Home » Drug Information » FDA-Approved Drugs » 2000
Medical Areas: Dermatology/Plastic Surgery | Immunology/Infectious Diseases
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Drug Information
The following information is obtained from various newswires, published
medical journal articles, and medical conference presentations.
Company: Novartis
Approval Status: Approved March 2000
Treatment Area: For the treatment of interdigital-type pedis (athlete's foot), tinea cruris (jock itch) and tinea corporis (ringworm)
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
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.
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.
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)
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.