Clofazimine

What it is and how it works

Mechanism of Action LAMPRENE is an anti-mycobacterial drug .

Indications

is an antimycobacterial indicated for the treatment of lepromatous leprosy, including dapsone-resistant lepromatous leprosy and lepromatous leprosy complicated by erythema nodosum leprosum. To prevent the development of drug-resistance, LAMPRENE should be used only as a part of combination therapy for initial treatment of lepromatous leprosy. Lepromatous Leprosy LAMPRENE is indicated in combination with other anti-leprosy drugs for the treatment of lepromatous leprosy, including dapsone-resistant lepromatous leprosy, and lepromatous leprosy complicated by erythema nodosum leprosum. Usage To prevent the development of drug-resistance, LAMPRENE should be used only as a part of combination therapy for initial treatment of lepromatous (multibacillary) leprosy . For further guidance on the treatment of leprosy, contact the National Hansen’s Disease Clinical Center, Baton Rouge, Louisiana (LA) at (1-800-642-2477) or http://www.hrsa.gov/hansensdisease/clinicalcenter.html .

Dosage and administration (summary)

For dapsone-sensitive lepromatous leprosy, 100 mg (two 50 mg capsules) daily with meals as a part of a combination regimen for at least 2 years is recommended. For dapsone-resistant lepromatous leprosy, 100 mg (two 50 mg capsules) daily with meals in combination with one or more other agents for 3 years. For lepromatous leprosy complicated by erythema nodosum leprosum, 100 mg (two 50 mg capsules) to 200 mg (four 50 mg capsules) daily for up to 3 months. Taper dose to 100 mg (two 50 mg capsules) as quickly as possible.

Contraindications

is contraindicated in patients with known hypersensitivity to clofazimine or any of the excipients of LAMPRENE. Known hypersensitivity to clofazimine or to any of the excipients of LAMPRENE.

Warnings and precautions

Abdominal obstruction and other gastrointestinal adverse reactions: LAMPRENE may deposit in intestinal mucosa causing intestinal disturbances, including abdominal obstruction, bleeding, splenic infarction and death. Reduce dose or discontinue LAMPRENE if patient complains of pain in abdomen or other gastrointestinal symptoms. QT prolongation: QT prolongation and Torsade de Pointes may occur with LAMPRENE. Concomitant use with other QT prolonging drugs or bedaquiline may cause additive QT prolongation.

Pregnancy

Pregnancy Risk Summary There are no data with LAMPRENE use in pregnant women to inform associated risk. Retardation of fetal skull ossification, increased incidences of abortions and stillbirths, and impaired neonatal survival were observed in mice following prenatal exposure to LAMPRENE at 25 mg/kg, equivalent to the 0.6 times maximum recommended …

Storage and supply

How Supplied Soft Gelatin Capsules 50 mg-brown, opaque, spherical Bottles of 100..............................................................NDC 0078-1049-05 Storage and Handling Store at 20℃ to 25℃ (68℉ to 77℉); excursions permitted between 15℃ and 30℃ (59℉ and 86℉) . Store and dispense in original container. Protect from moisture.

Source: Clofazimine (Lamprene) — US FDA prescribing information, 2026-08-17, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.