From the Guidelines
Terbinafine should be considered as the first-line treatment for onychomycosis due to its higher efficacy and tolerability compared to other oral antifungal medications. The British Association of Dermatologists' guidelines for the management of onychomycosis 2014 recommend terbinafine as the first choice, unless there are contraindications, based on its higher efficacy and tolerability 1.
Treatment Options
- Terbinafine is licensed at a dose of 250 mg per day for 6 weeks in fingernail and 12–16 weeks in toenail infection.
- 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.
- Fluconazole may be a useful alternative in patients unable to tolerate terbinafine or itraconazole, with a once-weekly dosing regimen of 450 mg per week for 3 months in fingernail infections, and for at least 6 months in toenail infections 1.
Efficacy and Safety
- Several large studies demonstrate higher efficacy rates for terbinafine in comparison with itraconazole, with complete cure rates ranging from 40-80% depending on severity and treatment adherence 1.
- Fluconazole appears to be less effective than itraconazole or terbinafine, but may be a useful alternative in certain patients, with mycological cure rates ranging from 47% to 62% in toenail infections and from 89% to 100% in fingernail infections 1.
- Patients should be monitored for potential side effects, particularly with oral medications which may cause liver enzyme elevations, and treatment may need to be adjusted based on response and tolerability.
Patient Monitoring
- Patients should be re-evaluated 3–6 months after treatment initiation and further treatment should be given if the disease persists.
- Treatment success requires patience as visible improvement may take months while the infected nail grows out.
From the FDA Drug Label
Terbinafine tablets, USP are indicated for the treatment of onychomycosis of the toenail or fingernail due to dermatophytes (tinea unguium). 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 treatment of onychomycosis can be done using:
- Terbinafine (PO), which is indicated for the treatment of onychomycosis of the toenail or fingernail due to dermatophytes (tinea unguium) 2.
- Ciclopirox (TOP), which is indicated as a topical treatment in immunocompetent patients with mild to moderate onychomycosis of fingernails and toenails without lunula involvement, due to Trichophyton rubrum, as part of a comprehensive management program 3.
From the Research
Treatment Options for Onychomycosis
- Oral antifungal medications such as terbinafine and itraconazole have shown significant improvement in treatment outcomes for toenail onychomycosis 4, 5.
- A study comparing pulse and continuous terbinafine therapy found that continuous treatment had a higher clinical cure rate of 76.67% compared to 26.67% for pulse treatment 4.
- Combination therapy of oral terbinafine and topical ciclopirox nail lacquer has been shown to be more effective than terbinafine alone, with a mycological cure rate of 88.2% compared to 64.7% 6.
Efficacy of Different Treatments
- Terbinafine has been found to be more effective than placebo for achieving clinical and mycological cure, with a risk ratio of 6.00 and 4.53 respectively 5.
- Azoles have also been shown to be effective, with a risk ratio of 22.18 and 5.86 for clinical and mycological cure respectively 5.
- Topical treatments such as amorolfine, ciclopirox, tavaborole, and efinaconazole have been found to be effective for mild to moderate toenail onychomycosis, with efinaconazole showing the highest cure rates 7.
Safety Considerations
- Systemic antifungals such as terbinafine and azoles can have risks of systemic toxicity and drug-drug interactions, and should be used with caution 8.
- Topical antifungals are generally well-tolerated and safe, with only potential local side effects 8, 7.
- Laser therapy may be a safe alternative for patients who cannot use systemic or topical treatments, but its efficacy is still uncertain 8.