Naftifine Cream
Generic name: naftifine hydrochloride
Dosage form: cream
Drug class:Topical antifungals
Medically reviewed by Drugs.com. Last updated on Jan 1, 2021.
On This Page
- Indications and Usage
- Dosage and Administration
- Dosage Forms and Strengths
- Contraindications
- Warnings and Precautions
- Adverse Reactions/Side Effects
- Use In Specific Populations
- Description
- Clinical Pharmacology
- Nonclinical Toxicology
- Clinical Studies
- How Supplied/Storage and Handling
- Patient Counseling Information
Indications and Usage for Naftifine Cream
Naftifine hydrochloride cream is indicated for the treatment of interdigital tinea pedis, tinea cruris, and tinea corporis caused by the organism Trichophyton rubrum.
Naftifine Cream Dosage and Administration
For topical use only. Naftifine hydrochloride cream is not for ophthalmic, oral, or intravaginal use. Apply a thin layer of naftifine hydrochloride cream once-daily to the affected areas plus a ½ inch margin of healthy surrounding skin for 2 weeks.
Dosage Forms and Strengths
Each gram contains 20 mg of naftifine hydrochloride (2%) in a white to off-white base.
Contraindications
None
Warnings and Precautions
Local Adverse Reactions
Discontinue treatment if irritation or sensitivity develops with the use of naftifine hydrochloride cream. Direct patients to contact their physician if these conditions develop following use of naftifine hydrochloride cream.
Adverse Reactions
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.
During clinical trials, 903 subjects were exposed to naftifine 1% and 2% cream formulations. A total of 564 subjects with interdigital tinea pedis, tinea cruris, or tinea corporis were treated with naftifine hydrochloride cream.
In two randomized, vehicle-controlled trials (...