NAFTIN CREAM 1%
naftifine hydrochloride cream
DPT Laboratories, Ltd.
Naftin® Cream, 1% contains the synthetic, broad-spectrum, antifungal agent naftifine hydrochloride. Naftin® Cream, 1% is for topical use only.
(E)-N-Cinnamyl-N-methyl-1- naphthalenemethylamine hydrochloride. Naftifine hydrochloride has an empirical formula of C21H21N•HCl and a molecular weight of 323.86.
Naftifine hydrochloride . . . . . . . . . . . . . 1%
Inactive Ingredients: benzyl alcohol, cetyl alcohol, cetyl esters wax, isopropyl myristate, polysorbate 60, purified water, sodium hydroxide, sorbitan monostearate, and stearyl alcohol. Hydrochloric acid may be added to adjust pH.
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® Cream, 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 a single topical application of 1% naftifine cream to the skin of healthy subjects, systemic absorption of naftifine was approximately 6% of the applied dose. Naftifine and/or its metabolites are excreted via the urine and feces with a half-life of approximately two to three days.
Naftin® Cream, 1% is indicated for the topical treatment of tinea pedis, tinea cruris and tinea corporis caused by the organisms Trichophyton rubrum, Trichophyton mentagrophytes, and Epidermophyton floccosum.
Naftin® Cream, 1% is contraindicated in individuals who have shown hypersensitivity to any of its components.
Naftin® Cream, 1% is for topical use only and not for ophthalmic use.
During clinical trials with Naftin® Cream, 1%, the incidence of adverse reactions was as follows: burning/stinging (6%), dryness (3%), erythema (2%), itching (2%), local irritation (2%).
A sufficient quantity of Naftin® Cream, 1% should be gently massaged into the affected and surrounding skin areas once a day. The hands should be washed after application. If no clinical improvement is seen after four weeks of treatment with Naftin® Cream, 1%, the patient should be reevaluated.
Naftin® (naftifine hydrochloride) 1% Cream is supplied in the following sizes:15g – NDC 0259-4126-15 (tube)
|Tubes:||Store below 30°C (86°F).|
|Pumps:||Store at controlled room temperature: 25°C (77°F);|
||excursions permitted between 15°-30°C (59°-86°F).|
Manufactured for: Merz Pharmaceuticals, Greensboro, NC 27410
© 2008 Merz Pharmaceuticals
Rev. 5/08 Printed in U.S.A.
naftinine hydrochloride 1% cream cream
|Marketing Category||Application Number or Monograph Citation||Marketing Start Date||Marketing End Date|
|Labeler - DPT Laboratories, Ltd. (621782218)|
|Registrant - DPT Laboratories, Ltd. (621782218)|
|DPT Laboratories, Ltd.||621782218||manufacture|