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.
Administration
Rifaximin can be taken with or without food
CONTRAINDICATIONS:
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
DRUG INTERACTIONS:
- 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
Anaemia
Gastrointestinal disorders
Ascites
Nausea
Abdominal pain upper
General disorders and administration site conditions
Oedema peripheral
Pyrexia
Musculoskeletal and connective tissue disorders
Muscle spasms
Arthralgia
Nervous system disorders
Dizziness
Psychiatric disorders
Depression
Respiratory, thoracic and mediastinal disorders
Dyspnoea
Skin and subcutaneous tissue disorders
Pruritus
Rash
Reporting of suspected adverse reactions:
The PPB Department of Pharmacovigilance was set up with a vision to develop, implement and continuously upgrade an appropriate system for detecting, reporting, and monitoring adverse drug reactions (ADRs) and other relevant problems with medicines in Kenya. The department strives to ensure the safety and efficacy of pharmaceutical products in Kenya.
Reporting suspected adverse reactions after authorization of the medicinal product are important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals/ Patients are encouraged to report any suspected adverse reactions via Pharmacovigilance Yellow Form, pv@pharmacyboardkenya.org or clicking below button:
Rifaximin in Kenya
Rifaximin in Kenya
Rifaximin in Kenya
Rifaximin in Kenya
Rifaximin in Kenya
Clinical | Pharmacokinetic data
Pregnancy Category: C
Routes of Administration: Oral
Bioavailability: < 0.4%
Protein Binding: Not Available
Metabolosim: Liver
Onset of Action: Not Available
Elimination Half life: 6 hours
Excretion: Fecal (97%)
Legal Status | Dosage forms & Strengths
Prescription Category:
Prescription only Medicine (POM) , â„ž-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
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Drug Images
References/ Citation:
- 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.