Description

Rifampicin and Isoniazid Tablets (RH)

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 Rifampicin and Isoniazid Tablets in India. This Dual Fixed-Dose Combination (FDC) is the primary medication used during the Continuation Phase (usually the last 4 months) of tuberculosis treatment. By combining the two most potent first-line anti-TB drugs, this formulation ensures effective sterilization of remaining bacteria while simplifying the daily regimen for patients.

We offer Contract Manufacturing (Third Party) for this high-volume essential medicine. Our WHO-GMP certified facility in Mumbai uses advanced segregation technology to prevent chemical interactions between the two active ingredients, ensuring that full potency is delivered to the patient. Healthy Inc manages the export logistics, supplying National Tuberculosis Programs (NTP) and global health organizations across Africa, Southeast Asia, and Latin America.

2. Product Specifications

3. Manufacturing Dual FDC (RH) Tablets

Ensuring the bioavailability of Rifampicin in the presence of Isoniazid is the key challenge.

• The Manufacturer: Healthy Life Pharma Pvt. Ltd.

  • Bioavailability Protection: In acidic stomach conditions, Rifampicin can react with Isoniazid to form insoluble hydrazones, which reduces the drug’s effectiveness. We use pH-Modulating Excipients and specialized granulation techniques to physically separate the two drugs within the tablet matrix. This ensures that Rifampicin dissolves fully and remains active.

  • Micronization: We use micronized Rifampicin powder to increase its surface area, ensuring rapid dissolution and absorption.

• The Exporter: Healthy Inc

  • Moisture Barrier: Rifampicin is hygroscopic and sensitive to oxidation. We predominantly use Alu-Alu Cold Form Blisters to provide the highest level of protection against tropical humidity during sea freight.

  • Supply Chain: We are equipped to handle “Kit Packaging” where these tablets are packed alongside Ethambutol or other supplements as per national tender requirements.

4. Quality Assurance

We adhere to strict Pharmacopoeial standards for FDCs:

• Dissolution Profiling: We perform comparative dissolution testing to prove that the FDC releases drugs as effectively as taking them separately.

• Rifampicin Stability: We strictly monitor for the oxidation of Rifampicin (indicated by a color change to dark red/black) and ensure the Quinone impurity is within limits.

• Assay: We confirm 100% label claim for both active ingredients.

5. Why Use This Dual Combination?

It is the “finisher” for TB treatment.

• Mechanism:

  • Rifampicin: Targets semi-dormant organisms (persisters) to prevent relapse.

  • Isoniazid: Continues to kill any remaining rapidly dividing bacteria.

• Key Indications:

  • Continuation Phase: Used after the initial 2 months of intensive therapy (4 drugs) are completed.

  • Prophylaxis: Sometimes used for latent TB in specific high-risk populations.

• Compliance: Reduces the number of pills a patient must take daily, which is critical for a treatment that lasts 6 months.

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 Rifampicin Isoniazid Tablets?

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

• Q: Can I stop taking it once I feel better?

  A: No. You must complete the full course (usually 4 months of this tablet). Stopping early causes drug-resistant TB (MDR-TB), which is much harder to cure.

• Q: Why is the tablet red/brown?

  A: The color comes from Rifampicin itself, which is naturally a dark red-orange powder.

CLINICAL PHARMACOLOGY & SAFETY INFORMATION

(For Registered Medical Practitioners & Patient Reference)

8. Dosage and Administration

• Standard Dosage: Based on body weight bands. Taken daily or intermittently (3 times/week) depending on the National Program guidelines.

• Administration: Must be taken on an empty stomach (1 hour before or 2 hours after a meal) with water.

9. Side Effects and Precautions

• Hepatotoxicity: Both drugs are metabolized by the liver. Patients should report nausea, vomiting, or yellowing of eyes (jaundice) immediately.

• Peripheral Neuropathy: Isoniazid can cause nerve pain; Vitamin B6 (Pyridoxine) is often prescribed alongside to prevent this.

• Orange Body Fluids: Urine, sweat, saliva, and tears will turn orange-red. This is harmless but can stain clothes and contact lenses.

10. Storage Instructions

• Store below 25°C in a dry place.

• Keep strictly protected from moisture and light.