Generic Name: CLOTRIMAZOLE
Brand Name: Clotrimazole
- Substance Name(s):
WARNING Clotrimazole is not indicated for the treatment of systemic mycoses including systemic candidiasis.
No data available.
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 22 H 17 ClN 2 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.
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: 7×10 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
INDICATIONS AND USAGE
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 .)
Pediatric Use 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 efficacy of the prophylactic use of clotrimazole troches in children have not been established.
DOSAGE AND ADMINISTRATION
Clotrimazole is administered only as a lozenge that must be slowly dissolved in the mouth.
The recommended dose is one troche five times a day for fourteen consecutive days.
Only limited data are available on the safety and effectiveness of the clotrimazole troche after prolonged administration; therefore, therapy should be limited to short term use, if possible.
For prophylaxis 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, the recommended dose is one troche three times daily for the duration of chemotherapy or until steroids are reduced to maintenance levels.