Jane S. Ricciuti, RPh, MS


January 23, 2004

In This Article

Antifungal Agents

(sertaconazole nitrate) Cream, 2%

Manufacturer: Mylan Pharmaceuticals

Drug Approval Classification: Original New Drug Application (Approval Date: 12/10/03)

Indication: Ertaczo (sertaconazole nitrate) cream, 2%, is indicated for the topical treatment of interdigital tinea pedis in immunocompetent patients 12 years of age and older, caused by Trichophyton rubrum, Trichophyton mentagrophytes, and Epidermophyton floccosum.

Dosing: Sertaconazole should be applied in a sufficient amount to cover both affected areas between toes and the surrounding healthy skin, twice daily for 4 weeks.

Clinical Summary: Sertaconazole is an imidazole antifungal that has been shown to be active against isolates of the following microorganisms:

  • Trichophyton rubrum

  • Trichophyton mentagrophytes

  • Epidermophyton floccosum

Efficacy of sertaconazole was demonstrated in 2 randomized, double-blind, clinical trials, in which patients 12 years and older with interdigital tinea pedis applied either sertaconazole cream, 2%, or vehicle, twice daily for 4 weeks. Complete cure in sertaconazole-treated patients was achieved in 32 of 160 (20%) patients with Trichophyton rubrum, in 7 of 28 (25%) patients with Trichophyton mentagrophytes, and in 2 of 13 (15%) patients with Epidermophyton floccosum.

Adverse Effects: Dermatitis, dry skin, burning skin, and application site reaction and skin tenderness were the observed cutaneous adverse reactions in 2% of patients in clinical trials on sertaconazole; placebo patients experienced a 2% incidence of cutaneous reactions.

Ertaczo (sertaconazole nitrate) Cream, 2% Labeling

(voriconazole) Oral Suspension

Manufacturer: Pfizer, Inc.

Drug Approval Classification: Original New Drug Application (Approval Date: 12/19/03)

New Indication: Vfend (voriconazole) is now indicated for use in serious fungal infections caused by Scedosporium apiospermum (asexual form of Pseudallescheria boydii) and Fusarium spp, including Fusarium solani, in patients intolerant of, or refractory to, other therapy.

Clinical Summary: Voriconazole efficacy in Scedosporium apiospermum and Fusarium spp. Was derived from pooled analyses of patients:

  • Scedosporium apiospermum -- Successful response to voriconazole therapy was seen in 15 of 24 patients (63%). Three of these patients relapsed within 4 weeks, including 1 patient with pulmonary, skin and eye infections, 1 patient with cerebral disease, and 1 patient with skin infection. Ten patients had evidence of cerebral disease and 6 of these had a successful outcome (1 relapse). In addition, a successful response was seen in 1 of 3 patients with mixed organism infections.

  • Fusarium spp -- Nine of 21 (43%) patients were successfully treated with voriconazole. Of these 9 patients, 3 had eye infections, 1 had an eye and blood infection, 1 had a skin infection, 1 had a blood infection alone, 2 had sinus infections, and 1 had disseminated infection (pulmonary, skin, hepatosplenic). Three of these patients (1 with disseminated disease, 1 with an eye infection, and 1 with a blood infection) had Fusarium solani and were complete successes. Two of these patients relapsed, 1 with a sinus infection and profound neutropenia and 1 postsurgical patient with blood and eye infections.

Vfend (voriconazole) Oral Suspension Labeling

Vfend (voriconazole) Oral Suspension


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