CLOTRIMAZOLE

Each Clotrimazole lozenge USP contains 10 mg clotrimazole USP [1-(o-chloro-α,α-diphenylbenzyl) imidazole], a synthetic antifungal agent, for topical use in the mouth. Structural Formula: Chemical Formula: C 22 H 17 ClN 2 The lozenge dosage form is a large, slowly dissolving lozenge containing 10 mg of clotrimazole USP dispersed in croscarmellose sodium, dextrates, magnesium stearate, microcrystalline cellulose and povidone. clotrimazole-structure.jpg

Clotrimazole Lozenges are indicated for the local treatment of oropharyngeal candidiasis. The diagnosis should be confirmed by a KOH smear and/or culture prior to treatment. Clotrimazole Lozenges are also indicated prophylactically 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. There are no data from adequate and well-controlled trials to establish the safety and efficacy of this product for prophylactic use in patients immunocompromised by etiologies other than those listed in the previous sentence. (See DOSAGE AND ADMINISTRATION .)

Clotrimazole Lozenges are administered only as a lozenge that 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 clotrimazole 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 lozenge three times daily for the duration of chemotherapy or until steroids are reduced to maintenance levels.

Clotrimazole Lozenges are contraindicated in patients who are hypersensitive to any of its components.

Abnormal liver function tests have been reported in patients treated with clotrimazole lozenges; elevated SGOT levels were reported in about 15% of patients in the clinical trials (See PRECAUTIONS ). Nausea, vomiting, unpleasant mouth sensations and pruritus have also been reported with the use of the lozenge. To report SUSPECTED ADVERSE REACTIONS, contact Rising Pharma Holdings, Inc. at 1-844-874-7464 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Avoid freezing.