Rifaximin

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

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) , ℞-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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