Naftin Gel (Naftifine) Drug Information: Warnings and Precautions

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May 27, 2012

Naftin Gel

Ringworm »

Ringworm facts

Ringworm is a common fungal infection of the skin and is not due to a worm.
The medical term for ringworm is tinea. The condition is further named for the site of the body where the infection occurs.
Ringworm causes a scaly, crusted rash that may itch.
Ringworm can be successfully treated with antifungal medications used either topically or orally.

What does the term ringworm mean?

The term ringworm or ringworms refers to fungal infections that are on the surface of the skin. The name is derived from the early belief that the infection was due to a worm, which it is not. Ringworm is a fungal infection in the skin. Nevertheless, the name ringworm remains. Some of these fungi produce round spots on the skin, but many do not. On the other hand, many round, red spots on the skin are not due to a fungal infection. A physical examination of the affected s...

Read the Ringworm article »

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Naftin Gel

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WARNINGS

Naftin® (naftifine) Gel, 1% is for topical use only and not for ophthalmic use.

PRECAUTIONS

General: Naftin® (naftifine) Gel, 1% is for external use only. If irritation or sensitivity develops with the use of Naftin® (naftifine) Gel, 1%, treatment should be discontinued and appropriate therapy instituted. Diagnosis of the disease should be confirmed either by direct microscopic examination of a mounting of infected tissue in a solution of potassium hydroxide or by culture on an appropriate medium.

Carcinogenesis, mutagenesis, impairment of fertility: Long-term studies to evaluate the carcinogenic potential of Naftin® (naftifine) Gel, 1% have not been performed. In vitro and animal studies have not demonstrated any mutagenic effect or effect on fertility.

Pregnancy: Teratogenic Effects: Pregnancy Category B: Reproduction studies have been performed in rats and rabbits (via oral administration) at doses 150 times or more than the topical human dose and have revealed no evidence of impaired fertility or harm to the fetus due to naftifine. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

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 Naftin® (naftifine) Gel, 1% is administered to a nursing woman.

Pediatric use: Safety and effectiveness in pediatric patients have not been established.

Last reviewed on RxList: 6/11/2008
This monograph has been modified to include the generic and brand name in many instances.