Dosing & Uses
Dosage Forms & Strengths
topical solution
- 10%
Onychomycosis
Indicated for onychomycosis of the toenail(s) due to Trichophyton rubrum and Trichophyton mentagrophytes
Apply to affected toenail(s) qDay for 48 weeks using the integrated flow-through brush applicator
Dosage Forms & Strengths
topical solution
- 10%
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) qDay for 48 weeks using the integrated flow-through brush applicator
Adverse Effects
1-10%
Ingrown toenail (2.3%)
Application site dermatitis (2.2%)
Application site vesicles (1.6%)
Application site pain (1.1%)
Warnings
Contraindications
None
Cautions
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 & 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
Pregnancy Categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk. C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done. D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk. X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist. NA: Information not available.Pharmacology
Mechanism of Action
Triazole antifungal agent; inhibits fungal lanosterol 14α-demethylase involved in the biosynthesis of ergosterol, a constituent of fungal cell membranes
Pharmacokinetics
Peak plasma concentration (day 28): 0.67 ng/mL
AUC: 12.15 ng•h/mL
Metabolism: Neither inhibits nor induces CYP450 enzymes
Half-life (day 7): 29.9 hr
Administration
Topical Administration
For topical use only; not for oral, ophthalmic, or intravaginal use
When applying with flow-through brush applicator, ensure toenail, toenail folds, toenail bed, hyponychium, and undersurface of toenail plate are completely covered
Storage
Store at 20-25ºC (68-77ºF); excursions permitted to 15-30ºC (59-86ºF)
Solution is flammable; keep away from heat or flame
Protect from freezing
Keep out of reach of children
Keep bottle tightly closed
Store in upright position
Images
| BRAND | FORM. | UNIT PRICE | PILL IMAGE |
|---|---|---|---|
| Jublia topical - | 10 % solution |  | |
| Jublia topical - | 10 % solution |  |
Copyright © 2010 First DataBank, Inc.
Formulary
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