Prescribing Details
Description
Onicoma is a preparation of Efinaconazole which is an azole antifungal. Efinaconazole inhibits fungal lanosterol 14α-demethylase involved in the biosynthesis of ergosterol, a constituent of fungal cell membranes.
Uses
No Data
Indications
Onicoma is indicated for the treatment of onychomycosis of the toenail(s) due to Trichophyton rubrum and Trichophyton mentagrophytes
Dosage and administration
Onicoma 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 pregnancy & lactation
Pregnancy: 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.
Lactation: 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.
Use in children and adolescents
Safety and effectiveness of efinaconazole solution in pediatric patients under 6
years of age have not been established
Geriatric use
Precautions
Efinaconazole 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.
Side effects
The most common side effects are ingrown toenails, application site dermatitis, application site vesicles and application site pain
Contraindications
It is contraindicated in patients with known hypersensitivity to efinaconazole or any other components of this product.
Drug interactions
Drug interaction with medication: This solution, at therapeutic concentrations,
neither inhibits nor induces cytochrome P450 (CYP450) enzymes.
Drug interaction with food and others: Not applicable.
Overdose
There have been no reported sequelae in patients who have received significantly more efinaconazole solution than the recommended dosage.
Preparation
No Data
Pharmaceutical precautions
No Data
Presentation
No Data
Package quantities
Storage
Store in a cool (below 30ºC) & dry place protected from light. Keep out of the
reach of children.
Packing
Onicoma Topical Solution 10%: Plastic bottle of 8 ml.
