NAFTIN Gel (2020)

Βιβλιογραφική αναφορά

Συγγραφείς

Sebela Pharmaceuticals Inc.

Λέξεις κλειδιά

54766-772

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1. Indications and Usage

NAFTIN Gel is an allylamine antifungal indicated for the treatment of interdigital tinea pedis caused by the organisms Trichophyton rubrum, Trichophyton mentagrophytes, and Epidermophyton ...

2. Dosage and Administration

Apply a thin layer of NAFTIN Gel once daily to the affected areas plus an approximate ½ inch margin of healthy surrounding skin for 2 weeks. For topical use only. NAFTIN Gel is not for ophthalmic, oral, ...

3. Dosage Forms and Strengths

Gel, 2%. Each gram contains 20 mg of naftifine hydrochloride in a colorless to yellow gel.

4. Contraindications

None.

5. Warnings and Precautions

5.1 Local Adverse Reactions If irritation or sensitivity develops with the use of NAFTIN Gel, treatment should be discontinued.

6.1. 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 ...

6.2. Postmarketing Experience

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. ...

8.1. Pregnancy

Risk Summary There are no available data on NAFTIN Gel use in pregnant women to evaluate a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. In animal reproduction ...

8.2. Lactation

Risk Summary There is no information available on the presence of naftifine hydrochloride in human milk, the effects of the drug on the breastfed infant, or the effects of the drug on milk production after ...

8.4. Pediatric Use

The safety and effectiveness of NAFTIN Gel have been established in the age group 12 to 18 years of age with interdigital tinea pedis. Use of NAFTIN Gel in this age group is supported by evidence from ...

8.5. Geriatric Use

During clinical trials, 99 subjects (9%) aged 65 years and over were exposed to NAFTIN Gel. Safety and effectiveness were similar to those reported by younger subjects.

11. Description

NAFTIN Gel is a clear to yellow gel for topical use only. Each gram of NAFTIN Gel contains 20 mg of naftifine hydrochloride, a synthetic allylamine antifungal compound. Chemically, naftifine HCl is (E)-N-Cinnamyl-N-methyl-1-napthalenemethylamine ...

12.1. Mechanism of Action

NAFTIN Gel is a topical antifungal drug [see Clinical Pharmacology (12.4)].

12.2. Pharmacodynamics

The pharmacodynamics of NAFTIN Gel have not been established.

12.3. Pharmacokinetics

In vitro and in vivo bioavailability studies have demonstrated that naftifine penetrates the stratum corneum in sufficient concentration to inhibit the growth of dermatophytes. Pharmacokinetic analysis ...

12.4. Microbiology

Mechanism of Action Naftifine is an antifungal that belongs to the allylamine class. Although the exact mechanism of action against fungi is not known, naftifine hydrochloride appears to interfere with ...

13.1. Carcinogensis, Mutagenesis, Impairment of Fertility

In a 2-year dermal carcinogenicity study, naftifine hydrochloride cream was administered to Sprague-Dawley rats at topical doses of 1%, 2% and 3% (10, 20, and 30 mg/kg/day naftifine hydrochloride). No ...

14. Clinical Studies

NAFTIN Gel has been evaluated for efficacy in two randomized, double-blind, vehicle-controlled, multicenter trials that included 1175 subjects with symptomatic and dermatophyte culture-positive interdigital ...

16.1. How Supplied

NAFTIN Gel is a colorless to yellow gel supplied in collapsible tubes in the following size: 45g – NDC 54766-772-45 60g – NDC 54766-772-60

16.2. Storage and Handling

Store NAFTIN Gel at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].

17. Patient Counseling Information

Distributed by Sebela Pharmaceuticals Inc., 645 Hembree Parkway, Suite I, Roswell, GA 30076