Description
Rifampicin, Isoniazid & Pyrazinamide Tablets (150/75/400 mg)
Healthy Inc is a specialized global supplier of high-potency anti-tuberculosis therapies. We provide premium Triple-Action FDC Tablets, manufactured in WHO–GMP certified high-containment units. This formulation is the primary therapeutic tool for the Initial Phase of TB treatment, serving as a critical export for National Tuberculosis Programs (NTP), infectious disease hospitals, and Ministry of Health (MOH) tenders globally.
Product Overview
This triple combination is designed to simplify the World Health Organization (WHO) recommended DOTS regimen. By targeting Mycobacterium tuberculosis in three distinct metabolic states, it achieves rapid sputum conversion and reduces the risk of drug resistance.
The “Triple-Force” Bactericidal Specialist:
- Rifampicin (150 mg): A macrocyclic antibiotic that inhibits bacterial DNA-dependent RNA polymerase. It is essential for eliminating semi-dormant “persister” bacilli, preventing disease relapse.
- Isoniazid (75 mg): The most active drug against rapidly multiplying mycobacteria. It works by inhibiting mycolic acid synthesis, a vital component of the bacterial cell wall.
- Pyrazinamide (400 mg): A specialized agent that thrives in acidic environments. It is uniquely capable of killing mycobacteria residing within human macrophages and in the center of necrotic lesions.
Technical & Manufacturing Specifications
Engineered for molecular stability and synchronized bioavailability.
| Technical Metric | Specification Standard |
|---|---|
| Active Composition | Rifampicin (150mg) + Isoniazid (75mg) + Pyrazinamide (400mg) |
| Dosage Form | Film-Coated Tablet |
| HS Code | 3004.20.19 (Anti-TB Medicaments) |
| Packaging | Cold-Form Alu-Alu Blister (Crucial for moisture protection) |
| Zone IVb Stability | Validated for use in hot and humid tropical regions |
Manufacturing Authority
Marketed and Distributed by Healthy Inc from specialized anti-TB production blocks.
- Hydrazone Prevention: In an acidic stomach environment, Rifampicin and Isoniazid can react to form hydrazones, significantly lowering bioavailability. Our tablets utilize advanced aqueous coating and barrier technology to ensure each API is absorbed at its optimal site.
- High-Containment Standards: Manufactured in dedicated facilities with HEPA-filtered Air Handling Units (AHU) and negative pressure to prevent cross-contamination and ensure the highest safety for immunocompromised patients.
- Precision Dissolution: Every batch is tested using HPLC-based dissolution profiles to match the reference listed drug (RLD), ensuring consistent therapeutic plasma levels.
Therapeutic Indications & Clinical Symptoms
- Active Pulmonary Tuberculosis: Treatment during the initial 2-month Intensive Phase.
- Extrapulmonary TB: Management of TB in the lymph nodes, pleura, and gastrointestinal tract.
- Symptom Control: Rapidly reduces the cough-driven transmission risk by decreasing the bacterial load in sputum.
Dosage & Administration
- Administration: Must be taken on an empty stomach (at least 30-60 minutes before or 2 hours after meals) to ensure maximum absorption of Rifampicin.
- Weight-Based Dosing: Dosage is calculated based on the patient’s body weight to prevent sub-therapeutic levels or toxicity.
- Safety Note: Patients should be monitored for hepatotoxicity; a harmless orange discoloration of urine is normal due to Rifampicin.
Global Export & Contract Manufacturing Services
Healthy Inc is a verified Pharmaceutical Exporter in Mumbai, catering to GDF (Global Drug Facility) standards and international NGO procurement. We offer Third Party Manufacturing for the Triple Anti-TB Combination with full CTD Dossier and COPP support. Our logistics network facilitates bulk supply to South Africa, Vietnam, Nigeria, Ethiopia, and the CIS region.
Commercial Inquiries
WhatsApp/Call: +91 7710003340
Email: info@healthyinc.co.in
