Oral terbinafine (Lamisil®) in the short-term treatment of fungal infections of the skin: results of a post-marketing surveillance study

• Published in: Mycoses Vol. 42; no. 9-10; pp. 555 - 558
• Main Authors: Binder, M., Nell, G.
• Format: Journal Article
• Language: English
• Published: Oxford, UK Blackwell Science Ltd 01.11.1999; Blackwell
• Subjects: Administration, Oral; Adult; Antibiotics. Antiinfectious agents. Antiparasitic agents; Antifungal agents; Antifungal Agents - administration & dosage; Antifungal Agents - adverse effects; Biological and medical sciences; Child; Dermatomycoses - drug therapy; Female; Follow-Up Studies; Human mycoses; Humans; Infectious diseases; Male; Medical sciences; Middle Aged; Mycoses; Mycoses of the skin; Naphthalenes - administration & dosage; Naphthalenes - adverse effects; Pharmacology. Drug treatments; Product Surveillance, Postmarketing; terbinafine; Time Factors; Short term; Human; Skin disease; Mycosis; Oral administration; Statistical study; Allylic compound; Terbinafine; Infection; Antifungal agent; Chemotherapy; Amine; Treatment; Skin
• ISSN: 0933-7407; 1439-0507
• DOI: 10.1046/j.1439-0507.1999.00515.x

Oral terbinafine (Lamisil®, Novartis Pharma AG, Basel, Switzerland) is an effective therapy for fungal infections of the skin and nails. A post‐marketing surveillance study was undertaken to evaluate the clinical efficacy and safety of oral terbinafine. A total of 454 patients with clinically and mycologically confirmed superficial fungal infections of the skin were enrolled from 79 dermatology clinics. Patients received oral terbinafine (250 mg day−1) for 2 weeks. Specific signs and symptoms were assessed by standard questionnaire before, immediately after, and 4 weeks after treatment. Observed improvements in patients after 2 weeks treatment were: erythema 81%, blistering 33%, exudation 50%, scaling 89%, pruritus 83%. After 4 weeks treatment, erythema was absent in 85% of patients, blistering and exudation in 99.7%, scaling in 82%, and pruritus in 94%. Overall clinical efficacy was assessed as good to excellent in 97% of patients. Adverse effects – mainly gastrointestinal and minor skin rashes – were reported in 5.3% of patients. The results of this study confirm that oral terbinafine is safe and highly effective for the short‐term treatment of fungal skin infections.