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Naftin Gel, 1% contains the synthetic, broad-spectrum, antifungal agent naftifine hydrochloride. Naftin Gel, 1% is for topical use only.
Naftifine hydrochloride has an empirical formula of CHN•HCl and a molecular weight of 323.86.
Inactive Ingredients polysorbate 80, carbomer 934P, diisopropanolamine, edetate disodium, alcohol (52%v/v) and purified water.
Naftifine hydrochloride is a synthetic allylamine derivative. The following in vitro data are available, but their clinical significance is unknown. Naftifine hydrochloride has been shown to exhibit fungicidal activity in vitro against a broad spectrum of organisms, including Trichophyton rubrum, Trichophyton mentagrophytes, Trichophyton tonsurans, Epidermophyton floccosum, Microsporum canis, Microsporum audouini, and Microsporum gypseum; and fungistatic activity against Candida species, including Candida albicans. Naftin Gel, 1% has only been shown to be clinically effective against the disease entities listed in the INDICATIONS AND USAGE section.
Although the exact mechanism of action against fungi is not known, naftifine hydrochloride 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.
In vitro and in vivo bioavailability studies have demonstrated that naftifine penetrates the stratum corneum in sufficient concentration to inhibit the growth of dermatophytes.
Following single topical applications of H-labeled naftifine gel 1% to the skin of healthy subjects, up to 4.2% of the applied dose was absorbed. Naftifine and/or its metabolites are excreted via the urine and feces with a half-life of approximately two to three days.
Naftin Gel, 1% is indicated for the topical treatment of tinea pedis, tinea cruris and tinea corporis caused by the organisms Trichophyton rubrum, Trichophyton mentagrophytes, Trichophyton tonsurans and Epidermophyton floccosum.
Naftin Gel, 1% is contraindicated in individuals who have shown hypersensitivity to any of its components.
Naftin Gel, 1% is for topical use only and not for ophthalmic use.
Naftin Gel, 1% is for external use only. If irritation or sensitivity develops with the use of Naftin 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.
The patient should be told to:
Long-term studies to evaluate the carcinogenic potential of Naftin Gel, 1% have not been performed. In vitro and animal studies have not demonstrated any mutagenic effect or effect on fertility.
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.
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 Gel, 1% is administered to a nursing woman.
Safety and effectiveness in pediatric patients have not been established.
During clinical trials with Naftin Gel, 1%, the incidence of adverse reactions was as follows: burning/stinging (5.0%), itching (1.0%), erythema (0.5%), rash (0.5%), skin tenderness (0.5%).
A sufficient quantity of Naftin Gel, 1% should be gently massaged into the affected and surrounding skin areas twice a day in the morning and evening. The hands should be washed after application.
If no clinical improvement is seen after four weeks of treatment with Naftin Gel, 1%, the patient should be re-evaluated.
Naftin (naftifine hydrochloride) 1% Gel is supplied in collapsible tubes in the following sizes:
|40g – NDC 0259-4770-40|
|60g – NDC 0259-4770-60|
|90g -- NDC 0259-4770-90|
Note: Store at room temperature.
Manufactured for: Merz Pharmaceuticals, Greensboro, NC 27410
5011343© 2009 Merz PharmaceuticalsRev 2/09 Printed in U.S.A.
NAFTIN 40g gel
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