Clofazimine

Indications
 Oral
Multibacillary leprosy
Adult: 300 mg clofazimine with 600 mg rifampicin, both given once a mth together with daily doses of 50 mg clofazimine and 100 mg dapsone for 12 mth.
Child: 10-14 yr: 150 mg clofazimine with 450 mg rifampicin and 50 mg dapsone once a mth, taken with 50 mg dapsone daily and 50 mg clofazimine on alternate days. Treatment is given for 12 mth.
Oral
Erythema nodosum leprosum (Type 2)
Adult: Treatment depends on severity. 100-200 mg daily for up to 3 mth. Doses >200 mg daily are not recommended. Gradually taper the dose to 100 mg daily as soon as the reactive episode is controlled. In general, continue with basic antileprosy treatment.
Oral
Dapsone-resistant leprosy
Adult: 100 mg daily with 1 or more other antileprosy drugs for 3 yr, then continue as a monotherapy at 100 mg daily.
Contraindications
 Hypersensitivity. Lactation.
Warnings / Precautions
 Pregnancy. Patients with GI symptoms.
Adverse Reactions
 Red-brownish black discolouration of skin especially areas exposed to sunlight, hair, sweat, sputum, urine, faeces. Rash, pruritus, photosensitivity, diarrhoea, nausea, abdominal pain, vomiting, weight loss, headache, drowsiness, dizziness, taste disorders, dryness of the skin, ichthyosis, decreased tear and sweat production.
Potentially Fatal: Crystal depletion in the wall of small bowel mesenteric lymph nodes, liver and spleen. Severe abdominal symptoms including bowel obstruction, GI bleeding and splenic infarction.
Overdose Reactions
 In cases of acute overdosage, empty the stomach by inducing emesis or by gastric lavage, and initiate supportive and symptomatic treatment.
Mechanism of Actions
 Clofazamine inhibits mycobacterial growth by binding preferentially to mycobacterial DNA. It also has some anti-inflammatory activity.
Absorption: About 45-70% of the dose is absorbed from the GI tract (oral); increased absorption when taken as microcrystalline formulations or after food.
Distribution: Lipophilic; body tissues, reticuloendothelial cells, body organs and tissues; crosses the placenta and enters breast milk.
Excretion: Via faeces (as unchanged), via urine (1% as unchanged drug and metabolites), sebaceous and sweat glands.
Administration
 Should be taken with food.
Storage Conditions
 Oral: Store below 30°C.
ATC Classification
 J04BA01 - clofazimine ; Belongs to the class of drugs used in the systemic treatment of lepra.
Storage
 Oral: Store below 30°C.
Available As
  • Clofazimine 100 mg
  • Clofazimine 200 mg
  • Clofazimine 50 mg

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