Onicoma

Onicoma Topical Solution is indicated for the treatment of onychomycosis of the toenail(s) due to Trichophyton rubrum and Trichophyton mentagrophytes.

Route of administration

: Efinaconazole is for topical use only.

Apply this solution to affected toenails once daily for 48 weeks, using the

integrated flow-through brush applicator. When applying it, ensure the toenail, the toenail folds, toenail bed, hyponychium, and the undersurface of the toenail plate, are completely covered.

Use in children and adolescents

: Safety and effectiveness of efinaconazole solution in pediatric patients under 6 years of age have not been established.

Efinaconazole is an azole antifungal. It inhibits fungal lanosterol 14α-demethylase involved in the

biosynthesis of ergosterol, a constituent of fungal cell membranes.

The most common side effects are ingrown toenails, application site dermatitis, application site vesicles and application site pain.

It is contraindicated in patients with known hypersensitivity to efinaconazole or any other components of this product.

Onicoma is for topical use only and not for oral, ophthalmic or intravaginal use. If the area of application shows signs of persistent irritation (for example, redness, itching, swelling), stop the use of this solution. This solution is flammable, avoid use near heat or open flame.

There are no available human data for the use of this solution during pregnancy to inform any drug associated risks of major birth defects, miscarriage, or adverse maternal or fetal outcomes. It is not known whether efinaconazole is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when this solution is administered to nursing women.

There have been no reported sequelae in patients who have received significantly more Onicoma solution than the recommended dosage.

Drug interaction with medication

: This solution, at therapeutic concentrations, neither inhibits nor induces cytochrome P450 (CYP450) enzymes.

Store in a cool (below 30ºC) & dry place protected from light. Keep out of the reach of children.