Description

Ethambutol Tablets (400mg / 600mg / 800mg / 1000mg)

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 Ethambutol Hydrochloride Tablets in India. Ethambutol is a critical “First-Line” Anti-Tuberculosis Drug used in the initial intensive phase and continuation phase of TB treatment (as part of the standard HRZE regimen). It is specifically included to prevent the emergence of drug resistance to Isoniazid and Rifampicin.

We offer Contract Manufacturing (Third Party) services for this essential public health medicine. Ethambutol is highly hygroscopic (absorbs moisture) and requires precise formulation to ensure stability. Our WHO-GMP certified facility in Mumbai utilizes specialized humidity-controlled manufacturing zones and moisture-barrier Film Coating to ensure the tablets remain potent in the harsh tropical climates where TB is most prevalent. Healthy Inc manages the export logistics, supplying National TB Control Programs, NGOs, and hospitals across Africa, Southeast Asia, and the CIS region.

2. Product Specifications

3. Manufacturing Technology

Ensuring stability in humidity.

• The Manufacturer: Healthy Life Pharma Pvt. Ltd.

  • Hygroscopic Management: Ethambutol HCl avidly absorbs water from the air, which can cause tablets to become soft or sticky. We manufacture in suites with < 30% Relative Humidity (RH) and use Aqueous Film Coating with moisture-barrier polymers (like PVA-PEG) to seal the tablet core effectively.

  • Optical Purity: The drug exists as isomers, but only the (+)-Enantiomer is active against TB. We use high-purity API to ensure the tablet contains exclusively the active form, minimizing toxicity.

  • Direct Compression: To avoid the heat and moisture of wet granulation, we often use direct compression technology, which preserves the chemical integrity of the active ingredient.

• The Exporter: Healthy Inc

  • FDC Capabilities: We can also supply Fixed-Dose Combinations (FDCs) containing Ethambutol + Isoniazid + Rifampicin + Pyrazinamide (4-FDC) for simplified patient adherence.

4. Quality Assurance

We adhere to strict Pharmacopoeial standards:

• Dissolution: We test release profiles to ensure >75% of the drug releases within 45 minutes for rapid absorption.

• Assay: We confirm the potency is strictly within 95-105% of the label claim.

• Specific Optical Rotation: Tested to confirm the correct enantiomer is present.

5. Why Use Ethambutol?

The resistance breaker.

• Mechanism: Ethambutol inhibits the enzyme Arabinosyl Transferase. This enzyme is crucial for synthesizing Arabinogalactan, a key component of the mycobacterial cell wall. By disrupting the cell wall, it stops the bacteria from multiplying (Bacteriostatic).

• Key Indications:

  • Pulmonary Tuberculosis: Used in the initial 2-month intensive phase (HRZE) and sometimes in the continuation phase.

  • MAC Infection: Treatment of Mycobacterium avium complex in HIV patients.

  • Re-treatment Cases: Used in higher doses for patients who have relapsed.

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 Ethambutol Tablets?

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

• Q: Is it Myambutol?

  A: Myambutol is the brand name. We manufacture the Generic Equivalent (Ethambutol HCl).

• Q: Does it affect vision?

  A: Yes. The most serious side effect is Optic Neuritis (blurred vision or loss of red-green color discrimination). Patients should have their eyes checked regularly.

• Q: Is it safe for kidneys?

  A: Dose Adjustment Needed. Since it is excreted by the kidneys, the dose must be reduced in patients with renal impairment to prevent toxicity.

CLINICAL PHARMACOLOGY & SAFETY INFORMATION

(For Registered Medical Practitioners & Patient Reference)

8. Dosage and Administration

• New Patients: 15 mg/kg body weight once daily.

• Re-treatment: 25 mg/kg body weight once daily for 60 days, then 15 mg/kg.

• Administration: Take once daily. Can be taken with food if stomach upset occurs (absorption is not significantly affected by food).

9. Side Effects and Precautions

• Ocular Toxicity: Warning: Report any changes in vision immediately. Stop the drug if visual acuity drops or color blindness develops. Usually reversible if stopped early.

• Hyperuricemia: Can raise uric acid levels (Caution in Gout patients).

• Peripheral Neuropathy: Numbness in hands/feet (rare compared to Isoniazid).

• Pediatrics: Not recommended for children < 6 years (difficult to monitor vision).

10. Storage Instructions

• Store below 25°C in a dry place.

• Moisture Sensitive. Keep container tightly closed.