What is the recommended treatment for onychomycosis (nail fungal infection)?

From the Guidelines

The recommended treatment for onychomycosis is terbinafine, due to its higher cure rates and fewer drug interactions, with a dosage of 250 mg daily for 6 weeks for fingernails or 12 weeks for toenails. This recommendation is based on the British Association of Dermatologists' guidelines for the management of onychomycosis 2014 1, which states that terbinafine should be considered as the first choice of treatment unless there are contraindications. The guidelines also mention that terbinafine has been shown to be more effective than griseofulvin and itraconazole in treating dermatophyte onychomycosis.

Some key points to consider when treating onychomycosis include:

• The choice of treatment depends on the severity of the infection, with topical options like ciclopirox 8% nail lacquer or efinaconazole 10% solution being effective for mild to moderate cases.
• Oral medications like terbinafine, itraconazole, or fluconazole are typically preferred for more severe or resistant infections.
• Terbinafine has a higher cure rate and fewer drug interactions compared to itraconazole, making it the first-line treatment.
• Itraconazole and fluconazole can be used as alternative oral options, with itraconazole being used at a dose of 200 mg twice daily for 1 week per month, repeated for 2 months for fingernails or 3 months for toenails, and fluconazole being used at a dose of 150-300 mg once weekly for 3-6 months.
• Treatment success requires patience, as complete nail regrowth takes time, and recurrence rates can be high.
• Combining oral and topical treatments may improve outcomes in difficult cases, and patients should keep their nails short, dry, and clean during treatment.

It's also important to note that patients with diabetes or immunocompromised conditions should seek treatment promptly to prevent complications, as stated in the guidelines 1. Additionally, the guidelines mention that griseofulvin is no longer a treatment of choice for onychomycosis unless other drugs are unavailable or contraindicated, due to its lower efficacy and longer treatment duration 1.

From the FDA Drug Label

1 INDICATIONS AND USAGE Terbinafine tablets, USP are indicated for the treatment of onychomycosis of the toenail or fingernail due to dermatophytes (tinea unguium).

INDICATIONS AND USAGE (To understand fully the indication for this product, please read the entire INDICATIONS AND USAGE section of the labeling.) Ciclopirox Topical Solution, 8%, (Nail Lacquer), as a component of a comprehensive management program, is indicated as topical treatment in immunocompetent patients with mild to moderate onychomycosis of fingernails and toenails without lunula involvement, due to Trichophyton rubrum

The recommended treatments for onychomycosis (nail fungal infection) are:

• Terbinafine (PO): indicated for the treatment of onychomycosis of the toenail or fingernail due to dermatophytes (tinea unguium) 2
• Ciclopirox (TOP): indicated as topical treatment in immunocompetent patients with mild to moderate onychomycosis of fingernails and toenails without lunula involvement, due to Trichophyton rubrum, as a component of a comprehensive management program 3

From the Research

Treatment Options for Onychomycosis

• Oral terbinafine is a commonly recommended treatment for onychomycosis, particularly for dermatophyte infections 4, 5.
• Terbinafine has demonstrated excellent fungicidal activity against dermatophytes and variable activity against yeasts and non-dermatophyte molds in vitro 4.
• The typical dosage of oral terbinafine is 250 mg/day for 12 or 16 weeks, depending on the severity of the infection 4, 5.

Combination Therapy

• Combination therapy with amorolfine 5% solution nail lacquer and oral terbinafine may be effective in treating severe onychomycosis 6.
• This combination therapy has shown promising results in terms of mycological and clinical cure rates, as well as a better cost per cure ratio 6.

Safety and Efficacy

• Oral terbinafine is generally well tolerated, with most adverse events being transient and mild to moderate in severity 4, 5.
• However, severe acute liver injury is a known but unusual complication of terbinafine exposure, and liver function assessment before treatment and periodic monitoring are recommended 7, 8.
• Other oral antifungals, such as itraconazole and fluconazole, also have potential interactions and adverse events, and laboratory testing of liver function tests prior to administration is recommended 8.

Recommendations

• Oral terbinafine is considered the treatment of choice for dermatophyte onychomycosis due to its high efficacy and relatively low risk of adverse events 4.
• Combination therapy with amorolfine 5% solution nail lacquer and oral terbinafine may be considered for severe onychomycosis 6.
• Patients should be monitored for potential adverse events, particularly liver injury, and antifungal stewardship is recommended to reduce the incidence of antifungal resistance 8.