CLOTRIMAZOLE lozenge

البلد: الولايات المتحدة

اللغة: الإنجليزية

المصدر: NLM (National Library of Medicine)

العنصر النشط:

CLOTRIMAZOLE (UNII: G07GZ97H65) (CLOTRIMAZOLE - UNII:G07GZ97H65)

متاح من:

Physicians Total Care, Inc.

طريقة التعاطي:

ORAL

نوع الوصفة الطبية :

PRESCRIPTION DRUG

الخصائص العلاجية:

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. Safety and effectiveness of clotrimazole in children below the age of 3 years have not been established; therefore, its use in such patients is not recommended. The safety and effica

ملخص المنتج:

Clotrimazole lozenges, white discoid, uncoated tablets are supplied in bottles of 70 and 140. Each lozenge is debossed with "PAD" over "0107" on one side and plain on the other side. Store below 86°F (30°C). Avoid freezing.

الوضع إذن:

Abbreviated New Drug Application

خصائص المنتج

CLOTRIMAZOLE - CLOTRIMAZOLE LOZENGE
PHYSICIANS TOTAL CARE, INC.
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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 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 concentrations were 4.98 ± 3.7 and
3.23