In the pharmaceutical industry, Rifaximin 400 mg is a unique, non-systemic antibiotic belonging to the rifamycin class. As a pharmacist and manufacturer, I view Rifaximin as a “gut-targeted” therapy. Unlike standard antibiotics that circulate through the entire bloodstream, Rifaximin remains almost entirely in the gastrointestinal tract, providing localized action with minimal systemic side effects.
Primary Clinical Uses
-
Hepatic Encephalopathy (HE): Specifically used to reduce the risk of recurrence of overt HE in adults with chronic liver disease. It helps lower the ammonia-producing bacteria in the gut.
-
Irritable Bowel Syndrome with Diarrhea (IBS-D): Indicated for adults to manage the symptoms of bloating, abdominal pain, and loose stools by modulating the gut microbiota.
-
Traveler’s Diarrhea: Used to treat diarrhea caused by non-invasive strains of Escherichia coli in patients 12 years of age and older.
-
Small Intestinal Bacterial Overgrowth (SIBO): Frequently used off-label by gastroenterologists to treat an overgrowth of bacteria in the small intestine.
Mechanism of Action: RNA Synthesis Inhibition
Rifaximin works by stopping the bacteria from reproducing without killing the beneficial bacteria in the same way systemic antibiotics might.
Enzyme Targeting: It binds to the beta-subunit of bacterial DNA-dependent RNA polymerase.
Transcription Blockade: This binding inhibits the transcription of DNA into RNA, preventing the bacteria from synthesizing essential proteins.
Bacteriostatic Action: It primarily stops the growth of both Gram-positive and Gram-negative aerobic and anaerobic bacteria in the gut.
Non-Absorbability: Due to its chemical structure, less than 0.4% of the drug is absorbed into the blood. This ensures high concentrations in the feces and near-zero impact on other organs like the kidneys or lungs.
The Manufacturer’s Perspective: Technical & Export
From a production and B2B standpoint at your WHO-GMP facility in Mumbai, the 400 mg strength is a high-value specialty item:
-
The 400 mg “Sweet Spot”: While 200 mg is used for Traveler’s Diarrhea and 550 mg is the standard for Hepatic Encephalopathy, the 400 mg dose is a highly versatile intermediate often used in customized IBS-D protocols. Offering this strength on your digital platform sets you apart from firms only carrying the standard 200/550 mg.
-
Polymorphism Control: Rifaximin exists in several polymorphic forms (, , , , and ). As a manufacturer, you know that the (Alpha) form is preferred for its low absorption. Ensuring your Certificate of Analysis (COA) specifies the polymorph type is a major USP for international B2B buyers.
-
Stability & Bioavailability: Although it is non-systemic, the dissolution profile must be strictly controlled to ensure the drug is released at the correct site in the intestine. We utilize Alu-Alu blister packaging to protect the API from the high humidity of Zone IVb regions.
-
Dossier Support: This is a “Specialty Product” with high margins. Our Mumbai facility provides full CTD/eCTD Dossiers to support your export registrations against the innovator (Xifaxan).