Clofazimine Dosage

Applies to the following strengths: 50 mg

Usual Adult Dose for Leprosy - Dapsone-Resistant

100 mg orally once a day, in combination with one or more other antileprosy drugs, for 3 years, followed by monotherapy with clofazimine 100 mg daily.

Usual Adult Dose for Leprosy - Dapsone-Sensitive

100 mg orally once a day for at least 2 years, as part of triple-drug antileprosy regimen. Once negative smears are obtained, monotherapy with an appropriate antileprosy drug may be started.

Usual Adult Dose for Leprosy - Erythema Nodosum Leprosum

In general, the basic antileprosy treatment should be continued. For leprosy - dapsone resistance: 100 mg orally once a day, in combination with one or more other antileprosy drugs, for 3 years, followed by monotherapy with clofazimine 100 mg daily. For leprosy - dapsone-sensitive: 100 mg orally once a day for at least 2 years, as part of triple-drug antileprosy regimen. Once negative smears are obtained, monotherapy with an appropriate antileprosy drug may be started.

Usual Pediatric Dose for Leprosy

1 mg/kg/day (up to 100 mg) orally in combination with dapsone and rifampin.

Renal Dose Adjustments

Data not available

Liver Dose Adjustments

Data not available

Dose Adjustments

In erythema nodosum leprosum when corticosteroids are needed for the control of nerve injury or skin ulceration, clofazimine 100 to 200 mg orally once a day for up to 3 months may be administered to reduce or eliminate the corticosteroid requirements. Taper clofazimine dose to 100 mg/day as quickly as possible.

Precautions

Severe abdominal symptoms have necessitated exploratory laparotomies in clofazimine in various tissues including the intestinal mucosa, liver, spleen, and mesenteric lymph nodes. Splenic infarction, bowel obstruction, and gastrointestinal bleeding have been reported rarely. Reports of death following severe abdominal symptoms have also been reported. Clofazimine should be used with caution in patients who have gastrointestinal problems such as abdominal pain and diarrhea. Dosages of clofazimine of more than 100 mg daily should be given for as short a period as possible and only under close medical supervision. If a patient complains of colicky or burning pain in the abdomen, nausea, vomiting, or diarrhea, the dose should be reduced, and if necessary, the interval between doses should be increased, or the drug should be discontinued.

Prescribers should be aware that clofazimine therapy may cause skin discoloration from red to brownish-black, as well as discoloration of the conjunctivae, lacrimal fluid, sweat, sputum, urine, and feces. Patients should be advised that skin discoloration, although reversible, may take several months or years to disappear after the conclusion of treatment with clofazimine. Skin discoloration due to clofazimine may result in depression. Two suicides have been reported in patients administered clofazimine.

For ichthyosis and skin dryness, oil can be applied to the skin.

In general, dosage selection for elderly patients should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

Safety and efficacy in pediatric patients have not been determined. Several cases of pediatric patients administered clofazimine therapy have been reported in the literature.

Dialysis

Data not available

Other Comments

Clofazimine should be taken with meals.

Clofazimine should be used preferably in combination with one or more other antileprosy agents to prevent the emergence of drug resistance.