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Here’s what to ask a doctor about hereditary angioedema

Naftifine

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. [DSC] = Discontinued product

Cream, External, as hydrochloride:

Naftin: 1% (30 g [DSC], 60 g [DSC], 90 g [DSC]); 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)]

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, tinea cruris: Children ≥12 years and Adolescents: Topical: Cream 2%: Refer to adult dosing.

Tinea pedis: Children ≥12 years and Adolescents:Topical: Cream 2% and gel 2%: Refer to adult dosing.

Administration

Topical: 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, inflammation, leukopenia

Warnings/Precautions

Concerns related to adverse effects:

• Irritation: Discontinue if sensitivity or irritation occurs

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 Risk Factor

B

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

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Patient may experience itching. Have patient report immediately to prescriber redness, edema, or severe skin irritation (HCAHPS).

• Educate patient about signs of a significant reaction (eg, 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. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for healthcare professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience and judgment in diagnosing, treating and advising patients.

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