The authority listing for terbinafine 250 mg tablets was extended on 1 March 2010. Any child or adolescent (< 18 years) may now receive treatment for a dermatophyte infection that has not responded to topical treatment and oral griseofulvin. Similarly, the streamlined authority listing for terbinafine 1% cream now includes the treatment of fungal or yeast infections in this age group.¹ These authority listings were previously restricted to Aboriginal and Torres Strait Islander people only.²

The Pharmaceutical Benefits Advisory Committee recommended the extended listings on the basis of clinical need for children and adolescents.¹ The TGA-approved product information does not recommend terbinafine tablets for children or adolescents, and the cream is not recommended for children < 12 years.^3,4 However, there are some small trials to support use in children and adolescents^5‑7 and paediatric oral dose recommendations are available (see Box 1).^5,8 Terbinafine oral granules* are indicated for people > 4 years in the US (with slightly higher mg/kg dose recommendations).⁹

*Not available in Australia.

Box 1: Paediatric dose recommendations
for terbinafine tablets*

* 250 mg scored tablets are the only strength available
in Australia, so doses for children < 40 kg require
tablets to be broken.

Prescribe terbinafine tablets only if terbinafine cream and oral griseofulvin have not treated the fungal infection: if > 6 weeks of terbinafine tablets are required, monitor blood count and liver enzymes.¹⁰ Oral terbinafine is associated with rare but serious adverse effects (e.g. blood dyscrasias, liver failure).^3,11–13 The US FDA found that skin reactions were the most often reported postmarketing adverse event for terbinafine for children.¹⁴

References

1. Pharmaceutical Benefits Advisory Committee. Positive recommendations made by the Pharmaceutical Benefits Advisory Committee in November 2009 relating to the listing of drugs on the Pharmaceutical Benefits Scheme. Canberra: Australian Government Department of Health and Ageing, 2009. http://www.health.gov.au/internet/main/publishing.nsf/Content/pbacrec-nov09-positive (accessed 6 January 2010).
2. National Prescribing Service. Terbinafine authority listed for fungal infections in Aboriginal and Torres Strait Islander peoples. NPS RADAR In Brief, April 2008. Sydney: National Prescribing Service, 2008. http://nps.org.au/health_professionals/publications/nps_radar/2008/april_2008/brief_item_terbinafine_authority_listed_for_fungal_infections_in_aboriginal_and_torres_strait_ islander_peoples (accessed 6 January 2010).
3. Novartis Pharmaceuticals Australia Pty Ltd. Lamisil tablets product information. 9 September 2008.
   
4. Novartis Consumer Health Australasia Pty Ltd. Lamisil cream product information. 1 May 2002.
   
5. Jones TC. Overview of the use of terbinafine in children. Br J Dermatol 1995;132:683–9. [PubMed]
   
6. Abdel-Rahman SM, Herron J, Fallon-Friedlander S, et al. Pharmacokinetics of terbinafine in young children treated for tinea capitis. Ped Infect Dis J 2005;24:886–91. [PubMed]
7. Pau MA, Aste N, Aste N. Efficacy and tolerability of terbinafine in children. G Ital Dermatol Venereol 2006;141:29–31.
8. Kemp CA, McDowell JM, eds. Paediatric Pharmacopoeia. 13th edn. Melbourne: Royal Children's Hospital, 2002.
9. Novartis Pharmaceuticals Corporation, USA. Lamisil oral granules product information. September 2007. http://www.pharma.us.novartis.com/product/pi/pdf/Lamisil_Oral_Granules.pdf (accessed 7 January 2010).
10. Rossi S, ed. Australian Medicines Handbook. Adelaide: Australian Medicines Handbook Pty Ltd, 2010.
11. Adverse Drug Reactions Advisory Committee. Terbinafine and blood dyscrasias. Australian Adverse Drug Reactions Bulletin 2004;23:3. http://www.tga.gov.au/adr/aadrb/aadr0410.htm
12. Adverse Drug Reactions Advisory Committee. Life-threatening blood dyscrasias with oral terbinafine. Australian Adverse Drug Reactions Bulletin 2006;25:3. http://www.tga.gov.au/adr/aadrb/aadr0608.htm
    
13. Adverse Drug Reactions Advisory Committee. Hepatic reactions with terbinafine. Australian Adverse Drug Reactions Bulletin 2008;27:3. http://www.tga.gov.au/adr/aadrb/aadr0802.htm
    
14. FDA Center for Drug Evaluation and Research. 1 year pediatric exclusivity post-marketing adverse event review for terbinafine. U.S. Food and Drug Administration, 2008. http://www.fda.gov/ohrms/dockets/ac/08/briefing/2008-4399b1-35%20(Lamisil%20(terbinafine)%20Safety%20Review).pdf (accessed 6 January 2010).