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naftifine hcl 2% cream generic naftin

In stock Manufacturer IMPAX/AMNEAL 00115151258
$276.81 / 60 Grams Tube

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Uses

Dermatophytoses and Cutaneous Candidiasis

Naftifine hydrochloride 1% topical cream or gel is used topically for the treatment of certain dermatophytoses (i.e., tinea cruris, tinea corporis, tinea pedis, and tinea manuum) caused by Trichophyton mentagrophytes,T. rubrum, T. verrucosum,T. violaceum,Epidermophyton floccosum, or Microsporum canis. Naftifine topical gel has been used with some success in the treatment of tinea unguium (onychomycosis). The drug also has been effective when used topically for the treatment of cutaneous candidiasis.

Tinea corporis and tinea cruris generally can be effectively treated using a topical antifungal; however, an oral antifungal may be necessary if the disease is extensive, dermatophyte folliculitis is present, the infection is chronic or does not respond to topical therapy, or the patient is immunocompromised because of coexisting disease or concomitant therapy. Many clinicians consider topical imidazole-derivative azole antifungals (e.g., clotrimazole, econazole, ketoconazole, miconazole, oxiconazole, sulconazole) or topical allylamine antifungals (e.g., naftifine, terbinafine) the drugs of first choice for the topical treatment of tinea corporis or tinea cruris, although other antifungals agents (e.g., ciclopirox olamine, butenafine hydrochloride, tolnafate, undecylenic acid) also can be effective in the treatment of these infections. Uncomplicated interdigital and vesiculobullous forms of tinea pedis generally can be treated effectively using topical therapy with an imidazole-derivative azole antifungal (e.g., clotrimazole, econazole, ketoconazole, miconazole, oxiconazole, sulconazole), an allylamine antifungal (e.g., naftifine, terbinafine), or other topical antifungal agents such as ciclopirox olamine, butenafine hydrochloride, tolnaftate, or undecylenic acid. However, an oral antifungal regimen usually is necessary for the treatment of hyperkeratotic areas on the palms and soles, for chronic moccasin-type (dry-type) tinea pedis, and for the treatment of tinea unguium (onychomycosis).

Results of controlled studies indicate that naftifine hydrochloride 1% cream is equivalent in efficacy and safety to topical clotrimazole 1% cream, miconazole nitrate 1% cream, econazole nitrate 1% cream, or tolnaftate for the treatment of dermatophytoses. In clinical studies, 2-4 weeks of therapy with topical naftifine hydrochloride 1% cream resulted in a clinical and mycologic cure in 78-100% of patients with tinea cruris or tinea corporis and 4-5 weeks of therapy resulted in a clinical and mycologic cure in 69-82% of patients with tinea pedis. Like imidazole-derivative azole antifungal agents (e.g., clotrimazole, econazole, ketoconazole, miconazole, oxiconazole, sulconazole) and ciclopirox olamine, naftifine has an advantage over some other topical antifungal agents (e.g., nystatin, tolnaftate) in the treatment of mixed infections or for empiric treatment pending identification of the causative organism since the drug is active against both dermatophytes and Candida. However, in vitro on a weight basis, naftifine is considerably less active than imidazole derivatives against Candida.

Dosage and Administration

Administration

Naftifine hydrochloride is applied topically to the skin as a 1% cream or gel. The cream or gel should not be applied to the eye, and contact with the nose, mouth, and other mucous membranes should be avoided. Occlusive dressings or wrappings should not be used, and hands should be washed after applying the cream.

Dosage

For the treatment of tinea cruris, tinea corporis, or tinea pedis, a sufficient amount of naftifine hydrochloride topical cream or gel should be applied and rubbed gently into the affected and surrounding skin areas; naftifine hydrochloride topical cream should be applied once daily and naftifine hydrochloride topical gel should be applied twice daily, in the morning and evening.

Clinical improvement usually occurs within the first week of treatment with naftifine hydrochloride topical cream. Tinea cruris and tinea corporis generally are treated for 2-4 weeks and tinea pedis for 4-6 weeks; severe infections may require more prolonged therapy. If clinical improvement does not occur after 4 weeks of treatment with naftifine hydrochloride topical cream or gel, the diagnosis should be reevaluated.

Cautions

Adverse Effects

Topically applied naftifine hydrochloride appears to have a low order of toxicity and generally is well tolerated. The major adverse effect reported with the drug is transient burning and stinging, which occurred in 5-6% of patients during clinical studies. Dryness, erythema, pruritus, local irritation, rash, and skin tenderness occurred in 0.5-3% of patients. Although these local adverse effects generally are mild to moderate in severity, they rarely are severe enough to require discontinuance of the drug.

Contact dermatitis has been reported occasionally in patients receiving topical naftifine. In at least one case, the reaction appeared to be caused by the drug; in other reported cases, it was unclear whether the reaction was caused by the drug or the vehicle. Results of patch tests in some patients who had contact dermatitis during naftifine therapy indicate that these individuals were sensitive to benzyl alcohol or some other ingredient contained in the vehicle. Controlled studies in guinea pigs and rabbits indicate that naftifine appears to have minimal potential for inducing allergic contact sensitization following topical application. In a dermatotoxicity study in healthy adults, topical application of a cream, gel, or solution containing naftifine to intact or irritated skin did not reveal evidence of local irritation, contact sensitization, phototoxicity, or photoallergic dermatitis.

Adverse systemic effects have not been reported to date with topical naftifine.

Precautions and Contraindications

Patients receiving topical naftifine hydrochloride therapy should be instructed to use the medication for the full, prescribed treatment period, even if symptoms improve, and to contact their physician if their skin condition does not improve after the prescribed period of treatment (i.e., up to 4 weeks). Patients also should be instructed to contact their physician if signs of increased irritation indicative of possible sensitization occur at the site of application. If a reaction suggesting sensitivity or chemical irritation occurs during treatment with naftifine hydrochloride 1% cream or gel, the drug should be discontinued and an appropriate alternative anti-infective substituted. Patients receiving topical naftifine therapy also should be instructed to avoid the use of occlusive dressings or wrappings (unless otherwise directed by the physician) and to keep the cream away from eyes, nose, mouth, and other mucous membranes.

Prior to initiation of naftifine therapy, the diagnosis should be confirmed either by direct microscopic examination of a potassium hydroxide mounting of infected tissue or by culture on an appropriate medium.

Naftifine is contraindicated in patients who have known hypersensitivity to the drug or any ingredient in the formulation.Commercially available naftifine hydrochloride cream or gel is intended for topical application to the skin only and should not be applied to the eye.

Pediatric Precautions

Safety and efficacy of topical naftifine hydrochloride cream and gel in children younger than 12 years of age have not been established.

Mutagenicity and Carcinogenicity

Naftifine was not mutagenic in the rat hepatocyte DNA repair assay, mouse micronucleus test, or Chinese hamster V-79 cell test, or in the Salmonella microbial mutagen (Ames) test with metabolic activation. Long-term animal studies to determine the carcinogenic potential of naftifine have not been performed to date.

Pregnancy, Fertility, and Lactation

Pregnancy

Reproduction studies in rats and rabbits using oral naftifine hydrochloride in doses 150 or more times the usual topical human dose have not revealed evidence of harm to the fetus. In in vitro studies using rat embryos exposed to the drug, there was no evidence of embryotoxicity at concentrations of 10 mcg/mL or less; however, adverse effects on embryonic growth and differentiation and morphologic abnormalities of a nonspecific pattern did occur at concentrations of 30 mcg/mL or greater. There are no adequate and controlled studies to date using topical naftifine in pregnant women, and the drug should be used during pregnancy only when clearly needed.

Fertility

Reproduction studies in rats and rabbits using oral naftifine hydrochloride in doses 150 or more times the usual topical human dose have not revealed evidence of impaired fertility.

Lactation

Although naftifine is distributed into the milk of rats, it is not known whether the drug is distributed into human milk. The manufacturer states that topical naftifine should be used with caution in nursing women; however, it is unlikely that clinically important concentrations of naftifine could be achieved in breast milk following topical application of usual dosages to the skin.

Pharmacokinetics

Absorption

Following topical application of naftifine hydrochloride 1% cream or gel to intact skin of healthy adults, approximately 3-6% of the dose is absorbed systemically. Studies using radiolabeled naftifine indicate that following a single application of the drug, sufficient concentrations are retained in the upper skin layers to inhibit the growth of dermatophytes at this site for 24 hours.

Distribution

It is not known whether naftifine crosses the placenta. It also is not known whether naftifine is distributed into human milk; however, the drug is distributed into the milk of rats following topical administration.

Elimination

Naftifine is metabolized to at least 3 metabolites by oxidation of the phenyl and naphthyl rings and by N-dealkylation. Following topical application of naftifine to intact skin in healthy adults, percutaneously absorbed naftifine and/or its metabolites are excreted in urine and feces. Approximately 40-60% of the absorbed dose is excreted in urine as unchanged drug and metabolites; the remainder of the absorbed dose is excreted in feces via biliary elimination.

Naftifine has a half-life of approximately 2-3 days following topical administration.

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