Description

Rifampicin, Isoniazid and Pyrazinamide Tablets (RHZ)

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, Isoniazid, and Pyrazinamide Tablets in India. This Triple Fixed-Dose Combination (FDC) is a cornerstone of the Intensive Phase (first 2 months) of tuberculosis treatment recommended by the World Health Organization (WHO). By combining three powerful first-line antibiotics into a single tablet, we significantly reduce “pill burden” and improve patient adherence to therapy.

We offer Contract Manufacturing (Third Party) for this chemically complex formulation. Our WHO-GMP certified facility in Mumbai utilizes advanced formulation techniques to prevent the chemical interaction between Rifampicin and Isoniazid, ensuring the bioavailability of all three drugs. Healthy Inc manages the export logistics, supplying National Tuberculosis Elimination Programs (NTEP) and NGOs across Africa, Southeast Asia, and CIS countries.

2. Product Specifications

3. Manufacturing Triple FDC (RHZ) Tablets

Manufacturing this combination requires overcoming significant stability challenges.

• The Manufacturer: Healthy Life Pharma Pvt. Ltd.

  • Chemical Stability: In the presence of stomach acid or moisture, Rifampicin can react with Isoniazid to form inactive hydrazones, reducing efficacy. We use specific excipients and Molecular Shielding techniques during granulation to minimize physical contact between these two active ingredients before they dissolve.

  • Bioavailability: Rifampicin is poorly soluble. We use high-grade micronized API and specific surfactants to ensuring it dissolves rapidly (within 45 minutes) to reach therapeutic blood levels.

• The Exporter: Healthy Inc

  • Protection: Rifampicin is extremely sensitive to moisture and light. We use Alu-Alu Cold Form Blisters or dark amber glass/HDPE bottles with heavy-duty desiccants.

  • Logistics: We are experienced in managing large-scale tenders for TB programs, ensuring batch consistency and timely delivery for government procurements.

4. Quality Assurance

We adhere to strict Pharmacopoeial standards for FDCs:

• Dissolution Profiling: We test the release of all three drugs simultaneously to ensure bioequivalence.

• Related Substances: We strictly monitor for Rifampicin Quinone and Isoniazid degradation products.

• Rifampicin Content: We ensure the potency remains within 90-110% limits, as Rifampicin is the sterilization agent in the combo.

5. Why Use This Triple Combination?

It is essential for the initial “Intensive Phase” of TB treatment.

• Mechanism:

  • Rifampicin: Kills semi-dormant bacteria (sterilizing activity).

  • Isoniazid: Kills rapidly dividing bacteria (bactericidal).

  • Pyrazinamide: Kills bacteria hidden in acidic environments (like macrophages/inflammation sites).

• Key Indications:

  • Pulmonary and Extra-Pulmonary Tuberculosis: Used for the first 2 months of treatment to rapidly reduce the bacterial load.

• Advantage: Prevents monotherapy (taking only one drug), which causes drug resistance (MDR-TB).

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 Pyrazinamide Tablets?

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

• Q: Why does this tablet turn urine red?

  A: This is a harmless side effect of Rifampicin. It stains body fluids (urine, sweat, tears) orange-red.

• Q: Can this be taken with food?

  A: No. Food significantly reduces the absorption of Rifampicin. It must be taken on an empty stomach.

CLINICAL PHARMACOLOGY & SAFETY INFORMATION

(For Registered Medical Practitioners & Patient Reference)

8. Dosage and Administration

• Standard Dosage: Based on body weight bands (usually 2, 3, 4, or 5 tablets daily).

• Administration: The entire daily dose should be taken at once, on an empty stomach (1 hour before or 2 hours after a meal).

9. Side Effects and Precautions

• Hepatotoxicity: All three drugs can damage the liver. Monitor liver enzymes (SGOT/SGPT) regularly. Avoid alcohol completely.

• Joint Pain: Pyrazinamide can cause high uric acid (gout) leading to joint pain.

• Discoloration: Warn patients that urine, sweat, and tears may turn orange/red. Soft contact lenses may be permanently stained.

10. Storage Instructions

• Store below 25°C in a dry place.

• Keep strictly protected from moisture and light.