EXCRETION OF CLOFAZIMINE IN HUMAN-MILK IN LEPROSY PATIENTS

Clofazimine is an important and effective constituent of multi drug th erapy for leprosy. A study has been conducted to determine the distrib ution of clofazimine in maternal milk so that the safety of breast-fee ding during maternal ingestion of the drug can be ascertained. Eight f emale leprosy patients (LL/BL) on clofazimine, 50mg daily or 100mg on alternate days for 1-18 months, (mean 5.0 +/- 1.81 months; median 325 months) and in the early lactating phase were studied. Blood samples a nd milk specimens were collected 4-6 hr after the last daily dose. Clo fazimine was assayed in the milk and plasma samples by HPTLC. Mean pla sma and milk clofazimine levels were 0.9+/-0.03 mu g/ml and 1.33 +/- 0 .09 mu g/ml respectively. The ratio of milk to plasma drug concentrati on ranged from 1.0 to 1.7 with a mean of 1.48 +/- 0.08. The amount of drug ingested by the infants was 0.199 +/- 0.013 mg/kg/day which repre sented 22.1 +/- 1.9% of the maternal dose.