Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2015 Publisher: King Pharmaceuticals Ltd, Donegal Street, Ballybofey, County Donegal, Ireland
Actions: Capreomycin is active against human strains of Mycobacterium tuberculosis.
Frequent cross-resistance occurs between capreomycin and viomycin. Varying degrees of cross-resistance between capreomycin and kanamycin and neomycin have been reported. No cross-resistance has been observed between capreomycin and isoniazid, aminosalicylic acid, cycloserine, streptomycin, ethionamide or ethambutol.
Indications: Capreomycin should be used concomitantly with other appropriate antituberculous agents for the treatment of pulmonary infections caused by capreomycin-susceptible strains of Mycobacterium tuberculosis when the primary agents (isoniazid, rifampicin, streptomycin and ethambutol) have been ineffective or cannot be used because of toxicity or the presence of resistant tubercle bacilli.
The usual dose is 1g daily (but 20mg/kg/day should not be exceeded) given by deep intramuscular injection only for 60 to 120 days, followed by 1g intramuscularly two or three times a week. Capreomycin is always administered in combination with at least one other antituberculous agent to which the patient’s strain of tubercle bacillus is susceptible.
Capreomycin should be dissolved in 2ml of 0.9% Sodium Chloride Intravenous Infusion BP or Water for Injections PhEur. Two to three minutes should be allowed for complete solution.
For administration of a 1g dose, the entire contents of the vial should be given. For dosages of less than 1g the following dilution table may be used:
| Diluent to be added (ml) | Appropriate volume of Capreomycin solution (ml) | Approximate average concentration (mg/ml) in terms of mg of capreomycin activity |
|---|---|---|
| 2.15 | 2.85 | 370 |
| 2.63 | 3.33 | 315 |
| 3.3 | 4.0 | 260 |
| 4.3 | 5.0 | 210 |
As for adults. Reduce dosage if renal function is impaired.
A reduced dosage should be given based on creatinine clearance using the guidance given in the following table. These dosages are designed to achieve a mean steady-state capreomycin level of 10 micrograms/ml, at various levels of renal function:
| Creatinine Clearance | Capreomycin clearance | Half life | Dose for these dosing intervals (mg/kg) | ||
|---|---|---|---|---|---|
| (ml/min) | (l/kg/h x 102) | (hours) | 24h | 48h | 72h |
| 0 | 0.54 | 55.5 | 1.29 | 2.56 | 3.87 |
| 10 | 1.01 | 29.4 | 2.43 | 4.87 | 7.30 |
| 20 | 1.49 | 20.0 | 3.58 | 7.15 | 10.70 |
| 30 | 1.97 | 15.1 | 4.72 | 9.45 | 14.20 |
| 40 | 2.45 | 12.2 | 5.87 | 11.70 | |
| 50 | 2.92 | 10.2 | 7.01 | 14.00 | |
| 60 | 3.40 | 8.8 | 8.16 | ||
| 80 | 4.35 | 6.8 | 10.40 | ||
| 100 | 5.31 | 5.6 | 12.70 | ||
| 110 | 5.78 | 5.2 | 13.90 | ||
Not for paediatric use since the safety of capreomycin for use in infants and children has not been established. No data are available.
Hypokalaemia, hypocalcaemia, hypomagnesaemia and an electrolyte disturbance resembling Bartter’s syndrome have been reported to occur in patients with capreomycin toxicity. Nephrotoxicity, including acute tubular necrosis; and ototoxicity, including dizziness, tinnitus, vertigo and loss of high-tone acuity (see ‘Warnings’ and ‘Precautions’). Neuromuscular blockage or respiratory paralysis may occur following rapid intravenous administration.
If capreomycin is ingested, toxicity is unlikely because less than 1% is absorbed from an intact gastro-intestinal system.
Symptomatic and supportive therapy is recommended. Activated charcoal may be more effective than emesis or lavage in reducing absorption.
Patients who have received an overdose of capreomycin and have normal renal function should be hydrated to maintain a urine output of 3-5ml/kg/hr. Fluid balance electrolytes and creatinine clearance should be monitored.
Haemodialysis is effective in patients with significant renal disease.
Shelf life: Three years.
Reconstituted solutions of Capreomycin may be stored below 25°C for 24 hours. Discard unused portion.
Store below 25°C.
For storage conditions after reconstitution of the medicinal product, see section 6.3.
Rubber stoppered, clear glass vial, with aluminium or plastic seal, containing capreomycin sulphate equivalent to approximately 1g capreomycin base, as sterile white powder.
The solution may acquire a pale straw colour and darken with time, but this is not associated with loss of potency or the development of toxicity.
No special requirements for disposal.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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