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Isoniazide with Pyridoxin Tablets - original website product image

Isoniazid & Pyridoxine Hydrochloride Tablets

Composition described: Isoniazid 300 mg + Pyridoxine Hydrochloride 10 mg / 25 mg / 50 mg (strengths require verification).

Usage: Tuberculosis treatment regimens and prevention of isoniazid-associated vitamin B6 deficiency, as prescribed.

Category: Anti-Tuberculosis Drugs

Therapeutic category: Antitubercular / Vitamin B6 Supplement

SKU: Isoniazid Pyridoxine Hydrochloride Tablets

Categories: Tablets Manufacturer

Product Information

Isoniazid & Pyridoxine Hydrochloride 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

Isoniazid & Pyridoxine Hydrochloride Tablets

1. Product Introduction

Isoniazid & Pyridoxine Hydrochloride Tablets combine an anti-tuberculosis medicine with vitamin B6. Isoniazid acts against Mycobacterium tuberculosis; pyridoxine reduces the risk of isoniazid-associated peripheral neuropathy. Active tuberculosis requires an appropriate multidrug regimen and clinical monitoring; this combination must not be presented as complete standalone treatment.

Manufactured by: Healthy Life Pharma Pvt. Ltd. (WHO-GMP status as provided; confirm certificate)
Exported by: Healthy Inc (Star Export House status as provided; confirm documentation)

2. Product Specifications

ParameterSpecification
ProductIsoniazid & Pyridoxine Hydrochloride Tablets
Proposed compositionIsoniazid 300 mg + Pyridoxine HCl 10 mg, 25 mg or 50 mg — individual strengths require confirmation from approved formula and artwork
Other variant in original website archiveIsoniazid 100 mg + Pyridoxine HCl 5 mg, referenced in archived copy; verify separately
CAS (isoniazid)54-85-3
Dosage formOral tablet; coating and scoring to be verified
Therapeutic classAntitubercular agent + vitamin B6
Packaging, shelf life and compendial standardsConfirm using batch documents, approved specifications and market registration
Formulation verification: The description lists 300 mg isoniazid with 10, 25 or 50 mg pyridoxine, but no tablet-by-tablet composition label was provided. Do not publish these as confirmed marketed SKUs without checking approved documents.

3. Manufacturing Technology

Formulation development should assess blending uniformity, compatibility of isoniazid and pyridoxine, moisture and light sensitivity, disintegration, dissolution and packaging suitability. Specific manufacturing equipment, coating methods and process claims must be confirmed against actual batch records and validation documentation.

4. Quality Assurance

Appropriate quality controls may include identification and assay of both active ingredients, dosage-unit uniformity, dissolution, related substances including relevant hydrazine impurities, and stability testing. Exact acceptance limits depend on the applicable registered specification; blanket 90–110% claims should not replace validated release criteria.

5. Pharmacology and Clinical Use

Isoniazid inhibits mycolic-acid synthesis in susceptible mycobacteria. Pyridoxine supplementation helps prevent peripheral neuropathy, particularly in patients at higher risk, but does not eliminate all neurologic adverse effects. Isoniazid is used in selected active-TB regimens with other drugs and in appropriate tuberculosis preventive-treatment regimens under national guidelines. The regimen, duration and resistance considerations require clinician oversight.

6. Export and Regulatory Support

For institutional procurement or export, request product-specific dossiers, certificates of analysis, approved labels, stability data and applicable manufacturing certificates. Availability of CTD/ACTD documentation, COPP, free-sale certificates and tender eligibility must be confirmed for the specific product and destination market.

7. Frequently Asked Questions

Q: Why combine isoniazid with vitamin B6?
A: Pyridoxine helps reduce the risk of isoniazid-associated peripheral neuropathy.

Q: Is this tablet enough to treat active TB?
A: No. Active TB generally requires a prescribed combination of antitubercular medicines to avoid treatment failure and resistance.

Q: Is liver monitoring important?
A: Yes. Isoniazid may cause serious liver injury; clinicians assess symptoms, risk factors and the need for laboratory monitoring.

Q: Are all listed strengths confirmed?
A: Not yet. Verify each composition and label against approved product documents.

8. Dosage and Administration

Use only under a tuberculosis clinician or national TB-program protocol. The appropriate isoniazid and pyridoxine doses depend on indication, age, weight, comorbidities, interactions and the approved formulation. Do not use the illustrative 300 mg combinations as a universal dose, and do not interrupt a prescribed TB regimen without medical advice. Administration with or without food should follow the approved product label and clinician instructions.

9. Side Effects and Precautions

  • Liver injury: Seek prompt assessment for persistent nausea, loss of appetite, dark urine, yellowing of skin or eyes, or marked fatigue.
  • Neurologic effects: Tingling, numbness or burning in the hands and feet can occur despite supplementation.
  • Drug interactions: Important interactions can occur with phenytoin, carbamazepine and other medicines; medication review is essential.
  • Alcohol: Avoid alcohol during therapy because of liver toxicity risk.
  • Resistance: Inappropriate monotherapy for active TB can promote resistance.
  • Pregnancy and comorbidities: Require individualized risk-benefit assessment and monitoring.

10. Storage Instructions

Store in the original, well-closed packaging, protected from excess heat, light and moisture, according to the approved pack label. The proposed below-25°C condition and 36-month shelf life require product-specific stability confirmation. Keep out of reach of children.