What are the treatment guidelines for onychomycosis (fungal infection of the toenail)?

From the Guidelines

Terbinafine should be considered as the first choice for treating toenail fungus due to its higher efficacy and tolerability compared to itraconazole. When treating toenail fungus, it is essential to consider the most effective treatment options to minimize morbidity, mortality, and improve quality of life. According to the British Association of Dermatologists' guidelines for the management of onychomycosis 2014 1, terbinafine and itraconazole are both effective treatments, but terbinafine has been shown to have higher efficacy rates.

Some key points to consider when treating toenail fungus include:

• Terbinafine is licensed at a dose of 250 mg per day for 12–16 weeks in toenail infection 1
• Itraconazole is licensed at a dose of 200 mg per day for 12 weeks continuously, or alternatively as pulse therapy at a dose of 400 mg per day for 1 week per month 1
• Patients should be re-evaluated 3–6 months after treatment initiation and further treatment should be given if the disease persists 1
• Several large studies demonstrate higher efficacy rates for terbinafine in comparison with itraconazole, with complete cure rates of 55% for terbinafine compared to 26% for pulsed itraconazole 1

It is crucial to follow the recommended treatment guidelines and dosages to ensure effective treatment and minimize potential side effects. Additionally, patients should be advised on supportive measures such as keeping feet clean and dry, wearing breathable shoes, and trimming nails straight across to prevent the spread of the infection and promote healthy nail growth.

From the FDA Drug Label

Terbinafine tablets are an allylamine antifungal indicated for the treatment of onychomycosis of the toenail or fingernail due to dermatophytes (tinea unguium) Toenail onychomycosis: One 250 mg tablet, once daily for 12 weeks

The treatment guideline for toenail fungus is to take Terbinafine 250 mg orally once daily for 12 weeks 2.

• Indication: Onychomycosis of the toenail due to dermatophytes (tinea unguium)
• Dosage: 250 mg tablet, once daily
• Duration: 12 weeks

From the Research

Treatment Guidelines for Toe Nail Fungus

• The treatment for toenail onychomycosis can be either continuous or intermittent (pulsed) oral antifungal medications such as terbinafine and itraconazole 3, 4.
• A study comparing the efficacy of pulse versus continuous dose terbinafine therapy found that the continuous treatment group had a significantly higher clinical cure rate of 76.67% compared to 26.67% in the pulse treatment group 3.
• Another study found that combining oral terbinafine with topical amorolfine tended to be more effective than terbinafine in conjunction with ciclopirox, with additive effects observed in most combinations and synergy detected in combinations involving amorolfine in S. brevicaulis 5.
• A systematic review and network meta-analysis found that the likelihood of mycological cure was not significantly different between continuous and pulse regimens for each of terbinafine and itraconazole, but continuous terbinafine for 24 weeks was significantly more likely to result in mycological cure than continuous itraconazole for 12 weeks or weekly fluconazole for 9-12 months 4.
• A Cochrane review found high-quality evidence that terbinafine is more effective than placebo for achieving clinical cure and mycological cure, and moderate-quality evidence that terbinafine was probably more effective than azoles for achieving clinical cure and mycological cure 6.

Recommended Treatment Options

• Terbinafine is recommended as a first-line treatment for toenail onychomycosis, with a continuous regimen of 250 mg/d for 3 months being the most effective oral treatment 7, 6.
• Azoles may be considered as an alternative treatment option, but may have a higher risk of adverse events compared to terbinafine 6.
• Griseofulvin may be considered as a third-line treatment option, but may have a higher risk of adverse events and lower efficacy compared to terbinafine and azoles 6.

Combination Therapy

• Combining oral terbinafine with topical amorolfine may be beneficial for patients with onychomycosis, particularly if the pathogen is a non-dermatophyte fungus such as S. brevicaulis 5.
• Further studies are needed to investigate the efficacy and safety of combination therapy for toenail onychomycosis 3, 5.