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Isoniazid Tablets product image

Isoniazid Tablets

Composition: Isoniazid IP 50 mg / 100 mg / 300 mg; Isoniazid BP 100 mg / 300 mg. Separate PYRINH combination: Isoniazid IP 100 mg + Pyridoxine HCl IP 5 mg.

Usage: Treatment of tuberculosis as part of an appropriate regimen.

Category: Anti-tuberculosis drugs

Therapeutic category: Antitubercular / Antimycobacterial

SKU: Isoniazid Tablets

Categories: Contract Manufacturer, Formulations Exporter India, Manufacturing Pharmaceutical Company India, Pharmaceutical Exporter India, Pharmaceutical Formulations India, Tablets Manufacturer, WHO GMP Certified Formulations

Product Information

Isoniazid 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

Isoniazide / Isoniazid Tablets (50 mg / 100 mg / 300 mg)

Manufactured by: Healthy Life Pharma Pvt. Ltd. (WHO-GMP certification subject to verification)
Exported by: Healthy Inc (Star Export House status subject to verification)

1. Product Introduction

Isoniazid (INH) is a first-line antimycobacterial medicine used as part of combination therapy for active tuberculosis and in selected regimens for latent tuberculosis infection. Healthy Life Pharma Pvt. Ltd. is identified as the manufacturer and Healthy Inc as the exporter for this product range. Product availability, regulatory approvals and manufacturing capabilities should be confirmed for each market.

2. Product Specifications

ProductActive ingredient per tabletCoating
Isoniazide Tablets IP 50 mgIsoniazide IP 50 mgCoated
Isoniazid Tablets IP 100 mgIsoniazid IP 100 mgCoated
Isoniazid Tablets IP 300 mgIsoniazid IP 300 mgCoated
Isoniazid Tablets BP 100 mgIsoniazid BP 100 mgFilm-coated
Isoniazid Tablets BP 300 mgIsoniazid BP 300 mgFilm-coated
PYRINH (combination)Isoniazide IP 100 mg + Pyridoxine Hydrochloride IP 5 mgUncoated

CAS: 54-85-3 (isoniazid). Class: Antitubercular / antimycobacterial. Shelf life, pack sizes, specifications and dosage-form appearance must be checked against the approved product dossier.

3. Manufacturing Technology

Manufacturing considerations include compatible excipient selection, protection from moisture, controlled blending, content uniformity and coating integrity. The supplied IP and BP variants are coated or film-coated; an uncoated dosage form is identified only for the separate PYRINH combination. Stability, packaging and process parameters are established through validated product-specific studies; no particular manufacturing method is asserted without supporting records.

4. Quality Assurance

Appropriate testing may include identity, assay, content uniformity, dissolution, related substances, microbiological quality where applicable, and stability. Acceptance limits must follow the applicable approved pharmacopoeial monograph and regulatory dossier rather than assumed universal numerical thresholds.

5. Pharmacology and Clinical Use

Isoniazid is activated by the mycobacterial KatG enzyme and interferes with mycolic-acid synthesis in Mycobacterium tuberculosis. For active TB, it must be used with other effective antitubercular medicines according to susceptibility and current treatment guidance to reduce resistance risk. For latent TB infection, isoniazid-based preventive regimens may be selected after active disease has been excluded. Pyridoxine is used in patients at risk of isoniazid-associated neuropathy.

6. Export and Regulatory Support

For wholesale, tender and export enquiries, request market-specific product registration details, certificates of analysis, stability data, approved artwork and relevant certificates from the supplier. Availability of CTD/ACTD dossiers, COPP, FSC, WHO-GMP documentation and specific shipping terms requires confirmation.

7. Frequently Asked Questions

Q: Is isoniazid used alone for active TB?
No. Active TB requires a suitable multidrug regimen under a TB specialist or national programme.

Q: Why is vitamin B6 sometimes prescribed?
Pyridoxine can reduce the risk of peripheral neuropathy, especially in patients with risk factors. PYRINH is a separate combination formulation.

Q: Can I drink alcohol during treatment?
Alcohol may increase the risk of liver injury; discuss alcohol avoidance with your treating clinician.

Q: What if my hands or feet tingle?
Contact your clinician promptly for assessment of possible neuropathy.

8. Dosage and Administration

Adult and paediatric doses depend on weight, diagnosis, drug susceptibility, comorbidities and the national TB treatment regimen; the supplied 50 mg, 100 mg and 300 mg strengths are not interchangeable without a prescription. Follow the prescription and approved product information. Do not stop treatment early or substitute a combination product without medical advice. Food can affect absorption; follow the clinician’s administration instructions.

9. Side Effects and Precautions

Serious risks: Hepatitis or liver injury, peripheral neuropathy and hypersensitivity reactions. Seek urgent medical advice for jaundice, dark urine, persistent vomiting, severe fatigue, rash or neurological symptoms. Liver monitoring is risk-based and determined by the treating team. Drug interactions may occur, including with phenytoin and carbamazepine. Discuss pregnancy, existing liver disease, alcohol use and all other medicines with the prescriber.

10. Storage Instructions

Store according to the approved product label, protected from excessive moisture and light as directed. Keep medicines securely away from children.