Healthy Inc > Blog > Isoniazid BP/USP/IP
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What is isoniazid pyridoxine hydrochloride used for?

In the pharmaceutical industry, the combination of Isoniazid (INH) and Pyridoxine Hydrochloride (Vitamin B6) is the gold standard for both the treatment and prophylaxis of Tuberculosis (TB). As a pharmacist and manufacturer, I view this as a “preventative combination”: Isoniazid kills the bacteria, while Pyridoxine prevents the most common neurological side effect of the treatment.

Primary Clinical Uses

  • Active Tuberculosis: Used as a core component of the “RIPE” regimen (Rifampicin, Isoniazid, Pyrazinamide, and Ethambutol) for the treatment of Mycobacterium tuberculosis.

  • Latent TB Infection (LTBI): Often used as monotherapy for 6–9 months to prevent a dormant infection from becoming active.

  • TB Prophylaxis: Prescribed for individuals in close contact with TB patients or immunocompromised patients (such as those with HIV) who are at high risk of infection.

The Dual Mechanism: Action vs. Protection

1. Isoniazid (The Bactericidal Agent)

Isoniazid is a prodrug that is activated by the mycobacterial enzyme KatG.

  • Mechanism: It inhibits the synthesis of mycolic acids, which are essential components of the waxy mycobacterial cell wall.

  • Result: Without a cell wall, the bacteria lose structural integrity and die.

2. Pyridoxine Hydrochloride (The Neuroprotective Agent)

Isoniazid interferes with the metabolism of Vitamin B6 in the human body.

  • The Problem: INH forms a complex with Vitamin B6 and inhibits the enzyme pyridoxine kinase, leading to a deficiency.

  • The Result: Without Pyridoxine, patients often develop peripheral neuropathy (tingling, numbness, or “pins and needles” in the hands and feet).

  • The Solution: Including Pyridoxine in the tablet prevents this nerve damage, ensuring better patient compliance during long-term TB therapy.

The Manufacturer’s Perspective: Formulation & Export

From a production standpoint in a WHO-GMP facility, this combination is a high-demand “Essential Medicine”:

  • Fixed-Dose Combination (FDC) Stability: Isoniazid is sensitive to moisture and can react with certain excipients (reducing sugars like lactose) through the Maillard reaction, which can cause the tablets to discolor. We utilize specialized, non-reactive diluents to ensure stability.

  • Dose Ratios: While INH is typically 100 mg or 300 mg, the Pyridoxine dose is usually 10 mg to 50 mg. We utilize validated blending processes to ensure micro-dose uniformity of the Vitamin B6 across the entire batch.

  • Packaging for Global Trade: TB is endemic in high-humidity regions. We utilize Alu-Alu or high-barrier PVC/PVDC blister packaging to ensure a 36-month shelf life for export to Zone IVb regions (Africa, SE Asia, and CIS countries).

  • B2B & Public Health Tenders: This product is a staple for the Global Drug Facility (GDF) and national TB programs. Our Mumbai facility provides the necessary CTD/eCTD Dossiers to support international supply.

 

Isoniazid & Pyridoxine hydrochloride Tablets

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What is isoniazid 300mg used for?

In the pharmaceutical industry, Isoniazid (INH) 300 mg is a foundational first-line antitubercular agent. As a pharmacist, I view this 300 mg strength as the gold standard daily dose for adults in both the treatment of active disease and the prevention of latent infection. It is a highly specific “narrow-spectrum” antibiotic, targeting only mycobacteria.

Primary Clinical Uses

  • Active Tuberculosis (TB): Used as a core component of the standard four-drug regimen (alongside Rifampicin, Pyrazinamide, and Ethambutol) to treat pulmonary and extra-pulmonary TB.

  • Latent Tuberculosis Infection (LTBI): Prescribed as monotherapy (usually 300 mg daily for 6–9 months) to prevent the progression of latent TB to active disease in high-risk individuals.

  • Prophylaxis: Given to individuals who have been in close contact with patients having active TB, regardless of their skin test results.

Mechanism of Action

Isoniazid is a prodrug that must be activated by the bacterial enzyme KatG (a catalase-peroxidase).

Inhibition of Mycolic Acid Synthesis: Once activated, it binds to and inhibits the enzyme InhA (enoyl-ACP reductase).

Cell Wall Disruption: This blockade prevents the synthesis of mycolic acids, which are the essential long-chain fatty acids that make up the “waxy” protective cell wall of Mycobacterium tuberculosis.

Bactericidal Effect: For actively dividing bacteria, this loss of cell wall integrity is lethal, making INH highly bactericidal.

The Manufacturer’s Perspective: Formulation & Export

From a manufacturing and global trade standpoint, Isoniazid 300 mg is a high-volume “Essential Medicine” with specific technical requirements:

  • Fixed-Dose Combinations (FDCs): While we manufacture 300 mg single-drug tablets, the global export market (especially via the Global Drug Facility – GDF) heavily favors FDCs like Rifampicin + Isoniazid (150mg/75mg or 300mg/150mg). For your digital platform, showcasing these FDCs is key to attracting B2B buyers.

  • API Purity & Hydrazine Monitoring: During synthesis and storage, INH can degrade into hydrazine, a toxic impurity. As a WHO-GMP firm, we maintain strict assay controls to ensure hydrazine levels remain well below pharmacopeial limits.

  • Stability for Tropical Export: INH is sensitive to moisture and light. We utilize Alu-Alu or high-grade PVC/PVDC blister packaging to ensure a 36-month shelf life for export to Zone IVb regions (Africa, SE Asia, and CIS countries).

  • Pharmacovigilance (Vitamin B6): It is industry standard to recommend co-administration with Pyridoxine (Vitamin B6) to prevent peripheral neuropathy, a common side effect of INH. We often market these as a bundle or a “combipack.”

Isoniazid Tablets

 

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