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Topical Dermatological Antifungals
Topical azole antifungal solutionIndicated for treatment of onychomycosis of the toenails in adultsOnychocryptosis (ingrown toenail) was the most frequently reported adverse event during clinical trials
JUBLIA Topical Sol: 10%
Apply solution, using the integrated brush applicator, topically to the affected toenail(s) once daily for 48 weeks. Ensure the entire toenail (toenail beds, folds, hyponychium, and undersurface of the toenail plate) is completely covered.
Specific maximum dosage information not available.
Safety and efficacy have not been established.
Specific guidelines for dosage adjustments in hepatic impairment are not available; it appears that no dosage adjustments are needed.
Specific guidelines for dosage adjustments in renal impairment are not available; it appears that no dosage adjustments are needed.
For topical use on toenails only; not for ophthalmic, oral, or intravaginal use.Instruct patients to avoid pedicures, and use of nail polish or cosmetic nail products during treatment.Efinaconazole solution is flammable. Avoid heat, flame, and tobacco smoking during and immediately following application.
Topical Nail Solution:Clean and dry toenails prior to application. Instruct patients to wait at least 10 minutes after showering, bathing, or washing before applying.Hold the bottle upside down directly over the affected toenail. Lightly squeeze the bottle to release 1 drop onto the toenail. For the big toenail, squeeze a 2nd drop to the end of the toenail.Spread the drop(s) around the affected toenail(s) using the integrated brush applicator. Ensure the entire toenail (toenail bed, folds, hyponychium, and undersurface of the toenail plate) is completely covered.Allow solution to dry completely.Wash hands with soap and water after the application process.
JUBLIA:- Flammable, keep away from heat and flame- Protect from freezing- Store between 68 to 77 degrees F, excursions permitted 59 to 86 degrees F
Efinaconazole is only approved for external use on toenails; it is not for ophthalmic administration, oral administration, or vaginal administration. During topical application, take care to avoid accidental ocular exposure.
Efinaconazole is classified as a FDA pregnancy category C drug. There are no adequate or well-controlled studies in pregnancy women. Animal studies involving rats revealed embryofetal toxicities (embryofetal deaths, decreased live fetuses, placental effects) following subcutaneous administration of doses 559-times the maximum recommended human dose. Of note, these embryofetal toxicities occurred in the presence of maternal toxicities. No fetal malformations have been observed. Administer during pregnancy only if the potential benefits justify the potential risks to the fetus.
Data are limited regarding use of efinaconazole during breast-feeding, and its' excretion into human milk is unknown. Consider the benefits of breast-feeding, the risk of potential infant drug exposure, and the risk of an untreated or inadequately treated condition. If a breast-feeding infant experiences an adverse effect related to a maternally administered drug, health care providers are encouraged to report the adverse effect to the FDA.
Efinaconazole is an azole antifungal; caution is advised when applying to patients with a history of azole antifungals hypersensitivity. Instruct patients to discontinue use of the drug and seek immediate medical attention if a hypersensitivity reaction develops during treatment.
Efinaconazole solution is flammable. Avoid heat, flame, and tobacco smoking during and immediately following application.
contact dermatitis / Delayed / 2.2-2.2
There are no drug interactions associated with Efinaconazole products.
Efinaconazole exerts its antifungal activity by inhibiting fungal lanosterol 14-alpha-demethylase, an enzyme necessary for the biosynthesis of ergosterol. Ergosterol is an essential component of fungal cell membranes. By decreasing ergosterol concentrations, the fungal cell membrane permeability is increased, resulting in leakage of cellular contents.
Efinaconazole is applied topically to toenails. In healthy volunteers, the plasma half-life of efinaconazole, following 7 daily applications to all 10 toenails, was 29.9 hours. Distribution, metabolism, and excretion data are not available. Affected cytochrome P450 isoenzymes: NoneBased on data from in vitro studies, therapeutic concentrations of efinaconazole do NOT inhibit CYP1A2, CYP2A6, CYP2C8, CYP2C9, CYP2C19, CYP2D6, CYP2PE1, nor CYP3A4. In addition, the drug does NOT induce CYP1A2 or CYP3A4.
Pharmacokinetic parameters were evaluated in 18 patients with severe onychomycosis. The drug was administered topically once daily for 28 days to patients' 10 toenails and 0.5 cm of adjacent skin. On treatment day 28, the mean plasma Cmax was 0.67 +/- 0.37 ng/mL and the mean AUC was 12.15 +/- 6.91 ng x hour/mL. At steady state, plasma drug concentrations generally remain consistent over a 24-hour dosing interval.