Home » Drug Information » FDA-Approved Drugs » 1996
Medical Areas: Immunology/Infectious Diseases | Pharmacology/Toxicology
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Drug Information
The following information is obtained from various newswires, published
medical journal articles, and medical conference presentations.
Company: Sandoz Pharmaceuticals
Approval Status: Approved May 1996
Treatment Area: nail fungal infections
Lamisil has been approved as a treatment for nail fungal
infections (onychomycosis). Lamisil leads to the death of the
fungal cells that cause onychomycosis, as demonstrated by in vitro
studies.
The course of treatment with Lamisil tablets is 12 weeks for
toenail infections and 6 weeks for fingernail infections. The drug
works faster than the nail grows. Therefore, it may be several
months before new clear nails grow in. Lamisil is available in a
once-a-day dosing with no dietary restrictions and can be taken
with or without food.
The most common side effects associated with Lamisil were
gastrointestinal symptoms, headaches, and rash. These were
generally mild and transient in nature. Lamisil is contraindicated
in individuals who are hypersensitive to terbinafine. Rare
instances of symptomatic hepatobiliary dysfunction and serious skin
reactions have been reported. In such cases, therapy should be
discontinued.
Onychomycosis, one of the hardest to treat forms of external
infection, aggressively discolors, thickens, and destroys the nail
plate. An estimated 10 million individuals in the continental
United States suffer from onychomycosis, an invasive infection of
the nail caused by dermatophytes--fungi like Tricophyton rubrum and
Tricophyton mentagrophytes.
People who work with their hands or on their feet, or those who
are frequently exposed to detergents, perspiration, and water, are
at high risk for contracting onychomycosis. Nail fungal infections
are prevalent among the elderly, athletes, military personnel, and
laborers, and may be more severe in immunocompromised patients,
particularly those with HIV.