CAPREOMYCIN

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.

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. 0 370 315 260 210 The elderly: As for adults.

Reduce dosage if renal function is impaired.

Patients with reduced renal function:

A reduced dosage should be given based on creatinine clearance using the guidance given in the following table. 20 Paediatric population Not for paediatric use since the safety of capreomycin for use in infants and children has not been established.

No data are available.

Renal:

Elevation of serum creatinine or blood urea and abnormal urine sediment have been observed. Toxic nephritis was reported in one patient with tuberculosis and portal cirrhosis who was treated with capreomycin (1g) and aminosalicylic acid daily for one month.

This patient developed renal insufficiency and oliguria and died. The post-mortem showed subsiding acute tubular necrosis. Electrolyte disturbances resembling Bartter’s syndrome have been reported in one patient.

Hepatic:

A decrease in bromsulphthalein excretion without change in serum enzymes has been noted in the presence of pre-existing liver disease. Abnormal results in liver function tests have occurred in many patients receiving capreomycin in combination with other antituberculous agents which are also known to cause changes in hepatic function.

Periodic determinations of liver function are recommended.

Haematological:

Leucocytosis and leucopenia have been observed. Rare cases of thrombocytopenia have been reported. Most patients receiving daily capreomycin have had eosinophilia exceeding 5%, but this has subsided with the reduction of capreomycin dosage to two or three times weekly.

Hypersensitivity:

Urticaria and maculopapular rashes associated in some cases with febrile reactions have been reported when capreomycin and other antituberculous drugs were given concomitantly.

Otic:

Clinical and subclinical auditory loss has been noted. Some audiometric changes have proved reversible and others, with permanent loss have not been progressive following withdrawal of capreomycin. Tinnitus and vertigo have occurred.

Warnings The use of capreomycin in patients with renal insufficiency or pre-existing auditory impairment must be undertaken with great caution, and the risk of additional eighth cranial nerve impairment or renal injury should be weighed against the benefits to be derived from treatment.

Capreomycin must be used only in conjunction with adequate doses of other antituberculous drugs. The use of Capreomycin alone allows the rapid development of strains resistant to it. Precautions As capreomycin is potentially ototoxic, audiometry and assessment of vestibular function should be performed before starting treatment and at regular intervals during treatment.

Regular tests of renal function should be made throughout the period of treatment, and reduced dosage should be used in patients known, or suspected, renal impairment (see "Dosage and Administration"). Since hypokalaemia may occur during capreomycin therapy, serum potassium levels should be determined frequently.

A partial neuromuscular block can occur after large doses of capreomycin. Capreomycin should be administered cautiously to patients with a history of allergy, particularly to drugs.

Hypersensitivity to the active substance.