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Hepatab

Rifaximin

NAME STRENGTH PACK SIZE DOSAGE FORM
Hepatab 550 550 mg 1X10 Tablet
Hepatab 200 200 mg 2X10 Tablet

Description

Rifaximin is a non-aminoglycoside, semi-synthetic non-systemic antibiotic derived from Rifamycin. Rifaximin acts by binding to the beta-subunit of bacterial DNA-dependent RNA polymerase resulting in inhibition of bacterial RNA synthesis.

Hepatab-200 Tablet: Each film coated tablet contains Rifaximin BP 200 mg. Hepatab-550 Tablet: Each film coated tablet contains Rifaximin BP 550 mg.

Acute infectious diarrhea including travelers' diarrhea, Diarrhea predominant Irritable Bowel Syndrome (IBS-D), Hepatic Encephalopathy (H.E.).

"Acute Infectious Diarrhea including Travelers' Diarrhea: 200 mg three times daily for 3 days. Diarrhea predominant Irritable Bowel Syndrome (IBS-D):400 mg three times daily for 10 days. Hepatic Encephalopathy (H.E.):550 mg twice daily. "

Common side effects are nausea, vomiting, abdominal pain, flatulence, headache and dizziness.

Pregnancy Category C. There are no adequate and well-controlled studies in pregnant women. Hepatab should be used during pregnancy only if the potential benefit outweighs the potential risk to the fetus. Use in Lactation: It is not known whether Rifaximin is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for adverse reactions in nursing infants from Hepatab, a decision should be made whether to discontinue nursing or to discontinue the drug,taking into account the importance of the drug to the mother.

Although In vitro studies demonstrated the potential of Rifaximin to interact with cytochrome P450 (CYP3A4), a clinical drug-drug interaction study demonstrated that Rifaximin did not significantly affect the pharmacokinetics of midazolam. An additional clinical drug-drug interaction study showed no effect of Rifaximin on the presystemic metabolism of an oral contraceptive containing ethinyl estradiol and norgestimate. Therefore, clinical interactions with drugs metabolized by human cytochrome P450 isozymes are not expected.

No specific information is available on the treatment of over dosage with Rifaximin. In case of over dosage, discontinue Rifaximin, treat symptomatically and institute supportive measures as required.

Store in cool & dry place, protect from light. Keep out of the reach of children.

Hepatab is contraindicated in patients with a hypersensitivity to Rifaximin, or any of the Rifamycin antimicrobial agents, or any of the components of this preparation.

Hepatab-200 Tablet: Each box contains 2x10's tablets in alu-alu blister pack. Hepatab -550 Tablet: Each box contains 1x10's tablets in alu-alu blister pack.