WHO Model Prescribing Information: Drugs Used in Mycobacterial Diseases
(1991; 44 pages) [French] [Spanish] View the PDF document
Table of Contents
View the documentPreface
Open this folder and view contentsTuberculosis
Close this folderLeprosy
View the documentClofazimine
View the documentDapsone
View the documentRifampicin
View the documentEthionamide and protionamide
Open this folder and view contentsNontuberculous mycobacterial diseases


Group: antimycobacterial agent
Capsule 50 mg, 100 mg

General information

A substance with both antileprosy and anti-inflammatory activity. It is weakly bactericidal against M. leprae and antimicrobial activity can be demonstrated in humans only after continuous exposure for about 50 days. When taken orally it is well absorbed and intermittent dosage is effective because the drug accumulates in fatty tissues and the cells of the reticuloendothelial system. It is very slowly eliminated in the faeces with a half-life of about 70 days. As yet, resistance to clofazimine is rare.

Clinical information


Treatment of:

• multibacillary leprosy in combination with dapsone and rifampicin
• type II reactions, as an alternative or in addition to corticosteroids or thalidomide.

Dosage and administration

Clofazimine should be taken with food or milk.

Multibacillary leprosy

Adults: 50 mg daily for at least 2 years, supplemented by one monthly supervised dose of 300 mg.

Children: 50 mg given on alternate days for at least 2 years, supplemented by one monthly supervised dose of 200 mg.

Erythema nodosum leprosum

Adults and children: 200-300 mg daily (given under medical supervision) for no longer than 3 months.


Patients with pre-existing gastrointestinal disease should be kept under medical supervision. If symptoms become severe, it may be necessary to reduce the dosage or to prolong the interval between doses. Liver function and creatinine clearance should be monitored.

Use in pregnancy

Since leprosy is exacerbated during pregnancy, it is important that treatment should be continued. Infants exposed in utero may be more deeply pigmented than normal at birth.

Adverse effects

Reversible skin discoloration may occur during treatment to an extent that some lighter-skinned patients find unacceptable. Discoloration of the hair, cornea, conjunctiva, tears, sweat, sputum, faeces and urine also occurs.

Dose-related gastrointestinal symptoms include pain, nausea, vomiting and diarrhoea.

Clofazimine tends to accumulate in the phagocytic monocytes of the small intestine. Prolonged treatment with doses higher than those currently recommended for the treatment of multibacillary disease has resulted in mucosal and submucosal oedema severe enough to produce symptoms of subacute small-bowel obstruction. Because of this rare but serious adverse effect it is recommended that the high dosages used in the treatment of erythema nodosum leprosum should be given only under medical supervision and for no longer than 3 months.


Clofazimine capsules should be kept in well-closed containers.

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