In the pharmaceutical industry, Ethambutol Hydrochloride 200 mg is a specific bacteriostatic antimycobacterial agent. As a pharmacist, I characterize this 200 mg strength as a fundamental component of the RHE (Rifampicin, Hyrazinamide, Ethambutol) or RHZE intensive-phase tuberculosis treatment, often utilized in weight-based dosing for pediatric or low-body-weight adult patients.

Primary Clinical Uses

• Pulmonary Tuberculosis (TB): Used as part of a multi-drug regimen to treat active TB caused by Mycobacterium tuberculosis. It is never used alone to prevent the rapid development of drug resistance.

• Extrapulmonary Tuberculosis: Indicated for TB infections outside the lungs, such as TB meningitis or miliary tuberculosis.

• Mycobacterium Avium Complex (MAC): Used to treat and prevent disseminated MAC infections, particularly in immunocompromised patients (such as those with HIV).

Mechanism of Action

Ethambutol works by disrupting the structural integrity of the bacterial cell wall.

1. Enzyme Inhibition: It specifically inhibits the enzyme arabinosyltransferase.

2. Cell Wall Disruption: This enzyme is responsible for the synthesis of arabino-galactan, a critical component of the mycobacterial cell wall.

3. Growth Arrest: By halting the production of this structural “glue,” the cell wall becomes permeable and incomplete, effectively stopping the bacteria from dividing and spreading.

The Manufacturer’s Perspective: Formulation & Export

From a manufacturing and global trade standpoint, Ethambutol 200 mg is a high-volume “Essential Medicine” with specific technical requirements:

• Hygroscopic API: Ethambutol Hydrochloride is highly hygroscopic (it absorbs moisture from the air). As a WHO-GMP manufacturer, we maintain strict humidity controls during the compression process and utilize Alu-Alu blister packaging to ensure a stable 36-month shelf life for export to Zone IVb regions.

• Assay Precision: Because TB treatment requires precise weight-based dosing (typically 15–25 mg/kg), we ensure absolute content uniformity in the 200 mg tablet to guarantee the patient receives the exact therapeutic dose.

• Public Health Tenders: This product is a staple for the World Health Organization (WHO), the Global Fund, and national TB programs. Our Mumbai-based facility provides the CTD/eCTD Dossiers and stability data required for international registration.

• Pharmacovigilance (Ocular Toxicity): As a pharmacist, you know Ethambutol carries a risk of optic neuritis. We ensure our Product Information Leaflets (PIL) emphasize the need for baseline and periodic visual acuity tests.