Description
Ethambutol Hydrochloride Tablets
Healthy Inc is a specialized global supplier and exporter of primary bacteriostatic antitubercular agents. We provide high-purity Ethambutol Hydrochloride Tablets, sourced from WHO–GMP certified solid dosage facilities. This “Resistance Preventer” is a top export to National Tuberculosis Elimination Programs (NTEP), DOTS centers, and infectious disease units in Africa, LATAM, and Southeast Asia, serving as a vital companion drug in the first-line treatment of active tuberculosis.
Product Overview
This formulation contains Ethambutol Hydrochloride, a synthetic ethylenediamine derivative.
The “Wall Inhibitor” Specialist:
- Mechanism: Ethambutol works by inhibiting the enzyme arabinosyl transferase. This enzyme is crucial for the polymerization of arabinogalactan, an essential component of the mycobacterial cell wall. By blocking this process, Ethambutol halts cell wall synthesis, suppressing bacterial growth.
- Bacteriostatic Action: Unlike Isoniazid or Rifampicin which kill bacteria outright, Ethambutol primarily stops them from multiplying (bacteriostatic). This makes it the perfect “partner drug” to prevent the emergence of drug resistance during the initial intensive phase of therapy.
- Selectivity: It is highly specific for mycobacteria (genus Mycobacterium) and has no effect on other bacteria, fungi, or viruses.
Product Composition & Strength
We supply this product as Film Coated Tablets (often Gray or White). Coating is essential as the API is hygroscopic and has a bitter taste.
| Active Ingredient | Strength (Standard) | Primary Role |
|---|---|---|
| Ethambutol HCl USP/BP/IP | 200 mg | Pediatric / Renal Adjustment |
| Ethambutol HCl USP/BP/IP | 400 mg | Standard Adult Unit |
| Ethambutol HCl USP/BP/IP | 600 mg | High Strength (Daily Regimen) |
| Ethambutol HCl USP/BP/IP | 800 mg | Intensive Phase Loading |
*Pack Sizes: Blister packs of 10s (Box of 10×10), 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 | Film Coated Tablet (Oral) |
| Packaging | PVC-Alu Blister, Alu-Alu Blister, or Bulk Jar |
| Storage | Store below 30°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.
- Hygroscopicity Management: Ethambutol HCl is extremely hygroscopic (absorbs moisture). If exposed to humidity, the tablets become soft and sticky. We manufacture in low-humidity suites and use moisture-protective film coatings (Opadry AMB) to ensure stability in tropical climates.
- Stereochemistry: The drug exists as isomers. Only the dextro (+) isomer is therapeutically active and less toxic. We strictly assay our API to ensure it is free from the levo (-) isomer, which causes optical toxicity without therapeutic benefit.
Therapeutic Indications (Human Use)
Indicated for the treatment of Tuberculosis:
- Primary Treatment: Used in combination with other antitubercular drugs (Isoniazid, Rifampicin, Pyrazinamide) for the initial treatment of pulmonary tuberculosis.
- Re-treatment Cases: A critical component in re-treatment regimens for patients who have relapsed or have failed previous therapy.
- M. avium Complex (MAC): Used in combination therapy for opportunistic mycobacterial infections in HIV patients.
Dosage & Administration
Recommended Dosage (Strictly as per Pulmonologist/DOTS Guidelines):
- Route: Oral.
- Initial Treatment (Adults): 15 mg/kg body weight once every 24 hours.
- Re-treatment: 25 mg/kg body weight daily for 60 days, then reduce to 15 mg/kg.
- Renal Impairment: Ethambutol accumulates in kidney failure. Dose adjustment is mandatory based on Creatinine Clearance.
- Administration: Can be taken with food if gastric irritation occurs (absorption is not significantly affected by food).
Safety Warnings:
- Optic Neuritis (Critical): The most serious side effect is toxicity to the optic nerve. This causes decreased visual acuity, loss of color discrimination (red-green color blindness), and visual field constriction.
- Monitoring: Patients should have their vision tested *before* starting therapy and monthly thereafter.
- Discontinue immediately if vision changes occur; effects are usually reversible if caught early.
- Uric Acid: Can decrease the renal excretion of uric acid, potentially precipitating acute Gout.
- Pediatrics: Not recommended for children under 5 years (or those unable to report visual changes) due to the risk of undiagnosed optic neuritis.
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
