title: Excretion of clofazimine in human milk in leprosy patients.
abstract: Clofazimine is an important and effective constituent of multi drug therapy for leprosy. A study has been conducted to determine the distribution of clofazimine in maternal milk so that the safety of breast-feeding during maternal ingestion of the drug can be ascertained. Eight female leprosy patients (LL/BL) on clofazimine, 50 mg daily or 100 mg on alternate days for 1-18 months, (mean 5.0 +/- 1.81 months; median 3.25 months) and in the early lactating phase were studied. Blood samples and milk specimens were collected 4-6 hr after the last daily dose. Clofazimine was assayed in the milk and plasma samples by HPTLC. Mean plasma and milk clofazimine levels were 0.9 +/- 0.03 micrograms/ml and 1.33 +/- 0.09 micrograms/ml respectively. The ratio of milk to plasma drug concentration 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 represented 22.1 +/- 1.9% of the maternal dose.
authors.affiliation: Central JALMA Institute for Leprosy, Taj Ganj, Agra, India.
authors.forename: K
authors.initials: K
authors.lastname: Venkatesan
authors.forename: A
authors.initials: A
authors.lastname: Mathur
authors.forename: A
authors.initials: A
authors.lastname: Girdhar
authors.forename: B K
authors.initials: BK
authors.lastname: Girdhar
mesh_terms: D000328:Adult; D002851:Chromatography, High Pressure Liquid; D002991:Clofazimine / Q000009:adverse effects / Q000493:pharmacokinetics* / Q000627:therapeutic use; D005260:Female; D006801:Humans; D007917:Leprostatic Agents / Q000009:adverse effects / Q000493:pharmacokinetics* / Q000627:therapeutic use; D015439:Leprosy, Borderline / Q000097:blood / Q000188:drug therapy*; D015440:Leprosy, Lepromatous / Q000097:blood / Q000188:drug therapy*; D008895:Milk, Human / Q000737:chemistry / Q000378:metabolism*
chemical_list: D007917:Leprostatic Agents; D002991:Clofazimine