Capreomycin 1g powder for solution for injection vials

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Capreomycin sulfate

Available from:

Neon Healthcare Ltd

ATC code:

J04AB30

INN (International Name):

Capreomycin sulfate

Dosage:

1gram

Pharmaceutical form:

Powder for solution for injection

Administration route:

Intramuscular

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 05010900; GTIN: 5033003002264

Summary of Product characteristics

OBJECT 1
CAPREOMYCIN INJECTION
Summary of Product Characteristics Updated 27-Nov-2015 | King
Pharmaceuticals Ltd
1. Name of the medicinal product
CAPREOMYCIN Injection
2. Qualitative and quantitative composition
Each vial contains Capreomycin Sulphate (approximately equivalent to
1g Capreomycin base).
3. Pharmaceutical form
Powder for solution for injection.
4. Clinical particulars
4.1 Therapeutic indications
_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.
4.2 Posology and method of administration
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 concentratio