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Jublia (efinaconazole) Topical Solution 10%
Jublia is a topical antifungal solution formulated to go around, under, and through the nail to treat onychomycosis at the site of infection.
Ortho Dermatologics
Ortho Dermatologics is one of the largest specialty pharmaceutical businesses and a leader in the podiatry and medical dermatology markets. We develop, manufacture, and market a broad range of prescription products to treat conditions including toenail onychomycosis, interdigital tinea pedis, and inflammatory disorders.
Ortho Dermatologics believes in supporting the podiatric specialty community, especially in the advancement of podiatric education. Through the sponsorship of educational programs and podiatric societies at local, regional, and national levels, Ortho Dermatologics supports initiatives that educate podiatric providers on disease states, treatment practices, and product information to enhance patient care.
4mL and 8mL bottles with flow-through brush applicators
· Approved for use in patients 6 years of age and above
· Proven to restore healthy fungus-free nails
· Alcohol based, non-lacquer formulation
· Low affinity for keratin binding
· Once daily application
· Proven efficacy as measured by mycological, complete, and complete/almost complete cure rates
· Favorable tolerability profile
· No requirement for liver toxicity testing
· Treats at the source of infection, regardless of the presence of nail polish
Jublia is an azole antifungal indicated for the topical treatment of onychomycosis of the toenail(s) due to Trichophyton rubrum and Trichophyton mentagrophytes.
Important Safety Information
• Jublia is for topical use only and is not for oral, ophthalmic, or intravaginal use.
Patients should be instructed to contact their health care professional if a reaction suggesting sensitivity or severe irritation occurs.
• The most common adverse reactions (incidence ≥1%) were (vs vehicle): ingrown toenail (2.3% vs 0.7%), application-site dermatitis (2.2% vs 0.2%), application-site vesicles (1.6% vs 0%), and application-site pain (1.1% vs 0.2%).
• Jublia should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus, and should be used with caution in nursing women. Safety and effectiveness in pediatric patients have not been established.
Adverse reactions reported in at least 1% of subjects treated for up to 48 weeks were ingrown toenail, application site dermatitis, application site vesicles, and application site pain.
Store Jublia at room temperature, between 68° to 77°F (20° to 25°C). Do not freeze Jublia. Keep the bottle tightly closed and store in an upright position. Jublia is flammable. Keep away from heat and flame.
Efinaconazole
Alcohol, anhydrous citric acid, butylated hydroxytoluene, C12-15 alkyl lactate, cyclomethicone, diisopropyl adipate, disodium edetate, and purified water
Apply Jublia to affected toenails once daily for 48 weeks, using the integrated flow-through brush applicator provided. When applying Jublia, ensure the toenail, the toenail folds, toenail bed, hyponychium, and the undersurface of the nail plate are completely covered. Jublia is for topical use only and not for oral, ophthalmic, or intravaginal use. Wait for at least 10 minutes after showering, bathing, or washing before applying.
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