Classes
DEA Class; Rx
Common Brand Names; Jublia
- Antifungals, Topical
Description
Topical azole antifungal solution
Used for the treatment of onychomycosis of the toenails in adults and pediatric patients 6 years and older
Onychocryptosis (ingrown toenail) was the most frequently reported adverse event during clinical trials
Indications
Indicated for onychomycosis of the toenail(s) due to Trichophyton rubrum and Trichophyton mentagrophytes
Adverse Effects
Ingrown toenail (2.3%)
Application site dermatitis (2.2%)
Application site vesicles (1.6%)
Application site pain (1.1%)
Warnings
For topical use only
Not for oral, ophthalmic, or intravaginal use
Instruct patient to avoid using nail polish or cosmetic nail products
Persistent local pain, irritation, or dermatitis may develop; contact health provider if it occurs
Pregnancy and Lactation
Data are not available for use during pregnancy to inform any drug associated risks of major birth defects, miscarriage, or adverse maternal or fetal outcomes
Unknown if excreted in human milk
Maximum Dosage
Specific maximum dosage information not available.
Specific maximum dosage information not available.
Specific maximum dosage information not available.
6 to 12 years: Specific maximum dosage information not available.
1 to 5 years: Safety and efficacy have not been established.
Safety and efficacy have not been established.
Safety and efficacy have not been established.
How supplied
Efinaconazole
topical solution
- 10%