|Formoterol||Long-acting beta-adrenoceptor agonist|
|Pregnancy cat.||C (US)|
|Legal status||℞-only (US)|
| (what is this?)
Budesonide/formoterol is a combination formulation containing budesonide and formoterol used in the management of asthma and chronic obstructive pulmonary disease (COPD) in the EU. Budesonide acts by reducing and preventing respiratory tract inflammation, while formoterol dilates the respiratory tract. Budesonide is an inhaled corticosteroid and thus functions as an anti-inflammatory agent. Formoterol works as a long acting beta 2 agonist resulting in bronchodilation.
It is marketed by AstraZeneca under the trade names Symbicort (although it is marketed as Symbicord in South Africa and Rilast in Spain) and Vannair. Symbicort in the United States is a metered-dose inhaler while in the EU, Australia, Canada, Israel, Saudi Arabia and elsewhere Symbicort is available as a dry powder inhaler.In India it is marketed by Intas under the trade name 'Quikhale FB'
Symbicort contains two active ingredients delivered via a single inhaler:
- budesonide (Pulmicort), an anti-inflammatory corticosteroid
- formoterol (Oxis, Foradil), a rapid-acting and long-lasting β2-agonist bronchodilator
In Europe, Symbicort is available in doses of 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).
In March 2009, the FDA approved the use of Symbicort pMDI to treat chronic obstructive pulmonary disease ( COPD).
In the United States, Symbicort is available in 160/4.5mcg and 80/4.5mcg per actuation in India it is also marketed by MACLEODS PHARMACEUTICALS with trade name BUDETROL.
Use as-needed for asthma attack
Symbicort 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., although the role of budesonide in these cases is questionable[by whom?]. 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 patients with asthma, Symbicort 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.
- Mild throat irritation
- Heartbeat acceleration
- thrush (infection)
- Difficulty falling asleep
- Muscular cramps
- Respiratory spasms
Very rare side-effects
- High blood sugar level
- Face bloatedness
- Chest pain
- Steroid psychosis
Symbicort was introduced in Sweden in 2000. It was not approved for use in the United States until July 2006. 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 Symbicort, some of them are already expired.
- 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.
- 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.
- 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
- Haber, Gary (2006-11-19). "AstraZeneca banking on asthma inhaler". Delaware News-Journal (delawareonline).
- "Symbicort (budesonide/formoterol) - Inhaled corticosteroid for maintenance treatment of asthma". AstraZeneca Respiratory Products. AstraZeneca Pharmaceuticals. 2010. Retrieved 2010-04-27.