montelukast (Singulair)

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Introduction

Tradename: Singulair. Generic August 2012[10]

Indications

Contraindications

* considered safe in pregnancy[11]

Dosage

Tabs: 4, 5 & 10 mg chewable tablets.

Pharmacokinetics

elimination via liver

1/2life = 2.7-5.5 hours

Adverse effects

* Boxed warning

  • serious behavior & mood-related changes[12]

Toxicity:

  • no mortality in single doses of 5000 mg/kg in mice & rats.

Drug interactions

  • phenobarbital (no dose adjustment recommended)
  • any drug which inhibits cyt P450 2C9 or 3A4 can increase montelukast levels
  • any drug which induces cyt P450 2C9 or 3A4 can diminish montelukast levels

Mechanism of action

leukotriene D4 receptor inhibitor

More general terms

Additional terms

References

  1. Merck & Company
  2. Prescriber's Letter 13(3): 2006 Cytochrome P450 drug interactions Detail-Document#: http://prescribersletter.com/(5bhgn1a4ni4cyp2tvybwfh55)/pl/ArticleDD.aspx?li=1&st=1&cs=&s=PRL&pt=3&fpt=25&dd=220233&pb=PRL (subscription needed) http://www.prescribersletter.com
  3. 3.0 3.1 Journal Watch 21(19):154, 2001 Knorr et al, Pediatrics 108:e48, 2001
  4. 4.0 4.1 Singulair (Montelukast) for Seasonal Allergic Rhinitis Prescriber's Letter 10(2):9 2003 Detail-Document#: http://prescribersletter.com/(5bhgn1a4ni4cyp2tvybwfh55)/pl/ArticleDD.aspx?li=1&st=1&cs=&s=PRL&pt=3&fpt=25&dd=190210&pb=PRL (subscription needed) http://www.prescribersletter.com
  5. 5.0 5.1 Journal Watch 23(24):192, 2003 Bjermer L et al, BMJ 327:891, 2003 <PubMed> PMID: https://www.ncbi.nlm.nih.gov/pubmed/14563743 <Internet> http://bmj.bmjjournals.com/cgi/content/full/327/7420/891
  6. Department of Veterans Affairs, VA National Formulary
    non formulary drug request
  7. 7.0 7.1 7.2 Prescriber's Letter 14(7): 2007 Montelukast (Singulair) for Exercise-induced Bronchospasm Detail-Document#: http://prescribersletter.com/(5bhgn1a4ni4cyp2tvybwfh55)/pl/ArticleDD.aspx?li=1&st=1&cs=&s=PRL&pt=3&fpt=25&dd=230707&pb=PRL (subscription needed) http://www.prescribersletter.com
  8. 8.0 8.1 FDA MedWatch http://www.fda.gov/medwatch/safety/2008/safety08.htm#Singulair
    Prescriber's Letter 15(5): 2008 Singulair (Montelukast) and Suicide Detail-Document#: http://prescribersletter.com/(5bhgn1a4ni4cyp2tvybwfh55)/pl/ArticleDD.aspx?li=1&st=1&cs=&s=PRL&pt=3&fpt=25&dd=240507&pb=PRL (subscription needed) http://www.prescribersletter.com
  9. 9.0 9.1 9.2 FDA Safety Alert 6/12/2009 Updated Information on Leukotriene Inhibitors: Montelukast (marketed as Singulair), Zafirlukast (marketed as Accolate), and Zileuton (marketed as Zyflo and Zyflo CR) http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/DrugSafetyInformationforHeathcareProfessionals/ucm165489.htm
  10. 10.0 10.1 Prescriber's Letter 19(4): 2012 CHART: Anticipated Availability of First-Time Generics Detail-Document#: http://prescribersletter.com/(5bhgn1a4ni4cyp2tvybwfh55)/pl/ArticleDD.aspx?li=1&st=1&cs=&s=PRL&pt=3&fpt=25&dd=280401&pb=PRL (subscription needed) http://www.prescribersletter.com
    FDA News Release: Aug. 3, 2012 FDA approves first generic versions of Singulair to treat asthma, allergies http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm314436.htm
  11. 11.0 11.1 Medical Knowledge Self Assessment Program (MKSAP) 17. 18, American College of Physicians, Philadelphia 2015, 2018.
  12. 12.0 12.1 Brooks M FDA Adds Boxed Warning to Montelukast Over Mental Health Risks. Medscape - Mar 04, 2020. https://www.medscape.com/viewarticle/926271
  13. 13.0 13.1 13.2 Paljarvi T, Forton J, Luciano S et al Analysis of Neuropsychiatric Diagnoses After Montelukast Initiation. JAMA Netw Open. 2022;5(5):e2213643 PMID: https://www.ncbi.nlm.nih.gov/pubmed/35608857 Free article https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2792596

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