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Summary

This review summarizes the efficacy and tolerability of terbinafine (Lamisil®) in the treatment of dermatophytoses in children. In six clinical studies, 152 children who received terbinafine were evaluable for efficacy and 196 were evaluable for tolerability. In these studies, terbinaline was used for between 1 and 28 weeks. The median treatment was 4 weeks, the duration of treatment in the tinea capitis studies.

As a result of extensive experience in adults at doses of 10 mg/kg and less, and the overall pharmacokinetic profile in children, including the lower volume of distribution of terbinafine into lipophilic tissue, the use of a dose of 125 mg/day for children weighing 20–40 kg, and 62.5 mg/day in children weighing less than 20 kg, has been proposed. This dose was shown to be well tolerated and effective. For children weighing >40kg, the adult dose of 250mg is appropriate.

Terbinafine was shown to be very effective (93% cured), in the treatment of children with tinea capitis, using a shorter treatment duration (4 weeks) than that usually employed with presently available antifungal drugs. It is also effective in children with various dermatophyte infections of the skin, with a cure rate of more than 90%. Terbinafine was shown to be well tolerated in children aged between 2 and 17 years.

The recommended duration of treatment for tinea capitis is 4 weeks. The recommended duration of treatment for other skin or nail dermatophyte infections, based on extensive studies in adults, and confirmed in children, is 2 weeks for tinea corporis and tinea pedis, 6 weeks for finger-nail onychomycosis and 12 weeks for toe-nail onychomycosis.