Clofazimine is an antimycobacterial indicated for the treatment of lepromatous leprosy, including dapsone-resistant lepromatous leprosy and lepromatous leprosy complicated by erythema nodosum leprosum, among other approved uses. It is available as capsules for oral use. MedsAcross supplies Clofazimine for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
From the regulator-approved product information. Each section names its source.
LAMPRENE 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.
Source: US FDA prescribing information
LAMPRENE is an anti-mycobacterial drug.
Source: US FDA prescribing information
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.
Source: US FDA prescribing information
LAMPRENE 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.
Source: US FDA prescribing information
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. Monitor ECGs and discontinue LAMPRENE if significant ventricular arrhythmia or QTcF interval greater than or equal to 500 ms develop. Skin and body fluid discoloration and other skin reactions: Advise patients that skin and body fluid discoloration frequently occur with use of LAMPRENE. Depression and suicide due to skin discoloration.
Source: US FDA prescribing information
The following serious adverse reactions are discussed in greater detail in other sections of the labeling: Abdominal Obstruction and Gastrointestinal Adverse Reactions QT Prolongation Skin and Body Fluid Discoloration and Other Skin Reactions Psychological Effects of Skin Discoloration The following adverse reactions associated with the use of LAMPRENE were identified. Because these adverse reactions are reported from different studies, these adverse reactions cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Adverse Reactions Occurring In More Than 1% of Patients Skin: Pigmentation from pink to brownish-black in 75% to 100% of the patients within a few weeks of treatment, ichthyosis and dryness (8% to 28%), rash and pruritus (1% to 5%).
Source: US FDA prescribing information
Substrates of CYP3A4/5: Monitor for toxicities when used concomitantly with LAMPRENE. Effect of LAMPRENE on Substrates of CYP3A Concomitant use of LAMPRENE may increase concentrations of drugs that are substrates of CYP3A4/5 which may increase the risk of toxicity of these drugs. Monitor for toxicities of these drugs when used concomitantly with LAMPRENE.
Source: US FDA prescribing information
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: US FDA prescribing information
For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
1 presentations of Clofazimine, sorted by availability.
| Medicine | Manufacturer | Register | Availability |
|---|---|---|---|
| Lamprene 50 mg capsuleOral | Novartis Pharmaceuticals | US FDA | Available on request |
1 brand names across 1 markets.
United States
Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.
| Register | Status | Source |
|---|---|---|
| US FDA | First approved 15 December 1986 | Drugs@FDA |
| EU (EMA) | Not recorded | — |
| India (CDSCO) | Not yet confirmed against CDSCO approval lists | — |
| United States | Registered | US FDA (NDC directory, openFDA)Checked 12 November 2026 |
Conditions linked to Clofazimine in public data. This is not a list of approved uses, see the clinical information.
Yes, on request. MedsAcross lists 1 presentations of Clofazimine and sources them for licensed hospitals, importers and physicians against valid import documents.
The catalogue lists 1 brand names for Clofazimine, including Lamprene.
Yes. The US FDA first approved Clofazimine on 15 December 1986, according to Drugs@FDA.
No listed presentation of Clofazimine is recorded as needing a cold chain. Storage conditions are shown on each presentation page.
Clofazimine is classified under ATC code J04BA01 (Clofazimine).
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