Henlix^®

Henlix^® is a preparation of Rifaximin which is a semi-synthetic, Rifamycin based non-systemic antibiotic. Rifaximin acts by binding to the beta-subunit of bacterial DNA-dependent RNA polymerase resulting in inhibition of bacterial RNA synthesis. It results in inhibition of bacterial protein synthesis and consequently inhibits the growth of bacteria. 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.

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Henlix^® tablet is indicated for -

• Travelers' Diarrhea (TD) caused by noninvasive strains of Escherichia coli
• Irritable Bowel Syndrome with Diarrhea (IBS-D)
• Reduction in rsk of overt Hepatic Encephalopathy (HE)

The recommended dose of Henlix^® tablet -

Travelers' Diarrhea in adult and children over 12 years: One Henlix® 200 tablet three times daily for 3 days.

Irritable Bowel Syndrome in adults over 18 years: One Henlix® 550 tablet three times daily for 14 days.

Hepatic Encephalopathy in adults over 18 years: One Henlix® 550 tablet twice daily.

Rifaximin is pregnancy category C. Rifaximin should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

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 Rifaximin, 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.

Rifaximin is not found to be effective in patients with diarrhea complicated by fever or blood in the stools due to pathogens other than Escherichia coli. Rifaximin therapy should be discontinued if diarrhea symptoms get worse or persist for more than 24-48 hours and an 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.

Rifaximin is contraindicated in patients with a known history of hypersensitivity to Rifaximin, Rifamycin antimicrobial agents, or any of the components of the formulation.

Rifaximin 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 pre-systemic metabolism of an oral contraceptive containing ethinyl estradiol and norgestimate. Therefore, clinical interactions with drugs metabolized by human cytochrome P450 isozymes are not expected.

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Store in a cool and dry place protected from light. Keep out of the reach of children.

Henlix^® 200 tablet: Each coated tablet contains Rifaximin BP 200 mg.
Henlix^® 550 tablet: Each coated tablet contains Rifaximin BP 550 mg.

Henlix^® 200 tablet: Carton of 18 tablets in blister pack.
Henlix^® 550 tablet: Carton of 10 tablets in blister pack.