Budesonide/formoterol

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Budesonide/formoterol
Combination of
Budesonide Glucocorticoid
Formoterol Long-acting beta-adrenoceptor agonist
Clinical data
Pregnancy cat.
Legal status
Routes Inhaled
Identifiers
CAS number  YesY
ATC code R03AK07
 YesY (what is this?)  (verify)

Budesonide/formoterol is a combination formulation 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:

The formulation is marketed under various trade names, notably by AstraZeneca under the trade name Symbicort and others.

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: 80/4.5, 100/6, 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).

Use as-needed for asthma attack[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.[1][2]

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.[3]

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).

Side-effects[edit]

Common side-effects[edit]

Uncommon side-effects[edit]

  • Difficulty falling asleep
  • Restlessness
  • Nausea
  • Muscular cramps
  • Agitation

Rare side-effects[edit]

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

Very rare side-effects[edit]

  • High blood sugar level
  • Face bloatedness
  • Chest pain
  • Steroid psychosis

Market[edit]

Budesonide/formoterol formulation was introduced in Sweden in 2000. It was not approved for use in the United States until July 2006.[4] It is now approved for use in at least 70 countries, yielding global sales in excess of $1 billion in 2005, and now approx $3.7 billion per annum.

There are several patents related to the drug, some of them are already expired.[5]

References[edit]

  1. ^ 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. doi:10.1016/j.pupt.2005.04.009. PMID 16009588. 
  2. ^ 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. 
  3. ^ 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
  4. ^ Haber, Gary (2006-11-19). "AstraZeneca banking on asthma inhaler". Delaware News-Journal (delawareonline). 
  5. ^ http://www.drugs.com/availability/generic-symbicort.html

Notes[edit]

External links[edit]