Dosage Forms
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Cream, External, as hydrochloride:
Naftin: 2% (45 g, 60 g) [contains benzyl alcohol, cetyl alcohol]
Generic: 1% (60 g, 90 g); 2% (45 g, 60 g)
Gel, External, as hydrochloride:
Naftin: 1% (40 g, 60 g, 90 g) [contains alcohol, usp, edetate disodium, polysorbate 80]
Naftin: 2% (45 g, 60 g) [contains alcohol, usp, benzyl alcohol, edetate disodium, propylene glycol, trolamine (triethanolamine)]
Generic: 1% (40 g, 60 g, 90 g)
Pharmacology
Mechanism of Action
Synthetic, broad-spectrum antifungal agent in the allylamine class; appears to have both fungistatic and fungicidal activity. Exhibits antifungal activity by selectively inhibiting the enzyme squalene epoxidase in a dose-dependent manner which results in a reduced synthesis of ergosterol, the primary sterol within the fungal membrane, and increased squalene in cells.
Pharmacokinetics/Pharmacodynamics
Absorption
Systemic: Cream: 6%; Gel: 4%
Excretion
Urine and feces (as unchanged drug and/or metabolites)
Half-Life Elimination
2 to 3 days
Use: Labeled Indications
Tinea infections: Cream 1% and 2%, Gel 1%: Topical treatment of tinea cruris (jock itch), tinea corporis (ringworm), and tinea pedis (athlete's foot).
Tinea pedis: Gel 2%: Topical treatment of tinea pedis (athlete's foot).
Contraindications
Hypersensitivity to naftifine or any component of the formulation
Dosage and Administration
Dosing: Adult
Tinea corporis, tinea cruris: Topical:
Cream 1% and gel 1%: Apply once daily (cream) or twice daily (gel; morning and evening) to affected area and surrounding skin for up to 4 weeks
Cream 2%: Apply a thin layer once daily to affected area and healthy surrounding skin (1/2 inch margin) for 2 weeks
Tinea pedis: Topical:
Cream 1% and gel 1%: Apply once daily (cream) or twice daily (gel; morning and evening) to affected area and surrounding skin for up to 4 weeks
Cream 2% and gel 2%: Apply a thin layer once daily to affected area and surrounding skin (1/2 inch margin) for 2 weeks
Dosing: Geriatric
Refer to adult dosing.
Dosing: Pediatric
Tinea corporis: Children ≥2 years and Adolescents: Topical Cream 2%: Refer to adult dosing.
Tinea cruris, tinea pedis: Children ≥12 years and Adolescents: Topical: Cream 2%: Refer to adult dosing.
Tinea pedis: Children ≥12 years and Adolescents: Topical: Gel 2%: Refer to adult dosing.
Administration
Topical: For topical use only; avoid nasal, ophthalmic, oral or intravaginal use. Wash hands before and after use. Apply to clean, dry skin. Avoid occlusive dressings.
Storage
Cream 1%: Store below 30°C (86°F).
Cream 2%, gel 2%: Store at 25°C (77°F); excursions are permitted between 15°C and 30°C (59°F and 86°F).
Gel 1%: Store at room temperature.
Drug Interactions
There are no known significant interactions.
Adverse Reactions
1% to 10%:
Dermatologic: Burning sensation of skin (5% to 6%), xeroderma (3%), skin irritation (2%), erythema (≤2%), pruritus (1% to 2%)
Local: Application site reaction (2%)
<1%, postmarketing, and/or case reports: Agranulocytosis, crusted skin, dizziness, headache, inflammation, leukopenia, maceration, pain, rash, serous drainage, skin blister, skin tenderness, swelling of skin
Warnings/Precautions
Concerns related to adverse effects:
- Irritation: Discontinue if sensitivity or irritation occurs and institute appropriate therapy.
Other warnings/precautions:
- Appropriate use: For topical use only; not intended for oral, ophthalmic, or vaginal use. Avoid use of occlusive dressings and contact with eyes, nose, mouth, or mucous membranes.
Monitoring Parameters
Culture and KOH exam; re-evaluate if no improvement after 4 weeks of therapy
Pregnancy
Pregnancy Considerations
Adverse events were not observed in animal reproduction studies following oral administration. Naftifine is absorbed systemically (4% to 6%) following topical administration.
Patient Education
What is this drug used for?
- It is used to treat fungal infections of the skin.
Frequently reported side effects of this drug
- Burning
- Stinging
Other side effects of this drug: Talk with your doctor right away if you have any of these signs of:
- Application site irritation
- Signs of a significant reaction like wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat.
Note: This is not a comprehensive list of all side effects. Talk to your doctor if you have questions.
Consumer Information Use and Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.
