Budesonide/formoterol

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Budesonide/formoterol
Budesonide and formoterol.svg
Combination of
Budesonide Glucocorticoid
Formoterol Long-acting beta-adrenoceptor agonist
Clinical data
License data
Pregnancy
category
  • US: C (Risk not ruled out)
Routes of
administration
Inhaled[1]
ATC code
Legal status
Legal status
  (verify)

Budesonide/formoterol, sold under the brand name Symbicort among others, is a combination medication used in the management of asthma or chronic obstructive pulmonary disease (COPD).[1] It contains budesonide, a steroid and formoterol, a long-acting β2-agonist (LABA).[1] It is not recommended for sudden worsening or treatment of active bronchospasm.[1] It is used by breathing in the medication.[1]

Common side effects include throat pain, influenza, runny nose, and a yeast infection of the mouth.[1] There were concerns that the LABA component increases the risk of death in children with asthma, however these concerns were removed in 2017.[2] Therefore, this combination is only recommended in those who are not controlled on an inhaled steroid alone.[1] It is unclear if use in pregnancy is safe.[1]

Budesonide/formoterol was approved for medical use in the United States in 2006.[1] It is on the World Health Organization's List of Essential Medicines, the most effective and safe medicines needed in a health system.[3] In the United States, as of 2017, the wholesale cost of an inhaler is about 30 USD.[4] In the United Kingdom the cost as of 2015 was about 35 pounds for a unit with 120 doses.[5]

Medical uses[edit]

Budesonide/formoterol is a combination inhaled corticosteroid/long-acting beta agonist (ICS/LABA) that has shown some efficacy to prevent asthma attacks.[6]

In people with asthma, budesonide/formoterol formulation for both maintenance and as-needed treatment reduces exacerbations better than as-needed formoterol or as-needed terbutaline. Nevertheless, it is unclear as to whether this strategy is better than increasing a maintenance dose of Symbicort or similar combined inhaler.[7]

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

Doses[edit]

Unopened Symbicort Turbuhaler (left) and opened (middle and right)

Symbicort in the United States is a metered-dose inhaler and is available in 160/4.5mcg and 80/4.5mcg per actuation.

In the European Union, Australia, Canada, Israel, Saudi Arabia and elsewhere the combination is available as a dry powder inhaler in the following doses: 100/6 (80/4.5), 200/6 (160/4.5) and 400/12 (320/9), where the larger number is the dose per actuation of budesonide (in micrograms) and the lower number the dose of formoterol (also in micrograms).

Side effects[edit]

Common[edit]

Uncommon side-effects[edit]

Rare[edit]

  • Rash
  • Itchiness
  • Respiratory spasms
  • Palpitation
  • Bruises
  • Dizziness

Very rare[edit]

Market[edit]

Budesonide/formoterol formulation was introduced in Sweden in 2000. It was approved for use in the United States in July 2006.[8] It is now approved for use in at least 70 countries, yielding global sales in excess of $1 billion in 2005, and now approximately $3.7 billion per annum.

There are several patents related to the drug; some of them are already expired.[9] It was initially marketed by AstraZeneca.

References[edit]

  1. ^ a b c d e f g h i "Symbicort - FDA prescribing information, side effects and uses". Drugs.com. September 2017. Retrieved 13 December 2017. 
  2. ^ "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. 
  3. ^ "WHO Model List of Essential Medicines (20th List)" (PDF). World Health Organization. March 2017. Retrieved 29 June 2017. 
  4. ^ "NADAC as of 2017-12-13". Centers for Medicare and Medicaid Services. Retrieved 13 December 2017. 
  5. ^ British national formulary : BNF 69 (69 ed.). British Medical Association. 2015. p. 202. ISBN 9780857111562. 
  6. ^ Vogelmeier, C; D'Urzo A; Pauwels R; Merino JM; Jaspal M; Boutet S; Naya I; Price D (November 2005). "Budesonide/formoterol maintenance and reliever therapy: an effective asthma treatment option?". European Respiratory Journal. 26 (5): 819–828. doi:10.1183/09031936.05.00028305. PMID 16264042. 
  7. ^ Klaus F. Rabe et al., Effect of budesonide in combination with formoterol for reliever therapy in asthma exacerbations: a randomised controlled, double-blind study, The Lancet,2006,368, 744-753
  8. ^ Haber, Gary (2006-11-19). "AstraZeneca banking on asthma inhaler". Delaware News-Journal (delawareonline). 
  9. ^ https://www.drugs.com/availability/generic-symbicort.html

External links[edit]