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Antimycobacterial Pregnancy: US label, verbatim. PREGNANCY (8.1): '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 human daily dose (200 mg), based on body surface area comparisons. Advise pregnant women of the potential risk to the fetus.' 'The skin of infants born to pregnant mothers who had received LAMPRENE during pregnancy is pigmented at birth.' 'LAMPRENE should be used during pregnancy only if the potential benefit justifies the risk to the fetus.' LACTATION (8.2): 'LAMPRENE is excreted in human milk. Skin discoloration has been observed in breast fed neonates of mothers receiving clofazimine.' CONTRACEPTION (8.3): 'Advise sexually active females of reproductive potential to use effective contraception (methods that result in less than 1% pregnancy rates) when using LAMPRENE during treatment and for at least 4 months after stopping treatment with LAMPRENE. Advise males taking LAMPRENE to use a condom during intercourse while on treatment and for at least 4 months after stopping treatment with LAMPRENE.'

Clofazimine

Clofazimine is a riminophenazine antimycobacterial used as part of multidrug regimens for leprosy and for some forms of drug-resistant tuberculosis.

Adult dose

Dose: Lepromatous (multibacillary) leprosy, dapsone-sensitive: 100 mg (two 50 mg capsules) daily with meals, in combination with two other anti-leprosy drugs, for at least 2 years and if possible until negative skin smears are obtained, followed by monotherapy with an appropriate anti-leprosy drug. Dapsone-resistant lepromatous leprosy: 100 mg (two 50 mg capsules) daily with meals, in combination with one or more other anti-leprosy drugs, for 3 years, followed by monotherapy with 100 mg (two 50 mg capsules) daily. Lepromatous leprosy complicated by erythema nodosum leprosum (ENL) reactions: 100 mg (two 50 mg capsules) to 200 mg (four 50 mg capsules) daily for up to 3 months, in conjunction with baseline anti-leprosy treatment and steroids as clinically indicated; if 200 mg is used, taper to 100 mg as soon as possible after the reaction is controlled.
Route: Oral (50 mg soft gelatin capsules), with meals
Frequency: Daily with meals, always as part of combination therapy for initial treatment
SCOPE: this US label covers lepromatous (multibacillary) leprosy only. The page's multidrug-resistant tuberculosis use is NOT in the retrieved label and no MDR-TB regimen is written; the WHO entry in the bundle is a reference link only and carries no dose. COMBINATION (section 1.2, verbatim): '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'. DURATION AND CEILING: 'Doses of LAMPRENE of more than 100 mg daily should be given for as short a period as possible and only under close medical supervision' (section 2.1); section 5.1 adds '(less than 3 months)'. No maximum daily dose is printed for the base leprosy regimens; the label's only ceiling wording, 'maximum recommended human daily dose (200 mg)', sits in the pregnancy section and corresponds to the ENL regimen, so maxDose is left blank rather than importing it. PRE-TEST (section 2.2): 'Sexually-active females of reproductive potential should have a pregnancy test prior to LAMPRENE administration'. HIV: 'No dose adjustment of LAMPRENE is needed for HIV-infected patients.' ELDERLY: 'dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range'. PAEDIATRIC (paedDose is null): 'Safety and effectiveness of LAMPRENE in pediatric patients have not been established.' Children: use a children's formulary. TRUNCATION: the Use in Specific Populations text is cut off at the source-fetch limit; the posology section is complete. No UK SPC for clofazimine is listed on eMC — this dose is from US prescribing information (Lamprene) and must be verified against UK practice.

Dose adjustments

Renal

Severe renal impairment: 'Use with caution.' (US label, Use in Specific Populations summary, section 8.7). The full section 8.7 text falls beyond the source-fetch truncation, so no dose adjustment figure is available.

Hepatic

Hepatic impairment: 'Avoid use.' (US label, Use in Specific Populations summary, section 8.8). The full section 8.8 text falls beyond the source-fetch truncation, so no dose adjustment figure is available.

Dose independently re-sourced from US FDA prescribing information (openFDA / DailyMed) — cross-check; US labelling may differ from UK — clinician-reviewed. Always confirm against the product SmPC and your local formulary before prescribing.

Contraindications

  • Known hypersensitivity to clofazimine or to any of the excipients of LAMPRENE (US section 4 — the only contraindication listed)
  • Not a contraindication but a use restriction: hepatic impairment — 'Avoid use' (US section 8.8 summary)

Side effects

  • Skin and body fluid discoloration: orange-pink to brownish-black discoloration of the skin, conjunctivae, tears, sweat, sputum, urine and feces in 75%-100% of patients; it may take several months or years to reverse after therapy ends (US sections 5.3, 6)
  • Ichthyosis and dryness (8% to 28%); rash and pruritus (1% to 5%) (US section 6)
  • Gastrointestinal intolerance (40% to 50%): abdominal and epigastric pain, diarrhea, nausea, vomiting (US section 6)
  • Abdominal obstruction and other gastrointestinal reactions: deposition in the intestinal mucosa may lead to intestinal obstruction needing exploratory laparotomy; splenic infarction, gastrointestinal bleeding and death have been reported (US section 5.1)
  • QT prolongation and Torsade de Pointes, reported with daily doses above 100 mg or with QT-prolonging medicines, including bedaquiline (US section 5.2)
  • Ocular: diminished vision, conjunctival and corneal pigmentation from clofazimine crystal deposits, dryness, burning, itching, irritation; maculopathy (bull's eye retinopathy) in under 1% (US section 6)
  • Depression and suicide secondary to skin discoloration (US sections 5.4, 6)
  • Other: elevated blood sugar and elevated ESR (more than 1%); phototoxicity, erythroderma, hepatitis, jaundice, splenic infarction, thromboembolism, anemia, bone pain, edema (under 1%) (US section 6)

Interactions

  • Substrates of CYP3A4/5: concomitant use may increase their concentrations and risk of toxicity — monitor for toxicities (US section 7.1)
  • QT-prolonging drugs, such as bedaquiline: additive QT prolongation and Torsade de Pointes — monitor ECGs (US sections 5.2, 7.2)

Monitoring

  • ECG monitoring for QT prolongation and cardiac rhythm disturbances; discontinue if clinically significant ventricular arrhythmia develops or QTcF is 500 ms or greater; monitor ECGs when co-prescribed with bedaquiline or other QT-prolonging drugs (US sections 5.2, 7.2)
  • Abdominal pain, nausea, vomiting or diarrhea: investigate and reduce the daily dose, lengthen the dosing interval or discontinue (US section 5.1)
  • Doses above 100 mg daily: for as short a period as possible (less than 3 months) and only under close medical supervision (US sections 2.1, 5.1)
  • Monitor for depression and suicidal ideation, and counsel patients about skin discoloration (US section 5.4)
  • Pregnancy test before starting in sexually active females of reproductive potential (US sections 2.2, 8.3)

Clinical monograph

How it works

It binds preferentially to mycobacterial DNA and generates reactive oxygen species, producing a slow bactericidal effect, and also has anti-inflammatory properties useful in leprosy reactions.

Prescribing in practice

  • Causes dose- and duration-related reddish-brown to black skin and bodily-fluid discolouration that may persist for months to years after stopping; counsel before starting to support adherence.
  • Can prolong the QT interval, so caution is needed with other QT-prolonging agents and in electrolyte disturbance.
  • Gastrointestinal effects can reflect crystal deposition in the bowel wall, occasionally causing severe abdominal pain or obstruction with prolonged high exposure.

Monitoring

Monitor for gastrointestinal symptoms and skin changes, with ECG review when combined with other QT-prolonging drugs.

Counselling the patient

  • Expect a reddish-brown skin tint and discolouration of urine, sweat and tears, which fades slowly after treatment.
  • Take with food to reduce stomach upset and improve absorption.
  • Report persistent or severe abdominal pain.

Evidence & guidelines

Use is grounded in WHO multidrug therapy recommendations for leprosy and resistant tuberculosis regimens.

Reference: WHO leprosy guidelines; Drug verified in RxNorm (NLM); confirm dosing against the manufacturer SPC (eMC). Verify against your local formulary and current prescribing references before prescribing. The structured dose values shown have been reviewed by a clinician. Monograph status: clinician-reviewed (2026-07-04).

Related

Curated clinical cross-links plus same-class fallbacks.

Pathways