Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED Ketoconazole Cream, 2% is supplied in 15, 30, and 60 gram tubes. 15 g tube (NDC 0093-3219-15) 30 g tube (NDC 0093-3219-30) 60 g tube (NDC 0093-3219-92) Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Manufactured In Croatia By: Pliva Hrvatska d.o.o. Zagreb, Croatia Manufactured For: Teva Pharmaceuticals USA, Inc. North Wales, PA 19454 Rev. B 8/2021; PRINCIPAL DISPLAY PANEL NDC 0093-3219-15 KETOCONAZOLE CREAM 2% For dermatologic use only Rx only 15 GRAMS 15g carton
- HOW SUPPLIED Ketoconazole Cream, 2% is supplied in 15, 30, and 60 gram tubes. 15 g tube (NDC 0093-3219-15) 30 g tube (NDC 0093-3219-30) 60 g tube (NDC 0093-3219-92) Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Manufactured In Croatia By: Pliva Hrvatska d.o.o. Zagreb, Croatia Manufactured For: Teva Pharmaceuticals USA, Inc. North Wales, PA 19454 Rev. B 8/2021
- PRINCIPAL DISPLAY PANEL NDC 0093-3219-15 KETOCONAZOLE CREAM 2% For dermatologic use only Rx only 15 GRAMS 15g carton
Overview
Ketoconazole Cream, 2% contains the broad-spectrum synthetic antifungal agent, ketoconazole 2%. Each gram, for topical administration, contains ketoconazole 20 mg and is formulated in an aqueous cream vehicle consisting of propylene glycol, purified water, cetyl alcohol, stearyl alcohol, isopropyl myristate, sorbitan monostearate, polysorbate 60, polysorbate 80, and sodium sulfite, anhydrous: Ketoconazole is cis -1-acetyl-4-[4-[[2-(2,4-dichlorophenyl)-2-(1 H -imidazol-1-ylmethyl)-1,3-dioxolan-4-yl]methoxy]phenyl]piperazine and has the following structural formula: C 26 H 28 Cl 2 N 4 O 4 M.W. 531.44 new
Indications & Usage
Ketoconazole Cream, 2% is indicated for the topical treatment of tinea corporis, tinea cruris and tinea pedis caused by Trichophyton rubrum , T. mentagrophytes and Epidermophyton floccosum ; in the treatment of tinea (pityriasis) versicolor caused by Malassezia furfur (Pityrosporum orbiculare) ; and in the treatment of cutaneous candidiasis caused by Candida spp .
Dosage & Administration
Cutaneous candidiasis, tinea corporis, tinea cruris, tinea pedis, and tinea (pityriasis) versicolor: It is recommended that ketoconazole cream, 2% be applied once daily to cover the affected and immediate surrounding area. Clinical improvement may be seen fairly soon after treatment is begun; however, candidal infections and tinea cruris and corporis should be treated for two weeks in order to reduce the possibility of recurrence. Patients with tinea versicolor usually require two weeks of treatment. Patients with tinea pedis require six weeks of treatment. If a patient shows no clinical improvement after the treatment period, the diagnosis should be redetermined.
Warnings & Precautions
WARNINGS Ketoconazole Cream, 2% is not for opthalmic use. Ketoconazole Cream, 2% contains sodium sulfite anhydrous, a sulfite that may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown and probably low. Sulfite sensitivity is seen more frequently in asthmatic than in nonasthmatic people.
Contraindications
Ketoconazole Cream, 2% is contraindicated in persons who have shown hypersensitivity to the active or excipient ingredients of this formulation.
Adverse Reactions
During clinical trials 45 (5%) of 905 patients treated with ketoconazole cream, 2% and 5 (2.4%) of 208 patients treated with placebo reported side effects consisting mainly of severe irritation, pruritus and stinging. One of the patients treated with ketoconazole cream developed a painful allergic reaction. In worldwide postmarketing experience, rare reports of contact dermatitis have been associated with ketoconazole cream or one of its excipients, namely sodium sulfite or propylene glycol.
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