Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED Clotrimazole lozenges, 10 mg, white discoid, uncoated tablets, debossed with "PAD" over "0107" on one side and plain on the other, are supplied as follows: Strength NDC Code Lozenge Identification Bottles of 70: 10 mg 0574-0107-70 PAD 0107 Bottles of 140: 10 mg 0574-0107-14 PAD 0107 Boxes of 70 foil packs: 10 mg 0574-0107-77 PAD 0107 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature] Avoid freezing. Rx Only; PRINCIPAL DISPLAY PANEL NDC 0574-0107-70 Rx Only Clotrimazole Lozenge (Clotrimazole Troche) 10 mg DESCRIPTION: Each lozenge contains 10 mg of clotrimazole, [1-(ο-chloro-α,α-diphenylbenzyl)imidazole]. DOSAGE: Each lozenge must be dissolved slowly in the mouth. See accompanying literature for complete information. Dispense in tight containers (USP). Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature] Avoid freezing. 70 Lozenges The following image is a placeholder representing the product identifier that is either affixed or imprinted on the drug package label during the packaging operation. label image serialization-template
- HOW SUPPLIED Clotrimazole lozenges, 10 mg, white discoid, uncoated tablets, debossed with "PAD" over "0107" on one side and plain on the other, are supplied as follows: Strength NDC Code Lozenge Identification Bottles of 70: 10 mg 0574-0107-70 PAD 0107 Bottles of 140: 10 mg 0574-0107-14 PAD 0107 Boxes of 70 foil packs: 10 mg 0574-0107-77 PAD 0107 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature] Avoid freezing. Rx Only
- PRINCIPAL DISPLAY PANEL NDC 0574-0107-70 Rx Only Clotrimazole Lozenge (Clotrimazole Troche) 10 mg DESCRIPTION: Each lozenge contains 10 mg of clotrimazole, [1-(ο-chloro-α,α-diphenylbenzyl)imidazole]. DOSAGE: Each lozenge must be dissolved slowly in the mouth. See accompanying literature for complete information. Dispense in tight containers (USP). Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature] Avoid freezing. 70 Lozenges The following image is a placeholder representing the product identifier that is either affixed or imprinted on the drug package label during the packaging operation. label image serialization-template
Overview
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 22 H 17 ClN 2 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. structural formula
Indications & Usage
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 .)
Dosage & Administration
Clotrimazole lozenges must be slowly dissolved in the mouth. The recommended dose is one lozenge five times a day for fourteen consecutive days. Only limited data are available on the safety and effectiveness of the clotrimazole lozenge 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 lozenge three times daily for the duration of chemotherapy or until steroids are reduced to maintenance levels.
Warnings & Precautions
WARNING Clotrimazole lozenges are not indicated for the treatment of systemic mycoses including systemic candidiasis.
Contraindications
Clotrimazole lozenges are contraindicated in patients who are hypersensitive to any of its components.
Adverse Reactions
Abnormal liver function tests have been reported in patients treated with clotrimazole lozenges; elevated SGOT levels were reported in about 15% of patients in the clinical trials (See Precautions section). Nausea, vomiting, unpleasant mouth sensations and pruritus have also been reported with the use of the lozenge.
Storage & Handling
Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature] Avoid freezing. Rx Only
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