Ország: Egyesült Államok
Nyelv: angol
Forrás: NLM (National Library of Medicine)
CLOTRIMAZOLE (UNII: G07GZ97H65) (CLOTRIMAZOLE - UNII:G07GZ97H65)
Padagis US LLC
CLOTRIMAZOLE
CLOTRIMAZOLE 10 mg
ORAL
PRESCRIPTION DRUG
Clotrimazole lozenges are indicated for the local treatment of oropharyngeal candidiasis. The diagnoses 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 contraindicated in patients who are hypersensitive to any of its components. No data available.
Clotrimazole lozenges, 10 mg, white discoid, uncoated tablets, debossed with "PAD" over "0107" on one side and plain on the other, are supplied as follows: Bottles of 70: 10 mg 0574-0107-70 PAD 0107 Bottles of 140: 10 mg 0574-0107-14 PAD 0107 Boxes of 70 foil packs: 10 mg 0574-0107-77 PAD 0107 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature] Avoid freezing. Rx Only
Abbreviated New Drug Application
CLOTRIMAZOLE- CLOTRIMAZOLE LOZENGE PADAGIS US LLC ---------- CLOTRIMAZOLE LOZENGE (CLOTRIMAZOLE TROCHE) FOR TOPICAL ORAL ADMINISTRATION DESCRIPTION Each clotrimazole lozenge contains 10 mg clotrimazole [1-(o-chloro-α, α-diphenylbenzyl) imidazole], a synthetic antifungal agent, for topical use in the mouth. Structural Formula: Chemical Formula: C H ClN The lozenge dosage form is a large, slowly dissolving tablet (troche) containing 10 mg of clotrimazole dispersed in dextrose, microcrystalline cellulose, povidone, and magnesium stearate. CLINICAL PHARMACOLOGY Clotrimazole is a broad-spectrum antifungal agent that inhibits the growth of pathogenic yeasts by altering the permeability of cell membranes. The action of clotrimazole is fungistatic at concentrations of drug up to 20 mcg/mL and may be fungicidal _in vitro_ against _Candida albicans_ and other species of the genus Candida at higher concentrations. No single-step or multiple-step resistance to clotrimazole has developed during successive passages of _Candida albicans_ in the laboratory; however, individual organism tolerance has been observed during successive passages in the laboratory. Such _in vitro_ tolerance has resolved once the organism has been removed from the antifungal environment. After oral administration of a 10 mg clotrimazole lozenge to healthy volunteers, concentrations sufficient to inhibit most species of _Candida_ persist in saliva for up to three hours following the approximately 30 minutes needed for a lozenge to dissolve. The long term persistence of drug in saliva appears to be related to the slow release of 22 17 2 clotrimazole from the oral mucosa to which the drug is apparently bound. Repetitive dosing at three hour intervals maintains salivary levels above the minimum inhibitory concentrations of most strains of _Candida;_ however, the relationship between _in vitro_ susceptibility of pathogenic fungi to clotrimazole and prophylaxis or cure of infections in humans has not been established. In another study, the mean serum concen Olvassa el a teljes dokumentumot