Can terbinafin be given to a 7-year old child?/nA 7-year-old girl has ring worm on her chest (tinea

Fråga: Can terbinafin be given to a 7-year old child?

A 7-year-old girl has ring worm on her chest (tinea corporis) and topical treatment has not been sufficient. The physician has prescribed terbinafine 250 mg/ day for two weeks.

The father of the patient calls the physician after he has bought the medicine and is upset since the medicine was quite expensive and now he has read on the packaging that terbinafin should not been given to children younger than 18 years of age. The physician wonders if there are any studies where terbinafine has been given to children.

Sammanfattning: Orally administrated terbinafin is not approved for treatment of tinea in children and is off-label prescription. Terbinafine has a well-documented effect against tinea corporis in adults but studies in children are lacking. However, there are five studies, comprising 1422 terbinafine treated children, showing that terbinafin is as safe and efficient as griseofulvin against tinea capitis in children. Importantly, the dosage must be adjusted to the bodyweight of the child (250 mg/day for children weighing > 40 kg, 125 mg/day in children weighing 20-40 kg and 62.5 mg for children < 20 kg). Fluconazole might be an alternative treatment.

Svar: Tinea is fungal infections caused by different species of Trichophyton and Mycosporum and can be localised on different part of the body (tinea corporis, capitis, pedis, manus) (1,2). The first hand therapy for tinea corporis in children is topical treatment with tebinafine or imidazole (2). Terbinafine per os is not approved for use in children but has a well-documented effect against tinea in adults (1). The first hand choice for tinea corporis in children where topical treatment not has been successful is griseofulvin, a medicine prescribed exclusively by dermatologists (2,3).

In a Cochrane analysis from 2007 about antifungal therapy for tinea capitis in children there a three studies comprising 382 children where griseofulvin has been compared with terbinafine. Terbinafine was as efficient and safe as griseofulvin. There were also three comparing studies for griseofulvin and itraconazole (N= 295) and two with flukonazole (N=140). The authors conclude that terbinafine, itraconazole or fluconazole are equally efficient and safe for treating tinea capitis in children as griseofulvin. Terbinafine, itraconazole or fluconazole could even be preferable due to the shorter treatment period. The recommended dosage for terbinafine was two weeks treatment with 250 mg/day for children weighing > 40 kg, 125 mg/day in children weighing 20-40 kg and 62.5 mg for children < 20 kg (3).

There is an additional article about griseofulvin and terbinafine treatment for tinea capitis in children published 2008, after the Cochrane analysis. This article comprises two identical trials where children diagnosed with tinea capitis were randomised to griseofulvin (10-20 mg/kg, N=509) or to terbinafine (5-8 mg/kg, N=1040) for a period of 6 weeks. Rates of complete cure were significantly higher for terbinafine than for griseofulvin in trial 1 and there was no difference between the two treatments in trial 2. There were no severe adverse reactions reported in any of the trials (4).

Generally, the safety-profile of the newer antifungal agent fluconazole is well-documented in children (5). However, terbinafine has a well-documented effect against different tinea infections in adults (including tinea corporis) and since the treatment time in this case is only two weeks, the risk of severe adverse reactions is considered to be small. In addition oral terbinafine had a better cure rate compared to itraconazole for tinea pedis and manus in several studies (1). Comparative studies between oral terbinafine and itraconazole or fluconazole for tinea corporis is lacking. McClellan KJ, Wiseman LR, Markham A. Terbinafine. An update of its use in superficial mycoses. Drugs 1999;58(1):179-202 www.fass.se/ LIF / lakarboken Ringorm av: Dr Olle Lyngstam i Praktisk Medicin (PM) 2008 Gonzalez U, Seaton T, Bergus G, Jacobson J, Martinez-Monzon C. Systemic antifungal therapy for tinea capitis in children. Cochrane Database Syst Rev 2007;(4):CD004685 2007 Elewski BE, Caceres HW, DeLeon L, El SS, Hunter JA, Korotkiy N et al. Terbinafine hydrochloride oral granules versus oral griseofulvin suspension in children with tinea capitis: results of two randomized, investigator-blinded, multicenter, international, controlled trials. J Am Acad Dermatol 2008;59(1):41-54 Steinbach WJ. Antifungal agents in children. Pediatr Clin North Am 2005;52(3):895-915, viii