Onychomycosis: Topical: Apply to affected toenail(s) once daily for 48 weeks.
There are no dosage adjustments provided in the manufacturer’s labeling.
There are no dosage adjustments provided in the manufacturer’s labeling.
(For additional information see "Efinaconazole: Pediatric drug information")
Onychomycosis: Children ≥6 years and Adolescents: Topical: Apply to affected toenail(s) once daily for 48 weeks.
There are no dosage adjustments provided in the manufacturer's labeling. However, dosage adjustment unlikely necessary due to low systemic absorption.
There are no dosage adjustments provided in the manufacturer's labeling. However, dosage adjustment unlikely necessary due to low systemic absorption.
Refer to adult dosing.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Solution, External:
Jublia: 10% (4 mL, 8 mL) [contains edetate (edta) disodium]
No
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Solution, External:
Jublia: 10% (6 mL) [contains edetate (edta) disodium]
Topical: Affected toenail(s) should be clean and dry. Wait at least 10 minutes after showering, bathing, or washing the area prior to application. Gently spread the solution completely around the toenail (toenail bed, folds, hyponychium, undersurface of the toenail plate) with the attached applicator brush and let dry thoroughly; wash hands with soap and water after use.
Topical: Affected toenail(s) should be clean and dry. Wait at least 10 minutes after showering, bathing, or washing the area prior to application. Gently spread the solution completely around the toenail (toenail bed, folds, hyponychium, undersurface of the toenail plate) with the attached applicator brush and let dry thoroughly; wash hands with soap and water after use. For external use only (do not use orally, intravaginally, or in the eyes). Do not apply near heat or flame.
Onychomycosis: Topical treatment of onychomycosis of the toenail(s) due to Trichophyton rubrum and Trichophyton mentagrophytes
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.
1% to 10%:
Dermatologic: Ingrown nail (2%)
Local: Application site dermatitis (2%), application site vesicles (2%), application site pain (1%)
There are no contraindications listed in the US manufacturer’s labeling.
Canadian labeling: Additional contraindications (not in US labeling): Hypersensitivity to efinaconazole or any component of the formulation.
Concerns related to adverse events:
• Local irritation: Persistent local pain, irritation, or dermatitis may develop. If this occurs, contact health care provider.
Other warnings/precautions:
• Appropriate use: For topical use only on toenail(s) and surrounding skin. Not for ophthalmologic, oral, or vaginal administration. Use of nail polish or cosmetic nail products has not been evaluated.
None known.
There are no known significant interactions.
Small amounts of efinaconazole are absorbed systemically following topical administration. If antifungal treatment cannot be delayed until after pregnancy, topical therapy, when appropriate, is preferred over systemic treatment (Kaul 2017). Information specific to efinaconazole in pregnancy has not been located (Lipner 2015).
It is not known if efinaconazole is present in breast milk.
Small amounts of efinaconazole are absorbed systemically following topical administration. The manufacturer recommends that caution be used if administered to a breastfeeding woman.
An azole antifungal; inhibits fungal lanosterol 14alpha-demethylase involved in the biosynthesis of ergosterol, a constituent of fungal cell membranes, resulting in fungal cell death.
Half-life elimination: 29.9 hours.
Solution (Jublia External)
10% (per mL): $204.67
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