Description
Rifampicin, Isoniazid, Pyrazinamide & Ethambutol Tablets (4-FDC)
Healthy Inc is a specialized global supplier and exporter of Fixed-Dose Combination (FDC) Anti-Tubercular Drugs. We provide high-stability 4-Drug FDC Tablets (AKZ-4), sourced from WHO–GMP certified solid dosage facilities. This “All-in-One” Intensive Phase kit is a top export to National Tuberculosis Elimination Programs (NTEP), DOTS centers, and WHO humanitarian missions in Africa, LATAM, and Southeast Asia, simplifying patient compliance during the critical first 2 months of TB treatment.
Product Overview
This formulation combines the four first-line anti-TB drugs into a single tablet to prevent monotherapy and drug resistance.
The “Intensive Phase” Specialist:
- Rifampicin (R): The sterilizing agent that kills semi-dormant bacteria.
- Isoniazid (H): The most potent early bactericidal agent, killing actively dividing bacteria in the first 2 days.
- Pyrazinamide (Z): Acts in the acidic environment of macrophages to kill intracellular bacteria (sterilizing activity).
- Ethambutol (E): Bacteriostatic agent that prevents the emergence of resistance to the other three drugs.
- Synergy (The FDC Advantage): By combining all 4 into one tablet, we eliminate the risk of “selective non-compliance” (where a patient takes only one drug but not the others), which is the primary cause of Multi-Drug Resistant TB (MDR-TB).
Product Composition & Strength
We supply this product as Film Coated Tablets (usually Brown or Reddish-Brown). We offer both the “Daily Regimen” and “Intermittent Regimen” strengths.
| Active Ingredient | Strength (WHO Daily FDC) | Therapeutic Role |
|---|---|---|
| Rifampicin IP/BP/USP | 150 mg | Sterilizing / Broad Spectrum |
| Isoniazid IP/BP/USP | 75 mg | Early Bactericidal |
| Pyrazinamide IP/BP/USP | 400 mg | Intracellular Sterilizing |
| Ethambutol HCl IP/BP/USP | 275 mg | Resistance Prevention |
*Pack Sizes: Blister strips of 28s (Monthly Kit), 672s (Patient Wise Box), or Bulk Hospital Packs.
Technical & Logistics Specifications
Critical data for Pharmaceutical Importers and Distributors.
| HS Code | 3004.20.99 (Medicaments containing antibiotics) |
| Dosage Form | Tablet (Film Coated / Bi-layer) |
| Packaging | Alu-Alu Blister (Triple Laminate) |
| Storage | Store below 25°C. Protect strictly from Moisture. |
| Certificates | WHO-GMP, COPP, Free Sale Certificate |
Manufacturing Authority
Marketed and Distributed by Healthy Inc from WHO-GMP & ISO 9001:2015 certified units.
- Chemical Stability (CRITICAL): Rifampicin and Isoniazid are chemically incompatible in the presence of moisture (they react to form isonicotinyl hydrazone, reducing potency). Pyrazinamide and Ethambutol are highly hygroscopic. We utilize Bi-layer Technology or specialized barrier coating techniques to physically separate the reactive layers within the tablet, ensuring full potency for the entire shelf life (24–36 months).
- Dissolution: The tablet is engineered to release all four drugs simultaneously in the stomach, mimicking the bioavailability of taking four separate pills.
Therapeutic Indications (Human Use)
Indicated for the Intensive Phase (Initial 2 Months) of treatment for:
- Pulmonary Tuberculosis: New cases of smear-positive or smear-negative TB.
- Extra-Pulmonary Tuberculosis: TB of the lymph nodes, pleura, etc.
- Retreatment Cases: Used as per specific WHO Category II protocols.
Dosage & Administration
Recommended Dosage (Strictly as per WHO Weight Bands):
- Route: Oral.
- 30–39 kg: 2 tablets daily.
- 40–54 kg: 3 tablets daily.
- 55–70 kg: 4 tablets daily.
- >70 kg: 5 tablets daily.
- Administration: Take the full dose (all tablets together) on an empty stomach with water, 1 hour before breakfast.
Safety Warnings:
- Hepatotoxicity: 3 of the 4 drugs (R, H, Z) are potentially toxic to the liver. Stop immediately if jaundice (yellow eyes/skin) occurs. Avoid alcohol completely.
- Ocular Toxicity: Ethambutol can cause optic neuritis (blurred vision/color blindness). Patients should have their vision checked regularly.
- Hyperuricemia: Pyrazinamide raises uric acid levels, which may cause joint pain (gout).
- Discoloration: Urine will turn reddish-orange (due to Rifampicin).
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
