In the pharmaceutical industry, Ethambutol 400 mg is a foundational antimycobacterial agent specifically used in the treatment of Tuberculosis (TB). As a pharmacist and manufacturer, I classify this as a core component of “First-Line” TB therapy, almost always used in combination with other drugs like Isoniazid, Rifampicin, and Pyrazinamide.
At your WHO-GMP facility in Mumbai, you likely manufacture this in 400 mg and 800 mg tablets to support the RNTCP (Revised National TB Control Program) or international DOTS programs.
Primary Clinical Indications
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Pulmonary Tuberculosis: Used to treat active TB infections of the lungs.
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Extrapulmonary Tuberculosis: Indicated for TB affecting other organs, such as the lymph nodes, bones, or kidneys.
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MAC Infections: Used to treat Mycobacterium avium complex, particularly in immunocompromised patients.
Mechanism: Cell Wall Synthesis Inhibition
Ethambutol is primarily bacteriostatic, meaning it prevents the bacteria from multiplying.
Enzyme Targeting: It inhibits the enzyme arabinosyl transferase.
Disrupting the Wall: This enzyme is essential for synthesizing arabinogalactan, a critical component of the mycobacterial cell wall.
Increased Permeability: By damaging the cell wall, Ethambutol makes the bacteria more vulnerable and enhances the penetration of other TB drugs like Isoniazid.
The Pharmacist’s “Technical Warning”
As you promote your firm on digital platforms, highlighting these technical nuances is essential for clinical authority:
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Optic Neuritis: The most significant side effect is inflammation of the optic nerve. Patients must be advised to report any changes in visual acuity or red-green color blindness immediately.
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Renal Monitoring: Since Ethambutol is primarily excreted by the kidneys, the 400 mg dose may need adjustment in patients with renal impairment.
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Uric Acid Levels: It can decrease the excretion of uric acid, potentially triggering Gout in susceptible patients.
The Manufacturer’s Perspective: Technical & Export
From a production and B2B standpoint at your facility in Mumbai:
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The “FDC” Strategy: On your marketplace, highlight your Fixed-Dose Combinations (FDCs) (e.g., 3-FDC or 4-FDC). FDCs are the global standard for improving patient compliance in TB treatment and are highly sought after by international health ministries.
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Stability for Export: Ethambutol is stable but moisture-sensitive. Utilizing Alu-Alu blister packaging ensures a 36-month shelf life, which is critical for export to Zone IVb tropical regions in Africa and SE Asia.
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Dossier Support: We provide full CTD/eCTD Dossiers to support your firm’s registration in regulated markets and for bidding on WHO pre-qualification tenders.