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 combination is marketed under various trade names, notably by AstraZeneca under the trade names Symbicort (Symbicord in South Africa and Rilast in Spain) and Vannair, by Intas in India as 'Quikhale FB', by Macleods Pharmaceuticals in India as Vudetrol, 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 EU, Australia, Canada, Israel, Saudi Arabia and elsewhere Symbicort 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]

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.[1][2].

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.[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]

Symbicort 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 Symbicort, 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]