Ketoconazole Cream, 2%

Prescription

Nombres comerciales: Ketoconazole

Forma Farmacéutica

Topical

Vía de Administración

TOPICAL

Fabricante

NuCare Pharmaceuticals,Inc.

About This Medication

DESCRIPTION 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-(1H-imidazol-1-ylmethyl)-1,3-dioxolan-4-yl]methoxy]phenyl] piperazine and has the following structural formula: M. Formula: C 26 H 28 Cl 2 N 4 O 4 M.W.: 531.44 Ketoconazole Structure

Principios Activos

Ingrediente	Concentración
Ketoconazole	-

Indicaciones y Uso

INDICATIONS AND 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 . and in the treatment of seborrheic dermatitis.

Dosificación y Administración

DOSAGE AND 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. Seborrheic dermatitis : Ketoconazole cream, 2% should be applied to the affected area twice daily for four weeks or until no clinical clearing. If a patient shows no clinical improvement after the treatment period, the diagnosis should be redetermined.

Side Effects Overview

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. To report SUSPECTED ADVERSE REACTIONS, contact Encube Ethicals Private Limited at 1-833-285-4151 or FDA at 1-800- FDA-1088 or www.fda.gov/medwatch.

Advertencias y Precauciones

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.

Contraindicaciones

CONTRAINDICATIONS Ketoconazole Cream, 2% is contraindicated in persons who have shown hypersensitivity to the active or excipient ingredients of this formulation.

Frequently Asked Questions

INDICATIONS AND 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 . and in the treatment of seborrheic dermatitis.

DOSAGE AND 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 …

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.

Ketoconazole Cream, 2% is a prescription medication. You will need a valid prescription from a licensed healthcare provider.

References & Data Sources

• DailyMed — Ketoconazole Cream, 2% drug label (National Library of Medicine)
• openFDA — Ketoconazole Cream, 2% label data (U.S. Food & Drug Administration)
• RxNorm — RXCUI 203088 (NLM Normalized Drug Names)
• NDC Directory — Ketoconazole Cream, 2% (FDA National Drug Code)

Aviso Médico

La información en esta página tiene fines exclusivamente educativos y no debe utilizarse como sustituto del consejo médico profesional, diagnóstico o tratamiento.

Siempre consulte a su médico u otro proveedor de salud calificado ante cualquier pregunta que pueda tener sobre una condición médica o medicamento.

Fuentes de datos: DailyMed (NLM), openFDA, MFDS