Naftifine Hydrochloride
Generic Name: naftifine hydrochloride
Brand Names:
Naftifine Hydrochloride
11 DESCRIPTION Naftifine Hydrochloride Gel USP, 2% is a clear to yellow gel for topical use only. Each gram of naftifine hydrochloride gel contains 20 mg of naftifine hydrochloride, a synthetic allylamine antifungal compound. Chemically, naftifine HCl is (E)-N-Cinnamyl-N-methyl-1-napthalenemethylamine hydrochloride. The molecular formula is C 21 H 21 N∙HCl with a molecular weight of 323.86.
Overview
11 DESCRIPTION Naftifine Hydrochloride Gel USP, 2% is a clear to yellow gel for topical use only. Each gram of naftifine hydrochloride gel contains 20 mg of naftifine hydrochloride, a synthetic allylamine antifungal compound. Chemically, naftifine HCl is (E)-N-Cinnamyl-N-methyl-1-napthalenemethylamine hydrochloride. The molecular formula is C 21 H 21 N∙HCl with a molecular weight of 323.86.
Uses
1 INDICATIONS AND USAGE Naftifine hydrochloride gel USP, 2% is indicated for the treatment of interdigital tinea pedis caused by the organisms Trichophyton rubrum , Trichophyton mentagrophytes , and Epidermophyton floccosum . Naftifine Hydrochloride Gel USP, 2% is an allylamine antifungal indicated for the treatment of interdigital tinea pedis caused by the organisms Trichophyton rubrum, Trichophyton mentagrophytes, and Epidermophyton floccosum . ( 1 )
Dosage
2 DOSAGE AND ADMINISTRATION Apply a thin layer of naftifine hydrochloride gel, 2% once daily to the affected areas plus an approximate ½ inch margin of healthy surrounding skin for 2 weeks. For topical use only. Naftifine hydrochloride gel, 2% is not for ophthalmic, oral, or intravaginal use. Apply a thin layer of naftifine hydrochloride gel, 2% once daily to the affected areas plus an approximate ½ inch margin of healthy surrounding skin for 2 weeks. ( 2 ) For topical use only. Naftifine hydrochloride gel, 2% is not for ophthalmic, oral, or intravaginal use. ( 2 )
Side Effects
6 ADVERSE REACTIONS The most common adverse reactions are application site reactions (2%). ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Sun Pharmaceutical Industries, Inc., at 1-866-923-4914 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 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 drug and may not reflect the rates observed in clinical practice. In two randomized, vehicle-controlled trials, 1143 subjects were treated with naftifine hydrochloride gel versus 571 subjects treated with the vehicle.
Warnings
5 WARNINGS AND PRECAUTIONS If redness or irritation develops with the use of naftifine hydrochloride gel treatment should be discontinued. ( 5.1 ) 5.1 Local Adverse Reactions If irritation or sensitivity develops with the use of naftifine hydrochloride gel, treatment should be discontinued. 4 CONTRAINDICATIONS None. None. ( 4 )
Pregnancy
8.1 Pregnancy Risk Summary There are no available data on naftifine hydrochloride 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 studies, no adverse effects on embryofetal development were seen at oral doses administered during the period of organogenesis up to 37 times the maximum recommended human dose (MRHD) in pregnant rats or subcutaneous doses administered during the period of organogenesis up to 4 times the MRHD in pregnant rats or 7 times the MRHD in pregnant rabbits ( see D...
Storage
Storage Store at 20° to 25°C (68° to 77°F); [see USP Controlled Room Temperature].
Frequently Asked Questions
What is Naftifine Hydrochloride used for?▼
1 INDICATIONS AND USAGE Naftifine hydrochloride gel USP, 2% is indicated for the treatment of interdigital tinea pedis caused by the organisms Trichophyton rubrum , Trichophyton mentagrophytes , and Epidermophyton floccosum . Naftifine Hydrochloride Gel USP, 2% is an allylamine antifungal indicated for the treatment of interdigital tinea pedis caused by the organisms Trichophyton rubrum, Trichophyton mentagrophytes, and Epidermophyton floccosum . ( 1 )
What are the side effects of Naftifine Hydrochloride?▼
6 ADVERSE REACTIONS The most common adverse reactions are application site reactions (2%). ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Sun Pharmaceutical Industries, Inc., at 1-866-923-4914 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 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 drug and may not reflect the rates observed in clinical practice. In two randomized, vehicle-controlled trials, 1143 subjects were treated with naftifine hydrochloride gel versus 571 subjects treated with the vehicle.
Can I take Naftifine Hydrochloride during pregnancy?▼
8.1 Pregnancy Risk Summary There are no available data on naftifine hydrochloride 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 studies, no adverse effects on embryofetal development were seen at oral doses administered during the period of organogenesis up to 37 times the maximum recommended human dose (MRHD) in pregnant rats or subcutaneous doses administered during the period of organogenesis up to 4 times the MRHD in pregnant rats or 7 times the MRHD in pregnant rabbits ( see D...
What are the important warnings for Naftifine Hydrochloride?▼
5 WARNINGS AND PRECAUTIONS If redness or irritation develops with the use of naftifine hydrochloride gel treatment should be discontinued. ( 5.1 ) 5.1 Local Adverse Reactions If irritation or sensitivity develops with the use of naftifine hydrochloride gel, treatment should be discontinued. 4 CONTRAINDICATIONS None. None. ( 4 )
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Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.