Capreomycin parenteral
- Drugs List
- Therapeutic Indications
- Dosage
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Injectable formulations containing capreomycin (as capreomycin sulfate)
Drugs List
Therapeutic Indications
Uses
Tuberculosis - resistant to first-line treatment
Treatment of pulmonary infections caused by capreomycin-susceptible strains of Mycobacterium tuberculosis in combination with other appropriate antituberculosis agents. Capreomycin should only be used when primary treatments (isoniazid, rifampicin, streptomycin and ethambutol) have been ineffective or cannot be used due to toxicity or the presence of resistant tubercle bacilli.
Capreomycin is active against human strains of Mycobacterium tuberculosis
Cross-resistance may occur between capreomycin and kanamycin and neomycin. No cross-resistance has been observed between capreomycin and isoniazid, aspirin, cycloserine, streptomycin, or ethambutol.
Dosage
Adults
Initial dose is 1 gram daily for 60 to 120 days (do not exceed 20mg/kg/day).
The initial dose should be followed by 1 gram to be administered 2 or 3 times per week.
Elderly
Initial dose is 1 gram daily for 60 to 120 days (do not exceed 20mg/kg/day).
The initial dose should be followed by 1 gram to be administered 2 or 3 times per week.
Patients with Renal Impairment
Dosage should be reduced depending on the level of creatinine clearance. The following recommended dosages aim to achieve a mean steady-state capreomycin level of 10 micrograms/ml:
Creatinine clearance 0 ml/min - 1.29 mg/kg every 24 hours OR 2.58 mg/kg every 48 hours OR 3.87 mg/kg every 72 hours
Creatinine clearance 10 ml/min - 2.43 mg/kg every 24 hours OR 4.87 mg/kg every 48 hours OR 7.3 mg/kg every 72 hours
Creatinine clearance 20 ml/min - 3.58 mg/kg every 24 hours OR 7.16 mg/kg every 48 hours OR 10.7 mg/kg every 72 hours
Creatinine clearance 30 ml/min - 4.72 mg/kg every 24 hours OR 9.45 mg/kg every 48 hours OR 14.2 mg/kg every 72 hours
Creatinine clearance 40 ml/min - 5.87 mg/kg every 24 hours OR 11.7 mg/kg every 48 hours
Creatinine clearance 50 ml/min - 7.01 mg/kg every 24 hours OR 14 mg/kg every 48 hours
Creatinine clearance 60 ml/min - 8.16 mg/kg every 24 hours
Creatinine clearance 80 ml/min - 10.4 mg/kg every 24 hours
Creatinine clearance 100 ml/min - 12.7 mg/kg every 24 hours
Creatinine clearance 110 ml/min - 13.9 mg/kg every 24 hours
Contraindications
Children under 18 years
Precautions and Warnings
History of allergies including anaphylaxis
Auditory impairment
Breastfeeding
Hepatic impairment
Pregnancy
Renal impairment
Reduce dose in patients with renal impairment
Must be used in combination with other anti-tuberculous drugs
Monitor auditory and vestibular function
Monitor hepatic function
Monitor renal function
Monitor serum potassium regularly
Pregnancy and Lactation
Pregnancy
May be used during pregnancy only if the potential benefits of therapy outweigh the possible risks to the foetus.
The safety of capreomycin use during human pregnancy has not been established.
Studies to determine the potential for carcinogenicity, mutagenicity, or impairment of fertility have not been carried out. Animal studies in rats have shown evidence of teratogenicity with doses 3.5 times higher than human doses.
Schaefer suggests capreomycin is contraindicated during pregnancy due to its ototoxic properties. Inadvertent use does not require termination of pregnancy or invasive diagnostic procedures, but hearing tests should be performed after birth.
The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14-17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).
Lactation
Use with caution when treating breast-feeding women.
It is not known if capreomycin is excreted in human breast milk. The low molecular weight (about 653-669) suggests that capreomycin will be excreted into breast milk.
Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
Specialist advice is available from the UK Drugs in Lactation Advisory Service at https://www.midlandsmedicines.nhs.uk/content.asp?section=6&subsection=17&pageIdx=1
Side Effects
Abnormal liver function tests
Abscess formation (injection site)
Acute tubular necrosis
Blood urea increased
Electrolyte disturbances
Eosinophilia
Febrile reactions
Haemorrhage (injection site)
Hearing loss
Increase in bromsulphalein retention
Induration (injection site)
Leucocytosis
Leucopenia
Local pain (injection site)
Maculopapular rash
Nephrotoxicity
Neuromuscular block
Oliguria
Renal impairment
Serum creatinine increased
Thrombocytopenia
Tinnitus
Urinary abnormalities
Urticaria
Vertigo
Overdosage
It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.
The following number will direct the caller to the relevant local centre (0844) 892 0111
Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).
Further Information
Last Full Review Date: February 2013
Reference Sources
British National Formulary, 64th Edition (2012) Pharmaceutical Press, London.
Drugs During Pregnancy and Lactation: Treatment Options and Risk Assessment, 2nd edition (2007) ed. Schaefer, C., Peters, P. and Miller, R. Elsevier, London.
Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk, 9th edition (2011) ed. Briggs, G., Freeman, R. and Yaffe, S. Lippincott Williams & Wilkins, Philadelphia.
Summary of Product Characteristics: Capreomycin Injection. King Pharmaceuticals Ltd. September 2009.
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