Clofazimine is an antimycobacterial drug primarily used for the treatment of leprosy.

How to Use Clofazimine

Administration Method

Clofazimine is administered orally, with each capsule containing 50 mg of the active ingredient.

It is recommended to be taken with food to improve absorption.

For Dapsone-Sensitive Lepromatous Leprosy

100 mg per day, as part of a combined treatment regimen, for a minimum of 2 years.

If possible, treatment should continue until skin smears become negative, after which a single-drug treatment may be switched to.

For Dapsone-Resistant Lepromatous Leprosy

100 mg per day, used in combination with one or more other anti-leprosy drugs for 3 years, after which maintenance treatment with 100 mg per day as a single drug may be initiated.

For Lepromatous Leprosy with Erythema Nodosum Leprosum

Initial dose: 100-200 mg per day, used in combination with basic anti-leprosy treatment and glucocorticoids (as clinically required).

If a dose of 200 mg per day is used, it should be reduced to 100 mg per day as soon as the erythema nodosum reaction is controlled.

When the daily dose exceeds 100 mg, the duration of use should be shortened as much as possible (no more than 3 months), and close medical monitoring is required.

Dosage Adjustment of Clofazimine

Dosage Adjustment Based on Adverse Reactions

Gastrointestinal reactions: In case of abdominal pain, nausea, vomiting, or diarrhea, relevant medical evaluation is required. The daily dose may be reduced, the administration interval extended, or the drug discontinued.

QT interval prolongation: If significant ventricular arrhythmia occurs or the QTcF interval is ≥ 500 ms, the drug should be discontinued.

Skin adverse reactions: Severe skin reactions may require dosage adjustment.

Dosage Adjustment Under Special Circumstances

Patients with hepatic impairment: The use of clofazimine should be avoided unless the benefits are clearly greater than the risks.

Patients with renal impairment:

Mild to moderate renal impairment: No dosage adjustment is needed.

Severe renal impairment: Use with caution.

HIV-infected patients: No dosage adjustment is needed.

Medication for Special Populations of Clofazimine

Pregnant Women

Animal studies have shown embryotoxicity and fetotoxicity.

The drug can cross the placenta, leading to skin pigmentation in newborns.

Women of childbearing age should undergo a pregnancy test before using the drug.

It should only be used during pregnancy when the potential benefits outweigh the risks.

Pregnant women should be informed of the potential risks of the drug to the fetus.

Lactating Women

The drug can be excreted into breast milk.

Breastfed infants may develop skin pigmentation.

The benefits of breastfeeding should be weighed against the potential effects of the drug on the infant.

If the drug is used, the infant should be monitored for adverse reactions.

People of Childbearing Age

Women of childbearing age should use highly effective contraceptive measures during treatment and for at least 4 months after discontinuing the drug.

Male patients should use condoms during treatment and for at least 4 months after discontinuing the drug.