Naftine X

Uses

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

Naftine X is a synthetic, broad spectrum, antifungal agent and allylamine derivative. The following in vitro data are available, but their clinical significance is unknown. Naftine X 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.

Naftine X is also used to associated treatment for these conditions: Tinea Corporis, Tinea Cruris, Tinea Pedis

How Naftine X works

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.

Dosage

Naftine X dosage

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

Side Effects

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

Precaution

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

Food Interaction

Elimination Route

Following single topical applications of 3H-labeled naftifine gel 1% to the skin of healthy subjects, up to 4.2% of the applied dose was absorbed.

Half Life

Approximately 2 to 3 days following topical administration.

Elimination Route

Naftine X and/or its metabolites are excreted via the urine and feces with a half-life of approximately two to three days.

Pregnancy & Breastfeeding use

Pregnancy Category B. There are no adequate and well-controlled studies of Naftine X Cream in pregnant women. Because animal reproduction studies are not always predictive of human response, Naftine X 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 Naftine X Cream is administered to a nursing woman.

Special Warning

Pediatric Use: The safety and effectiveness of Naftine X 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 Naftine X Cream did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.

Storage Condition

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

Innovators Monograph

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