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Tavaborole Topical Solution
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  • FDA PI

Tavaborole Topical Solution

Dosage form: topical solution
Drug class:Topical antifungals

Medically reviewed by Drugs.com. Last updated on May 1, 2021.

Indications and Usage for Tavaborole Topical Solution

Tavaborole Topical Solution, 5% is an oxaborole antifungal indicated for the treatment of onychomycosis of the toenails due to Trichophyton rubrum or Trichophyton mentagrophytes.

Tavaborole Topical Solution Dosage and Administration

Apply Tavaborole Topical Solution to affected toenails once daily for 48 weeks.

Tavaborole Topical Solution should be applied to the entire toenail surface and under the tip of each toenail being treated.

Tavaborole Topical Solution is for topical use only and not for oral, ophthalmic, or intravaginal use.

Dosage Forms and Strengths

Tavaborole Topical Solution, 5% is a clear, colorless alcohol-based solution. Each milliliter of solution contains 43.5 mg (5% w/w) of tavaborole.

Contraindications

None.

Adverse Reactions

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

In two clinical trials, 791 subjects were treated with Tavaborole Topical Solution. The most commonly reported adverse reactions are listed below (Table 1).

Table 1: Adverse Reactions Occurring in ≥1% of Tavaborole Topical Solution, 5%-Treated Subjects and at a Greater Frequency than Observed with Vehicle
Preferred TermTavaborole Topical Solution, 5%
N = 791
n (%)
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