Product image of Lamprene (Clofazimine) supplied by GNH India

Lamprene

Active Ingredient:
Clofazimine
Origin:
EU

Lamprene (Clofazimine)

Clofazimine, the active ingredient in Lamprene, is a phenazine dye presented as a 100 mg oral capsule for oral use. It is indicated for the treatment of multibacillary leprosy and for adjunct therapy of Mycobacterium avium complex infections, particularly in patients with compromised immune systems.

GNH India supplies Lamprene as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide, providing quality‑assured products to a global network of healthcare institutions and adhering to EU GMP standards, and supports reliable supply chains across Europe, Asia and the Americas.

Manufacturer / TM Owner

Novartis Pharma S.A.S.

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Indications & Clinical Uses

Clofazimine is employed in the management of mycobacterial infections, primarily targeting leprosy and related conditions.

  • Multibacillary leprosy: reduces bacterial load and contributes to clinical remission.
  • Mycobacterium avium complex infections: used as adjunct therapy to improve outcomes in immunocompromised patients.
  • Leprosy reaction (erythema nodosum leprosum): helps modulate inflammatory response and alleviate symptoms.

How It Works

  • Clofazimine binds to bacterial DNA and intercalates within the guanine‑rich regions, disrupting replication. It also undergoes redox cycling to generate reactive oxygen species that damage mycobacterial cell membranes. These actions inhibit the growth of Mycobacterium leprae and other mycobacteria, while its anti‑inflammatory properties modulate host immune responses, contributing to control of leprosy reactions. The drug accumulates within macrophages, providing sustained intracellular activity against dormant bacilli.

Side Effects

Clofazimine may cause a range of adverse reactions, varying in frequency and severity.

Common Side Effects

  • Skin discoloration: brown to black pigmentation of the skin.
  • Gastrointestinal upset: nausea, abdominal pain, or dyspepsia.
  • Pruritus: itching, sometimes with rash.
  • Mild headache.

Serious or Rare Side Effects

  • Photosensitivity: increased risk of sunburn.
  • Severe cutaneous reactions: Stevens‑Johnson syndrome or toxic epidermal necrolysis.
  • Hepatotoxicity: elevated liver enzymes or liver injury.
  • Hematologic abnormalities: neutropenia, eosinophilia, or anemia.

Precautions & Warnings

When prescribing Clofazimine, clinicians should consider several precautionary measures to ensure safe use.

  • Pregnancy: safety not established; avoid unless benefits outweigh risks.
  • Breastfeeding: unknown; monitor infant for discoloration.
  • Renal impairment: use with caution; dose adjustment may be required.
  • Hepatic impairment: monitor liver function tests regularly.
  • Skin discoloration: counsel patients about reversible and permanent pigmentation changes.
  • Store at ambient temperature: keep below 25 °C in the original container, protect from moisture and light.

Avoid Interactions

Clofazimine can interact with other medicines, affecting its efficacy or safety.

Major Interactions (Avoid)

  • Rifampicin: induces metabolism, reducing Clofazimine levels.
  • Protease inhibitor antiretrovirals: may increase toxicity.
  • Warfarin: potential additive anticoagulant effect.

Moderate Interactions (Monitor Closely)

  • Macrolide antibiotics (e.g., azithromycin): may increase QT prolongation risk.
  • Antifungal azoles (e.g., ketoconazole): may affect Clofazimine clearance.
  • Diabetes medications: monitor blood glucose as Clofazimine may affect glucose control.

Frequently Asked Questions

Lamprene contains Clofazimine and is prescribed for the treatment of multibacillary leprosy and as adjunct therapy for Mycobacterium avium complex infections, especially in patients with weakened immune systems. It may also be used to manage leprosy reactions such as erythema nodosum leprosum.

Clofazimine intercalates into bacterial DNA, disrupting replication, and generates reactive oxygen species through redox cycling that damage mycobacterial cell membranes. It also accumulates in macrophages, providing sustained activity against dormant bacilli, and exerts anti‑inflammatory effects that help control leprosy reactions.

The specific dose of Lamprene is determined by the prescribing clinician based on the patient’s condition, weight, and treatment guidelines. Dosage regimens may vary, and adjustments are made for renal or hepatic impairment as needed.

Safety of Clofazimine in pregnancy and lactation has not been established. It should only be used during pregnancy if the potential benefit justifies the potential risk to the fetus, and breastfeeding is generally discouraged unless the infant is closely monitored for skin discoloration or other effects.

To order Lamprene, submit an enquiry on the product page at gnhindia.com specifying the required quantity. GNH India supplies hospitals, pharmacies and procurement teams worldwide, verifies trade or institutional credentials, and then provides pricing, availability, shipping details and any necessary import documentation.

The primary alternative for leprosy treatment is the multidrug regimen that includes dapsone and rifampicin. Compared with dapsone, Clofazimine has a distinct mechanism involving DNA intercalation and reactive oxygen species generation, and it offers additional anti‑inflammatory benefits, though it is more associated with skin pigmentation changes.

Lamprene capsules should be stored at ambient temperature, preferably below 25 °C. Keep them in the original packaging to protect from moisture and light. Do not store in a refrigerator or freezer, and keep out of reach of children.

Lamprene is taken orally as a 100 mg capsule. It can be swallowed whole with a glass of water, with or without food, as directed by the prescriber. Consistency in timing helps maintain steady drug levels.

Serious risks include severe skin reactions such as Stevens‑Johnson syndrome or toxic epidermal necrolysis, significant hepatotoxicity, and hematologic abnormalities like neutropenia or eosinophilia. Patients should report any unexplained rash, yellowing of the skin or eyes, or unusual bruising promptly.

Lamprene should be avoided in individuals with known hypersensitivity to Clofazimine or any phenazine dyes. Patients with severe liver disease or uncontrolled hepatic impairment should not use it without close monitoring. Caution is also advised for those with pre‑existing cardiac conditions that predispose to QT prolongation.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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