Hepatab 550 mg

INDICATIONS

Rifaximin is indicaed in-

Treatment of traveler's diarrhea by noninvasive strains of E. coli
reduction in risk of overt hepatic encephalopathy
bacterial overgrowth of irritable bowel syndrome.

PHARMACOLOGY

Rifaximin is a semisynthetic, rifamycin-based non-systemic antibiotic. Very little of the drug will pass the gastrointestinal wall into the circulation as is common for other types of orally administered antibiotics. Rifaximin inhibits bacterial RNA synthesis by its action on the beta-subunit of the DNA-dependent RNA polymerase. It shows the same broad spectrum activity as rifamycin which exerts bactericidal action against many species of Gram-positive and Gram-negative, aerobic and anaerobic bacteria.

DOSAGE & ADMINISTRATION

Traveler's Diarrhea: For patients ≥12 years of age: 200 mg 3 times daily for 3 days.Hepatic Encephalopathy: For patients ≥18 years of age: 550 mg 2 times daily.Bacterial overgrowth of irritable bowel syndrome: 400 mg 3 times daily for 10 days or 550 mg 3 times daily for 14 days. Can be taken with or without food

INTERACTION

In an in vitro study has suggested that Rifaximin induces CYP3A4. However, in patients with normal liver function, Rifaximin at the recommended dosing regimen is not expected to induce CYP3A4.

SIDE EFFECTS

Side effects include flatulence, headache, abdominal pain, rectal tenesmus, defecation urgency, nausea, constipation, pyrexia, vomiting. Reactions have been reported, including anaphylaxis, angioneurotic edema, and exfoliative dermatitis.

PREGNANCY & LACTATION

Pregnancy category C. It is not known whether Rifaximin is excreted in human milk or not.

PRECAUTIONS & WARNINGS

Rifaximin is not found to be effective in patients with diarrhea complicated by fever and/or blood in the stools. Rifaximin therapy should be discontinued if diarrhea symptoms get worse or persist for more than 24-48 hours and alternative antibiotic therapy should be considered. Pseudomembranous colitis has been reported with nearly all antibacterial agents and may range in severity from mild to life-threatening. Therefore, it is important to consider this diagnosis in patients who present with diarrhea subsequent to the administration of antibacterial agents.

USE IN SPECIAL POPULATIONS

Renal Impairment: The pharmacokinetics of Rifaximin in patients with impaired renal function has not been studied.Hepatic Impairment: The systemic exposure of Rifaximin was markedly elevated in patients with hepatic impairment compared to healthy subjects.

THERAPEUTIC CLASS

4-Quinolone preparations

STORAGE CONDITIONS

Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.