Product Information
Registration Status: ActiveXIFAXAN FILM-COATED TABLET 550MG is approved to be sold in Singapore with effective from 2015-03-23. It is marketed by UNITED ITALIAN TRADING CORPORATION PTE LTD, with the registration number of SIN14761P.
This product contains Rifaximin 550mg in the form of TABLET, FILM-COATED. It is approved for ORAL use.
This product is manufactured by Alfa Wassermann S.p.A. in ITALY.
It is a Prescription Only Medicine that can only be obtained from a doctor or a dentist, or a pharmacist with a prescription from a Singapore-registered doctor or dentist.
Description
Rifaximin is a semisynthetic, rifamycin-based non-systemic antibiotic, meaning that the drug will not pass the gastrointestinal wall into the circulation as is common for other types of orally administered antibiotics. It has multiple indications and is used in treatment of traveller's diarrhea caused by E. coli; reduction in risk of overt hepatic encephalopathy recurrence; as well as diarrhea-predominant irritable bowel syndrome (IBS-D) in adult women and men. It is marketed under the brand name Xifaxan by Salix Pharmaceuticals.
Indication
Rifaximin has multiple indications by the FDA: for the treatment of patients (≥12 years of age) with traveller's diarrhea caused by noninvasive strains of Escherichia coli; for the reduction of overt hepatic encephalopathy recurrence in patients ≥18 years of age; and in May 2015 it was approved for irritable bowel syndrome with diarrhea (IBS-D) treatment in adult men and women.
Mechanism of Action
Rifaximin acts by inhibiting RNA synthesis in susceptible bacteria by binding to the beta-subunit of bacterial deoxyribonucleic acid (DNA)-dependent ribonucleic acid (RNA) polymerase enzyme. This results in the blockage of the translocation step that normally follows the formation of the first phosphodiester bond, which occurs in the transcription process.
Pharmacokinetics
- Absorption
- Low absorption in both the fasting state and when administered within 30 minutes of a high-fat breakfast.
- Distribution
- Metabolism
- In vitro drug interactions studies have shown that rifaximin, at concentrations ranging from 2 to 200 ng/mL, did not inhibit human hepatic cytochrome P450 isoenzymes: 1A2, 2A6, 2B6, 2C9, 2C19, 2D6, 2E1, and 3A4. In an in vitro hepa-tocyte induction model, rifaximin was shown to induce cytochrome P450 3A4 (CYP3A4), an isoenzyme which rifampin is known to induce.
- Elimination
Toxicity
LD50 > 2 g/kg (orally, in rats)
Active Ingredient/Synonyms
Rifamycin L 105 | Rifamycin L 105SV | Rifaxidin | Rifaximin | Rifaximina | Rifaximine | Rifaximinum | Rifaximinun | Xifaxsan | Rifaximin |
Source of information: Drugbank (External Link). Last updated on: 3rd July 18. *Trade Name used in the content below may not be the same as the HSA-registered product.