Pregnancy Category C: Clotrimazole has been shown to be embryotoxic in rats and mice when given in doses 100 times the adult human dose (in mg/kg), possibly secondary to maternal toxicity. CarcinogenesisĪn 18 month dosing study with clotrimazole in rats has not revealed any carcinogenic effect. Since patients must be instructed to allow each troche 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. Periodic assessment of hepatic function is advisable particularly in patients with pre-existing hepatic impairment. 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). PrecautionsĪbnormal liver function tests have been reported in patients treated with clotrimazole troches elevated SGOT levels were reported in about 15% of patients in the clinical trials. WarningĬlotrimazole is not indicated for the treatment of systemic mycoses including systemic candidiasis. (See DOSAGE AND ADMINISTRATION.) ContraindicationsĬlotrimazole is contraindicated in patients who are hypersensitive to any of its components. 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.
The diagnosis should be confirmed by a KOH smear and/or culture prior to treatment.Ĭlotrimazole is 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.
Indications and Usage for Clotrimazole LozengeĬlotrimazole is indicated for the local treatment of oropharyngeal candidiasis. In another study, the mean serum concentrations were 4.98 ± 3.7 and 3.23 ± 1.4 nanograms/mL of clotrimazole at 30 and 60 minutes, respectively, after administration as a troche. 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. The long term persistence of drug in saliva appears to be related to the slow release of clotrimazole from the oral mucosa to which the drug is apparently bound. Such in vitro tolerance has resolved once the organism has been removed from the antifungal environment.Īfter oral administration of a 10 mg clotrimazole troche 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 troche to dissolve. 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.
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. Clotrimazole Lozenge - Clinical PharmacologyĬlotrimazole is a broad-spectrum antifungal agent that inhibits the growth of pathogenic yeasts by altering the permeability of cell membranes. The troche dosage form is a large, slowly dissolving tablet (lozenge) containing 10 mg of clotrimazole USP dispersed in croscarmellose sodium, dextrates, magnesium stearate, microcrystalline cellulose and povidone.
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