Budesonide/formoterol

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

Budesonide/formoterol, sold under the brand name Symbicort among others, is a combination medication containing budesonide and formoterol used in the management of asthma and chronic obstructive pulmonary disease (COPD). It contains two active ingredients delivered via a single inhaler:

It was initially marketed by AstraZeneca. It is on the World Health Organization's List of Essential Medicines, the most effective and safe medicines needed in a health system.[1]

Medical uses[edit]

Budesonide/formoterol is the first combination inhaled corticosteroid/long-acting beta agonist (ICS/LABA) that has shown some efficacy as a medicine not only used to prevent asthma attacks, but also provide quick relief of an asthma attack.[2][3]

In patients 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.[4]

The use for quick relief has been approved by the GINA guidelines 2006 (Evidence A), however Symbicort is indicated in the United States only as a maintenance medication. In March 2009, the FDA approved the use of Symbicort pMDI to treat 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.[5] 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.[6]

References[edit]

  1. ^ "WHO Model List of Essential Medicines (20th List)" (PDF). World Health Organization. March 2017. Retrieved 29 June 2017. 
  2. ^ Balanag, VM; Yunus F; Yang PC; Jorup C (April 2006). "Efficacy and safety of budesonide/formoterol compared with salbutamol in the treatment of acute asthma". Pulmonary Pharmacology & Therapeutics. 19 (2): 139–147. PMID 16009588. doi:10.1016/j.pupt.2005.04.009. 
  3. ^ 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. PMID 16264042. doi:10.1183/09031936.05.00028305. 
  4. ^ 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
  5. ^ Haber, Gary (2006-11-19). "AstraZeneca banking on asthma inhaler". Delaware News-Journal (delawareonline). 
  6. ^ http://www.drugs.com/availability/generic-symbicort.html

External links[edit]