Onicoma Topical Solution
Efinaconazole topical
10%
ACI Limited
| Pack size | 8 ml bot |
|---|---|
| Dispensing mode | |
| Source | |
| Agent | |
| Retail Price | 1500.00 AED |
Indications
Onicoma Topical Solution is used for:
Onychomycosis
Adult Dose
Topical
Onychomycosis
Indicated for onychomycosis of the toenail(s) due to Trichophyton rubrum and Trichophyton mentagrophytes
Apply to affected toenail(s) once daily for 48 weeks
Child Dose
Onychomycosis
Indicated for onychomycosis of the toenail(s) due to Trichophyton rubrum and Trichophyton mentagrophytes in children aged >6 yr
<6 years: Safety and efficacy not established
>6 years
Apply to affected toenail(s) once daily for 48 weeks
Renal Dose
Administration
For topical use only. Not for oral, ophthalmic, or intravaginal use.
Apply to affected toenail(s) using the integrated flow-through brush applicator
When applying with flow-through brush applicator, ensure toenail, toenail folds, toenail bed, hyponychium, and undersurface of toenail plate are completely covered
Contra Indications
Precautions
For topical use only
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-Lactation
Pregnancy
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
Animal data
In animal reproduction studies, efinaconazole did not cause malformations or any harm to the fetus when administered to pregnant rabbits and rats during organogenesis at SC doses up to 112 and 154 times, respectively, the maximum recommended human dose (MRHD) based on area under the curve (AUC) comparisons
Lactation
Unknown if excreted in human milk; after repeated SC administration, efinaconazole was detected in milk of nursing rats
Consider developmental and health benefits of breastfeeding, along with mother’s clinical need for therapy, and any potential adverse effects on breastfed infant from drug
Interactions
Adverse Effects
Side effects of Efinaconazole topical :
1-10%
Ingrown toenail (2.3%)
Application site dermatitis (2.2%)
Application site vesicles (1.6%)
Application site pain (1.1%)
Mechanism of Action
Triazole antifungal agent; inhibits fungal lanosterol 14α-demethylase involved in the biosynthesis of ergosterol, a constituent of fungal cell membranes.
Note
Onicoma 10% Topical Solution manufactured by ACI Limited. Its generic name is Efinaconazole topical. Onicoma is availble in Bangladesh.
Farmaco BD drug index information on Onicoma Topical Solution is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.