From the FDA Drug Label
CLINICAL PHARMACOLOGY Pharmacokinetics: In a multiple dose pharmacokinetic study that included 5 male patients with interdigital tinea pedis (range of diseased area, 42 - 140 cm2; mean, 93 cm2), ERTACZO® Cream, 2%, was topically applied every 12 hours for a total of 13 doses to the diseased skin (0. 5 grams sertaconazole nitrate per 100 cm2 ). Sertaconazole concentrations in plasma measured by serial blood sampling for 72 hours after the thirteenth dose were below the limit of quantitation (2. 5 ng/mL) of the analytical method used. Microbiology: Sertaconazole is an antifungal that belongs to the imidazole class of antifungals. While the exact mechanism of action of this class of antifungals is not known, it is believed that they act primarily by inhibiting the cytochrome P450-dependent synthesis of ergosterol Ergosterol is a key component of the cell membrane of fungi, and lack of this component leads to fungal cell injury primarily by leakage of key constituents in the cytoplasm from the cell ActivityIn Vivo: Sertaconazole nitrate has been shown to be active against isolates of the following microorganisms in clinical infections as described in the INDICATIONS AND USAGE section: Trichophyton rubrum Trichophyton mentagrophytes Epidermophyton floccosum
The main use of Sertaconazole is as an antifungal agent. It belongs to the imidazole class of antifungals and is active against certain microorganisms, including:
- Trichophyton rubrum
- Trichophyton mentagrophytes
- Epidermophyton floccosum 1
From the Research
Sertaconazole is a highly effective antifungal medication for the treatment of superficial skin mycoses, including dermatophytosis, cutaneous candidiasis, pityriasis versicolor, and seborrhoeic dermatitis of the scalp, with a broad-spectrum antifungal activity against dermatophytes and yeasts 2. The standard treatment regimen for sertaconazole involves applying a thin layer of the 2% cream or solution to the affected area and surrounding skin once or twice daily for 2-4 weeks, depending on the specific infection being treated.
- The medication works by inhibiting the synthesis of ergosterol, an essential component of fungal cell membranes, which disrupts membrane integrity and ultimately leads to fungal cell death.
- Sertaconazole has been shown to be effective in clinical trials, with a significantly greater proportion of patients achieving a successful mycological cure compared to those receiving 2% miconazole cream twice-daily treatment 2.
- Common side effects may include mild burning, stinging, or redness at the application site, but the medication is generally well tolerated, with no evidence of a sensitizing action in causing contact dermatitis in healthy volunteers 2.
- Patients should avoid covering treated areas with occlusive dressings unless directed by a healthcare provider and should wash hands thoroughly after application to prevent spreading the infection.
- The antifungal activity of sertaconazole is maintained in clinical isolates of dermatophytes that show reduced susceptibility to other azoles, making it a useful treatment option for patients with fungal infections resistant to other azoles 2.