Description
Isoniazid & Pyridoxine Hydrochloride Tablets
Healthy Inc is a specialized global supplier and exporter of essential antitubercular (anti-TB) medications. We provide high-potency Isoniazid & Pyridoxine Hydrochloride Tablets, manufactured in WHO–GMP certified facilities. This critical combination is a staple export to National TB Programs (NTPs), infectious disease hospitals, and global health NGOs in Africa, Southeast Asia, and Eastern Europe, specifically designed to ensure patient safety and compliance during long-term tuberculosis therapy.
Product Overview
This formulation combines a primary bactericidal agent with a vital neuroprotective vitamin to treat latent and active tuberculosis while preventing medication-induced side effects.
The “Safe-Guard” Antitubercular Specialist:
- Isoniazid (INH): The most potent bactericidal agent against actively dividing Mycobacterium tuberculosis. It works by inhibiting the synthesis of mycolic acids, essential components of the mycobacterial cell wall. Without mycolic acids, the bacteria lose their structural integrity and die.
- Pyridoxine Hydrochloride (Vitamin B6): Chronic use of Isoniazid causes the depletion of Vitamin B6, leading to peripheral neuropathy (tingling, numbness, or pain in limbs). Pyridoxine is co-formulated to prevent this neurotoxicity, ensuring patients can complete their 6-to-9 month treatment course without neurological complications.
- Synergistic Compliance: By combining the active antibiotic with its protective agent in a single Fixed-Dose Combination (FDC), we reduce the daily pill burden, which is critical in preventing treatment default and the emergence of Multi-Drug Resistant TB (MDR-TB).
Product Composition & Strength
We supply this product as Uncoated or Film Coated Tablets. The ratio of Isoniazid to Pyridoxine is carefully calibrated to meet international clinical guidelines for neuroprotection.
| Active Ingredient | Strength (Standard) | Therapeutic Role | |
|---|---|---|---|
| Isoniazid BP/USP | 300 mg | Primary Antitubercular (Bactericidal) | |
| Pyridoxine Hydrochloride BP/USP | 10 mg / 25 mg / 50 mg | Neuroprotective Vitamin (B6) | |
| Excipients | Q.S. | Starch / Lactose / Magnesium Stearate | Tablet Core Matrix |
*Pediatric strengths (e.g., 100mg INH) are available for specialized pediatric TB programs.
Technical & Logistics Specifications
Critical data for Pharmaceutical Importers and Regulatory Bodies.
| HS Code | 2933.39.17 (Isoniazid) / 3004.20 (Medicaments containing Antibiotics) |
| Dosage Form | Tablet (Plain or Film Coated) |
| Packaging | HDPE Bottles of 100s/1000s or PVC-Alu Blister Packs |
| Storage | Store below 30°C. Protect from light and moisture. Keep container tightly closed. |
| Certificates | WHO-GMP, COPP, Free Sale Certificate, Dossier (CTD Format) |
Manufacturing Authority
Marketed and Distributed by Healthy Inc from WHO-GMP & ISO 9001:2015 certified units.
- Bioavailability Testing: Isoniazid absorption can be affected by gastric pH. Our quality control team ensures that every batch meets stringent In-Vitro Dissolution standards to guarantee rapid absorption and therapeutic peak plasma levels.
- Stability Assurance: Pyridoxine is light-sensitive. Our tablets are protected by specialized UV-opaque film coatings or amber-colored HDPE containers to maintain vitamin potency in high-sunlight export regions like Sub-Saharan Africa.
Therapeutic Indications
Indicated for both the prevention and treatment of tuberculosis:
- Latent TB Infection (LTBI): Monotherapy or as part of a regimen to prevent progression to active TB.
- Active Pulmonary & Extra-pulmonary TB: Used as a core component of the “Intensive Phase” and “Continuation Phase” of standard short-course therapy.
- HIV-Associated TB: Recommended for Preventive Therapy (IPT) in people living with HIV.
Dosage & Administration
Recommended Dosage (Strictly as per National TB Guidelines):
- Route: Oral.
- Adult Dose: Typically 300 mg Isoniazid (one tablet) daily.
- Administration (CRITICAL): Should be taken on an empty stomach (1 hour before or 2 hours after meals) as food significantly reduces the absorption of Isoniazid.
Safety Warnings:
- Hepatotoxicity: Isoniazid is associated with severe and sometimes fatal hepatitis. Monitor liver enzymes (ALT/AST) regularly, especially in patients over 35 or those who consume alcohol.
- Drug Interactions: Inhibits certain enzymes (CYP450), increasing levels of drugs like Phenytoin or Carbamazepine.
- Alcohol Avoidance: Patients must avoid alcohol during treatment to reduce the risk of liver damage.
Global Export & Contract Manufacturing Services
Healthy Inc is a premier Pharmaceutical Exporter in India, serving international Pharma Wholesalers and Health Ministries. As a verified Medicine Supplier in Mumbai, we specialize in supplying large-volume Public Health Tenders and offer Third Party Manufacturing for anti-TB products. Our logistics team is experienced in the cold-chain and non-cold-chain maritime transport required for bulk exports to African and Southeast Asian ports, ensuring that Generic Medicine Wholesalers receive top-tier antituberculars at competitive global prices.
Commercial Inquiries
For institutional tenders or bulk pricing, please contact our export team.
WhatsApp/Call: +91 7710003340
Email: info@healthyinc.co.in
