BRANDS OF RIFAXIMIN IN KENYA:
Rifaxa® , Ferozsons Laboratories Limited
RIFAXIMIN MODE OF ACTION:
Rifaximin is a semi-synthetic derivative of rifampin and acts by binding to the beta-subunit of bacterial DNA-dependent RNA polymerase blocking one of the steps in transcription. This results in inhibition of bacterial protein synthesis and consequently inhibits the growth of bacteria.
INDICATIONS OF RIFAXIMIN:
- Traveler’s Diarrhea
Rifaximin is indicated for the treatment of travelers’ diarrhea (TD) caused by noninvasive strains of Escherichia coli in adults and pediatric patients 12 years of age and older.
Limitations of Use
Rifaximin should not be used in patients with diarrhea complicated by fever or blood in the stool or diarrhea due to pathogens other than Escherichia coli
- Hepatic Encephalopathy
Rifaximin is indicated for reduction in risk of overt hepatic encephalopathy (HE) recurrence in adults.
- Irritable Bowel Syndrome with Diarrhea
Rifaximin is indicated for the treatment of irritable bowel syndrome with diarrhea (IBS-D) in adults.
DOSAGE AND ADMINISTRATION:
Dosage for Travelers’ Diarrhea
The recommended dose of Rifaximin is 200 mg taken orally three times a day for 3 days.
Dosage for Hepatic Encephalopathy
The recommended dose of Rifaximin is 550 mg taken orally two times a day.
Dosage for Irritable Bowel Syndrome with Diarrhea
The recommended dose of Rifaximin is 550 mg taken orally three times a day for 14 days. Patients who experience a recurrence of symptoms can be retreated up to two times with the same dosage regimen.
Rifaximin can be taken with or without food
Rifaximin is contraindicated in patients with a hypersensitivity to rifaximin, any of the rifamycin antimicrobial agents, or any of the components in Rifaximin. Hypersensitivity reactions have included exfoliative dermatitis, angioneurotic edema, and anaphylaxis
- Concomitant administration of cyclosporine, an inhibitor of P-gp and OATPs significantly increased the systemic exposure of rifaximin. In patients with hepatic impairment, a potential additive effect of reduced metabolism and concomitant P-gp inhibitors may further increase the systemic exposure to rifaximin.
- Changes in INR have been reported postmarketing in patients receiving rifaximin and warfarin concomitantly. Monitor INR and prothrombin time. Dose adjustment of warfarin may be needed to maintain target INR range.
- Rifaximin at the recommended dosing regimen is not expected to induce CYP3A4. It is unknown whether rifaximin can have a significant effect on the pharmacokinetics of concomitant CYP3A4 substrates in patients with reduced liver function who have elevated rifaximin concentrations.
RIFAXIMIN ADVERSE EFFECTS:
Blood and lymphatic system disorders
Abdominal pain upper
General disorders and administration site conditions
Musculoskeletal and connective tissue disorders
Nervous system disorders
Respiratory, thoracic and mediastinal disorders
Skin and subcutaneous tissue disorders
Clinical | Pharmacokinetic data
Pregnancy Category: C
Routes of Administration: Oral
Bioavailability: < 0.4%
Protein Binding: Not Available
Onset of Action: Not Available
Elimination Half life: 6 hours
Excretion: Fecal (97%)
Legal Status | Dosage forms & Strengths
Prescription only Medicine (POM) , ℞-only
Narcotic Drugs and Psychotropic Substances (Control ) Act Schedule:
This Drug is not Subject to DDA drugs Act
Dosage Forms | Strengths:
Tablets : 200mg and 550mg
|CompTox Dashboard (EPA)|
- PPB Retention Register
- Gillis, Jane C., and Rex N. Brogden. “Rifaximin.” Drugs 49.3 (1995): 467-484.
- Bass, Nathan M., et al. “Rifaximin treatment in hepatic encephalopathy.” New England Journal of Medicine 362.12 (2010): 1071-1081.
- Pimentel, Mark, et al. “Rifaximin therapy for patients with irritable bowel syndrome without constipation.” New england journal of medicine 364.1 (2011): 22-32.
- Scarpignato, Carmelo, and Iva Pelosini. “Rifaximin, a poorly absorbed antibiotic: pharmacology and clinical potential.” Chemotherapy 51.Suppl. 1 (2005): 36-66.