✅ Active Ingredient Overview Table:

🔬 Active Ingredient (Generic Name):	Clofazimine
💊 Indication:	Multibacillary Leprosy, Skin-Related Mycobacterial Infections, Anti-Inflammatory Adjunct in Erythema Nodosum Leprosum (ENL)
🇺🇸 US Brand Equivalent:	Lamprene (Clofazimine) – Limited U.S. Availability for Compassionate Use
🏭 Manufacturer:	Abbott India Pvt Ltd (Founded: 1948)
📦 Packaging:	10 Capsules per Strip
🧪 Strength:	100 mg
🚚 Delivery Time:	6–15 days

🌿 What is Clofazimine 100 mg (Hansepran)?

Hansepran 100 mg contains Clofazimine, a lipophilic riminophenazine dye with potent antimycobacterial and anti-inflammatory properties. Primarily used in the treatment of multibacillary leprosy (MB leprosy) as part of WHO-recommended multidrug therapy (MDT), Clofazimine also addresses chronic inflammatory manifestations such as erythema nodosum leprosum (ENL). Abbott India produces high-quality Clofazimine capsules adhering to global Good Manufacturing Practices (GMP).

Clofazimine accumulates in macrophages and reticuloendothelial tissues, exerting bactericidal action against Mycobacterium leprae and other atypical mycobacteria. It also modulates immune response, reducing the severity of lepra reactions.

🧬 Pharmacology & Mechanism of Action

Attribute	Details
Chemical Formula	C27H22Cl2N4O
Molecular Weight	473.38 g/mol
Mechanism	• Antimycobacterial: Binds to bacterial DNA, interfering with template function and preventing replication. Accumulates in macrophages, generating reactive oxygen species.
• Anti-Inflammatory: Inhibits neutrophil myeloperoxidase and eosinophil chemotaxis, reducing inflammatory cytokines in ENL reactions.
Pharmacokinetics	• Absorption: Oral bioavailability ~45%; enhanced with fatty meals.
• Distribution: High tissue affinity; accumulates in skin, reticuloendothelial system, fatty tissues.
• Metabolism: Minimal hepatic metabolism; forms reduced clofazimine metabolites.
• Half-Life: ~70 days (due to tissue deposition), leading to prolonged action.

💡 Indications & Usage

Condition	Dosage & Regimen
Multibacillary Leprosy (MDT Regimen)	• Initial Phase: 100 mg Clofazimine once monthly under supervision + 50 mg daily, combined with Rifampicin 600 mg monthly + Dapsone 100 mg daily for 12 months. • Continuation: Continue Dapsone & monthly Rifampicin for 12 months; Clofazimine tapered per reaction severity.
Erythema Nodosum Leprosum (ENL) Reaction	• Standard ENL Management: 300 mg once daily until reaction subsides (2–4 weeks), then reduce to 100 mg every other day for maintenance. • High-Dose Short Course: 300 mg daily for severe, then taper.
Atypical Mycobacterial Infections (e.g., Mycobacterium avium complex)	• Adjunct Usage: 100–200 mg daily combined with other anti-mycobacterial agents as per specialist guidelines.

Administration Tips:

Administration: Swallow capsule whole with water; food increases absorption.
Monitoring: Baseline liver function tests, complete blood count, and skin pigmentation records. Periodic monitoring of liver enzymes and visual acuity recommended due to rare ocular pigment deposition.
Duration: MDT typically 12 months; ENL therapy varies by clinical response.

⚠️ Warnings & Side Effects

Common:

Skin discoloration (reddish-brown or black pigmentation of skin, sclera, and bodily fluids) reversible upon discontinuation.
Gastrointestinal upset (nausea, abdominal pain, diarrhea)

Less Common:

Ichthyosis (dry, scaly skin)
Photosensitivity

Serious (Rare):

Crystal Deposition: Formation of clofazimine crystals in intestinal lamina propria → malabsorption, obstruction (rare).
Ocular Pigmentation: Conjunctival discoloration, corneal crystal deposition; monitor visual acuity.
Hepatotoxicity: Elevation of liver enzymes; discontinue if severe hepatic impairment develops.
Cardiotoxicity: QT prolongation → arrhythmias (rare; avoid concurrent QT-prolonging drugs).

Precautions:

Baseline and periodic assessment of hepatic and renal function.
Monitor for psychological effects (depression) due to chronic therapy.
Use caution in patients with pre-existing cardiac conditions.
Inform patients about reversible skin/eye pigmentation to ensure adherence.
Contraindicated in known hypersensitivity to Clofazimine or its excipients.

🏥 Storage Instructions

Store Hansepran 100 mg capsules at room temperature (20–25°C). Protect from light and moisture. Keep in original blister packaging until use. Discard 6 months after opening. Store out of reach of children.

🌐 Global Availability & Purchasing

United States: Clofazimine available under restricted access programs; prescription required; primarily for compassionate use or clinical trial settings.
United Kingdom & EU: Available by specialty import for leprosy; prescription-only; consult national leprosy control guidelines.
Australia: Approved for leprosy; prescription required; linked to national leprosy eradication efforts.

Importing from India:
Purchasing Hansepran 100 mg from India can provide significant cost savings. Ensure compliance with local personal import regulations, maintain valid prescription, and provide appropriate documentation to customs to prevent shipment delays.

🔗 Authoritative Resources

FDA: Clofazimine (Lamprene) Label & Information

🔗 Internal Links to Related Antileprosy & Antimycobacterial Therapies (Indian Brands)

Isonex 300 mg – Isoniazid by Lupin Ltd., essential for MDR-TB and leprosy regimens.
Dapsone 100 mg – Sulfone antibiotic by GSK for leprosy MDT.

🎥 Educational Video on Clofazimine in Leprosy Therapy

👨‍⚕️ Expert Insight: Dr. Anjali Mehta, Infectious Disease Specialist

“Clofazimine remains indispensable in leprosy control programs due to its robust antimycobacterial action and anti-inflammatory benefits in lepra reactions. Counseling patients on expected skin discoloration improves adherence and outcomes.”