CLOTRIMAZOLE lozenge

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

clotrimazole (UNII: G07GZ97H65) (clotrimazole - UNII:G07GZ97H65)

Tilgjengelig fra:

Roxane

INN (International Name):

Clotrimazole

Legemiddelform:

LOZENGE

Administreringsrute:

ORAL

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

Clotrimazole Troches (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 Troches (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 Troches (clotrimazole lozenges) are contraindicated in patients who are hypersensitive to any of its components. No data available.

Produkt oppsummering:

Clotrimazole Troches (clotrimazole lozenges) are white, flat face tablets that are plain on one side and embossed with “54 552” on the other side. Clotrimazole Troche (clotrimazole lozenge), 10 mg 0054-4146-22: Bottles of 70 0054-4146-23: Bottles of 140 0054-8146-22: 7 x 10 Unit-Dose Tablets Store below 86°F (30°C). Avoid freezing. 10001777/03 Revised October 2007 © RLI, 2007

Preparatomtale

CLOTRIMAZOLE- CLOTRIMAZOLE LOZENGE
ROXANE
----------
CLOTRIMAZOLE TROCHE
(CLOTRIMAZOLE LOZENGES)
FOR TOPICAL ORAL ADMINISTRATION
RX ONLY
DESCRIPTION
Each Clotrimazole Troche (clotrimazole lozenges) contains 10 mg
clotrimazole [1-(o-chloro-α,α-
diphenylbenzyl) imidazole], a synthetic antifungal agent, for topical
use in the mouth.
Structural Formula:
C
H CLN
The troche dosage form is a large, slowly dissolving tablet (lozenge)
containing 10 mg of clotrimazole
dispersed in croscarmellose sodium, dextrates, magnesium stearate,
microcrystalline cellulose, and
povidone.
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 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. 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.
22
17
2
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 anothe