Budesonide/formoterol
![]() | |
Combination of | |
---|---|
Budesonide | Glucocorticoid |
Formoterol | Long-acting beta-adrenoceptor agonist |
Clinical data | |
Pregnancy category |
|
Routes of administration | Inhaled |
ATC code | R03AK07 (WHO) |
Legal status | |
Legal status |
|
Identifiers | |
(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:
- budesonide, an anti-inflammatory corticosteroid which acts by reducing and preventing respiratory tract inflammation
- formoterol, a rapid-acting and long-lasting β2-agonist which acts by causing bronchodilation
The formulation is marketed under various trade names, notably by AstraZeneca under the trade name Symbicort and others.
Doses
![](../I/m/Symbicort.jpg)
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).
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
- Mild throat irritation
- Coughing
- Hoarseness
- Aphthae
- Headache
- Trembling
- Heartbeat acceleration
- Insomnia
- Oral candidiasis
Uncommon side-effects
- Restlessness
- Nausea
- Muscular cramps
- Agitation
Rare side-effects
- Rash
- Itchiness
- Respiratory spasms
- Palpitation
- Bruises
- Dizziness
Very rare side-effects
- High blood sugar level
- Face bloatedness
- Chest pain
- Steroid psychosis
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 approximately $3.7 billion per annum.
There are several patents related to the drug; some of them are already expired.[5]
References
- ↑ 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).
- ↑ 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.