Adult Dosing

Onychomycosis of the toenails

• Apply SOLN to affected toenails Daily x 48wks

Note:

• The toenail, the toenail folds, toenail bed, hyponychium, and the undersurface of the toenail plate should be completely covered by the solution

Pediatric Dosing

• Safety and effectiveness in pediatric patients have not been established

[Outline]

• Adult Dosing
• Pediatric Dosing

• Treatment of onychomycosis of the toenails due to Trichophyton rubrum and Trichophyton mentagrophytes

• Hypersensitivity to any of the ingredients of the product

• N/A

Renal Dose Adjustment

• Renal impairment: Dose adjustment not defined

Hepatic Dose Adjustment

• Hepatic impairment: Dose adjustment not defined

See Supplemental Patient Information

• Use only on toenails and immediate adjacent skin
• Not for oral, ophthalmic, or intravaginal use
• During therapy avoid use of nail polish and cosmetic nail products
• Avoid use near heat or open flame

Supplemental Patient Information

• For external use only
• Apply therapy to clean dry toenails
• After showering, bathing, or washing, wait for atleast 10 minutes before application
• If persistent irritation (for example, redness, itching, swelling) exists, inform a health care professional

Pregnancy Category:C

Breastfeeding: Unknown if excreted in human milk. Manufacturer advises caution.

• LOCAL: Ingrown toenail, application site dermatitis, vesicles and pain

• Azole antifungal; inhibits fungal lanosterol 14-demethylase involved in the biosynthesis of ergosterol, a constituent of fungal cell membranes
• Metabolism: Neither inhibits nor induces CYP450 enzymes
• Excretion: Unknown
• Half-life (day 7): 29.9 hrs

US Trade Name(s)

• Jublia

US Availability

Jublia

• SOLN: 10%

Canadian Trade Name(s)

• N/A

Canadian Availability

• N/A

UK Trade Name(s)

• N/A

UK Availability

• N/A

Australian Trade Name(s)

• N/A

Australian Availability

• N/A

[Outline]

Dermatologic

Antifungals (Topical)

Azole Derivatives