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	US: ℞-only
Routes of administration	Inhaled
Identifiers
ATC code	R03AK07 (WHO)
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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

File:Symbicort.jpg

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.

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.

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

• Difficulty falling asleep
• 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. 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.

External links

• Symbicort official website
• Symbicort official US website