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Ethionamide Tablets

Ethionamide Tablets

Ethionamide Tablets IP 125 mg: Each film-coated tablet contains Ethionamide IP 125 mg.

Ethionamide Tablets IP 250 mg: Each film-coated tablet contains Ethionamide IP 250 mg.

Ethionamide Tablets BP 250 mg: Each film-coated tablet contains Ethionamide BP 250 mg.

Usage: Tuberculosis treatment as part of an appropriate combination regimen.

Category: Antibiotic Drugs

Therapeutic Category: Anti-tuberculosis / Antimycobacterial

SKU: Ethionamide Tablets

Categories: Pharmaceutical Exporter India, Pharmaceutical Formulations India, WHO GMP Certified Formulations

Product Information

Ethionamide Tablets is listed in our pharmaceutical product portfolio for business-to-business enquiries. Product-specific formulation details, available strengths, dosage form, pack configuration and supply terms should be confirmed against the current product specification before ordering.

For distributor, wholesaler, hospital procurement and export enquiries, please request the applicable product specifications, batch documentation, shelf-life information, packaging options and regulatory documents. Availability and documentation depend on the product and destination market.

Description

Ethionamide Tablets (125 mg / 250 mg)

Manufactured by: Healthy Life Pharma Pvt. Ltd. (WHO-GMP Certified)
Exported by: Healthy Inc (Star Export House)

1. Product Introduction

Healthy Life Pharma Pvt. Ltd. manufactures Ethionamide Tablets in India. Ethionamide is an antimycobacterial medicine that may be included in selected treatment regimens for drug-resistant tuberculosis when susceptibility and current treatment guidelines support its use. It must be used in combination with other effective anti-TB medicines, not alone. Newer all-oral regimens may be preferred depending on the resistance pattern, availability and national program guidance.

2. Product Specifications

ParameterSpecification
Product NameEthionamide Tablets
Active IngredientEthionamide
CAS Number536-33-4
Strengths125 mg and 250 mg
Dosage FormFilm-coated tablets
StandardsIP 125 mg / IP 250 mg / BP 250 mg, according to product
Therapeutic ClassAntimycobacterial / Anti-tuberculosis agent
Shelf LifeAs supported by product-specific stability studies
PackagingBlister or bottle according to registered presentation

3. Manufacturing Technology

  • Film coating: Coating may help mask taste and odor and improve handling, but cannot be assumed to eliminate nausea or other systemic adverse effects.
  • Formulation: Excipients, compression and coating are controlled according to validated manufacturing procedures and registered specifications.
  • Packaging: Appropriate protective packs are selected on the basis of product-specific stability studies.

4. Quality Assurance

  • Identity, assay, dosage-unit uniformity, dissolution and related substances are tested against applicable pharmacopoeial or registered specifications.
  • Dissolution percentages, assay limits and shelf-life claims are specific to the product and should not be generalized without supporting records.
  • Batch release and stability testing are performed according to validated methods.

5. Pharmacology and Clinical Use

Ethionamide is a prodrug activated by the mycobacterial enzyme EthA. Its active metabolite inhibits InhA, disrupting mycolic-acid synthesis in the mycobacterial cell wall. Cross-resistance with isoniazid can occur through shared target-related resistance mechanisms; susceptibility should not be assumed. Ethionamide is used only as part of an appropriately selected multidrug regimen for TB. Other uses, including in selected leprosy regimens, depend on specialist guidance and local authorization.

6. Export and Regulatory Support

CTD/ACTD dossiers, certificates of analysis, FSC and COPP may be available for specific registered products, subject to regulatory requirements. Export packaging and logistics are arranged according to market authorization and applicable distribution standards.

7. Frequently Asked Questions

Q: Who manufactures Ethionamide Tablets?
A: Healthy Life Pharma Pvt. Ltd., India.

Q: Is this Trecator?
A: Trecator is a brand of ethionamide. Generic equivalence or bioequivalence to a reference product should only be claimed when supported by the required regulatory evidence.

Q: Why can Ethionamide cause nausea?
A: Gastrointestinal intolerance is common. The treating TB clinician may adjust administration or provide supportive care without compromising the regimen.

Q: Can I drink alcohol?
A: Alcohol can increase the risk of adverse effects, including liver injury; patients should discuss avoidance with their treating clinician.

8. Dosage and Administration

Ethionamide dose, frequency, titration and duration depend on body weight, tolerance, susceptibility, other TB medicines and current national or WHO-aligned guidance. It should never be used as monotherapy for active TB. Food and dose-splitting strategies may be considered by the treating clinician for tolerability. Pyridoxine may be recommended in appropriate patients or regimens; follow the TB program protocol.

9. Side Effects and Precautions

  • Gastrointestinal: Nausea, vomiting, abdominal pain, altered taste and loss of appetite can be prominent.
  • Liver: Hepatotoxicity can occur; assess symptoms and liver tests according to the treatment protocol.
  • Neurologic / Psychiatric: Peripheral neuropathy, mood changes and other neuropsychiatric effects require monitoring.
  • Endocrine / Metabolic: Hypothyroidism, particularly with certain companion medicines, and hypoglycemia may occur; monitor when clinically indicated.
  • Drug resistance: Resistance and cross-resistance considerations require expert regimen selection and susceptibility testing.

10. Storage Instructions

Store at the temperature specified by the approved product label, protected from excessive heat and moisture. Keep the pack closed and out of reach of children.