Professional Information
Naftifine (Topical)
VA CLASSIFICATION
Primary: DE102.
Commonly used brand name(s): Naftin.
Note: For a listing of dosage forms and brand names by country availability, see Dosage Forms section(s).
Category:
Antifungal (topical)—
Note: Naftifine is a broad-spectrum antifungal. {01} {02}
Indications
Note: Bracketed information in the Indications section refers to uses that are not included in U.S. product labeling.
Accepted
Tinea corporis (treatment)
Tinea cruris (treatment) or
Tinea pedis (treatment){06}{07}{08}—Naftifine hydrochloride is indicated [as a primary agent] {06} in the topical treatment of tinea corporis (ringworm of the body), tinea cruris (jock itch; ringworm of the groin), and tinea pedis (athlete's foot; ringworm of the foot) {06} {07} caused by Epidermophyton floccosum , Microsporum canis , Trichophyton rubrum , and T. mentagrophytes . {01} {02} {03} {06} {07}
[Tinea barbae (treatment)] or
[Tinea capitis (treatment)]—Naftifine is used in combination with griseofulvin or systemic ketoconazole (for griseofulvin-resistant cases) in the topical treatment of tinea barbae (ringworm of the beard) and tinea capitis (ringworm of the scalp). {06}
[Tinea versicolor (treatment)]—Naftifine is used as a primary agent in the topical treatment of tinea versicolor (pityriasis versicolor; ``sun fungus'') caused by Pityrosporon orbiculare (Malassezia furfur) . {06}
—Not all species or strains of a particular organism may be susceptible to naftifine.
Pharmacology/Pharmacokinetics
Physicochemical characteristics:
Chemical group—
Allylamine derivative {01} {02} {03}.
Molecular weight—
323.86
Mechanism of action/Effect:
Fungicidal to dermatophytes at low concentrations and fungistatic to yeasts at somewhat higher concentrations. Exact mechanism unknown. Appears to selectively inhibit the enzyme squalene 2,3-epoxidase, resulting in inhibition of sterol biosynthesis. This results in decreased amounts of sterols, especially ergosterol (the primary fungal membrane sterol), and a corresponding accumulation of squalene in fungal cells. {01} {02}
Absorption:
Following a single application to the skin of healthy patients, approximately 6% of the applied dose of 1% cream, {01} and approximately 4.2% of the applied dose of 1% gel, {05} is absorbed systemically. {01} {05}
Half-life:
Approximately 2 to 3 days {01}.
Elimination:
Renal and fecal; naftifine and/or metabolites excreted in the urine and feces. {01}
Precautions to Consider
Cross-sensitivity and/or related problems
Patients sensitive to benzoates may be sensitive to naftifine hydrochloride cream also since it may contain benzyl alcohol as a preservative. {01}
Carcinogenicity
Long-term studies in animals to evaluate the carcinogenic potential of naftifine have not been done. {01}
Mutagenicity
In vitro and animal studies have not shown that naftifine is mutagenic. {01}
Pregnancy/Reproduction
Fertility—
Adequate and well-controlled studies in humans have not been done.
Studies in rats and rabbits given oral doses of 150 or more times the topical dose have not shown that naftifine causes impaired fertility. {01}
Pregnancy—
Adequate and well-controlled studies in humans have not been done.
Studies in rats and rabbits given oral doses of 150 or more times the topical dose have not shown that naftifine causes adverse effects on the fetus. {01}
FDA Pregnancy Category B. {01}
Breast-feeding
Approximately 4.2 and 6%, respectively, of the applied dose of 1% naftifine hydrochloride gel and cream is absorbed systemically following a single application to the skin of healthy patients. In addition, naftifine has a long half-life (2 to 3 days) in the body. Therefore, it may be necessary to discontinue breast-feeding or discontinue the medication. {06} However, it is not known whether naftifine is distributed into human breast milk and problems in humans have not been documented. {01}
Pediatrics
Appropriate studies on the relationship of age to the effects of naftifine have not been performed in the pediatric population. Safety and efficacy have not been established. {08}
Geriatrics
Appropriate studies on the relationship of age to the effects of naftifine have not been performed in the geriatric population. However, no geriatrics-specific problems have been documented to date.
Medical considerations/Contraindications
The medical considerations/contraindications included have been selected on the basis of their potential clinical significance (reasons given in parentheses where appropriate)— not necessarily inclusive (» = major clinical significance).
Risk-benefit should be considered when the following medical problem exists
Sensitivity to naftifine or benzoates
Side/Adverse Effects
The following side/adverse effects have been selected on the basis of their potential clinical significance (possible signs and symptoms in parentheses where appropriate)—not necessarily inclusive:
Those indicating need for medical attention only if they continue or are bothersome
Incidence more frequent
Burning or stinging feeling{01}{02} on treated area(s)
Incidence less frequent
Dry skin{01}
itching, redness, or other sign of skin irritation not present before therapy{01}{02}
Patient Consultation
As an aid to patient consultation, refer to Advice for the Patient, Naftifine (Topical).
In providing consultation, consider emphasizing the following selected information (» = major clinical significance):
Before using this medication
» Conditions affecting use, especially:
Sensitivity to naftifine or benzoates
Breast-feeding—Approximately 4.2 and 6%, respectively, of applied dose of naftifine hydrochloride gel and cream absorbed systemically; also naftifine has long half-life; may be necessary to discontinue breast-feeding or discontinue medication
Proper use of this medication
» Avoiding contact with the eyes and mucous membranes such as the inside of the nose, mouth, or vagina
» Avoiding use of occlusive dressings on the area being treated unless otherwise directed by physician {08}
To use
» Applying sufficient medication to cover affected skin and surrounding areas, and rubbing in gently
Washing hands after application to remove any residual medication
» Compliance with full course of therapy; continuing therapy for 1 to 2 weeks after symptoms have subsided
» Proper dosing
Missed dose: Applying as soon as possible; not applying if almost time for next dose
» Proper storage
Precautions while using this medication
Checking with physician if no improvement within 4 weeks
» Using hygienic measures to help cure infection and to help prevent reinfection:
For tinea pedis
Carefully drying feet, especially between toes, after bathing
Not wearing socks made from wool or synthetic materials; wearing clean, cotton socks and changing them daily or more often if feet perspire excessively
Wearing well-ventilated shoes or sandals
Using a bland, absorbent powder or an antifungal powder liberally between toes, on feet, and in socks and shoes once or twice daily; using the powder after naftifine has been applied and has disappeared into the skin; not using the powder as the only therapy for your fungal infection
For tinea cruris
Carefully drying inguinal area after bathing
Not wearing underwear that is tight-fitting or made from synthetic materials; wearing loose-fitting cotton underwear instead
Using a bland, absorbent powder or an antifungal powder liberally once or twice daily; using the powder after naftifine has been applied and has disappeared into the skin; not using the powder as the only therapy for your fungal infection
For tinea corporis
Carefully drying the body after bathing
Avoiding excess heat and humidity if possible; keeping moisture from accumulating on affected areas of the body
Wearing well-ventilated clothing
Using a bland, absorbent powder or an antifungal powder liberally once or twice daily; using the powder after naftifine has been applied and has disappeared into the skin; not using the powder as the only therapy for your fungal infection
General Dosing Information
Naftifine hydrochloride should not be used in the eyes and on mucous membranes such as the inside of the nose, mouth, or vagina. {01}
A sufficient quantity of naftifine hydrochloride cream should be gently massaged into the affected skin and surrounding areas once a day. {08} Naftifine hydrochloride gel should be applied two times a day, morning and evening. {05} The hands should be washed after application to remove any residual medication. {01}
Use of topical antifungals may lead to skin sensitization, resulting in hypersensitivity reactions with subsequent topical use of the medication.
If skin irritation or hypersensitivity develops, treatment with naftifine hydrochloride should be discontinued. {01}
To reduce the possibility of recurrence of infection, treatment should be continued for 1 to 2 weeks after symptoms have subsided. {01}
Topical Dosage Forms
NAFTIFINE HYDROCHLORIDE CREAM
Usual adult and adolescent dose
Tinea corporis or
Tinea cruris or
Tinea pedis {06} {07} {08}
Topical, to the affected skin and surrounding areas, once a day. {08}
Usual pediatric dose
Safety and efficacy have not been established. {08}
Strength(s) usually available
U.S.—
1% (Rx) [Naftin]
Canada—
1% (OTC) [Naftin]{09}{10}
Packaging and storage:
Store below 30 °C (86 °F), in a well-closed container, unless otherwise specified by manufacturer. Protect from freezing.
Auxiliary labeling:
• For external use only.
• Continue medication for full time of treatment.
NAFTIFINE HYDROCHLORIDE GEL
Usual adult and adolescent dose
Tinea corporis or
Tinea cruris or
Tinea pedis {05}
Topical, to the affected skin and surrounding areas, two times a day, morning and evening. {05}
Usual pediatric dose
Safety and efficacy have not been established. {05}
Strength(s) usually available
U.S.—
1% (Rx) [Naftin]
Canada—
1% (OTC) [Naftin]{09}{10}
Packaging and storage:
Store below 30 °C (86 °F), in a well-closed container, unless otherwise specified by manufacturer. Protect from freezing.
Auxiliary labeling:
• For external use only.
• Continue medication for full time of treatment.
Revised: 07/25/1994
References
- Naftifine package insert (Herbert—US), Rev 2/88, Rec 5/88.
- Millikan LE, Galen WK, Gewirtzman GB, Horwitz SN, Landow RK, Nesbitt LT, et al. Naftifine cream 1% versus econazole cream 1% in the treatment of tinea cruris and tinea corporis. J Am Acad Dermatol 1988; 18: 52-6.
- Ganzinger U, Stutz A, Petranyl G, Stephen A. Allylamines: topical and oral treatment of dermatomycosis with a new class of antifungal agents. Acta Derm Venereol 1986; 121: 155-6.
- Hold
- Naftin Gel package insert (Herbert—US), Rev 9/90, Rec 2/94.
- Panel comments, 1/13/89.
- Manufacturer's comment, 6/13/89.
- Naftin Cream package insert (Herbert—US), Rev 5/90, Rec 2/94.
- Krogh CME, editor. CPS Compendium of pharmaceuticals and specialties. 29th ed. Ottawa: Canadian Pharmaceutical Association, 1994: 834.
- Reviewer comment, 6/94.
| Link to this page |  |
Printable Version |  |
Email Page |
