Description
Isoniazid Tablets
Healthy Inc is a specialized global supplier and exporter of first-line antitubercular agents. We provide high-purity Isoniazid (INH) Tablets, sourced from WHO–GMP certified solid dosage facilities. This “Bactericidal Backbone” is a top export to National Tuberculosis Elimination Programs (NTEP), DOTS centers, and NGO healthcare supply chains in Africa, LATAM, and Southeast Asia, serving as the most critical component in the global fight against *Mycobacterium tuberculosis*.
[Image of Isoniazid mechanism of action inhibiting mycolic acid synthesis]
Product Overview
This formulation contains Isoniazid, a synthetic derivative of nicotinic acid (isonicotinylhydrazine).
The “Wall Breaker” Specialist:
- Mechanism (Mycolic Acid Inhibition): Isoniazid is a prodrug. Once activated by the bacterial enzyme *KatG*, it inhibits the synthesis of mycolic acids—long fatty acids that are unique and essential structural components of the mycobacterial cell wall. Without this wall, the bacteria lose structural integrity and die.
- Bactericidal Power: It is highly bactericidal against rapidly dividing bacilli (killing them quickly), making it essential for rapidly reducing the infectiousness of a TB patient.
- Penetration: It penetrates well into all body fluids and tissues, including the Cerebrospinal Fluid (CSF) and caseous (cheese-like) lesions (tubercles), ensuring deep-seated infections are treated.
Product Composition & Strength
We supply this product as Uncoated Tablets (White/Scored). It is often co-administered with Pyridoxine (Vitamin B6) to prevent nerve damage.
| Active Ingredient | Strength (Standard) | Target Patient |
|---|---|---|
| Isoniazid USP/BP/IP | 100 mg | Pediatric / Prophylaxis |
| Isoniazid USP/BP/IP | 300 mg | Standard Adult Dose |
| Excipients | Q.S. | Binder / Disintegrant |
*Pack Sizes: Blister packs of 10s, 28s (Calendar Pack), strips of 10s, or Bulk HDPE Jars of 1000s (Institutional Packs).
Technical & Logistics Specifications
Critical data for Pharmaceutical Importers and Distributors.
| HS Code | 3004.90.99 (Other Medicaments) |
| Dosage Form | Tablet (Oral) |
| Packaging | PVC-Alu Blister, Strip, or Bulk Jar |
| Storage | Store below 30°C. Protect from light and moisture. |
| Certificates | WHO-GMP, COPP, Free Sale Certificate |
Manufacturing Authority
Marketed and Distributed by Healthy Inc from WHO-GMP & ISO 9001:2015 certified units.
- Dissolution Uniformity: Isoniazid is highly soluble, but our manufacturing process ensures rapid disintegration (< 15 mins) to guarantee high peak serum concentrations, which is correlated with bacterial kill rates.
- Impurity Control: We strictly monitor the levels of free hydrazine (a potential impurity) to ensure the product meets stringent USP/BP safety limits.
Therapeutic Indications (Human Use)
Indicated for the treatment and prevention of Tuberculosis:
- Active Tuberculosis: Used in combination with other anti-TB drugs (Rifampicin, Pyrazinamide, Ethambutol) for the treatment of pulmonary and extrapulmonary TB.
- Latent Tuberculosis Infection (LTBI): Used as monotherapy (typically for 6–9 months) to prevent the progression of latent infection to active disease in high-risk individuals (e.g., HIV patients, close contacts).
Dosage & Administration
Recommended Dosage (Strictly as per Pulmonologist/DOTS Guidelines):
- Route: Oral.
- Active TB (Adults): 5 mg/kg body weight daily. Maximum 300 mg daily.
- Prophylaxis (Latent TB): 300 mg daily for 6 to 9 months.
- Administration: Best taken on an empty stomach (1 hour before or 2 hours after meals) as food reduces absorption.
- Vitamin B6 (Pyridoxine): 10 mg to 50 mg of Vitamin B6 should be administered daily along with Isoniazid to prevent peripheral neuropathy.
Safety Warnings:
- Hepatotoxicity (Black Box Warning): Can cause severe and sometimes fatal hepatitis (liver damage). Risk increases with age (>35 yrs) and alcohol consumption. Patients must report nausea, fatigue, or yellowing of eyes immediately.
- Peripheral Neuropathy: Causes numbness, tingling, or burning in hands and feet by depleting Vitamin B6. Mandatory supplementation is required for malnourished patients, diabetics, and pregnant women.
- Acetylator Status: Genetics determine how fast a patient metabolizes Isoniazid. “Slow acetylators” are at higher risk of toxicity; “Fast acetylators” may require higher doses.
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
