Rifaximin Ph.Eur Tablets

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Description

Rifaximin Tablets Ph.Eur. (200 mg / 400 mg / 550 mg)

Healthy Inc is a specialized global supplier and exporter of advanced gastroenterological, hepatology, and anti-infective therapeutics. We provide ultra-high-purity, kinetically controlled Rifaximin Film-Coated Tablets (200 mg / 400 mg / 550 mg), manufactured in WHO–GMP certified, high-precision oral solid dosage facilities. This “Gut-Selective Non-Absorbable Antibiotic” is a massive-volume, premium export to hepatology centers, gastroenterology clinics, infectious disease NGOs, and government health ministries in LATAM, the Middle East, Africa, and Southeast Asia, serving as the globally mandated intervention for Hepatic Encephalopathy, Irritable Bowel Syndrome (IBS-D), and Traveler’s Diarrhea.


Product Overview

This highly advanced formulation contains Rifaximin, a structural analog of rifampin that has been specifically engineered to remain entirely trapped inside the gastrointestinal tract, acting as a powerful “topical” antibiotic for the gut lining.

The “Non-Systemic Gut Modulator” Specialist:

  • Mechanism 1 (The Localized RNA Blockade): Less than 1% of Rifaximin is absorbed into the bloodstream. It travels down the digestive tract and directly binds to the beta-subunit of the bacterial DNA-dependent RNA polymerase enzyme. This aggressively shuts down the bacteria’s ability to produce RNA and proteins, rapidly eradicating targeted pathogens directly at the site of infection in the gut.
  • Mechanism 2 (Hepatic Encephalopathy Shield – 550 mg): In patients with severe liver cirrhosis, the failing liver cannot filter out ammonia produced by gut bacteria. This ammonia crosses into the brain, causing confusion, coma, and death (Hepatic Encephalopathy). High-dose Rifaximin constantly suppresses these ammonia-producing bacteria in the colon, preventing the neurotoxins from ever forming, drastically reducing hospital readmissions for cirrhosis patients.
  • The “Eubiotic” Advantage (IBS-D): Unlike broad-spectrum systemic antibiotics (like Ciprofloxacin) that napalm the entire body’s microbiome, Rifaximin acts as a “eubiotic.” It resets the gut flora in patients with Irritable Bowel Syndrome with Diarrhea (IBS-D) and Small Intestinal Bacterial Overgrowth (SIBO) without causing massive systemic side effects or heavy collateral damage to beneficial systemic bacteria.

Product Composition & Strength

We supply this product as a Precision-Engineered Film-Coated Tablet, packed exclusively in highly secure, moisture-resistant Alu-Alu blister strips to ensure the absolute stability of the crystalline polymorph structure.

Active IngredientStrengthPrimary Clinical Function
Rifaximin Ph.Eur.200 mg / 400 mgGI Infection Dose: Acute eradication of non-invasive E. coli (Traveler’s Diarrhea).
Rifaximin Ph.Eur.550 mgHepatology & IBS Standard: High-dose maintenance therapy for Hepatic Encephalopathy and IBS-D.
ExcipientsMicrocrystalline Cellulose / Sodium Starch Glycolate / Colloidal Silicon Dioxide / Propylene GlycolDiluent / Superdisintegrant / Glidant / Film-Coating Plasticizer (Engineered for optimal dispersion throughout the intestinal lumen)

*Pack Sizes: 10×10 Alu-Alu Blisters or 14-Tablet Blisters (Optimized specifically for standard acute infection or chronic hepatology dispensing regimens).


Technical & Logistics Specifications

Critical data for Pharmaceutical Importers, Gastroenterology Distributors, and Hospital Procurement Boards.

HS Code3004.20.99 (Medicaments containing other antibiotics)
CAS Number80621-81-4
Dosage FormFilm-Coated Tablet (Localized GI Action)
PackagingAlu-Alu Blisters (STRICTLY MANDATORY). Rifaximin’s crystalline structure is susceptible to phase changes if exposed to extreme humidity. Heavy-gauge Alu-Alu packaging guarantees structural integrity across Zone IVb tropical climates.
StorageStore strictly below 25°C in a dry place. Protect from Light and Moisture.

Manufacturing Authority

Marketed and Distributed by Healthy Inc from WHO-GMP & ISO 9001:2015 certified units.

  • Strict Polymorph-Alpha Engineering (CRITICAL COMPLIANCE): The safety of Rifaximin relies entirely on its insolubility. If the wrong crystalline form (like Polymorph Gamma) is manufactured, the drug will absorb into the patient’s bloodstream and cause severe systemic toxicity. Our facilities utilize elite crystallization control and rigorous X-ray Powder Diffraction (XRPD) testing to guarantee that 100% of the API is the highly insoluble, completely non-absorbable Polymorph Alpha (or equivalent pharmacopeial standard), ensuring absolute clinical safety and bioequivalence.

Therapeutic Indications (Human Use)

Indicated for the targeted management of severe gastrointestinal and hepatological conditions:

  • Hepatic Encephalopathy (HE): Reduction in risk of overt HE recurrence in adults with advanced liver disease (typically 550 mg).
  • Irritable Bowel Syndrome with Diarrhea (IBS-D): Treatment of IBS-D in adult patients.
  • Traveler’s Diarrhea: Treatment of traveler’s diarrhea caused by non-invasive strains of Escherichia coli (typically 200 mg).

Dosage & Administration

Recommended Dosage (Strictly as per Gastroenterologist/Hepatologist Guidelines):

  • Hepatic Encephalopathy: 550 mg taken orally twice daily (BID).
  • IBS-D: 550 mg taken orally three times a day (TID) for 14 days.
  • Traveler’s Diarrhea: 200 mg taken orally three times a day (TID) for 3 days.
  • Administration: Tablets can be taken with or without food and must be swallowed whole.

Safety Warnings (CRITICAL Regulatory & Clinical Data):

  • Invasive Pathogen Contraindication: Rifaximin is strictly contraindicated in patients experiencing diarrhea complicated by fever, or blood in the stool (dysentery). These symptoms indicate an invasive pathogen (like Campylobacter or Salmonella) that has penetrated the gut wall. Because Rifaximin stays in the gut lumen, it cannot reach these invasive bacteria, leading to treatment failure.
  • Clostridium difficile-Associated Diarrhea (CDAD): Although rare due to its eubiotic nature, nearly all antibiotics can alter the normal flora of the colon leading to overgrowth of C. difficile. If CDAD is suspected, therapy must be stopped immediately.
  • Severe Hepatic Impairment: Because a tiny fraction of the drug is absorbed and cleared by the liver, systemic exposure is significantly increased in patients with severe hepatic impairment (Child-Pugh Class C). Caution must be exercised in this population.

Global Export & Contract Manufacturing Services

Healthy Inc stands as a premier Pharmaceutical Exporter in India, dedicated to serving international Pharma Traders, Wholesalers, and NGO Health Networks. As a verified Medicine Supplier in Mumbai, we offer flexible Third Party Manufacturing (Contract Manufacturing) services for Advanced Hepatology and Gastrointestinal Formulations. Whether you need a reliable Hospital Tender Supplier for HE management in Africa or a B2B Pharma Marketplace partner for Latin America, our logistics network ensures timely delivery of WHO-GMP certified products.

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