Budesonide/formoterol

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).[2] It contains budesonide, a steroid and formoterol, a long-acting β2-agonist (LABA).[2] The product monograph does not support its use for sudden worsening or treatment of active bronchospasm.[2] However, a 2020 review of the literature does support such use.[5] It is used by breathing in the medication.[2]

Budesonide/formoterol
Combination of
BudesonideGlucocorticoids
FormoterolLong-acting beta-adrenoceptor agonist
Clinical data
Trade namesSymbicort, DuoResp Spiromax, BiResp Spiromax, others
AHFS/Drugs.comProfessional Drug Facts
License data
Pregnancy
category
Routes of
administration		Inhalation[2]
ATC code
Legal status
Legal status
  • AU: S4 (Prescription only)
  • UK: POM (Prescription only)[3]
  • US: ℞-only[2]
  • EU: Rx-only[4]
  • In general: ℞ (Prescription only)
Identifiers
CAS Number
KEGG
CompTox Dashboard (EPA)
Chemical and physical data
FormulaC44H58N2O10
Molar mass774.952 g·mol−1
3D model (JSmol)
  • 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
  • InChI=1S/C25H34O6.C19H24N2O4/c1-4-5-21-30-20-11-17-16-7-6-14-10-15(27)8-9-23(14,2)22(16)18(28)12-24(17,3)25(20,31-21)19(29)13-26;1-13(9-14-3-6-16(25-2)7-4-14)20-11-19(24)15-5-8-18(23)17(10-15)21-12-22/h8-10,16-18,20-22,26,28H,4-7,11-13H2,1-3H3;3-8,10,12-13,19-20,23-24H,9,11H2,1-2H3,(H,21,22)/t16-,17-,18-,20+,21?,22+,23-,24-,25+;13-,19+/m00/s1
  • Key:PJFHZKIDENOSJB-JIVDDGRNSA-N
  (verify)

Common (≥1/100 to <1/10) side effects include candidiasis, headache, tremor, palpitations, throat irritation, coughing, and dysphonia.[6] Pneumonia is a common side effect in people with COPD, and other, less common side effects have been documented.[2][3] There were concerns that the LABA component increases the risk of death in children with asthma, however these concerns were removed in 2017.[7] Therefore, this combination is only recommended in those who are not controlled on an inhaled steroid alone.[2] There is tentative evidence that typical doses of inhaled steroids and LABAs are safe in pregnancy.[8] Both formoterol and budesonide are excreted in breast-milk.[1]

Budesonide/formoterol was approved for medical use in the United States in 2006.[2][9] It is on the World Health Organization's List of Essential Medicines.[10][11] It is available as a generic medication.[12] In 2020, it was the 61st most commonly prescribed medication in the United States, with more than 11 million prescriptions.[13][14]

Medical uses

Maintenance

Budesonide/formoterol has shown efficacy to prevent asthma attacks.[5] It is unclear if the efficacy of budesonide/formoterol differs from that of fluticasone and salmeterol in chronic asthma.[15]

Exacerbation

The combination is approved in the United States only as a maintenance medication in asthma and chronic obstructive pulmonary disease (COPD).[2] 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.[5]

Use for both maintenance and as-needed treatment is also known as single maintenance and reliever therapy (SMART) and is a well-established treatment.[16][17] 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.[16][17]

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)
  • Rash
  • Itchiness
  • Bronchospasm (tightening of the muscles in the airways causing wheezing immediately after use of the medication, which is possibly sign of an allergic reaction and should be met with immediate medical attention)
  • Hypokalemia (low levels of potassium in the blood)
  • Heart arrhythmia

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

Other

With high doses for a long period of time.

[18]

Allergic reaction
  • Angioedema (swelling of the face, mouth, tongue, and/or throat. Difficulty swallowing. Hives. Difficulty breathing. Feeling of faintness)
  • Bronchospasm (sudden acute wheezing or shortness of breath immediately after use of medication. The patient should use their reliever medication immediately.)[19]

Society and culture

It was approved for use in the United States in July 2006.[9][20]

Budesonide/formoterol was approved for use in the European Union in April 2014.[4][21]

There are several patents related to the drug; some of which have expired.[22] It was initially marketed by AstraZeneca.

References
  1. "Budesonide / formoterol (Symbicort) Use During Pregnancy". Drugs.com. 28 August 2019. Retrieved 13 April 2020.
  2. "Symbicort- budesonide and formoterol fumarate dihydrate aerosol". DailyMed. 24 July 2019. Retrieved 29 April 2020.
  3. "Symbicort Turbohaler 200/6 Inhalation powder - Summary of Product Characteristics (SmPC)". (emc). 30 August 2019. Retrieved 13 April 2020.
  4. "BiResp Spiromax EPAR". European Medicines Agency (EMA). 17 September 2018. Retrieved 29 April 2020.
  5. Jenkins CR, Bateman ED, Sears MR, O'Byrne PM (August 2020). "What have we learnt about asthma control from trials of budesonide/formoterol as maintenance and reliever?". Respirology. 25 (8): 804–815. doi:10.1111/resp.13804. PMID 32237004.
  6. "Symbicort Turbohaler 100/6 Summary of Product Characteristics". Medicines.ie. Irish Pharmaceutical Healthcare Association. 2 February 2021. Retrieved 2 July 2021.
  7. "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. Retrieved 23 December 2017.
  8. "Global Strategy for Asthma Management and Prevention" (PDF). Ginasthma.org. 2020. p. 90. Retrieved 9 May 2020. evidence for safety of usual doses of ICS and LABA
  9. "Drug Approval Package: Symbicort (budesonide/formoterol fumarate dihydrate) NDA #021929". U.S. Food and Drug Administration (FDA). 30 October 2008. Retrieved 29 April 2020.
  10. World Health Organization (2019). World Health Organization model list of essential medicines: 21st list 2019. Geneva: World Health Organization. hdl:10665/325771. WHO/MVP/EMP/IAU/2019.06. License: CC BY-NC-SA 3.0 IGO.
  11. World Health Organization (2021). World Health Organization model list of essential medicines: 22nd list (2021). Geneva: World Health Organization. hdl:10665/345533. WHO/MHP/HPS/EML/2021.02.
  12. "FDA Approves First Generic of Symbicort to Treat Asthma and COPD". U.S. Food and Drug Administration (Press release). 15 March 2022. Retrieved 15 March 2022.
  13. "The Top 300 of 2020". ClinCalc. Retrieved 7 October 2022.
  14. "Budesonide; Formoterol - Drug Usage Statistics". ClinCalc. Retrieved 7 October 2022.
  15. Lasserson TJ, Ferrara G, Casali L, et al. (Cochrane Airways Group) (December 2011). "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. doi:10.1002/14651858.CD004106.pub4. PMID 22161385.
  16. Kew KM, Karner C, Mindus SM, Ferrara G, et al. (Cochrane Airways Group) (December 2013). "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. doi:10.1002/14651858.CD009019.pub2. PMC 8949777. PMID 24343671.
  17. Sobieraj DM, Weeda ER, Nguyen E, Coleman CI, White CM, Lazarus SC, et al. (April 2018). "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. doi:10.1001/jama.2018.2769. PMC 5876810. PMID 29554195.
  18. "Symbicort Turbohaler 100/6, Inhalation powder - Patient Information Leaflet". Electronic Medicines Compendium. September 2020. Retrieved 9 September 2021.
  19. "PACKAGE LEAFLET:INFORMATION FOR THE USER Symbicort® Turbohaler® 200 micrograms/6 micrograms/inhalation, inhalation powder budesonide, formoterol fumarate dihydrate" (PDF). hpra.ie - Health Products Regulatory Authority (Irish state agency). July 2015. Archived (PDF) from the original on 9 August 2018.
  20. Haber G (19 November 2006). "AstraZeneca banking on asthma inhaler". Delaware News-Journal (delawareonline). Archived from the original on 30 September 2007. Retrieved 9 July 2020.
  21. "DuoResp Spiromax EPAR". European Medicines Agency (EMA). 17 September 2018. Retrieved 29 April 2020.
  22. "Has a generic version of Symbicort been approved?". Drugs.com.
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