Budesonide/formoterol

Budesonide/formoterol

Budesonide/formoterol
Combination of
Budesonide Glucocorticoid
Formoterol Long-acting beta-adrenoceptor agonist
Clinical data
Pregnancy
category
  • US: C (Risk not ruled out)
Legal status
Routes of
administration
Inhaled
Identifiers
CAS Registry Number  Y
ATC code R03
 Y   

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.

Contents

  • Doses 1
  • Use as-needed for asthma attack 2
  • Side-effects 3
    • Common side-effects 3.1
    • Uncommon side-effects 3.2
    • Rare side-effects 3.3
    • Very rare side-effects 3.4
  • Market 4
  • References 5
  • Notes 6
  • External links 7

Doses

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

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

Common side-effects

Uncommon side-effects

Rare side-effects

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

Very rare side-effects

Market

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

  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".  
  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?".  
  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

  • "Symbicort (budesonide/formoterol) - Inhaled corticosteroid for maintenance treatment of asthma". AstraZeneca Respiratory Products. AstraZeneca Pharmaceuticals. 2010. Retrieved 2010-04-27. 

External links

  • Symbicort official website
  • Symbicort official US website