Description

Isoniazid Tablets (100mg / 300mg)

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. is a specialized Manufacturer of Isoniazid Tablets in India. Isoniazid (INH) is the cornerstone First-Line Anti-Tuberculosis (TB) Drug used globally for the treatment of active tuberculosis and for Latent TB Infection (LTBI) prophylaxis. It is highly bactericidal against replicating Mycobacterium tuberculosis.

We offer Contract Manufacturing (Third Party) services for this essential public health medicine. Isoniazid is unstable in the presence of moisture and certain excipients (like lactose) if not processed correctly. Our WHO-GMP certified facility in Mumbai utilizes advanced Granulation Technology to ensure stability and precise dosing. Healthy Inc manages the export logistics, supplying National TB Control Programs, NGOs, and hospitals across Africa, Southeast Asia, and CIS countries.

2. Product Specifications

3. Manufacturing Technology

Stability and bioavailability are the keys to a cure.

• The Manufacturer: Healthy Life Pharma Pvt. Ltd.

  • Maillard Reaction Prevention: Isoniazid can react with lactose (a common filler) to form a brownish impurity if the formulation is incorrect. We use lactose-free or compatible fillers and specific binders to prevent discoloration and loss of potency.

  • Dissolution: Rapid absorption is critical for killing bacteria. We optimize the disintegration time to ensure the drug releases quickly (< 30 mins) in the stomach.

  • Pediatric Formulations: We are capable of manufacturing Dispersible Tablets (100mg) for children, which dissolve easily in water, supporting pediatric TB eradication goals.

• The Exporter: Healthy Inc

  • Bulk Tenders: We specialize in high-volume HDPE Jar packaging (1000 tablets) often required for government DOTS (Directly Observed Therapy, Short-course) centers.

4. Quality Assurance

We adhere to strict Pharmacopoeial standards:

• Dissolution: We test release profiles to ensure >80% of the drug releases within 45 minutes.

• Assay: We confirm the potency is strictly within 90-110% of the label claim.

• Impurity Profiling: We strictly monitor for Hydrazine (a toxic impurity) to ensure it remains below stringent international limits.

5. Why Use Isoniazid?

It destroys the TB bacteria’s protective wall.

• Mechanism: Isoniazid is a prodrug. It must be activated by the bacterial enzyme KatG. Once active, it inhibits the synthesis of Mycolic Acids, which are essential components of the mycobacterial cell wall. Without this wall, the bacteria lose their structure and die.

• Key Indications:

  • Active TB: Always used in combination with Rifampicin, Pyrazinamide, and Ethambutol (HRZE regimen).

  • Latent TB: Used alone (monotherapy) for 6-9 months to prevent dormant TB from becoming active.

6. Export and Regulatory Support

We streamline the registration process for our B2B partners:

• Dossier Support: We offer CTD and ACTD Dossiers for quick registration.

• Certificates: Free Sale Certificate (FSC), COPP (WHO-GMP), and COA.

• Logistics: Efficient shipping via Air or Sea (FOB Mumbai / CIF).

7. Frequently Asked Questions

• Q: Who manufactures Isoniazid Tablets?

  A: Healthy Life Pharma Pvt. Ltd. manufactures them in India.

• Q: Do I need Vitamin B6 (Pyridoxine)?

  A: YES. Isoniazid depletes Vitamin B6 in the body, which can cause nerve damage (neuropathy). It is standard practice to take Pyridoxine (10-50mg) daily alongside Isoniazid.

• Q: Can I drink alcohol?

  A: Avoid it. Alcohol increases the risk of Hepatitis (liver damage) caused by Isoniazid.

• Q: Why is my skin tingling?

  A: This is “Peripheral Neuropathy,” a side effect of B6 deficiency. Tell your doctor immediately; you may need more Vitamin B6.

CLINICAL PHARMACOLOGY & SAFETY INFORMATION

(For Registered Medical Practitioners & Patient Reference)

8. Dosage and Administration

• Active TB (Adults): 5mg/kg daily (Max 300mg).

• Latent TB (Adults): 300mg daily for 6 to 9 months.

• Children: 10mg/kg daily (Max 300mg).

• Administration: Take on an empty stomach (1 hour before meals).

9. Side Effects and Precautions

• Hepatotoxicity: Black Box Warning: Severe and sometimes fatal hepatitis can occur. Monitor liver enzymes (ALT/AST) monthly. Stop if enzymes rise >3x normal with symptoms.

• Neuropathy: Numbness/tingling in hands and feet (preventable with B6).

• Hypersensitivity: Fever, rash, or lupus-like syndrome.

• Interaction: Increases levels of Phenytoin (seizure drug).

10. Storage Instructions

• Store below 25°C in a dry place.

• Protect from light and moisture.