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Overview of the use of terbinafine (Lamisil) in children
1Clinical Research Centre, Sandoz Pharma Ltd, Basle, Switzerland.
Insights
Terbinafine is an effective and well-tolerated antifungal treatment for children's fungal infections, including tinea capitis. Recommended dosages and a 4-week treatment course show high cure rates.
Area of Science:
- Dermatology
- Pediatric Mycology
- Pharmacology
Background:
- Dermatophytoses are common fungal infections in children.
- Terbinafine is an established antifungal agent with known efficacy in adults.
- Data on terbinafine's use in pediatric populations were previously limited.
Purpose of the Study:
- To review the efficacy and tolerability of terbinafine in treating pediatric dermatophytoses.
- To establish appropriate dosing and treatment durations for children.
- To assess terbinafine's effectiveness against specific fungal infections like tinea capitis.
Main Methods:
- Systematic review of six clinical studies involving pediatric patients.
- Analysis of efficacy and tolerability data from 152 and 196 children, respectively.
- Evaluation of various treatment durations, ranging from 1 to 28 weeks.
Main Results:
- Terbinafine demonstrated high efficacy, with cure rates exceeding 90% for tinea capitis and other skin dermatophytoses.
- A proposed dosing regimen (62.5-125 mg/day for <40 kg, 250 mg/day for >40 kg) was found to be well-tolerated and effective.
- Treatment duration, particularly the 4-week course for tinea capitis, was shorter than for existing antifungal drugs.
Conclusions:
- Terbinafine is a highly effective and well-tolerated oral antifungal medication for treating dermatophytoses in children aged 2-17 years.
- Specific pediatric dosing guidelines support its safe and effective use.
- The drug offers a favorable treatment option with shorter durations for common pediatric fungal infections.
Abstract:
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, terbinafine 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 > 40 kg, the adult dose of 250 mg 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.(ABSTRACT TRUNCATED AT 250 WORDS)
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