Naftifine Hydrochloride

Naftifine cream is an allylamine antifungal indicated for the treatment of interdigital tinea pedis, tinea cruris, and tinea corporis caused by the organism Trichophyton rubrum

Naftifine is a synthetic, broad spectrum, antifungal agent and allylamine derivative. The following in vitro data are available, but their clinical significance is unknown. Naftifine has been shown to exhibit fungicidal activity in vitro against a broad spectrum of organisms including Trichophyton rubrum, Trichophyton mentagrophytes, Trichophyton tonsurans, Epidermophyton floccosum, and Microsporum canis, Microsporum audouini, and Microsporum gypseum; and fungistatic activity against Candida species including Candida albicans. However it is only used to treat the organisms listed in the indications.

Although the exact mechanism of action against fungi is not known, naftifine appears to interfere with sterol biosynthesis by inhibiting the enzyme squalene 2,3-epoxidase. This inhibition of enzyme activity results in decreased amounts of sterols, especially ergosterol, and a corresponding accumulation of squalene in the cells.

For topical use only. Naftifine Cream is not for ophthalmic, oral, or intravaginal use. Apply a thin layer of Naftifine Cream once-daily to the affected areas plus a ½ inch margin of healthy surrounding skin for 2 weeks

The most common adverse reaction (≥1%) is pruritus.

Pregnancy Category B. There are no adequate and well-controlled studies of Naftifine Cream in pregnant women. Because animal reproduction studies are not always predictive of human response, Naftifine Cream should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nursing Mothers: It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Naftifine Cream is administered to a nursing woman.

If redness or irritation develops with the use of Naftifine Cream treatment should be discontinued.

Pediatric Use: The safety and effectiveness of Naftifine Cream have been established in the age group 12-17 with interdigital tinea pedis and tinea cruris. Safety and effectiveness in pediatric patients <12 years of age have not been established. 

Geriatric Use: Clinical studies of Naftifine Cream did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.

Topical Antifungal preparations

Store at 25°C; excursions permitted to 15-30°C