derived from therapy.
• Renal impairment: [U.S. Boxed Warning]: Use in patients with renal impairment must be undertaken with great caution, and the risk of additional renal injury should be weighed against the benefits to be derived from therapy.
Concurrent drug therapy issues:
• Drugs with ototoxic or nephrotoxic potential: [U.S. Boxed Warning]: Use with nonantituberculous drugs (ie, aminoglycoside antibiotics) having ototoxic or nephrotoxic potential should be undertaken only with great caution.
• Parenteral antituberculous agents: [U.S. Boxed Warning]: Since other parenteral antituberculous agents (eg, streptomycin) also have similar and sometimes irreversible toxic effects, particularly on eighth cranial nerve and renal function, simultaneous administration of these agents with capreomycin is not recommended.
Special populations;
• Elderly: Use with caution in the elderly.
• Pediatrics: [U.S. Boxed Warning]: Safety has not been established in children.
• Pregnancy: [U.S. Boxed Warning]: Safety has not been established in pregnant women.
Adverse Reactions
>10%:
Otic: Ototoxicity [subclinical hearing loss (11%), clinical loss (3%)], tinnitus
Renal: Nephrotoxicity (36%, increased BUN)
1% to 10%: Hematologic: Eosinophilia (dose related, mild)
<1%: Vertigo, hypokalemia, leukocytosis, thrombocytopenia (rare); pain, induration, and bleeding at injection site; hypersensitivity (urticaria, rash, fever)
Postmarketing and/or case reports: Acute tubular necrosis, Bartter's syndrome
Drug Interactions
There are no known significant interactions.
Storage
Powder for injection should be stored at room temperature of 15°C to 30°C (59°F to 86°F). Following reconstitution, may store under refrigeration for up to 24 hours.
Reconstitution
Dissolve powder in 2 mL of NS or SWFI; allow 2-3 minutes for dissolution. For I.V. administration, further dilute in NS 100 mL. For I.M. administration, dose <1 g may be further diluted to concentrations of 200-350 mg/mL.
Mechanism of Action
Capreomycin is a cyclic polypeptide antimicrobial. It is administered as a mixture of capreomycin IA and capreomycin IB. The mechanism of action of capreomycin is not well understood. Mycobacterial species that have become resistant to other agents are usually still sensitive to the action of capreomycin. However, significant cross-resistance with viomycin, kanamycin, and neomycin occurs.
Pharmacodynamics/Kinetics
Half-life elimination: Normal renal function: 4-6 hours
Time to peak, serum: I.M.: ?1 hour
Excretion: Urine (as unchanged drug)
Dosage
I.M., I.V.:
Infants and Children: 15-30 mg/kg/day, up to 1 g/day maximum
Adults: 1 g/day (not to exceed 20 mg/kg/day) for 60-120 days, followed by 1 g 2-3 times/week
Elderly: Use with caution due to the increased potential for pre-existing renal dysfunction or impaired hearing
Dosing interval in renal impairment: Adults:
Clcr >100 mL/minute: Administer 13-15 mg/kg every 24 hours
Clcr 80-100 mL/minute: Administer 10-13 mg/kg every 24 hours
Clcr 60-80 mL/minute: Administer 7-10 mg/kg every 24 hours
Clcr 40-60 mL/minute: Administer 11-14 mg/kg every 48 hours
Clcr 20-40 mL/minute: Administer 10-14 mg/kg every 72 hours
Clcr <20 mL/minute: Administer 4-7 mg/kg every 72 hours
Administration: I.M.
Administer by deep I.M. injection into a large muscle mass.
Administration: I.V.
Administer over 60 minutes.
Monitoring Parameters
Audiometric measurements and vestibular function at baseline and during therapy; renal function at baseline and weekly during therapy; serum potassium; liver function tests
Reference Range
10 mcg/mL
Geriatric Considerations
Has not been studied in the elderly. I.M. administration may limit use due to painful injection or lack of sites in patients with decreased muscle mass. Use with caution in patients with pre-existing hearing impairment due to potential ototoxicity.
Dental Health: Effects on Dental Treatment
No significant effects or complications reported
Dental Health: Vasoconstrictor/Local Anesthetic Precautions
No information available to require special precautions
Mental Health: Effects on Mental Status
May cause dizziness
Mental Health: Effects on Psychiatric Treatment
None reported
Dosage Forms
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Injection, powder for reconstitution, as sulfate: 1 g
References
Davidson PT and Le HQ, “Drug Treatment of Tuberculosis - 1992,” Drugs, 1992, 43(5):651-73.
“Drugs for Tuberculosis,” Med Lett Drugs Ther, 1993, 35(908):99-101.
Iseman MD, “Treatment of Multidrug-Resistant Tuberculosis,” N Engl J Med, 1993, 329(11):784-91.
“Treatment of Tuberculosis. Joint Statement of the American Thoracic Society, CDC, and the Infectious Diseases Society of America.” Available at: http://www.cdc.gov/mmwr/preview/mmwrhtml/rr5211a1.htm. Accessed July 21, 2003.
International Brand Names
Lexi-Comp.com
Last full review/revision August 2008
Content last modified August 2008
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