Budesonide/formoterol

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Budesonide/formoterol, sold under the brand name Symbicort among others, is a fixed-dose combination medication used in the management of asthma or chronic obstructive pulmonary disease (COPD).<ref name="Symbicort FDA label" /> It contains budesonide, a steroid; and formoterol, a long-acting β2-agonist (LABA).<ref name="Symbicort FDA label" /> The product monograph does not support its use for sudden worsening or treatment of active bronchospasm.<ref name="Symbicort FDA label" /> However, a 2020 review of the literature does support such use.<ref name=Jen2020>Template:Cite journal</ref> It is used by breathing in the medication.<ref name="Symbicort FDA label">{{#invoke:citation/CS1|citation |CitationClass=web }}</ref>

Common (≥1/100 to <1/10) side effects include candidiasis, headache, tremor, palpitations, throat irritation, coughing, and dysphonia.<ref>{{#invoke:citation/CS1|citation |CitationClass=web }}</ref> Pneumonia is a common side effect in people with COPD, and other, less common side effects have been documented.<ref name="Symbicort FDA label" /><ref name="EMC symbicort"/> There were concerns that the LABA component increases the risk of death in children with asthma, however these concerns were removed in 2017.<ref name=FDA2017Dec>{{#invoke:citation/CS1|citation |CitationClass=web }}Template:Dead linkTemplate:Cbignore</ref> Therefore, this combination is only recommended in those who are not controlled on an inhaled steroid alone.<ref name="Symbicort FDA label" /> There is tentative evidence that typical doses of inhaled steroids and LABAs are safe in pregnancy.<ref>{{#invoke:citation/CS1|citation |CitationClass=web }}</ref> Both formoterol and budesonide are excreted in breast-milk.<ref name="Drugs.com Pregnancy">{{#invoke:citation/CS1|citation |CitationClass=web }}</ref>

Budesonide/formoterol was approved for medical use in the United States in 2006.<ref name="Symbicort FDA label" /><ref name="FDA approval" /> It is on the World Health Organization's List of Essential Medicines.<ref name="WHO21st">Template:Cite book</ref><ref name="WHO22nd">Template:Cite book</ref> It is available as a generic medication.<ref>Template:Cite press release</ref> In 2023, it was the 74th most commonly prescribed medication in the United States, with more than 9Template:Nbspmillion prescriptions.<ref name="Top300Drugs">{{#invoke:citation/CS1|citation |CitationClass=web }}</ref><ref>{{#invoke:citation/CS1|citation |CitationClass=web }}</ref>

Medical uses

Budesonide/formoterol is indicated for the treatment of asthma and for the maintenance treatment of airflow obstruction and reducing exacerbations in people with chronic obstructive pulmonary disease.<ref name="Symbicort FDA label" /><ref name="BiResp Spiromax EPAR" /><ref name="DuoResp Spiromax EPAR" />

Maintenance

Budesonide/formoterol has shown efficacy to prevent asthma attacks.<ref name="Jen2020"/> It is unclear if the efficacy of budesonide/formoterol differs from that of fluticasone and salmeterol in chronic asthma.<ref>Template:Cite journal</ref>

Exacerbation

The combination is approved in the United States only as a maintenance medication in asthma and chronic obstructive pulmonary disease (COPD).<ref name="Symbicort FDA label" /> However, a 2020 review of the literature does support use as needed during acute worsening in those with mild disease, and as maintenance followed by extra doses during worsening.<ref name=Jen2020/>

Use for both maintenance and as-needed treatment is also known as single maintenance and reliever therapy (SMART) and is a well-established treatment.<ref name=Kew2013>Template:Cite journal</ref><ref name=Sob2018>Template:Cite journal</ref> It has been shown to, 1) reduce asthma exacerbations that require oral corticosteroids, 2) reduce hospital visits better than maintenance on inhaled corticosteroids alone at a higher dose, or 3) inhaled corticosteroid at the same or higher dose together with a long-acting bronchodilator (LABA), with a short-acting bronchodilator (SABA) as a reliever.<ref name=Kew2013 /><ref name=Sob2018 />

Side effects

Common (up to 1 in 10 people)

Often mild, and usually disappear as the medication continues to be used:

Uncommon (up to 1 in 100 people)

Rare (up to 1 in 1,000 people)

  • Rash
  • Itchiness
  • Bronchospasm (tightening of the muscles in the airways causing wheezing immediately after use of the medication, which is possibly sign of an allergic reaction and should be met with immediate medical attention)
  • Hypokalemia (low levels of potassium in the blood)
  • Heart arrhythmia

Very rare (up to 1 in 10,000 people)

Other

With high doses for a long period of time.

<ref>{{#invoke:citation/CS1|citation |CitationClass=web }}</ref>

Allergic reaction

  • Angioedema (swelling of the face, mouth, tongue, and/or throat. Difficulty swallowing. Hives. Difficulty breathing. Feeling of faintness)
  • Bronchospasm (sudden acute wheezing or shortness of breath immediately after use of medication. The patient should use their reliever medication immediately.)<ref>{{#invoke:citation/CS1|citation

|CitationClass=web }}</ref>

Society and culture

Budesonide/formoterol was approved for use in the United States in July 2006.<ref name="Symbicort FDA label" /><ref name="FDA approval">{{#invoke:citation/CS1|citation |CitationClass=web }}</ref><ref>Template:Cite news</ref>

Budesonide/formoterol was approved for use in the European Union in April 2014.<ref name="BiResp Spiromax EPAR">{{#invoke:citation/CS1|citation |CitationClass=web }}</ref><ref name="DuoResp Spiromax EPAR">{{#invoke:citation/CS1|citation |CitationClass=web }}</ref>

There are several patents related to the drug; some of which have expired.<ref>{{#invoke:citation/CS1|citation |CitationClass=web }}</ref> It was initially marketed by AstraZeneca.

Brand names

It is sold under various brand names including Symbicort,<ref name="Symbicort FDA label" /> BiResp Spiromax,<ref name="BiResp Spiromax EPAR" /> and DuoResp Spiromax.<ref name="DuoResp Spiromax EPAR" />

References

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