Sporofine Tube

Uses

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

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

Sporofine Tube is also used to associated treatment for these conditions: Tinea Corporis, Tinea Cruris, Tinea Pedis

How Sporofine Tube 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

Sporofine Tube dosage

For topical use only. Sporofine Tube Cream is not for ophthalmic, oral, or intravaginal use.Apply a thin layer of Sporofine Tube 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 Sporofine Tube 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

Sporofine Tube 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 Sporofine Tube Cream in pregnant women. Because animal reproduction studies are not always predictive of human response, Sporofine Tube 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 Sporofine Tube Cream is administered to a nursing woman.

Special Warning

Pediatric Use: The safety and effectiveness of Sporofine Tube 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 Sporofine Tube 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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