Ethambutol Tablets

Description

Ethambutol Tablets (200 mg / 400 mg / 800 mg)

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. manufactures Ethambutol Hydrochloride Tablets in India. Ethambutol is an antimycobacterial medicine used as part of combination regimens for tuberculosis (TB). It is not used alone to treat active TB because resistance can develop. The combination and duration of therapy depend on drug susceptibility, national TB program guidance and individual clinical circumstances.

2. Product Specifications

3. Manufacturing Technology

• Moisture management: Process conditions, excipients and protective packaging are selected based on formulation-specific moisture and stability studies; a universal humidity threshold should not be assumed.
• Manufacturing: Direct compression or another validated process may be used according to the registered formula.
• Quality of API: Appropriate identity, stereochemical specifications and impurity controls are applied according to relevant standards.
• Combination therapy: Fixed-dose combination products are separate formulations and require their own development and registration.

4. Quality Assurance

• Identity, assay, content uniformity, dissolution and related substances are tested using the applicable registered or pharmacopoeial methods.
• Specific optical rotation or other stereochemical testing is applied where required by the standard.
• Acceptance limits and shelf life are product-specific and should not be represented by universal figures.

5. Pharmacology and Clinical Use

Ethambutol inhibits mycobacterial arabinosyl transferases involved in cell-wall arabinogalactan biosynthesis. It is primarily bacteriostatic and is used with other effective drugs for susceptible TB. It may also be included in selected regimens for nontuberculous mycobacterial infections, such as Mycobacterium avium complex, under specialist guidance.

Drug-resistant TB or retreatment regimens should be based on susceptibility testing and current guidelines, not automatic higher-dose schedules.

6. Export and Regulatory Support

Product-specific CTD/ACTD documentation, certificates of analysis and applicable regulatory certificates may be provided subject to availability and market requirements. Export packaging and shipping are arranged in line with registered storage and distribution specifications.

7. Frequently Asked Questions

Who manufactures Ethambutol Tablets?
Healthy Life Pharma Pvt. Ltd., India.

Is it Myambutol?
Myambutol is a brand containing ethambutol. Equivalence to a particular reference product requires appropriate product-specific regulatory evidence.

Can it affect vision?
Yes. Optic neuropathy can affect visual acuity and colour vision. Patients should report blurred vision or colour changes immediately and receive prompt medical assessment.

Is dose adjustment needed with kidney disease?
Yes, reduced renal function can increase exposure and may require dose or interval adjustment and closer monitoring.

8. Dosage and Administration

Ethambutol dosing is weight-based and depends on the treatment regimen, renal function, age, susceptibility results and applicable TB guidance. It must be taken with other prescribed anti-TB medicines, not as monotherapy for active TB. Prescribers should follow current national or WHO-aligned protocols and the registered product label.

9. Side Effects and Precautions

• Vision: Optic neuropathy is an important potentially serious adverse effect. Baseline and follow-up vision assessment should be considered according to treatment guidance, particularly in patients with renal impairment or prolonged exposure. Visual symptoms require urgent review.
• Kidneys: Ethambutol is substantially renally eliminated; dose adjustment may be necessary.
• Other: Increased uric acid, nausea, rash and peripheral neuropathy may occur.
• Children: Paediatric use is guided by weight-based protocols and appropriate monitoring; a blanket prohibition below six years is not accurate.

10. Storage Instructions

Store according to the registered product label, protected from excessive heat and moisture. Keep packaging tightly closed and out of reach of children.