Description

Rifampicin & Isoniazid Tablets (150 mg / 75 mg | 300 mg / 150 mg)

Healthy Inc is a specialized global supplier of first-line antitubercular therapies. We provide premium Rifampicin & Isoniazid Tablets, manufactured in WHO–GMP certified high-containment units. As the backbone of the DOTS (Directly Observed Treatment, Short-course) strategy, this FDC is a primary export for National Tuberculosis Programs (NTP), infectious disease hospitals, and Ministry of Health (MOH) tenders worldwide.

Product Overview

This combination therapy utilizes two of the most potent bactericidal agents to target Mycobacterium tuberculosis at different metabolic stages, ensuring rapid sputum conversion and preventing the development of drug resistance.

The “Double-Action” Bactericidal Specialist:

• Rifampicin (The Transcription Inhibitor): A semi-synthetic derivative of rifamycin that inhibits bacterial DNA-dependent RNA polymerase. By blocking the initiation of RNA transcription, it effectively kills actively dividing and semi-dormant bacilli.
• Isoniazid (The Cell Wall Inhibitor): A prodrug that is activated by the mycobacterial enzyme KatG. It inhibits the synthesis of mycolic acids, which are essential components of the mycobacterial cell wall. It is highly effective against rapidly dividing intra- and extracellular organisms.
• Synergistic Efficacy: The combination of these two agents provides a comprehensive “kill zone,” targeting both metabolically active and latent mycobacteria, significantly shortening the duration of treatment required for a clinical cure.

Technical & Manufacturing Specifications

Formulated for chemical stability and precise bioavailability of both active ingredients.

Manufacturing Authority

Marketed and Distributed by Healthy Inc from ISO 9001:2015 certified units.

• Interaction Prevention: In Fixed-Dose Combinations, Rifampicin and Isoniazid can react in an acidic environment (like the stomach) to form hydrazones, reducing bioavailability. Our tablets are engineered with specialized micro-encapsulation or barrier coating to ensure each API is released at the optimal site.
• High-Containment Production: Due to the sensitive nature of TB treatment and the risk of resistance, our facility operates under Negative Pressure with HEPA filtration to ensure 100% purity and zero cross-contamination.
• Zone IVb Stability: Every batch is validated for stability under “Hot and Humid” conditions to ensure the medication remains potent for patients in tropical regions of Africa and Southeast Asia.

Therapeutic Indications & Clinical Symptoms

• Pulmonary Tuberculosis: Initial and continuation phases of treatment for drug-susceptible TB.
• Extrapulmonary Tuberculosis: Treatment of TB in bones, joints, and the renal system.
• Latent TB Infection (LTBI): Prophylaxis in high-risk individuals and HIV-positive patients.

Dosage & Administration

• Administration: Must be taken on an empty stomach (at least 30 minutes before or 2 hours after a meal) to ensure maximum absorption of Rifampicin.
• Note: Patients should be informed that Rifampicin may cause a harmless red-orange discoloration of urine, sweat, and tears.
• Warning: Regular monitoring of Liver Function Tests (LFT) is required due to the risk of hepatotoxicity.

Global Export & Contract Manufacturing Services

Healthy Inc is a verified Pharmaceutical Exporter in Mumbai, catering to GDF (Global Drug Facility) standards and NGO Tenders (e.g., Global Fund, USAID). We offer Third Party Manufacturing for Rifampicin & Isoniazid FDCs with full CTD Dossier support for global registration. Our logistics network facilitates bulk supply to South Africa, Vietnam, Nigeria, and Ethiopia, ensuring competitive B2B pricing and WHO-GMP quality.

Commercial Inquiries

WhatsApp/Call: +91 7710003340
Email: info@healthyinc.co.in