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  • Agisten Lozenges
    / Perrigo

    Active Ingredient
    Clotrimazole 10 mg

    Status in Israel

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    Agisten Lozenges must be slowly dissolved in the mouth. The recommended dose is one lozenge five times a day for fourteen consecutive days. Only limited data are available on the safety and effectiveness of the Agisten Lozenge after prolonged administration; therefore, therapy should be limited to short term use, if possible.
    For prophylaxis, to reduce the incidence of oropharyngeal candidiasis in patients immunocompromised by conditions that include chemotherapy, radiotherapy, or steroid therapy utilized in the treatment of leukemia, solid tumors, or renal transplantation, the recommended dose is one troche three times daily for the duration of chemotherapy or until steroids are reduced to
    maintenance levels.


    Local treatment of oropharyngeal candidiasis. Prophylactic treatment to reduce incidence of oropharyngeal candidiasis in patients immune-compromised by: chemotherapy, radiotherapy, steroid therapy in Leukemia, solid tumors, renal transplantation.


    Hypersensitivity to active substance or its excipients.

    Special Precautions

    The drug is not indicated for the treatment of systemic mycoses including systemic candidiasis. Abnormal liver function tests have been reported in patients treated with this drug; elevated SGOT levels were reported in about 15% of patients in the clinical trials. In most cases the elevations were minimal and it was often impossible to distinguish effects of clotrimazole from those of other therapy and the underlying disease (malignancy in most cases). Periodic assessment of hepatic function is advisable particularly in patients with pre-existing hepatic impairment. Since patients must be instructed to allow each lozenge to dissolve slowly in the mouth in order to achieve maximum effect of the medication, they must be of such an age and physical and/or mental condition to comprehend such instructions.
    Carcinogenesis: An 18 month dosing study with clotrimazole in rats has not revealed any carcinogenic effect.
    See prescribing information for full details.

    Side Effects

    Abnormal liver function tests, nausea, vomiting, unpleasant mouth sensations and pruritus.
    See prescribing information for full details.

    Pregnancy and Lactation

    Pregnancy: The drug should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
    Lactation: See prescribing information for full details.


    No data available.

    Important notes

    Shelf life: 24 months
    Shelf life after first opening: 4 weeks

    Paddock Laboratories, LLC, USA