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  • CLASSES

    Topical Dermatological Antifungals

    DEA CLASS

    OTC

    DESCRIPTION

    Topical thiocarbamate antifungal used primarily for treatment of mild to moderate tinea pedis (athlete's foot), tinea cruris (jock itch), tinea corporis (ringworm), tinea manuum, and tinea versicolor.

    COMMON BRAND NAMES

    Absorbine Athletes Foot, Absorbine Jr. Antifungal, Aftate For Athletes Foot, Aftate for Jock Itch, Antifungal, Fungi-Guard, Lamisil AF, Q-Naftate, Termin8, Tinactin, Tinactin Jock Itch, Tinaderm, Ting Antifungal

    HOW SUPPLIED

    Absorbine Athletes Foot/Fungi-Guard/Q-Naftate/Tinactin/Tinactin Jock Itch/Ting Antifungal/Tolnaftate Topical Cream: 1%
    Absorbine Jr. Antifungal Topical Gel: 1%
    Antifungal/Lamisil AF/Tinactin/Tinactin Jock Itch/Tolnaftate Topical Pwd: 1%
    Fungi-Guard/Termin8/Tinaderm/Tolnaftate Topical Sol: 1%
    Lamisil AF/Ting Antifungal Topical Spray: 1%
    Tinactin Topical Aer: 1%

    DOSAGE & INDICATIONS

    For the treatment of tinea cruris, tinea corporis, tinea manuum, tinea pedis, tinea barbae, and tinea capitis caused by T. rubrum, T. mentagrophytes, T. tonsurans, M. canis, M. audouinii, and E. floccosum; also effective in the treatment of tinea versicolor infections due to M. furfur.
    NOTE: Tolnaftate is not recommended in the treatment of deeper skin infections or infection of the nail beds (onychomycosis).
    NOTE: Tolnaftate powder may not be effective as monotherapy; for active treatment, use of the powder may be combined with other topical dosage forms if required.
    Topical dosage (all skin products)
    Adults, Geriatric, Adolescents, and Children >= 2 years

    Apply to affected area twice daily, morning and evening for 2—4 weeks.

    For the treatment of fungal otitis externa†.
    Topical dosage (1% topical solution†)
    Adults, Geriatric, Adolescents, and Children >= 2 years

    A typical dosage is 3—4 drops into affected ear four times daily for 7 days.

    †Indicates off-label use

    MAXIMUM DOSAGE

    Adults

    Maximum dosage information not available.

    Elderly

    Maximum dosage information not available.

    Adolescents

    Maximum dosage information not available.

    Children

    >= 2 years: Maximum dosage information not available.
    < 2 years: Not recommended.

    Infants

    Not recommended.

    DOSING CONSIDERATIONS

    Hepatic Impairment

    It is not known if tolnaftate is absorbed through the epidermis nor how tolnaftate is metabolized, therefore use with caution. Quantitative recommendations are not available.

    Renal Impairment

    It is not known if tolnaftate is absorbed through the epidermis nor how tolnaftate is metabolized, therefore use with caution. Quantitative recommendations are not available.

    ADMINISTRATION

    For storage information, see specific product information within the How Supplied section.

    Topical Administration

    Topical tolnaftate preparations are for external use only. Do not apply to blistered, oozing, or raw skin. Do not apply to the eye or mucus membranes.
    Cleanse and dry affected area thoroughly prior to using topical tolnaftate preparations.
    Do not use dressings that do not allow air circulation over the affected area (occlusive dressings) unless otherwise directed. A light breathable dressing may be used to protect clothing.

    Cream/Ointment/Lotion Formulations

    Cream: Rub tolnaftate cream solution gently into cleansed affected skin.

    Other Topical Formulations

    Gel or solution: Rub tolnaftate gently into cleansed affected skin.
    Aerosol liquid or aerosol powder: Shake well before using. Spray onto cleansed affected skin. Spray evenly, at a distance of 6 to 10 inches from the infected area. If treating the feet, spray between the toes.
    Powder: Apply to cleansed affected skin. The powder may be used in conjunction with other preparations of tolnaftate for active treatment.
    Wipes or swabs: Rub wipe gently into cleansed affected skin.

    STORAGE

    Absorbine Athletes Foot:
    - Store at controlled room temperature (between 68 and 77 degrees F)
    Absorbine Jr. Antifungal:
    - Protect from freezing
    - Store at room temperature (between 59 to 86 degrees F)
    Aftate For Athletes Foot:
    - Store at controlled room temperature (between 68 and 77 degrees F)
    Aftate for Jock Itch:
    - Do Not Store at Temperatures Above 120 degrees F (49 degrees C)
    - Store at controlled room temperature (between 68 and 77 degrees F)
    Antifungal:
    - Protect from freezing
    - Store at room temperature (between 59 to 86 degrees F)
    Fungi-Guard :
    - Store at controlled room temperature (between 68 and 77 degrees F)
    Lamisil AF:
    - Do Not Store at Temperatures Above 120 degrees F (49 degrees C)
    - Store at controlled room temperature (between 68 and 77 degrees F)
    Q-Naftate:
    - Store at controlled room temperature (between 68 and 77 degrees F)
    Termin8:
    - Store at controlled room temperature (between 68 and 77 degrees F)
    Tinactin:
    - Store at controlled room temperature (between 68 and 77 degrees F)
    Tinactin Jock Itch:
    - Store at controlled room temperature (between 68 and 77 degrees F)
    Tinaderm :
    - Store at controlled room temperature (between 68 and 77 degrees F)
    Ting Antifungal:
    - Store at controlled room temperature (between 68 and 77 degrees F)

    CONTRAINDICATIONS / PRECAUTIONS

    General Information

    Clinical studies with tolnaftate did not include sufficient numbers of elderly patients 65 years of age and older to determine whether they respond differently from younger patients; however, differences in response are not expected.

    Occlusive dressing, ocular exposure, onychomycosis, paraben hypersensitivity, tobacco smoking, tolnaftate hypersensitivity

    Tolnaftate should not be used in patients with known tolnaftate hypersensitivity or sensitivity to any components of the specific formulation (components can include parabens, alcohols, propylene glycol, etc., check package labels); use with caution if paraben hypersensitivity or other hypersensitivities exist. If irritation or hypersensitivity occurs or if the patient's skin disease does not improve within 10 days or becomes worse during self medication with tolnaftate, treatment should be discontinued and the patient should consult a health care provider. This drug does not treat bacterial infections or yeast infections. Use of tolnaftate is recommended only in patients who have a superficial dermatophyte infection. As with many other topical antifungal drugs, topical tolnaftate is not effective for onychomycosis; this condition usually requires treatment with an oral (systemic) antifungal drug. Tolnaftate should be used externally only. It should not be applied to the eyes (avoid ocular exposure). Tolnaftate should not be applied to blistered, oozing, or raw skin. After application, the use of an occlusive dressing is not recommended, but a breathable dressing may be used to protect the area and clothing. Keep preparations containing alcohol or packaged with contents under pressure away from open flames or heat due to flammability; do not use while tobacco smoking.

    Diabetes mellitus, immunosuppression, peripheral vascular disease

    Tolnaftate should not be used for self-treatment in patients with immunosuppression or patients with diabetes mellitus or peripheral vascular disease. Fungi are more likely to penetrate the dermal layer and cause systemic infection in these patient populations. A health care provider should be consulted for evaluation of the condition before treatment.

    Children, infants, neonates

    Safe and effective use of tolnaftate for self treatment in neonates, infants and children < 2 years and infants has not been established; consult a health care provider before use.

    Pregnancy

    Tolnaftate has not been assigned a specific FDA pregnancy risk category rating. Its  absorption through the epidermis and potential effects on the fetus and reproductive capacity are unknown. As with any drug in pregnancy, use only under the advise of a physician (not for self medication).

    Breast-feeding

    Data are limited regarding use of tolnaftate during breast-feeding, and its excretion in human milk is unknown. Following topical application, it is poorly absorbed and likely poses low risk to a nursing infant. To minimize potential infant exposure, instruct patients to avoid topical application to the breast. Consider the benefits of breast-feeding, the risk of potential infant drug exposure, and the risk of an untreated or inadequately treated condition. If a breast-feeding infant experiences an adverse effect related to a maternally administered drug, health care providers are encouraged to report the adverse effect to the FDA.

    ADVERSE REACTIONS

    Moderate

    erythema / Early / Incidence not known
    contact dermatitis / Delayed / Incidence not known

    Mild

    pruritus / Rapid / Incidence not known
    xerosis / Delayed / Incidence not known
    skin irritation / Early / Incidence not known

    DRUG INTERACTIONS

    There are no drug interactions associated with Tolnaftate products.

    PREGNANCY AND LACTATION

    Pregnancy

    Tolnaftate has not been assigned a specific FDA pregnancy risk category rating. Its  absorption through the epidermis and potential effects on the fetus and reproductive capacity are unknown. As with any drug in pregnancy, use only under the advise of a physician (not for self medication).

    Data are limited regarding use of tolnaftate during breast-feeding, and its excretion in human milk is unknown. Following topical application, it is poorly absorbed and likely poses low risk to a nursing infant. To minimize potential infant exposure, instruct patients to avoid topical application to the breast. Consider the benefits of breast-feeding, the risk of potential infant drug exposure, and the risk of an untreated or inadequately treated condition. If a breast-feeding infant experiences an adverse effect related to a maternally administered drug, health care providers are encouraged to report the adverse effect to the FDA.

    MECHANISM OF ACTION

    Mechanism of Action: Tolnaftate, like naftifine and terbinafine, is a reversible and noncompetitive inhibitor of fungal squalene epoxidase. The membrane bound epoxidase plays a key role in the biosynthetic pathway from acetate to sterols. The blockade of this enzyme results in the accumulation of squalene and a deficiency of ergosterol. Tolnaftate has been shown to distort hyphae and stunt mycelial growth in susceptible fungi. Resistance to tolnaftate has been reported only rarely. However, the potential to develop resistance by the action of multidrug efflux transporters does exist. Tolnaftate is fungistatic or fungicidal depending on its concentration at the site of infection and the specific susceptibility of the organism.Tolnaftate, compared to naftifine and terbinafine, is the least effective topical antimycotic. In general, tolnaftate is active against the following organisms in vitro: Microsporum gypseum, M. canis, M. audouinii, M. japonicum, Trichophyton rubrum, T. mentagrophytes, T. schoenleinii, T tonsurans, and Epidermophyton floccosum. Tolnaftate is ineffective against Candida albicans, Cryptococcus neoformans, and Aspergillus fumigatus.

    PHARMACOKINETICS

    Tolnaftate is applied topically. There are no data available on the pharmacokinetics of tolnaftate. It is unknown if tolnaftate is absorbed through the epidermis or if detectable systemic concentrations of tolnaftate are achieved in the blood.