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Clofazimine Data - Uses, Dosage, Drug class, Brand name, Warnings, etc



Pharmacology Clofazimine is a lipophilic rhimophenazine dye.
Approved for treating leprosy; also used for atypical Mycobacterium infections, discoid lupus erythematosus, and pyoderma gangrenosum.
Adult Dosage PO for leprosy, Mycobacterium avium complex infections, discoid lupus erythematosus:
- 100 mg/day with food
PO for erythema nodosum leprosum:
- Up to 200 mg/day
PO for pyoderma gangrenosum:
- 300–400 mg/day (induces remission)
- Manufacturer advises against doses >200 mg/day
Pediatric Dosage PO for leprosy:
- 1 mg/kg/day
PO for Mycobacterium avium complex:
- 1–2 mg/kg/day
Dosage Forms - Capsule: 50 mg
Pharmacokinetics Bioavailability:
- ~50%
Peak Serum Concentration:
- 0.5–2 mg/L (1–4 µmol/L) 2 hr post 100–200 mg dose (adequate absorption)
Distribution:
- Accumulates in fatty tissues and reticuloendothelial system
Elimination Half-life:
- ~70 days
Adverse Reactions Frequent:
- Red to brownish-black discoloration of bodily secretions, skin, conjunctivae, cornea, urine, feces
- Orange-pink skin discoloration (common, reversible, may persist months to years)
Dose-related:
- GI pain, nausea, vomiting, diarrhea (due to crystalline deposits in GI tissue)
Rare (doses >100 mg/day):
- Eosinophilic enteritis, splenic infarction
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