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    Xifaxan

    Drug - Xifaxan ® (rifaximin), 200 mg tablets and 50 mg tablets [Salix Pharmaceuticals]

    March 2016

    FDA approved indications

    Xifaxan® (rifaximin) 200 mg tablets are indicated for the treatment of patients (≥12 years of age) with travelers' diarrhea caused by non-invasive strains of Escherichia coli. The dose is 200 mg TID for 3 days.

    Xifaxan® (rifaximin) 550 mg tablets are indicated to reduce the risk of overt hepatic encephalopathy (HE) recurrence in patients ≥ 18 years of age. The dose is 550 mg BID for treatment of HE. Xifaxan® (rifaximin) 550 mg tablets are also indicated in the treatment of Irritable Bowel syndrome with diarrhea in patients ≥ 18 years of age.

    Approval criteria

    200 mg tablet criteria

    • Patient is 12 years of age or older AND
    • Is being treated for Traveler’s Diarrhea AND
    • Has tried ciprofloxacin without benefit

    A quantity of 9 tablets total is allowed.

    Rationale
    Fluoroquinolones are the drugs of choice for Travelers’ Diarrhea. Commonly prescribed regimens are 500 mg of ciprofloxacin twice a day or 400 mg of norfloxacin twice a day for 3-5 days. Trimethoprim-sulfamethoxazole and doxycycline are no longer recommended because of the high level of resistance to these agents.

    550 mg tablet criteria

    Rifaximin may be approved for a patient being treated for hepatic encephalopathy after lactulose or in combination with lactulose.

    A quantity limit of 2 tablets per day is allowed.

    550 mg tablet criteria for Irritable Bowel Syndrome with Diarrhea (IBS-D)

    • Patient must be 18 years of age or older AND
    • Patient has a diagnosis of IBS-D AND
    • Patient has tried at least two other treatments for IBS-D including over-the-counter antidiarrheal in the past 30 days AND
    • Documentation of dietary consultation must be provided at time of request

    FDA approved dosing is one tablet three times daily for 14 days. Approval will be limited to one course of treatment at a time, with a quantity limit of 42 tablets. A maximum of 3 total treatments in 730 days may be allowed.

    Questions?

    MHCP Provider Call Center 651-431-2700 or 800-366-5411

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