Undecylenic acid and undecylenate salts (e.g., calcium undecylenate, copper undecylenate, zinc undecylenate) are topical antifungal agents used primarily for tinea pedis, tinea cruris, and tinea corporis caused by dermatophytic fungi. These medications are intended to treat adults and pediatric 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.
General Administration Information
For storage information, see specific product information within the How Supplied section.
Route-Specific Administration
Topical Administration
-Clean the affected area and dry thoroughly.
-Apply a thin layer 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. Do not use for diaper rash.
-Wash hands after use.
No significant adverse reactions have been reported with undecylenic acid, undecylenate salts, zincundecate; however, discontinue these products if skin irritation or localized hypersensitivity occur.
Undecylenic acid, undecylenate salts, zincundecate products are for external use only. These products are not intended for ophthalmic administration. Avoid ocular exposure and contact with the mucous membranes. Avoid inhaling the liquid product. Discontinue use if irritation occurs. Do not use on the scalp or nails or for diaper rash.
Topical undecylenic acid, undecylenate salts, zincundecate are not effective for the treatment of onychomycosis.
The use of undecylenic acid, undecylenate salts, zincundecate during pregnancy has not been established. These products should be used only under the advice of a healthcare provider during pregnancy.
The manufacturers of undecylenic acid, undecylenate, zincundecate do not give any recommendations for use during breast-feeding. It is advisable to avoid applied these products topically to the breast of breast-feeding mothers. 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.
For the treatment of tinea pedis (athlete's foot) and tinea corporis (ring worm):
Topical dosage (liquid, powder, cream, ointment):
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. Not for diaper rash.
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. Not for diaper rash.
For the treatment of tinea cruris (jock itch):
Topical dosage (cream, powder, ointment):
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. Not for diaper rash.
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. Not for diaper rash.
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 Undecylenic Acid, Undecylenate Salts, Zincundecate products.
Undecylenic acid is an unsaturated fatty acid with fungistatic activity. Fatty acids decrease proliferation of the fungus by altering the conditions of growth. Unsaturated fatty acids may have more activity than saturated fatty acids. Increased fatty acid chain length may increase activity and a decreased pH may increase activity.
Undecylenic acid, undecylenate salts, zincundecate products are applied topically. No pharmacokinetic data are available. It is unknown if these products are absorbed through the epidermis or if detectable systemic concentrations of undecylenic acid are achieved in the blood.