From the Guidelines
Terbinafine 250mg daily for 6 weeks (fingernails) or 12 weeks (toenails) is the recommended first-line oral therapy for onychomycosis due to its high cure rate and favorable safety profile. This recommendation is based on the British Association of Dermatologists' guidelines for the management of onychomycosis 2014, which suggests that terbinafine has a higher efficacy and tolerability compared to itraconazole 1. The guidelines also mention that terbinafine persists in the nail for a considerable period after elimination from the plasma, allowing for intermittent or 'pulse' treatment regimens.
Some key points to consider when treating onychomycosis include:
- Terbinafine is licensed at a dose of 250 mg per day for 6 weeks in fingernail and 12–16 weeks in toenail infection 1
- Itraconazole is an alternative option, 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
- Fluconazole 450 mg per week for 3 months in fingernail infections, and for at least 6 months in toenail infections, may be a useful alternative in patients unable to tolerate terbinafine or itraconazole 1
- Treatment success requires patience as complete nail regrowth takes months, and recurrence is common
- Patients should be advised to keep nails short, wear breathable footwear, use antifungal powders in shoes, and avoid walking barefoot in public areas to prevent reinfection
It's worth noting that fluconazole has a weaker efficacy compared to terbinafine and itraconazole, but its once-weekly dosing regimen may improve compliance in some patients 1. However, terbinafine remains the first-line treatment option due to its higher cure rate and favorable safety profile.
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
Onychomycosis treatment options include:
- 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 part of a comprehensive management program 3
From the Research
Onychomycosis Treatment Options
- Onychomycosis can be treated with various options, including oral and topical antifungal agents, as well as device-based therapies 4, 5.
- The goals of antifungal therapy are mycological cure and a normal looking nail 4.
- Treatment of onychomycosis depends on the clinical type of the onychomycosis, the number of affected nails, and the severity of nail involvement 4.
Oral Antifungal Agents
- Oral antifungal agents, such as terbinafine, offer greater efficacy for onychomycosis treatment but are limited by risks of systemic toxicity and drug-drug interactions 6.
- The risk of terbinafine-induced hepatotoxicity is negligible in healthy patients 6.
- Systemic therapies, especially azole antifungals, are associated with numerous drug-drug interactions, some of which are life-threatening and fatal 6.
Topical Antifungal Agents
- Topical antifungal agents, such as ciclopirox, amorolfine, tavaborole, and efinaconazole, are well tolerated and generally safe, with only potential local side effects 7, 6.
- Topical treatment with amorolfine, ciclopirox, tavaborole, or efinaconazole is appropriate for cases of mild to moderate toenail onychomycosis due to dermatophyte or mixed dermatophyte/Candida infection 7.
- Treatments are generally applied daily for 24-48 weeks, with longer treatment and follow-up showing better outcomes 7.
Combination Therapy
- Combination therapy of oral terbinafine and topical ciclopirox nail lacquer is a safe and more effective treatment for onychomycosis than terbinafine alone, especially in younger patients and in shorter-duration onychomycosis 8.
- The mycological cure rates were 22/34 (64.7%) for the terbinafine-only group and 30/34 (88.2%) for the combination therapy group (p<0.05) 8.