Capreomycin

The safety of capreomycin for use during pregnancy has not been established. Capreomycin has been shown to be teratogenic in rats when given at 3.5 times the human dose. There are no adequate and well controlled studies in pregnant women. Capreomycin should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

It is not known whether capreomycin is excreted in human milk. Caution should be exercised when administering to a nursing woman.

Fertility

Studies have not been performed to determine potential for carcinogenicity, mutagenicity, or impairment of fertility.

Not relevant.

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.

Injection site reactions: Pain and induration at injection sites have been observed. Excessive bleeding and sterile abscesses have also been reported at these sites.