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What is Rifampicin 150mg Isoniazid 75mg tablets used for?

In the pharmaceutical industry, the combination of Rifampicin (150 mg) and Isoniazid (75 mg) is a cornerstone Fixed-Dose Combination (FDC).

As a pharmacist and manufacturer, I classify this as the “Maintenance Phase” (or Continuation Phase) workhorse. After the initial intensive attack on Tuberculosis (TB), this $2\text{-}in\text{-}1$ ratio is used to ensure the complete eradication of remaining bacteria while significantly reducing “pill burden”—the primary factor in preventing the development of Multi-Drug Resistant TB (MDR-TB).

Primary Clinical Uses

  • Pulmonary Tuberculosis: Used during the continuation phase of treatment (typically months 3 through 6) to eliminate “persister” bacilli.

  • Extra-pulmonary Tuberculosis: Treatment of TB located in the bones, lymph nodes, or central nervous system.

  • Latent TB Infection (LTBI): Often used in high-risk patients (such as those with HIV or household contacts of active TB cases) as preventive therapy to stop the infection from becoming active.

Dual Mechanism of Action: The Synergistic Attack

These two APIs attack Mycobacterium tuberculosis through entirely different pathways, ensuring that the bacteria cannot easily develop resistance.

Isoniazid (INH): The Cell Wall Destroyer

Action: It inhibits the synthesis of mycolic acids, which are unique and essential components of the mycobacterial cell wall.

Result: Without this waxy protective layer, the bacteria become fragile and die. It is highly effective against rapidly dividing bacilli.

Rifampicin: The Genetic Silencer

Action: It inhibits bacterial DNA-dependent RNA polymerase.

    • Result: This prevents the bacteria from transcribing DNA into RNA, effectively stopping them from making the proteins necessary for survival. It is a powerful “sterilizing agent” that kills slow-growing or semi-dormant bacteria.

The Manufacturer’s Perspective: Technical & Export

From a production and global trade standpoint at your WHO-GMP facility in Mumbai, this FDC is a high-volume essential:

  • Rifampicin Stability: Rifampicin is notoriously sensitive to moisture and can act as a catalyst for the degradation of Isoniazid if the formulation isn’t optimized. At our facility, we prioritize Alu-Alu blister packaging to provide a total moisture barrier, ensuring a 36-month shelf life.

  • The “Orange Effect” (Technical Transparency): As a pharmacist, your digital product literature should note that Rifampicin causes a harmless orange-red discoloration of urine, sweat, and tears. Including this detail in your B2B dossiers builds trust and professional recognition.

  • Bioavailability (BA) Challenges: Achieving bioequivalence for Rifampicin in a combination tablet is technically demanding. Our Mumbai facility utilizes precise particle size distribution to ensure your export version matches the absorption rate of the innovator product.

  • NGO & Government Tenders: This combination is a staple for the Global Fund and Stop TB Partnership. We provide full CTD/eCTD Dossiers to help your firm bid for these large-scale international contracts.

Rifampicin Isoniazid Tablet

 

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What is Rifampicin Isoniazid and Ethambutol Hydrochloride tablets used for?

In the pharmaceutical industry, the combination of Rifampicin, Isoniazid, and Ethambutol Hydrochloride is a high-potency 3-in-1 Fixed-Dose Combination (FDC).As a pharmacist and manufacturer, I classify this as the “Intensive Phase” cornerstone for Tuberculosis (TB) treatment. By combining these three specific APIs into a single tablet, we significantly reduce the “pill burden” for patients, which is the most effective strategy to ensure treatment adherence and prevent the rise of Multi-Drug Resistant TB (MDR-TB).

Primary Clinical Uses

  • Initial (Intensive) Phase of Tuberculosis: Used during the first 2 months of a standard TB regimen to rapidly reduce the bacterial load in patients with active pulmonary or extra-pulmonary TB.

  • MDR-TB Prevention: Because it ensures the patient takes all three critical drugs simultaneously, it prevents “monotherapy by default” (where a patient might forget one pill), which is a leading cause of drug resistance.

Triple Mechanism of Action (The Multi-Target Attack)

This combination attacks Mycobacterium tuberculosis through three distinct pathways, ensuring that even resistant or dormant strains are neutralized.

Isoniazid (INH): The Cell Wall Inhibitor

Targets the synthesis of mycolic acids. Without these, the protective waxy cell wall of the TB bacilli collapses.

Rifampicin: The Genetic Disruptor

Inhibits DNA-dependent RNA polymerase. This stops the bacteria from transcribing DNA into protein, effectively “silencing” its life functions.

Ethambutol Hydrochloride: The Permeability Enhancer

    • Inhibits the enzyme arabinosyltransferase, which stops the synthesis of the cell wall component arabinogalactan. This makes the cell wall “leaky,” allowing the Isoniazid and Rifampicin to penetrate the bacteria more easily.

The Manufacturer’s Perspective: Technical & Export

From a production standpoint at your WHO-GMP facility in Mumbai, this 3-way FDC is a sophisticated product to manufacture:

  • Chemical Compatibility: Rifampicin can be highly reactive. As a firm owner, you know that ensuring the stability of these three APIs together requires specialized granulation techniques and pH-controlled excipients to prevent degradation.

  • Ethambutol’s Hygroscopicity: Ethambutol HCl is highly hygroscopic (absorbs moisture). To ensure a 36-month shelf life for export to Zone IVb regions (like Africa or SE Asia), we utilize Alu-Alu blister packaging to provide an absolute moisture barrier.

  • The “Vision & Urine” Technical Note: For your digital platform, professional recognition is built by providing clinical warnings. Rifampicin turns urine orange (harmless), but Ethambutol requires monitoring for Optic Neuritis (visual changes). Including this in your B2B dossiers shows you are a clinically-driven manufacturer.

  • B2B & NGO Tenders: This FDC is a high-volume requirement for the Global Fund and Stop TB Partnership. Our Mumbai facility provides full CTD/eCTD Dossiers to support your firm in bidding for these massive international contracts.

Rifampicin Isoniazid Ethambutol Tablets

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