Description
Rifampicin, Isoniazid & Pyrazinamide Tablets
Healthy Inc is a specialized global supplier and exporter of First-Line Anti-Tubercular Drugs (ATDs). We provide high-bioavailability Triple Fixed-Dose Combination (3-FDC) Tablets, sourced from WHO–GMP certified solid dosage facilities. This “Intensive Phase” powerhouse is a top export to National Tuberculosis Elimination Programs (NTEPs), DOTS centers, and Ministry of Health tenders in Africa, LATAM, and Southeast Asia, simplifying patient compliance during the critical first two months of TB treatment.
Product Overview
This formulation combines three essential bactericidal agents into a single tablet to treat Tuberculosis.
The “Intensive Phase” Specialist:
- Rifampicin (The Sterilizer): Inhibits bacterial DNA-dependent RNA polymerase. It is the most potent sterilizing drug, killing rapidly dividing bacteria and semi-dormant persisters.
- Isoniazid (The Killer): Inhibits the synthesis of mycolic acids, essential components of the mycobacterial cell wall. It acts as the primary bactericidal agent against rapidly multiplying organisms.
- Pyrazinamide (The Acid-Environment Specialist): Converted to pyrazinoic acid inside the bacteria. It uniquely kills semi-dormant bacilli residing in the acidic environment of macrophages (where other drugs fail), crucial for sterilizing the lesion and shortening therapy duration.
Product Composition & Strength
We supply this product as Film Coated Tablets (Red/Brown). Stability is paramount as Rifampicin can degrade in the presence of Isoniazid if not properly formulated.
| Active Ingredient | Strength (Standard Adult) | Strength (Pediatric) | Therapeutic Role |
|---|---|---|---|
| Rifampicin IP/BP/USP | 150 mg | 75 mg / 60 mg | Broad Spectrum Sterilizer |
| Isoniazid IP/BP/USP | 75 mg | 50 mg / 30 mg | Cell Wall Inhibitor |
| Pyrazinamide IP/BP/USP | 400 mg | 150 mg | Intracellular Sterilizer |
| Excipients | Q.S. | Ascorbic Acid (Stabilizer) | Bioavailability Enhancer |
*Pack Sizes: Blister packs of 10s, 28s (Calendar Pack for Monthly Compliance), or Bulk HDPE Jars of 1000s (Program Packs).
Technical & Logistics Specifications
Critical data for Pharmaceutical Importers and Distributors.
| HS Code | 3004.90.99 (Other Medicaments) |
| Dosage Form | Film Coated Tablet (Red/Brown) |
| Packaging | Alu-Alu Blister (Critical for Rifampicin stability) |
| Storage | Store below 25°C. Protect strictly from moisture and heat. |
| Certificates | WHO-GMP, COPP, Free Sale Certificate |
Manufacturing Authority
Marketed and Distributed by Healthy Inc from WHO-GMP & ISO 9001:2015 certified units.
- Segregated Granulation: Rifampicin reacts with Isoniazid in acidic conditions (stomach) to form inactive hydrazones, reducing bioavailability. Our manufacturing process uses segregated granulation or barrier coating technologies to physically separate the APIs within the tablet matrix until disintegration, ensuring maximum absorption of the Rifampicin.
- Dissolution Testing: We perform rigorous bio-relevant dissolution testing to ensure all three drugs release simultaneously and effectively.
Therapeutic Indications (Human Use)
Indicated for the treatment of Tuberculosis:
- Intensive Phase (Initial 2 Months): Used for the initial treatment of pulmonary and extra-pulmonary tuberculosis (often alongside Ethambutol).
- Note: This 3-FDC simplifies prescription and prevents mono-therapy, which causes drug resistance.
Dosage & Administration
Recommended Dosage (Strictly as per DOTS/WHO Weight Bands):
- Route: Oral.
- Daily Dosing: Taken once daily, strictly on an empty stomach (1 hour before or 2 hours after meals). Food decreases absorption.
- Weight Bands (Adult Example):
- 30–39 kg: 2 tablets.
- 40–54 kg: 3 tablets.
- 55–70 kg: 4 tablets.
- >70 kg: 5 tablets.
Safety Warnings:
- Hepatotoxicity (Liver Damage): All three drugs are potentially hepatotoxic. Patients must monitor for jaundice (yellow eyes), dark urine, and fatigue. Liver function tests (LFTs) are mandatory.
- Red Urine: Rifampicin colors body fluids (urine, sweat, tears) red-orange. This is harmless but stains contact lenses and clothing.
- Hyperuricemia (Gout): Pyrazinamide inhibits uric acid excretion, which can cause gouty arthritis (joint pain).
- Peripheral Neuropathy: Isoniazid depletes Vitamin B6. Pyridoxine (Vit B6) supplementation is recommended.
Global Export & Contract Manufacturing Services
Healthy Inc stands as a premier Pharmaceutical Exporter in India, dedicated to serving the needs of international Pharma Traders, Wholesalers, and Bulk Drug Distributors. As a verified Medicine Supplier in Mumbai, we offer flexible Third Party Manufacturing (Contract Manufacturing) services for OSD (Oral Solid Dosage) forms, allowing brands to launch high-quality generic medicines under their own label. Whether you are looking for a reliable Hospital Tender Supplier for government procurement in Africa or a B2B Pharma Marketplace partner for Latin America, our logistics network ensures timely delivery. We actively support Pharmaceutical Drop Shipping models and bulk indenting, ensuring that every Generic Medicine Wholesaler receives WHO-GMP certified products at competitive rates.
Commercial Inquiries
For hospital tenders, bulk export, or distributor pricing, please contact our export team.
WhatsApp/Call: +91 7710003340
Email: info@healthyinc.co.in
