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Authority listing for terbinafine extended to children and adolescents

  • 1 min read
  • 1 March 2010

 

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 adolescents5‑7 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*

Weight (kilogram)

Daily dose (mg)

< 20

62.5

20–40

125

> 40

250

* 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

 

Box 1: Paediatric dose recommendations for terbinafine tablets*

 

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\u20139. [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\u201391. [PubMed] .
  7. Pau MA, Aste N, Aste N. Efficacy and tolerability of terbinafine in children. G Ital Dermatol Venereol 2006;141:29\u201331.
  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 (Lamisil (terbinafine) Safety Review).pdf (accessed 6 January 2010).