Budesonide/formoterol

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Budesonide/formoterol
Budesonide and formoterol.svg
Combination of
Budesonide Glucocorticoid
Formoterol Long-acting beta-adrenoceptor agonist
Clinical data
License data
  • EU EMAby INN
Pregnancy
category
  • US: C (Risk not ruled out)
Routes of
administration
Inhaled[1]
ATC code
Legal status
Legal status
  (verify)

Budesonide/formoterol, sold under the brand name Symbicort among others, is a combination medication used in the management of asthma or chronic obstructive pulmonary disease (COPD).[1] It contains budesonide, a steroid and formoterol, a long-acting β2-agonist (LABA).[1] It is not recommended for sudden worsening or treatment of active bronchospasm.[1] It is used by breathing in the medication.[1]

Common side effects include throat pain, influenza, runny nose, and a yeast infection of the mouth.[1] There were concerns that the LABA component increases the risk of death in children with asthma, however these concerns were removed in 2017.[2] Therefore, this combination is only recommended in those who are not controlled on an inhaled steroid alone.[1] It is unclear if use of the combination is safe in pregnancy.[1] Both formoterol and budesonide are excreted in breast-milk.[3][4]

Budesonide/formoterol was approved for medical use in the United States in 2006.[1] It is on the World Health Organization's List of Essential Medicines, the most effective and safe medicines needed in a health system.[5] In the United States, as of 2017, the wholesale cost of an inhaler is about 30 USD.[6] In the United Kingdom the cost as of 2015 was about 35 pounds for a unit with 120 doses.[7]

Medical uses

Budesonide/formoterol is a combination inhaled corticosteroid/long-acting beta agonist (ICS/LABA) that has shown some efficacy to prevent asthma attacks.[8]

In people 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.[9]

The combination is approved in the United States only as a maintenance medication in asthma and chronic obstructive pulmonary disease ( COPD).

Doses

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: 50/3 (40/2.25), 100/3 (80/2.25), 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).

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.

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.)[10]

Market

Budesonide/formoterol formulation was introduced in Sweden in 2000. It was approved for use in the United States in July 2006.[11] 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.[12] It was initially marketed by AstraZeneca.

References

  1. ^ a b c d e f g h i "Symbicort - FDA prescribing information, side effects and uses". Drugs.com. September 2017. Retrieved 13 December 2017.
  2. ^ "Safety Alerts for Human Medical Products - Long-Acting Beta agonists (LABAs) and Inhaled Corticosteroids (ICS): Drug Safety Communication - Boxed Warning About Asthma-Related Death Removed". FDA. Retrieved 23 December 2017.
  3. ^ "Budesonide Use During Pregnancy | Drugs.com". Drugs.com. Retrieved 2018-08-09.
  4. ^ "Formoterol Use During Pregnancy | Drugs.com". Drugs.com. Retrieved 2018-08-09.
  5. ^ "WHO Model List of Essential Medicines (20th List)" (PDF). World Health Organization. March 2017. Retrieved 29 June 2017.
  6. ^ "NADAC as of 2017-12-13". Centers for Medicare and Medicaid Services. Retrieved 13 December 2017.
  7. ^ British national formulary : BNF 69 (69 ed.). British Medical Association. 2015. p. 202. ISBN 9780857111562.
  8. ^ 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&ndash, 828. doi:10.1183/09031936.05.00028305. PMID 16264042.
  9. ^ 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
  10. ^ "PACKAGE LEAFLET:INFORMATION FOR THE USER Symbicort® Turbohaler® 200 micrograms/6 micrograms/inhalation, inhalation powder budesonide, formoterol fumarate dihydrate" (PDF). hpra.ie - Health Products Regulatory Authority (Irish state agency). July 2015. Archived (PDF) from the original on 9 August 2018.
  11. ^ Haber, Gary (2006-11-19). "AstraZeneca banking on asthma inhaler". Delaware News-Journal (delawareonline).
  12. ^ https://www.drugs.com/availability/generic-symbicort.html

External links

  • FDA Highlights
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