Clofazimine is an antimycobacterial agent. Since its approval in the United States in 1986, it has been mainly used for the treatment of leprosy and its complications.

Indications for Clofazimine

Treatment of Leprosy

Lepromatous Leprosy: Including dapsone-sensitive lepromatous leprosy, dapsone-resistant lepromatous leprosy, and lepromatous leprosy accompanied by erythema nodosum reactions.

Principle of Combined Medication: To prevent drug resistance, clofazimine must be used in combination with other anti-leprosy drugs and should not be used alone for initial treatment.

Dose Adjustment for Special Cases

Dapsone-sensitive type: A daily dose of 100mg is recommended, combined with two other drugs for at least 2 years.

Dapsone-resistant type: Combination with one or more other drugs is required, and the treatment should last for 3 years.

Erythema nodosum reaction: The dose can be increased to 100–200mg per day, but it should be reduced to 100mg per day as soon as possible to lower the risk of adverse reactions.

Dosage Form, Strength and Properties of Clofazimine

Dosage Form and Strength

Clofazimine is available as soft capsules, with each capsule containing 50mg of the active ingredient.

The capsules are brown and spherical, and the contents consist of micronized clofazimine suspended in an oil-wax base.

Chemical Properties

Chemical Name: 3-(p-Chlorophenylamino)-10-(p-chlorophenyl)-2,10-dihydro-2-isopropyliminophenazine.

Molecular Formula and Molecular Weight: C₂₇H₂₂Cl₂N₄, with a molecular weight of 473.4.

Solubility: It is easily soluble in benzene and chloroform, poorly soluble in water, and slightly soluble in methanol and ethanol.

Excipient Ingredients

The capsule shell contains sodium ethyl parahydroxybenzoate, sodium propyl parahydroxybenzoate, gelatin, etc. The contents include inactive ingredients such as beeswax, lecithin, and vegetable oils.

Storage Methods for Clofazimine

Storage Conditions

Temperature Requirement: It should be stored below 25°C (77°F) to avoid exposure to high temperatures.

Moisture-proof Measure: It must be placed in a sealed container to prevent moisture from affecting the stability of the drug.