ketoconazole 2 % Topical Cream

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.

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: C26H28Cl2N4O4 M.W.

531.44 ketoconazole structural formula

HOW SUPPLIED

Ketoconazole Cream, 2% is supplied in 15, 30, and 60 gram tubes.

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.

C 3/2005

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.

PEDIATRIC USE

Pediatric Use Safety and effectiveness in children have not been established.

PREGNANCY

Pregnancy Teratogenic effects Pregnancy Category C Ketoconazole has been shown to be teratogenic (syndactylia and oligodactylia) in the rat when given orally in the diet at 80 mg/kg/day, (10 times the maximum recommended human oral dose).

However, these effects may be related to maternal toxicity, which was seen at this and higher dose levels.

There are no adequate and well-controlled studies in pregnant women.

Ketoconazole should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

NUSRING MOTHERS

Nursing Mothers It is not known whether ketoconazole cream, 2% administered topically could result in sufficient systemic absorption to produce detectable quantities in breast milk.

Nevertheless, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.

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.