Description

Rifampicin, Isoniazid, and Ethambutol Tablets (RHE FDC)

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 Ethambutol Tablets in India. This Triple Fixed-Dose Combination (FDC) is a vital component of anti-tuberculosis chemotherapy. It is typically utilized in the Continuation Phase of treatment for patients living in areas with high levels of Isoniazid resistance, or in specific clinical scenarios where Pyrazinamide is contraindicated (e.g., severe liver disease or pregnancy complications).

We offer Contract Manufacturing (Third Party) services for this complex multi-drug formulation. Combining three active ingredients—one of which (Ethambutol) is highly hygroscopic and another (Rifampicin) which is sensitive to oxidation—requires advanced manufacturing capabilities. Our WHO-GMP certified facility in Mumbai utilizes specialized Trilayer Tableting or barrier-coating technology to ensure physical separation and chemical stability of the ingredients. Healthy Inc manages the export logistics, supplying National Tuberculosis Elimination Programs (NTEP) and global NGOs across Africa, CIS countries, and Southeast Asia.

2. Product Specifications

3. Manufacturing Technology

Stability is the primary challenge in this triple combination.

• The Manufacturer: Healthy Life Pharma Pvt. Ltd.

  • Chemical Separation: Rifampicin can degrade Isoniazid, and Ethambutol is hygroscopic (absorbs moisture), which accelerates this degradation. We often use Bilayer or Trilayer Technology to physically separate the Rifampicin from the Isoniazid/Ethambutol layer, or use specialized barrier coating on the granules.

  • Hygroscopicity Management: Ethambutol Hydrochloride absorbs moisture easily, which ruins the tablet. We manufacture in Dehumidified Suites (< 20% RH) and use moisture-protective excipients to ensure the tablet remains hard and stable.

  • Bioavailability: We use super-disintegrants to ensure that despite the large size of the tablet, it breaks down rapidly in the stomach to release all three drugs effectively.

• The Exporter: Healthy Inc

  • Patient Kits: We specialize in packaging these tablets into Daily Treatment Kits (often combining blister packs for the intensive or continuation phase), which facilitates DOTS (Directly Observed Treatment, Short-course) compliance.

4. Quality Assurance

We adhere to strict Pharmacopoeial standards:

• Dissolution: We test release profiles to ensure >75% of all three drugs release within 45 minutes.

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

• Impurity Profiling: We strictly monitor for Rifampicin Quinone and Isonicotinyl Hydrazone (interaction products) to ensure the product remains safe and effective throughout the shelf life.

5. Why Use Rifampicin + Isoniazid + Ethambutol?

It provides a robust continuation phase regimen.

• Mechanism:

  • Rifampicin: Sterilizes lesions (kills dormant bacteria).

  • Isoniazid: Kills rapidly dividing bacteria.

  • Ethambutol: Inhibits cell wall synthesis (bacteriostatic) and helps prevent the emergence of resistance to Rifampicin if Isoniazid resistance is already present.

• Key Indications:

  • TB Treatment: Often used in the continuation phase (daily regimen) where Isoniazid resistance is suspected but MDR-TB is not confirmed.

  • Alternative Regimen: Used for the full duration of treatment in patients who cannot tolerate Pyrazinamide (e.g., severe hepatotoxicity).

6. Export and Regulatory Support

We streamline the registration process for our B2B partners:

• Dossier Support: We offer CTD and ACTD Dossiers (with Stability Data) 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 RHE Tablets?

  A: Healthy Life Pharma Pvt. Ltd. manufactures them in India using advanced stabilization technology.

• Q: Why are there 3 drugs in one pill?

  A: To prevent drug resistance. Taking single drugs alone (monotherapy) causes TB bacteria to become resistant. Taking them together ensures the bacteria are killed completely.

• Q: Can this cause eye problems?

  A: Yes. Ethambutol can cause optic neuritis (blurred vision or color blindness). Patients should have their vision checked regularly.

• Q: Why is my urine red?

  A: This is caused by Rifampicin. It is harmless and temporary.

CLINICAL PHARMACOLOGY & SAFETY INFORMATION

(For Registered Medical Practitioners & Patient Reference)

8. Dosage and Administration

• Standard Dosage: Dosed by body weight (usually 4 tablets of the 150/75/275 strength for a standard adult weight band).

• Administration: The entire daily dose must be taken at one time on an empty stomach (1 hour before or 2 hours after meals).

9. Side Effects and Precautions

• Ocular Toxicity: Ethambutol can cause retrobulbar neuritis (loss of visual acuity/color vision). Stop immediately if vision changes occur.

• Hepatotoxicity: Risk of liver damage from Rifampicin and Isoniazid. Monitor liver function tests (LFTs).

• Peripheral Neuropathy: Caused by Isoniazid. Pyridoxine (Vitamin B6) supplementation is recommended.

   

• Interactions: Rifampicin induces metabolic enzymes, reducing the efficacy of many other drugs (HIV meds, oral contraceptives).

10. Storage Instructions

• Store below 25°C in a dry place.

• Protect from moisture. (Crucial due to Ethambutol).