Tolnaftate is a synthetic topical thiocarbamate antifungal agent used for the treatment of tinea pedis (athlete's foot), tinea cruris (jock itch), and tinea corporis (ringworm) in patients 2 years of age and older. Instruct patients to seek medical attention if irritation occurs or if there is no improvement within 4 weeks for tinea pedis or tinea corporis or within 2 weeks for tinea cruris. Tolnaftate can also be used to prevention recurrent tinea pedis infections. The drug is not recommended for the treatment of fungal infections of the scalp or nail beds.
General Administration Information
For storage information, see specific product information within the How Supplied section.
Route-Specific Administration
Topical Administration
-Clean the affected area with soap and water and dry thoroughly.
-Apply over affected area.
-For tinea pedis (athlete's foot), pay special attention to the spaces between the toes; wear well fitting, ventilated shoes and change shoes and socks at least once daily.
-For external use only. Avoid contact with the eyes. Do not use on scalp or nails.
-Wash hands after use.
Other Topical Formulations
Aerosol liquid or aerosol powder:
-Shake well before using.
-Spray onto cleansed affected skin.
No significant adverse reactions have been reported with tolnaftate; however, discontinue these products if skin irritation or localized hypersensitivity occur.
Tolnaftate products are for external use only. These products are not intended for ophthalmic administration. Avoid ocular exposure and contact with the mucous membranes. If ocular contact occurs, rinse the eyes thoroughly with water. If swallowed, seek medical care or contact a Poison Control Center. Do not use for vaginal yeast infections or on the scalp or nails. Do not intentionally misuse these products, as inhaling the aerosolized powder can be harmful or fatal. Discontinue use if irritation occurs.
Tolnaftate aerosolized products are packaged with the contents under pressure; do not puncture or incinerate these products. Keep these preparations away from open flames or heat due to flammability; do not use while tobacco smoking.
The use of tolnaftate during pregnancy has not been established. These products should be used only under the advice of a healthcare provider during pregnancy.
Data are limited regarding the use of tolnaftate during breast-feeding, and its excretion in human milk is unknown. 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, healthcare providers are encouraged to report the adverse effect to the FDA.
This drug may also have activity against the following microorganisms: Epidermophyton sp., Malassezia furfur, Microsporum sp., Trichophyton sp.
NOTE: Some organisms may not have been adequately studied during clinical trials; therefore, exclusion from this list does not necessarily negate the drug's activity against the organism.
For the treatment of tinea pedis (athlete's foot) and tinea corporis (ring worm) and prevention of recurrent tinea pedis:
-for the treatment of tinea pedis (athlete's foot) and tinea corporis (ring worm):
Topical dosage:
Adults: Apply to affected area twice daily or as directed by a healthcare provider for 4 weeks. If condition persists longer, consult a healthcare provider. Not for use on the scalp or nails.
Children and Adolescents 2 years and older: Apply to affected area twice daily or as directed by a healthcare provider for 4 weeks. If condition persists longer, consult a healthcare provider. Not for use on the scalp or nails.
-for the prevention of recurrent tinea pedis (athlete's foot):
Topical dosage:
Adults: Apply to the feet once or twice daily.
Children and Adolescents 2 years and older: Apply to the feet once or twice daily.
For the treatment of tinea cruris (jock itch):
Topical dosage:
Adults: Apply to affected area twice daily or as directed by a healthcare provider for 2 weeks. If condition persists longer, consult a healthcare provider.
Children and Adolescents 2 years and older: Apply to affected area twice daily or as directed by a healthcare provider for 2 weeks. If condition persists longer, consult a healthcare provider.
Maximum Dosage Limits:
-Adults
Maximum dosage information is not available.
-Geriatric
Maximum dosage information is not available.
-Adolescents
Maximum dosage information is not available.
-Children
2 years and older: Maximum dosage information is not available.
1 year: Safety and efficacy have not been established.
-Infants
Safety and efficacy have not been established.
-Neonates
Safety and efficacy have not been established.
Patients with Hepatic Impairment Dosing
Specific guidelines for dosage adjustments in hepatic impairment are not available; it appears that no dosage adjustments are needed.
Patients with Renal Impairment Dosing
Specific guidelines for dosage adjustments in renal impairment are not available; it appears that no dosage adjustments are needed.
*non-FDA-approved indication
There are no drug interactions associated with Tolnaftate products.
Tolnaftate, a thiocarbamate antifungal, is a reversible, noncompetitive inhibitor of fungal squalene-2, 3-epoxidase. This membrane-bound squalene epoxidase plays a key role in the biosynthesis of ergosterol, an essential component of fungal cell walls. Inhibiting this enzyme results in the accumulation of squalene and a deficiency of ergosterol; thereby increasing fungal cell membrane permeability, disrupting cellular organization, and causing fungal cell death. Tolnaftate has also been shown to distort the hyphae and stunt mycelial growth in susceptible fungi.
Tolnaftate is fungistatic or fungicidal. Tolnaftate has active against the following fungal species: Epidermophyton, Microsporum, Trichophyton, and Malassezia furfur. The potential for resistance exists through the actions of multidrug efflux transporters.
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.
Affected cytochrome P450 isoenzymes and drug transporters: None