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montelukast
Montelukast …, Singulair

2020-12-09 Expertgrupp lung- och allergisjukdomar

Beslut

Kvarstår

Indikation

Barn 6 mån-5 år: Andrahandsalternativ till inhalationssteroid vid återkommande infektionsutlösta astmabesvär.

Barn 2-14 år: Andrahandsalternativ till lågdos inhalationssteroider vid lindrig astma.

Förbehåll / Kommentar

Barndosering för montelukast finns från 6 månaders ålder i form av dosgranulat 4 mg, 2-5 år tuggtablett 4 mg, 6-14 år 5 mg, 15 år och äldre 10 mg.

Generisk substitution tillämpas vid expedition på recept.

Montelukast är miljöklassificerat.

Registrerat 98-01-23.

Motivering

För barn ses montelukast som ett andrahandsalternativ till inhalationssteroider i låg dos, eftersom inhalationssteroider har bättre dokumenterad effekt.

Effekten av kontinuerlig behandling med montelukast bör utvärderas efter 4 veckor då cirka 30 procent av barnen är icke-responders.

Montelukast är den enda antileukotrien som är godkänd i Sverige.


Utredningsmaterial och referenser

  1. Läkemedelsbehandling vid astma- behandlingsrekommendation 2015. Läkemedelsverket
  2. Global Initiative for Asthma. Global Strategy for Asthma Management and Prevention, 2020. Available from GINA
  3. Lemanske RF Jr, Mauger DT, Sorkness CA, Jackson DJ, Boehmer SJ, Martinez FD et al. Step-up therapy for children with uncontrolled asthma receiving inhaled corticosteroids. N Engl J Med. 2010;362:975-85. PubMed
  4. Bacharier LB, Phillips BR, Zeiger BS, Szefler SJ, Martinez FD, Lemanske RF et al. Episodic use of an inhaled corticosteroid or leukotrienereceptor antagonist in preschool children with moderate-to-severe intermittent wheezing. J Allergy Clin Immunol 2008;122:1127-35. PubMed
  5. Brand PL, Baraldi E, Bisgaard H, Boner AL, Castro-Rodriguez JA, Custovic A et al. Definition, assessment and treatment of wheezing disorders in preschool children: an evidence-based approach. Eur Respir J. 2008;32:1096-110. PubMed
  6. Hakim F, Vilozni D, Adler A, Livnat G, Tal A, Bentur L. The effect of montelukast on bronchial hyperreactivity in preschool children. Chest 2007;131:180-6. PubMed
  7. Knorr B, Franchi LM, Bisgaard H, Vermeulen JH, LeSouef P, Santanello N et al. Montelukast, a leukotriene receptor antagonist, for the treatment of persistent asthma in children aged 2 to 5 years. Pediatrics 2001;108:E48. PubMed
  8. Johnston NW, Mandhane PJ, Dai J, Duncan JM, Greene JM, Lambert K, Sears MR. Attenuation of the September epidemic of asthma exacerbations in children: a randomized, controlled trial of montelukast added to usual therapy. Pediatrics 2007;120:e702-12. PubMed
  9. Chauhan BF, Ducharme FM. Anti-leukotriene agents compared to inhaled corticosteroids in the management of recurrent and/or chronic asthma in adults and children. Cochrane Database of Systematic Reviews 2012;5: CD002314. PubMed
  10. Lee SY, Kim HB, Kim JH, Kim BS, Kang MJ, Jang SO et al. Responsiveness to montelukast is associated with bronchial hyperresponsiveness and total immunoglobulin E but not polymorphisms in the leukotriene C4 synthase and cysteinyl leukotriene receptor 1 genes in Korean children with exercise-induced asthma (EIA). Clin Exp Allergy. 2007;37:1487-93. PubMed
  11. Brodlie M, Gupta A, Rodrigueez-Martines CE et al. Leukotriene receptor antagonists as maintenance and intermittent therapy for episodic viral wheeze in children. Cochrane Database of Systematic Reviews 2015, issue 10. Art no:CD008202. PubMed
  12. Castro-Rodriguez JA et al. Daily inhaled corticosteroids or montelukast for preschoolers with asthma or recurrent wheezing: A systematic review. Pediatric Pulmonology 2018;53:1670-1677. PubMed
  13. FDA requires Boxed Warning about serious mental health side effects for asthma and allergy drug montelukast (Singulair); advises restricting use for allergic rhinitis. Drug safety communication 2020-03-13. FDA.
  14. FDA Adverse event reporting system (FAERS)
  15. FDA Sentinel system January 1, 2010 – September 30, 2015
  16. Marschallinger J, Schäffner I, Klein B, Gelfert R, Rivera FJ, Illes S, et al. Structural and functional rejuvenation of the aged brain by an approved anti-asthmatic drug. Nat Commun 2015;6:8466. PubMed

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Expertgrupp lung- och allergisjukdomar