Clofazimine information from DrugsUpdate
L - Contraindicated in lactation
Clofazimine is a fat-soluble riminophenazine dye used in combination with rifampicin and dapsone as multidrug therapy for the treatment of leprosy. It has been used investigationally in combination with other antimycobacterial drugs to treat Mycobacterium avium infections in AIDS patients and Mycobacterium avium paratuberculosis infection in Crohn's disease patients. Clofazimine also has a marked anti-inflammatory effect and is given to control the leprosy reaction, erythema nodosum leprosum.
Clofazamine inhibits mycobacterial growth by binding preferentially to mycobacterial DNA. It also has some anti-inflammatory activity.
About 45-70% of the dose is absorbed from the GI tract (oral); increased absorption when taken as microcrystalline formulations or after food.
Lipophilic; body tissues, reticuloendothelial cells, body organs and tissues; crosses the placenta and enters breast milk.
Via faeces (as unchanged), via urine (1% as unchanged drug and metabolites), sebaceous and sweat glands.
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.
In cases of acute overdosage, empty the stomach by inducing emesis or by gastric lavage, and initiate supportive and symptomatic treatment.
Pregnancy. Patients with GI symptoms
Adult: 300 mg clofazimine with 600 mg rifampicin, both given once a month together with daily doses of 50 mg clofazimine and 100 mg dapsone for 12 month.
Child: 10-14 years: 150 mg clofazimine with 450 mg rifampicin and 50 mg dapsone once a month, taken with 50 mg dapsone daily and 50 mg clofazimine on alternate days. Treatment is given for 12 months.
Erythema nodosum leprosum
Adult: Treatment depends on severity. 100-200 mg daily for up to 3 months. 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.
Adult: 100 mg daily with 1 or more other antileprosy drugs for 3 years, then continue as a monotherapy at 100 mg daily.
Should be taken with food
List of Contraindications
Caution when used during pregnancy.
Category C: Either studies in animals have revealed adverse effects on the foetus (teratogenic or embryocidal or other) and there are no controlled studies in women or studies in women and animals are not available. Drugs should be given only if the potential benefit justifies the potential risk to the foetus.
Contraindicated in lactation
Store below 30°C