CLOTRIMAZOLE lozenge

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Hikma Pharmacuticals USA USA Inc.

INN (International Name):

CLOTRIMAZOLE

Composition:

CLOTRIMAZOLE 10 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Clotrimazole is indicated for the local treatment of oropharyngeal candidiasis. The diagnosis should be confirmed by a KOH smear and/or culture prior to treatment. Clotrimazole 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. 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 is contraindicated in patients who are hypersensitive to any of its components. No data available.

Product summary:

Clotrimazole Troche (lozenges) USP 10 mg troche is supplied as white, round, flat face beveled edge troche with product identification “54 552” on one side and plain on the other side. NDC 0054-4146-22: Bottle of 70 Troches NDC 0054-4146-23: Bottle of 140 Troches NDC 0054-8146-22: 7x10 Unit-Dose Troches Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Avoid freezing. Distributed by: Hikma Pharmaceuticals USA Inc. Berkeley Heights, NJ 07922 C50000435/01 Revised July 2021

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

CLOTRIMAZOLE- CLOTRIMAZOLE LOZENGE
HIKMA PHARMACUTICALS USA USA INC.
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CLOTRIMAZOLE TROCHE(LOZENGES) USP
FOR TOPICAL ORAL ADMINISTRATION
RX ONLY
DESCRIPTION
Each Clotrimazole Troche (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:
C
H
ClN
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.
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
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 establis