Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED Ketoconazole Cream 2% is supplied as follows: 15 gram NDC 0168-0099-15 30 gram NDC 0168-0099-30 60 gram NDC 0168-0099-60 Store below 77°F (25°C). E. FOUGERA & CO. A division of Fougera PHARMACEUTICALS INC. Melville, New York 11747 I299C R11/11 #39; PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 15 G CONTAINER NDC 0168-0099-15 FOUGERA ® KETOCONAZOLE CREAM 2% For dermatologic use only. Rx only Contains ketoconazole 20 mg/g, propylene glycol, stearyl and cetyl alcohols, sorbitan monostearate, polysorbate 60, isopropyl myristate, sodium sulfite anhydrous, polysorbate 80 and purified water. NET WT 15 grams tube15gram; PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 15 G CARTON NDC 0168-0099-15 Rx only FOUGERA ® KETOCONAZOLE CREAM 2% For dermatologic use only. Warning: Not for ophthalmic use. Keep out of reach of children. NET WT 15 grams PACKAGE LABEL - PRINCIPAL DISPLAY PANEL - 15 G CARTON
- HOW SUPPLIED Ketoconazole Cream 2% is supplied as follows: 15 gram NDC 0168-0099-15 30 gram NDC 0168-0099-30 60 gram NDC 0168-0099-60 Store below 77°F (25°C). E. FOUGERA & CO. A division of Fougera PHARMACEUTICALS INC. Melville, New York 11747 I299C R11/11 #39
- PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 15 G CONTAINER NDC 0168-0099-15 FOUGERA ® KETOCONAZOLE CREAM 2% For dermatologic use only. Rx only Contains ketoconazole 20 mg/g, propylene glycol, stearyl and cetyl alcohols, sorbitan monostearate, polysorbate 60, isopropyl myristate, sodium sulfite anhydrous, polysorbate 80 and purified water. NET WT 15 grams tube15gram
- PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 15 G CARTON NDC 0168-0099-15 Rx only FOUGERA ® KETOCONAZOLE CREAM 2% For dermatologic use only. Warning: Not for ophthalmic use. Keep out of reach of children. NET WT 15 grams PACKAGE LABEL - PRINCIPAL DISPLAY PANEL - 15 G CARTON
Overview
Ketoconazole Cream 2%, for topical administration only, contains the broad-spectrum synthetic antifungal agent, ketoconazole 2%, formulated in an aqueous cream vehicle consisting of propylene glycol, stearyl and cetyl alcohols, sorbitan monostearate, polysorbate 60, isopropyl myristate, sodium sulfite anhydrous, polysorbate 80 and purified water. 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: Structural Formula
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) ; in the treatment of cutaneous candidiasis caused by Candida spp. and in the treatment of seborrheic dermatitis.
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. Seborrheic dermatitis: Ketoconazole Cream 2% should be applied to the affected area twice daily for four weeks or until clinical clearing. 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 ophthalmic 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 (5.0%) 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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