Description
Pyrazinamide Tablets
Healthy Inc is a specialized global supplier and exporter of first-line anti-tuberculosis agents. We provide high-purity Pyrazinamide Tablets, sourced from WHO–GMP certified solid dosage facilities. This “Sterilizing Specialist” is a top export to National Tuberculosis Control Programs (NTPs), DOTS centers, and government health ministries in Africa, LATAM, and Southeast Asia, serving as the critical component that shortens TB therapy from 12 months to 6 months.
Product Overview
This formulation contains Pyrazinamide (PZA), a synthetic analogue of nicotinamide.
The “Acid-Phase” Killer:
- Mechanism (The Trojan Horse): Pyrazinamide is a prodrug. It passively diffuses into the *Mycobacterium tuberculosis* bacilli, where the bacterial enzyme pyrazinamidase converts it into the active toxic form, Pyrazinoic Acid (POA).
- Sterilizing Activity: Unlike Isoniazid (which kills rapidly growing bacteria), Pyrazinamide is unique because it kills semi-dormant bacilli residing in acidic environments (pH < 6.0), such as inside macrophages or inflammatory lesions.
- Course Shortener: By eliminating these persistent “persister” populations, PZA is the key drug responsible for reducing the standard TB treatment duration from 9-12 months down to the current 6-month standard regimen.
Product Composition & Strength
We supply this product as Uncoated Tablets (typically White, Round/Oval, Scored). The formulation is designed for high bioavailability.
| Active Ingredient | Strength (Standard) | Therapeutic Role | |
|---|---|---|---|
| Pyrazinamide USP/BP | 500 mg | Standard Pediatric/Adult Dose | |
| Pyrazinamide USP/BP | 750 mg | High Dose / Heavy Weight Band | |
| Pyrazinamide USP/BP | 1000 mg (1g) | Once Daily Regimen | |
| Excipients | Q.S. | Corn Starch / Colloidal Silicon Dioxide | Disintegrant / Glidant |
*Pack Sizes: Blister packs of 10s (Box of 10×10), 28s, 100s, or Bulk HDPE Jars of 1000s (Hospital/Clinic Packs).
Technical & Logistics Specifications
Critical data for Pharmaceutical Importers and Distributors.
| HS Code | 3004.90.99 (Other Medicaments) |
| Dosage Form | Tablet (Uncoated) |
| Packaging | PVC-Alu Blister or Alu-Alu (Moisture Sensitive) |
| Storage | Store below 25°C. Protect 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.
- Hydrolytic Stability: Pyrazinamide is sensitive to moisture and can hydrolyze into Pyrazinoic Acid before administration if not protected. Our manufacturing uses low-humidity granulation suites and moisture-barrier blistering (PVDC or Alu-Alu) to ensure the API remains intact until ingestion.
- Dissolution: Being a high-dose drug (often taken as multiple tablets), rapid dissolution is critical. Our tablets are engineered to disintegrate within 15 minutes to prevent GI clumping.
Therapeutic Indications (Human Use)
Indicated for the treatment of Tuberculosis (TB):
- Initial Phase (Intensive Phase): Always used in combination with other anti-TB agents (Isoniazid, Rifampicin, and Ethambutol) for the first 2 months of therapy.
- Drug-Resistant TB: Used in various MDR-TB regimens if susceptibility is confirmed.
- Note: Not typically used in the continuation phase (after 2 months) unless specified by specialized protocols.
Dosage & Administration
Recommended Dosage (Strictly as per WHO/DOTS Guidelines):
- Route: Oral.
- Adults (Daily Regimen): 20 mg/kg to 30 mg/kg body weight once daily.
- 40-55 kg: 1000 mg (2 tablets of 500mg)
- 56-75 kg: 1500 mg (3 tablets of 500mg)
- >75 kg: 2000 mg (4 tablets of 500mg)
- Administration: Take on an empty stomach if possible, or with a light meal to reduce nausea.
Safety Warnings:
- Hepatotoxicity (BLACK BOX WARNING): PZA is the most hepatotoxic of the first-line anti-TB drugs. Stop immediately if signs of hepatitis (jaundice, dark urine, fatigue) appear. Monitor Liver Function Tests (ALT/AST) regularly.
- Hyperuricemia (Gout): Inhibits the renal excretion of uric acid, often causing joint pain (arthralgia) or precipitating acute gout attacks. Treat with analgesics; Allopurinol is usually not effective for PZA-induced hyperuricemia.
- Diabetes: Makes diabetes management difficult (can alter blood glucose control).
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.
