Podiatrists commonly use debridement to reduce the thickness of nails affected by onychomycosis. This approach is appropriate for patients who are experiencing pain and discomfort and are unable or unwilling to take oral antifungal agents. However, debridement is not curative and should be used in combination with systemic antifungals in order to eradicate onychomycosis effectively. It may also be used together with topical antifungals in patients who will not take oral antifungals. (Katz et al, 1998; Niewerth et al, 1999)

Topical onychomycosis therapies alone generally do not cure onychomycosis. They are usually used when patients will not take oral medications. More than 85% of onychomycosis cases are chronic and do not respond well to topical therapies. (Katz et al, 1998; Niewerth et al, 1999)

Penlac™ (ciclopirox) Nail Lacquer is a prescription topical preparation that has a less than 10% cure rate. Treatment can take up to a year. Moreover, debridement is recommended in combination with Penlac treatment. (Penlac Package Insert)

The most significant advances in the treatment of onychomycosis involve the development of systemic therapy. Oral antifungals work by penetrating the nail plate from the nail matrix and nail bed. These agents have a "reservoir effect" nails retain effective antifungal concentrations for months after treatment has ceased. Moreover, these therapies are well-tolerated by most patients. (Katz et al, 1998; Niewerth et al, 1999)

Systemic therapy should be used in patients with multiple nail involvement or significant involvement of any nail; those with streaks extending to the nail matrix; those who have failed topical therapy; and those who are unable to apply a topical agent. (Katz et al, 1998; Niewerth et al, 1999)

Oral antifungal agents include fungicidal* LAMISIL® Tablets (terbinafine) and fungistatic Sporanox (itraconazole). These agents lead to increased patient satisfaction over the long-term. Relapse rates are low for both agents. Other systemic agents, such as griseofulvin and ketoconazole, are rarely used today for onychomycosis. (Katz et al, 1998)

How LAMISIL® Tablets Work
LAMISIL® Tablets are the No. 1 prescribed treatment for onychomycosis, used in millions of patients worldwide. LAMISIL® Tablets have a high cure rate with a low rate of relapse; a proven record of safety; and an easy and convenient once-a-day dosing regimen. (LAMISIL® Package Insert; Sclar, 1994)

Terbinafine, the active ingredient in LAMISIL® Tablets, is the first available orally active allylamine. The allylamines are a novel chemical class of antifungal agents. Like azole antifungals, terbinafine selectively inhibits biosynthesis of ergosterol, a component of fungal cell membranes vital to membrane integrity and growth of the organism.

Terbinafine selectively inhibits production of fungal cell squalene epoxidase (compared with mammalian cell squalene epoxidase), the enzyme that converts squalene to squalene epoxide. This action causes a fungicidal accumulation of squalene, which in high concentrations disrupts fungal cell membranes. (Elewski, 1993)

In vitro, terbinafine is active against Trichophyton mentagrophytes, Trichophyton rubrum, Candida albicans, Epidermophyton floccosum, and Scopulariopsis brevicaulis. Its fungicidal* action is primarily against dermatophytes, molds, dimorphic fungi, and the yeast Candida parapsilosis. (Ryder et al, 1997)

Dosage and Treatment Time
The dosage of LAMISIL® Tablets is one 250-mg tablet each day. For onychomycosis of the toenails, treatment time is 12 weeks of therapy with LAMISIL® Tablets. For fingernail onychomycosis, treatment time is 6 weeks. Nail growth takes longer than the treatment period, so the nail will continue to grow out and continued improvement will be observed beyond the treatment period. Indeed, therapeutic levels of terbinafine persist in the nail from 3 to 6 months after therapy is completed. (LAMISIL® Package Insert; Elewski et al, 1996)

Clinical Success Rates
In a 48-week assessment of clinical success rates with LAMISIL® Tablets, the following results were reported:

	70% achieved mycologic cure
	59% achieved effective treatment (mycologic cure plus 0% nail involvement or 5 mm of new unaffected nail growth)
	38% achieved mycologic plus clinical cure after 12 weeks of therapy (one 250-mg tablet daily) [mean time to overall success: 10 months]
	85% did not relapse among those who achieved mycologic plus clinical cure of toenails (mycologic cure is achieved before clinical cure; relapse rate based on 38% of patients who demonstrated both mycologic cure plus clinical cure) (LAMISIL® Package Insert)

Safety Information
LAMISIL® Tablets have an established record of safety and tolerability. In the largest prospective study of an oral antifungal agent, involving nearly 26,000 patients, the positive safety profile of LAMISIL® Tablets was established. In this group, only 10.5% of patients experienced an adverse event, and almost half (44%) of these were not considered to be causally related to terbinafine. (Hall et al, 1997)

LAMISIL (terbinafine HCl tablets) Tablets are indicated for the treatment of onychomycosis of the toenail or fingernail due to dermatophytes (tinea unguium).

Side effects that are generally mild or transient have been reported in patients taking LAMISIL Tablets. In clinical trials, the most common were headache (12.9%), rash (5.6%), and diarrhea (5.6%). LAMISIL Tablets are not recommended for patients with liver or kidney impairment. Rare cases of liver failure, some leading to death or liver transplant, have occurred with the use of LAMISIL Tablets for the treatment of onychomycosis in individuals with and without preexisting liver disease. All patients should be screened for hepatic function before prescribing LAMISIL Tablets. Patients who develop persistent nasusea, anorexia, fatigue, vomiting, right upper abdominal pain or jaundice, dark urine or pale stools should be advised to discontinue treatment and contact their physician immediately (see WARNINGS in full prescribing information).

LAMISIL Tablets are contraindicated in individuals who are hypersensitive to terbinafine. There have been isolated reports of serious skin reactions (e.g., Stevens-Johnson syndrome and toxic epidermal necrolysis). In such cases, and in cases where liver dysfunction develops, therapy should be discontinued.

Clinical trials and worldwide marketing experience in 70 countries have demonstrated a low potential for clinically significant drug interactions with LAMISIL® Tablets. LAMISIL® Tablets can be used with most commonly prescribed medications. Terbinafine clearance is decreased by 33% by cimetidine and increased 100% by rifampin, but no dosage adjustments are required in patients taking these medications. (LAMISIL® Package Insert)