Naftin Cream (Naftifine Hcl) Drug Information: Side Effects and Drug Interactions

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May 27, 2012

Naftin Cream

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...

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SIDE EFFECTS

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

During clinical trials, 760 subjects were exposed to naftifine 1% and 2% cream formulations. A total of 421 subjects with tinea pedis and/or tinea cruris were treated with NAFTIN (naftifine hydrochloride) Cream, 2%. In two randomized, vehicle-controlled trials (400 patients were treated with NAFTIN (naftifine hydrochloride) Cream, 2%). The population was 12 to 88 years old, primarily male (79%), 48% Caucasian, 36% Black or African American, 40% Hispanic or Latino and had either predominantly interdigital tinea pedis or tinea cruris. Most subjects received doses once-daily, topically, for 2 weeks to cover the affected skin areas plus a ½ inch margin of surrounding healthy skin. In the two vehicle-controlled trials, 17.5% of NAFTIN (naftifine hydrochloride) Cream, 2% treated subjects experienced an adverse reaction compared with 19.3% of vehicle subjects. The most common adverse reaction (.1%) is pruritus. Most adverse reactions were mild in severity. The incidence of Adverse Reactions in the NAFTIN Cream, 2% treated population were not significantly different than the vehicle treated population.

Postmarketing Experience

The following adverse reactions have been identified during postmarketing use of (naftifine hydrochloride): redness/irritation, inflammation, maceration, swelling, burning, blisters, serous drainage, crusting, headache, dizziness, leukopenia, agranulocytosis. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.