Budesonide/formoterol explained

Verifiedrevid:448962189
Type:combo
Component1:Budesonide
Class1:Glucocorticoids
Component2:Formoterol
Class2:Long-acting beta-adrenoceptor agonist
Tradename:Symbicort, DuoResp Spiromax, BiResp Spiromax, others
Dailymedid:Budesonide_and_formoterol
Pregnancy Au:B3
Pregnancy Au Comment:[1]
Routes Of Administration:Inhalation
Atc Prefix:R03
Atc Suffix:AK07
Legal Au:S4
Legal Uk:POM
Legal Uk Comment:[2]
Legal Us:Rx-only
Legal Eu:Rx-only
Legal Status:Rx-only
Cas Number:150693-37-1
Kegg:D09595
C:44
H:58
N:2
O:10
Smiles:CCCC1OC2CC3C4CCC5=CC(=O)C=CC5(C4C(CC3(C2(O1)C(=O)CO)C)O)C.CC(CC1=CC=C(C=C1)OC)NCC(C2=CC(=C(C=C2)O)NC=O)O
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Stdinchikey:PJFHZKIDENOSJB-JIVDDGRNSA-N

Budesonide/formoterol, sold under the brand name Symbicort among others, is a fixed-dose combination medication used in the management of asthma or chronic obstructive pulmonary disease (COPD). It contains budesonide, a steroid and formoterol, a long-acting β2-agonist (LABA). The product monograph does not support its use for sudden worsening or treatment of active bronchospasm. However, a 2020 review of the literature does support such use.[3] It is used by breathing in the medication.[4]

Common (≥1/100 to <1/10) side effects include candidiasis, headache, tremor, palpitations, throat irritation, coughing, and dysphonia.[5] Pneumonia is a common side effect in people with COPD, and other, less common side effects have been documented.[2] There were concerns that the LABA component increases the risk of death in children with asthma, however these concerns were removed in 2017.[6] Therefore, this combination is only recommended in those who are not controlled on an inhaled steroid alone. There is tentative evidence that typical doses of inhaled steroids and LABAs are safe in pregnancy.[7] Both formoterol and budesonide are excreted in breast-milk.[8]

Budesonide/formoterol was approved for medical use in the United States in 2006. It is on the World Health Organization's List of Essential Medicines.[9] [10] It is available as a generic medication.[11] In 2021, it was the 72nd most commonly prescribed medication in the United States, with more than 9million prescriptions.[12] [13]

Medical uses

Maintenance

Budesonide/formoterol has shown efficacy to prevent asthma attacks.[3] It is unclear if the efficacy of budesonide/formoterol differs from that of fluticasone and salmeterol in chronic asthma.[14]

Exacerbation

The combination is approved in the United States only as a maintenance medication in asthma and chronic obstructive pulmonary disease (COPD). However, a 2020 review of the literature does support use as needed during acute worsening in those with mild disease, and as maintenance followed by extra doses during worsening.[3]

Use for both maintenance and as-needed treatment is also known as single maintenance and reliever therapy (SMART) and is a well-established treatment.[15] [16] It has been shown to, 1) reduce asthma exacerbations that require oral corticosteroids, 2) reduce hospital visits better than maintenance on inhaled corticosteroids alone at a higher dose, or 3) inhaled corticosteroid at the same or higher dose together with a long-acting bronchodilator (LABA), with a short-acting bronchodilator (SABA) as a reliever.

Side effects

Common (up to 1 in 10 people)

Often mild, and usually disappear as the medication continues to be used:

Uncommon (up to 1 in 100 people)

Rare (up to 1 in 1,000 people)

Very rare (up to 1 in 10,000 people)

Other

With high doses for a long period of time.

[17]

Allergic reaction

Society and culture

Legal status

It was approved for use in the United States in July 2006.[19] [20]

Budesonide/formoterol was approved for use in the European Union in April 2014.[21] [22]

There are several patents related to the drug; some of which have expired.[23] It was initially marketed by AstraZeneca.

Notes and References

  1. Web site: Budesonide / formoterol (Symbicort) Use During Pregnancy . Drugs.com . 28 August 2019 . 13 April 2020.
  2. Web site: Symbicort Turbohaler 200/6 Inhalation powder - Summary of Product Characteristics (SmPC) . (emc) . 30 August 2019 . 13 April 2020.
  3. Jenkins CR, Bateman ED, Sears MR, O'Byrne PM . What have we learnt about asthma control from trials of budesonide/formoterol as maintenance and reliever? . Respirology . 25 . 8 . 804–815 . August 2020 . 32237004 . 10.1111/resp.13804 . free .
  4. Web site: Symbicort- budesonide and formoterol fumarate dihydrate aerosol . DailyMed . 24 July 2019 . 29 April 2020.
  5. Web site: Symbicort Turbohaler 100/6 Summary of Product Characteristics . . 2 February 2021 . Medicines.ie . Irish Pharmaceutical Healthcare Association . 2 July 2021 .
  6. Web site: Safety Alerts for Human Medical Products - Long-Acting Beta agonists (LABAs) and Inhaled Corticosteroids (ICS): Drug Safety Communication - Boxed Warning About Asthma-Related Death Removed. FDA. 23 December 2017.
  7. Web site: Global Strategy for Asthma Management and Prevention. 2020. Ginasthma.org. 90. 9 May 2020. evidence for safety of usual doses of ICS and LABA.
  8. Web site: Budesonide / formoterol (Symbicort) Use During Pregnancy . Drugs.com . 28 August 2019 . 13 April 2020.
  9. Book: ((World Health Organization)) . World Health Organization model list of essential medicines: 21st list 2019 . 2019 . 10665/325771 . World Health Organization . World Health Organization . Geneva . WHO/MVP/EMP/IAU/2019.06. License: CC BY-NC-SA 3.0 IGO . free .
  10. Book: ((World Health Organization)) . World Health Organization model list of essential medicines: 22nd list (2021) . 2021 . 10665/345533 . World Health Organization . World Health Organization . Geneva . WHO/MHP/HPS/EML/2021.02 . free .
  11. FDA Approves First Generic of Symbicort to Treat Asthma and COPD . U.S. Food and Drug Administration . 15 March 2022 . 15 March 2022.
  12. Web site: The Top 300 of 2021 . ClinCalc . 14 January 2024 . 15 January 2024 . https://web.archive.org/web/20240115223848/https://clincalc.com/DrugStats/Top300Drugs.aspx . live .
  13. Web site: Budesonide; Formoterol - Drug Usage Statistics . ClinCalc . 14 January 2024.
  14. Lasserson TJ, Ferrara G, Casali L . Combination fluticasone and salmeterol versus fixed dose combination budesonide and formoterol for chronic asthma in adults and children . The Cochrane Database of Systematic Reviews . 12 . CD004106 . December 2011 . 22161385 . 10.1002/14651858.CD004106.pub4 . Cochrane Airways Group .
  15. Kew KM, Karner C, Mindus SM, Ferrara G . Combination formoterol and budesonide as maintenance and reliever therapy versus combination inhaler maintenance for chronic asthma in adults and children . The Cochrane Database of Systematic Reviews . 2013 . 12 . CD009019 . December 2013 . 24343671 . 8949777 . 10.1002/14651858.CD009019.pub2 . Cochrane Airways Group .
  16. Sobieraj DM, Weeda ER, Nguyen E, Coleman CI, White CM, Lazarus SC, Blake KV, Lang JE, Baker WL . 6 . Association of Inhaled Corticosteroids and Long-Acting β-Agonists as Controller and Quick Relief Therapy With Exacerbations and Symptom Control in Persistent Asthma: A Systematic Review and Meta-analysis . JAMA . 319 . 14 . 1485–1496 . April 2018 . 29554195 . 5876810 . 10.1001/jama.2018.2769 .
  17. Web site: Symbicort Turbohaler 100/6, Inhalation powder - Patient Information Leaflet. Electronic Medicines Compendium. September 2020. 9 September 2021.
  18. Web site: PACKAGE LEAFLET:INFORMATION FOR THE USER Symbicort® Turbohaler® 200 micrograms/6 micrograms/inhalation, inhalation powder budesonide, formoterol fumarate dihydrate. July 2015. hpra.ie - Health Products Regulatory Authority (Irish state agency). https://web.archive.org/web/20180809190546/https://www.hpra.ie/img/uploaded/swedocuments/2164676.PPA1463_051_001.43ee9e2e-b98a-4451-891a-77d7c0b9f5be.000001Product%20Leaflet%20Approved%20(IP).150727.pdf. 9 August 2018. live.
  19. Web site: Drug Approval Package: Symbicort (budesonide/formoterol fumarate dihydrate) NDA #021929 . U.S. Food and Drug Administration (FDA) . 30 October 2008 . 29 April 2020.
  20. News: Haber G . AstraZeneca banking on asthma inhaler . Delaware News-Journal (delawareonline) . 19 November 2006 . 9 July 2020 . https://web.archive.org/web/20070930171657/http://www.delawareonline.com/apps/pbcs.dll/article?AID=%2F20061119%2FBUSINESS%2F611190331%2F1003%2FNLETTER01 . 30 September 2007 . dead .
  21. Web site: BiResp Spiromax EPAR . European Medicines Agency (EMA) . 17 September 2018 . 29 April 2020.
  22. Web site: DuoResp Spiromax EPAR . European Medicines Agency (EMA) . 17 September 2018 . 29 April 2020.
  23. Web site: Has a generic version of Symbicort been approved? . Drugs.com .

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