Description
Ethionamide Tablets
Healthy Inc is a specialized global supplier and exporter of critical “Second-Line” antitubercular agents. We provide high-purity Ethionamide Tablets, sourced from WHO–GMP certified solid dosage facilities. This “Reserve” agent is a top export to MDR-TB (Multi-Drug Resistant Tuberculosis) treatment centers, government DOTS-Plus initiatives, and NGO supply chains in Africa, LATAM, and Southeast Asia, serving as a vital lifeline when first-line drugs (like Isoniazid and Rifampicin) fail.
Product Overview
This formulation contains Ethionamide, a derivative of isonicotinic acid (structurally related to Isoniazid).
The “MDR-TB” Specialist:
- Mechanism: Like Isoniazid, Ethionamide is a prodrug. It is activated by the bacterial enzyme EthA. Once active, it inhibits the enzyme InhA (enoyl-ACP reductase), which blocks the synthesis of mycolic acids—the protective waxy shield of the TB bacteria.
- Resistance Breaker: Because it is activated by a different enzyme pathway (EthA) than Isoniazid (KatG), it remains effective against many strains of TB that have developed resistance to Isoniazid.
- Bacteriostatic/Bactericidal: It is bacteriostatic against *Mycobacterium tuberculosis* at standard doses but can be bactericidal at higher concentrations.
- CSF Penetration: It crosses the blood-brain barrier effectively, making it useful for Tuberculous Meningitis in resistant cases.
Product Composition & Strength
We supply this product as Film Coated Tablets (Yellow/Orange). Effective coating is mandatory as the drug causes significant gastric irritation and has a metallic taste.
| Active Ingredient | Strength (Standard) | Target Patient |
|---|---|---|
| Ethionamide USP/BP/IP | 250 mg | Standard Adult / Pediatric Unit |
| Excipients | Q.S. | Microcrystalline Cellulose / Hypromellose |
*Pack Sizes: Blister packs of 10s (Box of 10×10), strips of 10s, or Bulk HDPE Jars of 100s/500s (Program Packs).
Technical & Logistics Specifications
Critical data for Pharmaceutical Importers and Distributors.
| HS Code | 3004.90.99 (Other Medicaments) |
| Dosage Form | Film Coated Tablet (Oral) |
| Packaging | Alu-Alu Blister (Preferred for stability) |
| Storage | Store below 25°C. Protect 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.
- Gastric Tolerance Engineering: Ethionamide is notorious for causing severe nausea. Our tablets utilize specific excipients and a smooth film coating to facilitate easy swallowing and minimize immediate contact with the gastric mucosa, improving patient compliance in difficult MDR-TB regimens.
- Impurity Control: We strictly monitor sulfide impurities to ensure the drug remains stable and potent throughout its shelf life.
Therapeutic Indications (Human Use)
Indicated for the treatment of resistant mycobacterial infections:
- MDR-TB (Multi-Drug Resistant Tuberculosis): Used as a core component of second-line regimens when resistance to Isoniazid and Rifampicin is confirmed.
- Leprosy (Hansen’s Disease): Occasionally used as a substitute for Clofazimine in multidrug therapy (MDT) for leprosy (historical/specific cases).
Dosage & Administration
Recommended Dosage (Strictly as per MDR-TB Protocol):
- Route: Oral.
- Adults: 15–20 mg/kg body weight daily.
- Average Dose: 500 mg to 750 mg daily (2 to 3 tablets).
- Administration Strategy:
- To minimize severe nausea, the daily dose is often split into two or three divided doses.
- Taking the tablet with a light meal or at bedtime can help reduce gastrointestinal distress.
- Pyridoxine (Vitamin B6): Should be co-administered (50-100 mg daily) to prevent nerve damage.
Safety Warnings:
- Severe GI Distress: Nausea, vomiting, metallic taste, and loss of appetite are extremely common and can lead to patients stopping treatment. Anti-emetics are often required.
- Hepatotoxicity: Can cause liver damage. Liver function tests (LFTs) must be monitored regularly.
- Endocrine Effects: Can cause Hypothyroidism (Goiter) and Gynecomastia. Thyroid function (TSH) should be monitored.
- Neurotoxicity: Can cause depression, drowsiness, and peripheral neuropathy (preventable with Vitamin B6).
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
