Rifagut Tablets

Rifagut is an antibacterial used for the treatment of travelers' diarrhea (TD) caused by noninvasive strains of Escherichia coli in patients 12 years of age and older. It is also used for reduction in risk of overt hepatic encephalopathy (HE) recurrence in patients 18 years of age and older. The active ingedient present in Rifagut tablets is Rifaximin.

Rifagut Tablets is an antibacterial. Rifagut Tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. Rifagut 200 mg is indicated for the treatment of travelers' diarrhea (TD) caused by non-invasive strains of Escherichia coli in patients 12 years of age and older.

Indications

Rifagut Tablets (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.It is also used for reduction in risk of overt hepatic encephalopathy (HE) recurrence in patients 18 years of age and older.

Indications

Chemical Structure

The active pharmaceutical ingredient contained in Rifagut Tablets is Rifaximin. Rifaximin is a semisynthetic antibiotic based on Rifamycin.

Active Ingredient

The recommended dosage of Rifaximin for the treatment of various indications is given below:Travelers Diarrhea: The recommended dose of Rifagut is one 200 mg tablet taken orally three times a day for 3 days. Rifagut can be administered orally, with or without food.

Hepatic Encephalopathy: The recommended dose of Rifagut (Rifaximin) is one 550 mg tablet taken orally two times a day, with or without food.

Recommended Dosage

Contraindications

Rifagut (Rifaximin Tablets) is contraindicated in patients with the following conditions:

Hypersensitivity to Rifaximin, or any inactive component of this medication.

Side Effects of Rifagut Tablets

The most common side effects of Rifagut Tablets in the treatment of Travelers Diarrhea with an incidence rate of 5% or more Flatulence, headache, abdominal pain, rectal tenesmus, defecation urgency and nausea. Most common side effects of Rifaximin (Rifagut Tablets) in the treatment of Hepatic Encephalopathy with an incidence rate of 10% or more are Peripheral edema, nausea, dizziness, fatigue, ascites, flatulence, and headache.

Warnings And Precautions

Travelers' Diarrhea Not Caused by Escherichia coli: Rifagut was not found to be effective in patients with diarrhea complicated by fever and/or blood in the stool or diarrhea due to pathogens other than Escherichia coli. Rifagut has to be discontinued if diarrhea symptoms get worse or persist for more than 24 to 48 hours and alternative antibiotic therapy should be considered.

Rifagut is not effective in cases of travelers diarrhea due to Campylobacter jejuni. The effectiveness of Rifagut in travelers diarrhea caused by Shigella spp. and Salmonella spp. has not been proven. Rifagut should not be used in patients where Campylobacter jejuni, Shigella spp., or Salmonella spp. may be suspected as causative pathogens.

Warnings And Precautions

Clostridium difficile-Associated Diarrhea: Clostridium difficile-associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including Rifagut, and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon which may lead to overgrowth of C. difficile.

Development of Drug Resistant Bacteria: Prescribing Rifagut for travelers diarrhea in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.

Warnings And Precautions

Severe (Child-Pugh C) Hepatic Impairment: There is increased systemic exposure in patients with severe hepatic impairment. Therefore, caution should be exercised when administering Rifaximin (Rifagut Tablets) to patients with severe hepatic impairment (Child-Pugh C).

Overdose Symptoms

No specific information is available on the treatment of overdosage with Rifaximin (Rifagut Tablets). In clinical studies at doses higher than the recommended dose (more than 600 mg/day for travelers diarrhea or more than 1100 mg/day for hepatic encephalopathy), adverse reactions were similar in patients who received doses higher than the recommended dose and placebo. In the case of overdosage, discontinue Rifaximin, treat symptomatically, and institute supportive measures as required.

Rifagut Tablets from Sun Pharmaceutical Industries Ltd., India

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Rifagut Tablets

The Swiss Pharmacy, Geneva Switzerland