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Naftifine

Medically reviewed by Drugs.com. Last updated on Jan 25, 2020.

Pronunciation

(NAF ti feen)

Index Terms

  • Naftifine HCl
  • Naftifine Hydrochloride

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)

Brand Names: U.S.

  • Naftin

Pharmacologic Category

  • Antifungal Agent, Topical

Pharmacology

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.

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

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 Considerations

Naftifine is absorbed systemically (4% to 6%) following topical administration. Application over a limited area is considered likely acceptable during pregnancy (Patel 2017).

Patient Education

What is this drug used for?

• It is used to treat fungal infections of the skin.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Burning

• Stinging

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Application site irritation

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, 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 limited summary of general information about the medicine's uses from the patient education leaflet and is not intended to be comprehensive. This limited summary does NOT include all information available about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not intended to provide medical advice, diagnosis or treatment and does not replace information you receive from the healthcare provider. For a more detailed summary of information about the risks and benefits of using this medicine, please speak with your healthcare provider and review the entire patient education leaflet.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.