General Information

Lamisil Solution has been approved for the treatment of interdigital-type pedis (athlete's foot), tinea cruris (jock itch) and tinea corporis (ringworm) due to Trichophyton rubrum, Trichophyton mentagrophytes and Epidermophyton floccosum. This product contains the same prescription-strength medication as in the Lamilsi Cream. Both products have been approved for over-the-counter sales for the above indications. Lamisil Solution is also available as prescription-only for the indication of tinea versicolor.

Lamisil is a one week treatment, whereas most or all other over-the-counter (OTC) treatments for athlete's foot and other fungal infections are four week treatments. The product should be applied once daily for the treatment of tinea corporis and tinea cruris, and twice daily for the treatment of tinea pedis and tinea versicolor.

The indications:

• Tinea cruris (jock itch) is a fungal infection of the groin and gluteal cleft
• Tinea corporis (ringworm) is an infection of the body surface with mold-like fungi called dermatophytes. It often affects children, but can occur in people of all ages.
• Tinea pedis (Athlete's foot) is a fungal infection of the foot. It affects 1 out of 10 Americans each year and 75% of Americans over their lifetime. A majority of sufferers are males, ages 25-54. Athlete's foot can manifest itself in a variety of ways, ranging from moist, easily rubbed-off skin, to red flaky skin. Symptoms often include itching, blisters and cracking.
• Pityriasis (tinea) versicolor is a superficial infection caused by a commensal yeast. It is characterized by lesions, scaling and discoloration of the skin. Tinea versicolor affects mostly young adults, but can affect a person in any age group.

All of these fungal conditions are contagious. Good hygiene, keeping skin dry, and protecting minor skin injuries can all help prevent the spread of these fungal infections.

Other products with the Lamisil name:

• Lamisil Tablets prescription oral medication for the treatment of fungal nail infection (onychomycosis)
• Lamisil Cream over-the-counter cream medication for the treatment of athlete's foot, jock itch, and ringworm

Clinical Results

In clinical studies, the Lamisil Solution treatment was investigated versus placebo, for each of the indications. Results showed that at both the end of the one-week treatment period and at the end of the study (8 weeks), patients treated with Lamisil Solution achieved much better effective treatment and complete cure results than did the patients treated with the placebo.

Side Effects

Adverse reactions reported by Lamisil Solution-treated patients during clinical studies:

• Application site reactions, such as burning or irritation (occurred in 1.3% of patients)
• Itching (occurred in 1.1% of patients)
• Skin exfoliation (occurred in 1.0% or patients)
• Erythematous rash (occurred in 0.9% of patients)

0.2% or the 898 patients participating in clinical trials discontinued therapy due to adverse reactions.

Lamisil Solution is not for ophthalmic, oral, or intravaginal use.

Mechanism of Action

Terbinafine hydrochloride is a synthetic allylamine derivative. Terbinafine hydrochloride is hypothesized to act by inhibiting the epoxidation of squalene, thus blocking the biosynthesis of ergosterol, an essential component of fungal cell membranes. The allylamine derivatives, like the benzylamines, act at an earlier step in the ergosterol biosynthesis pathway than the azole class of antifungal drugs. Depending on the concentration of the drug and the fungal species tested in vitro, terbinafine hydrochloride may be fungicidal. However, the clinical significance of in vitro data is unknown. (From FDA Label)

Additional Information

Visit the Novartis Pharmaceuticals Corporation web site to learn more about Lamisil Solution and about other products, research, and services provided by the company that developed this drug.

To search the internet for dermatology-related topics, visit www.dermguide.com, an internet search engine devoted to dermatological issues.

For more information about current events in dermatology, case studies in dermatology, interactive emailing with experts in dermatology, etc., visit www.skindex.com.