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{{Short description|Medication for asthma & chronic obstructive pulmonary disease}} |
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{{Drugbox |
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{{Use dmy dates|date=October 2022}} |
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| verifiedrevid = 438575038 |
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{{cs1 config |name-list-style=vanc |display-authors=6}} |
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{{Infobox drug |
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<!--Combo data--> |
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| verifiedrevid = 448962189 |
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| type = combo |
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| type = combo |
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| image = Budesonide and formoterol.svg |
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| image_class = skin-invert-image |
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| width = |
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| alt= |
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| caption= |
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<!-- Combo data --> |
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| component1 = Budesonide |
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| component1 = Budesonide |
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| class1 = ] |
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| class1 = ] |
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| component2 = Formoterol |
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| component2 = Formoterol |
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| class2 = ] |
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| class2 = ] |
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<!--Clinical data--> |
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<!-- Clinical data --> |
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| tradename = |
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| pronounce = |
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| tradename = Symbicort, others |
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| pregnancy_AU = <!-- A / B1 / B2 / B3 / C / D / X --> |
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| Drugs.com = {{drugs.com|ppa|budesonide-and-formoterol}} |
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| pregnancy_US = |
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| MedlinePlus = a623022 |
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| pregnancy_category = |
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| DailyMedID = Budesonide and formoterol |
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| legal_AU = <!-- Unscheduled / S2 / S3 / S4 / S5 / S6 / S7 / S8 / S9 --> |
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| pregnancy_AU = B3 |
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| legal_CA = <!-- / Schedule I, II, III, IV, V, VI, VII, VIII --> |
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| pregnancy_AU_comment = <ref name="Drugs.com Pregnancy">{{cite web | title=Budesonide / formoterol (Symbicort) Use During Pregnancy | website=Drugs.com | date=28 August 2019 | url=https://www.drugs.com/pregnancy/budesonide-formoterol.html | access-date=13 April 2020}}</ref> |
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| legal_UK = |
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| pregnancy_category= |
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| legal_US = |
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| routes_of_administration = ]<ref name="Symbicort FDA label" /> |
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| legal_status = |
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| ATC_prefix = R03 |
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| routes_of_administration = Inhaled |
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| ATC_suffix = AK07 |
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| ATC_supplemental = |
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<!--Identifiers--> |
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<!-- Legal status --> |
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| CAS_number = |
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| legal_AU = S4 |
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| ATC_prefix = R03 |
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| legal_AU_comment = |
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| legal_BR = <!-- OTC, A1, A2, A3, B1, B2, C1, C2, C3, C4, C5, D1, D2, E, F--> |
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| ATC_suffix = AK07 |
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| PubChem = |
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| legal_BR_comment = |
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| legal_CA = <!-- OTC, Rx-only, Schedule I, II, III, IV, V, VI, VII, VIII --> |
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| DrugBank_Ref = {{drugbankcite|correct|drugbank}} |
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| DrugBank = |
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| legal_CA_comment = |
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| legal_DE = <!-- Anlage I, II, III or Unscheduled--> |
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| legal_DE_comment = |
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| legal_NZ = <!-- Class A, B, C --> |
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| legal_NZ_comment = |
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| legal_UK = POM |
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| legal_UK_comment = <ref name="EMC symbicort">{{cite web | title=Symbicort Turbohaler 200/6 Inhalation powder - Summary of Product Characteristics (SmPC) | website=(emc) | date=30 August 2019 | url=https://www.medicines.org.uk/emc/product/1327/smpc | access-date=13 April 2020}}</ref> |
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| legal_US = Rx-only |
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| legal_US_comment = <ref name="Symbicort FDA label" /> |
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| legal_EU = Rx-only |
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| legal_EU_comment = <ref name="BiResp Spiromax EPAR" /><ref name="DuoResp Spiromax EPAR" /> |
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| legal_UN = <!-- N I, II, III, IV / P I, II, III, IV--> |
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| legal_UN_comment = |
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| legal_status = Rx-only |
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<!--Chemical data--> |
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<!-- Identifiers --> |
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| CAS_number_Ref = {{cascite|changed|??}} |
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| CAS_number = 150693-37-1 |
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| CAS_supplemental = |
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| PubChem = |
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| IUPHAR_ligand = |
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| DrugBank = |
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| ChemSpiderID = |
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| UNII = |
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| KEGG = D09595 |
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| ChEBI = |
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| ChEMBL = |
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| NIAID_ChemDB = |
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| PDB_ligand = |
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| synonyms = |
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}} |
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}} |
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<!-- Definition and medical uses --> |
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'''Budesonide/formoterol''' is a combination formulation containing ] and ] used in the management of ] and ] (COPD) in the EU. Budesonide acts reducing and preventing respiratory tract inflammation, while formoterol dilates respiratory tract.<ref>Vannair prospect. AstraZeneca. 2010</ref> |
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'''Budesonide/formoterol''', sold under the brand name '''Symbicort''' among others, is a ] medication used in the management of ] or ] (COPD).<ref name="Symbicort FDA label" /> It contains ], a ]; and ], a ] (LABA).<ref name="Symbicort FDA label" /> The product ] does not support its use for sudden worsening or treatment of active ].<ref name="Symbicort FDA label" /><!-- Quote = is NOT indicated for the relief of acute bronchospasm. --> However, a 2020 review of the literature does support such use.<ref name=Jen2020>{{cite journal | vauthors = Jenkins CR, Bateman ED, Sears MR, O'Byrne PM | title = What have we learnt about asthma control from trials of budesonide/formoterol as maintenance and reliever? | journal = Respirology | volume = 25 | issue = 8 | pages = 804–815 | date = August 2020 | pmid = 32237004 | doi = 10.1111/resp.13804 | doi-access = free }}</ref> It is used by ].<ref name="Symbicort FDA label">{{cite web | title=Symbicort- budesonide and formoterol fumarate dihydrate aerosol | website=DailyMed | date=24 July 2019 | url=https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=fafa4cf1-99c2-43d5-73ad-51f256de3be0 | access-date=29 April 2020}}</ref> |
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<!-- Side effects and mechanism --> |
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It is marketed by ] under the trade names '''Symbicort''' (although it is marketed as Symbicord in ] and Rilast in ])<ref>http://managementasthma.com/</ref> and '''Vannair'''. Symbicort in the United States is a ]{{citation needed|date=October 2008}} while in the EU, Australia, Canada, Israel, and elsewhere Symbicort is available as a ]. |
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Common (≥1/100 to <1/10) side effects include ], ], ], ], throat irritation, coughing, and ].<ref>{{cite web |url=https://www.medicines.ie/medicines/symbicort-turbohaler-100-6-33890/spc |title=Symbicort Turbohaler 100/6 Summary of Product Characteristics |author=<!--Not stated--> |date=2 February 2021 |website=Medicines.ie |publisher=Irish Pharmaceutical Healthcare Association |access-date=2 July 2021 |quote=}}</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>{{cite web|title=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|url=https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm590001.htm|website=FDA|access-date=23 December 2017}}</ref> Therefore, this combination is only recommended in those who are not controlled on an ] alone.<ref name="Symbicort FDA label" /> There is tentative evidence that typical doses of inhaled steroids and LABAs are safe in pregnancy.<ref>{{Cite web|title=Global Strategy for Asthma Management and Prevention|url=https://ginasthma.org/wp-content/uploads/2020/04/GINA-2020-full-report_-final-_wms.pdf|date=2020|website=Ginasthma.org|page=90|access-date=9 May 2020|quote=evidence for safety of usual doses of ICS and LABA}}</ref> Both formoterol and budesonide are excreted in breast-milk.<ref name="Drugs.com Pregnancy">{{cite web | title=Budesonide / formoterol (Symbicort) Use During Pregnancy | website=Drugs.com | date=28 August 2019 | url=https://www.drugs.com/pregnancy/budesonide-formoterol.html | access-date=13 April 2020}}</ref> |
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<!-- History and culture --> |
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Symbicort contains two active ingredients delivered via a single inhaler: |
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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 ].<ref name="WHO21st">{{cite book | vauthors = ((World Health Organization)) | title = World Health Organization model list of essential medicines: 21st list 2019 | year = 2019 | hdl = 10665/325771 | author-link = World Health Organization | publisher = World Health Organization | location = Geneva | id = WHO/MVP/EMP/IAU/2019.06. License: CC BY-NC-SA 3.0 IGO | hdl-access=free }}</ref><ref name="WHO22nd">{{cite book | vauthors = ((World Health Organization)) | title = World Health Organization model list of essential medicines: 22nd list (2021) | year = 2021 | hdl = 10665/345533 | author-link = World Health Organization | publisher = World Health Organization | location = Geneva | id = WHO/MHP/HPS/EML/2021.02 | hdl-access=free }}</ref> It is available as a ].<ref>{{cite press release | title=FDA Approves First Generic of Symbicort to Treat Asthma and COPD | website=U.S. Food and Drug Administration | date=15 March 2022 | url=https://www.fda.gov/news-events/press-announcements/fda-approves-first-generic-symbicort-treat-asthma-and-copd | access-date=15 March 2022}}</ref> In 2022, it was the 83rd most commonly prescribed medication in the United States, with more than 8{{nbsp}}million prescriptions.<ref>{{cite web | title=The Top 300 of 2022 | url=https://clincalc.com/DrugStats/Top300Drugs.aspx | website=ClinCalc | access-date=30 August 2024 | archive-date=30 August 2024 | archive-url=https://web.archive.org/web/20240830202410/https://clincalc.com/DrugStats/Top300Drugs.aspx | url-status=live }}</ref><ref>{{cite web | title = Budesonide; Formoterol Drug Usage Statistics, United States, 2013 - 2022 | website = ClinCalc | url = https://clincalc.com/DrugStats/Drugs/BudesonideFormoterol | access-date = 30 August 2024 }}</ref> |
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* ] (Pulmicort), an anti-inflammatory ] |
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* ] (Oxis, Foradil), a rapid-acting and long-lasting ] (]) |
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==Doses== |
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==Medical uses== |
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Budesonide/formoterol is ] 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" /> |
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] |
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In Europe, Symbicort is available in doses of 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 ]s) and the lower number the dose of formoterol. |
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===Maintenance=== |
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In March 2009, the FDA approved the use of Symbicort pMDI to treat chronic obstructive pulmonary disease ( COPD). |
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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 ] in chronic asthma.<ref>{{cite journal | vauthors = Lasserson TJ, Ferrara G, Casali L | title = Combination fluticasone and salmeterol versus fixed dose combination budesonide and formoterol for chronic asthma in adults and children | journal = The Cochrane Database of Systematic Reviews | issue = 12 | pages = CD004106 | date = December 2011 | volume = 2012 | pmid = 22161385 | doi = 10.1002/14651858.CD004106.pub4 | pmc = 11437353 | collaboration = Cochrane Airways Group }}</ref> |
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===Exacerbation=== |
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In the United States, Symbicort is available in 160/4.5mcg and 80/4.5mcg per actuation |
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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/> |
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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>{{cite journal | vauthors = Kew KM, Karner C, Mindus SM, Ferrara G | title = Combination formoterol and budesonide as maintenance and reliever therapy versus combination inhaler maintenance for chronic asthma in adults and children | journal = The Cochrane Database of Systematic Reviews | volume = 2013 | issue = 12 | pages = CD009019 | date = December 2013 | pmid = 24343671 | pmc = 8949777 | doi = 10.1002/14651858.CD009019.pub2 | collaboration = Cochrane Airways Group }}</ref><ref name=Sob2018>{{cite journal | vauthors = Sobieraj DM, Weeda ER, Nguyen E, Coleman CI, White CM, Lazarus SC, Blake KV, Lang JE, Baker WL | display-authors = 6 | title = Association of Inhaled Corticosteroids and Long-Acting β-Agonists as Controller and Quick Relief Therapy With Exacerbations and Symptom Control in Persistent Asthma: A Systematic Review and Meta-analysis | journal = JAMA | volume = 319 | issue = 14 | pages = 1485–1496 | date = April 2018 | pmid = 29554195 | pmc = 5876810 | doi = 10.1001/jama.2018.2769 }}</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 /> |
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==Use as-needed for asthma attack== |
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Symbicort is the first combination ]/] (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.,<ref>{{cite journal |
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| last = Balanag | first = VM | coauthors = Yunus F, Yang PC, Jorup C |
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| year = 2006 | month = April |
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| title = Efficacy and safety of budesonide/formoterol compared with salbutamol in the treatment of acute asthma |
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| journal = ] |
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| volume = 19 | issue = 2 | pages = 139–147 |
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| doi = 10.1016/j.pupt.2005.04.009 | pmid = 16009588 | accessdate = |
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}}</ref><ref>{{cite journal |
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| last = Vogelmeier | first = C | coauthors = D'Urzo A, Pauwels R, Merino JM, Jaspal M, Boutet S, Naya I, Price D |
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| year = 2005 | month = November |
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| title = Budesonide/formoterol maintenance and reliever therapy: an effective asthma treatment option? |
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| journal = ] |
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| volume = 26 | issue = 5 | pages = 819–828 | pmid = 16264042 |
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| doi = 10.1183/09031936.05.00028305 |
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}}</ref> although the role of budesonide in these cases is questionable{{by whom|date=January 2011}}. |
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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. |
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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.<ref>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</ref> |
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==Side-effects== |
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==Side effects== |
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===Common side-effects=== |
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===Common (up to 1 in 10 people)=== |
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*Mild ] |
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*Mild ] |
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*]ing |
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*Coughing |
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*Hoarseness |
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*] |
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*Oral ] (thrush. significantly less likely if the patient rinses their mouth out with water after inhalations) |
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*] |
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*Headache |
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*] |
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*Trembling |
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*Heartbeat acceleration |
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Often mild, and usually disappear as the medication continues to be used: |
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===Uncommon side-effects=== |
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*Difficulty to fall asleep |
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*Restlessness |
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*Nausea |
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*Muscular cramps |
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*Agitation |
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* ] |
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===Rare side-effects=== |
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* ] |
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*Rash |
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*Itchiness |
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*Respiratory spasms |
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*] |
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*Bruises |
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*Dizziness |
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===Very rare side-effects=== |
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===Uncommon (up to 1 in 100 people)=== |
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*High blood sugar level |
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*Face bloatedness |
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*Depression |
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*Behavior disorders |
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*Chest pain |
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*Feeling restlessness, nervous, or agitated |
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==Market== |
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*Disturbed sleep |
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Symbicort was introduced in ] in 2000. It was not approved for use in the United States until July 2006.<ref>{{cite news |
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*Feeling dizzy |
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| first = Gary | last = Haber | title = AstraZeneca banking on asthma inhaler |
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*] |
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| url = http://www.delawareonline.com/apps/pbcs.dll/article?AID=/20061119/BUSINESS/611190331/1003/NLETTER01 |
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*] (fast heart rate) |
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| publisher = Delaware News-Journal (delawareonline) | date = 2006-11-19 |
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*] of the skin |
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}}</ref> |
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*] |
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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. The patent expires 2012. |
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===Rare (up to 1 in 1,000 people)=== |
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==References== |
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<References/> |
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*] |
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==Notes== |
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*]iness |
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* {{cite web |
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*] (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) |
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| url = http://asthma.symbicort.com/ |
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*] (low levels of potassium in the blood) |
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| title = Symbicort (budesonide/formoterol) - Inhaled corticosteroid for maintenance treatment of asthma |
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*] |
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| accessdate = 2010-04-27 |
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| year = 2010 |
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===Very rare (up to 1 in 10,000 people)=== |
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| work = AstraZeneca Respiratory Products |
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| publisher = AstraZeneca Pharmaceuticals |
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*] |
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}} |
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*Changes in behaviour, especially in children |
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*] or tightness in chest |
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*Increase in ] |
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*Taste changes, such as an unpleasant taste in the mouth |
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*Changes in ] |
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===Other=== |
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With high doses for a long period of time. |
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* Reduced bone mineral density, causing ] |
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* ]s |
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* ] |
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* ] in children and adolescents |
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* ], which affects the production of various hormones |
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<ref>{{cite web|url=https://www.medicines.org.uk/emc/product/1326/pil|work=]|title=Symbicort Turbohaler 100/6, Inhalation powder - Patient Information Leaflet|date=September 2020|access-date=9 September 2021}}</ref> |
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=== Allergic reaction === |
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* ] (swelling of the face, mouth, tongue, and/or throat. Difficulty swallowing. Hives. Difficulty breathing. Feeling of faintness) |
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* ] (sudden acute wheezing or shortness of breath immediately after use of medication. The patient should use their reliever medication immediately.)<ref>{{Cite web|url=https://www.hpra.ie/img/uploaded/swedocuments/2164676.PPA1463_051_001.43ee9e2e-b98a-4451-891a-77d7c0b9f5be.000001Product%20Leaflet%20Approved%20(IP).150727.pdf|title=PACKAGE LEAFLET:INFORMATION FOR THE USER Symbicort® Turbohaler® 200 micrograms/6 micrograms/inhalation, inhalation powder budesonide, formoterol fumarate dihydrate|date=July 2015|website=hpra.ie - Health Products Regulatory Authority (Irish state agency)|archive-url=https://web.archive.org/web/20180809190546/https://www.hpra.ie/img/uploaded/swedocuments/2164676.PPA1463_051_001.43ee9e2e-b98a-4451-891a-77d7c0b9f5be.000001Product%20Leaflet%20Approved%20(IP).150727.pdf|archive-date=9 August 2018|url-status=live}}</ref> |
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==Society and culture== |
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===Legal status=== |
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Budesonide/formoterol was approved for use in the United States in July 2006.<ref name="Symbicort FDA label" /><ref name="FDA approval">{{cite web | title=Drug Approval Package: Symbicort (budesonide/formoterol fumarate dihydrate) NDA #021929 | website=U.S. ] (FDA) | date=30 October 2008 | url=https://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021929_symbicort_toc.cfm | access-date=29 April 2020}}</ref><ref>{{cite news | vauthors = Haber G | title = AstraZeneca banking on asthma inhaler | url = http://www.delawareonline.com/apps/pbcs.dll/article?AID=/20061119/BUSINESS/611190331/1003/NLETTER01 | publisher = Delaware News-Journal (delawareonline) | date = 19 November 2006 | access-date = 9 July 2020 | archive-url = https://web.archive.org/web/20070930171657/http://www.delawareonline.com/apps/pbcs.dll/article?AID=%2F20061119%2FBUSINESS%2F611190331%2F1003%2FNLETTER01 | archive-date = 30 September 2007 | url-status = dead }}</ref> |
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Budesonide/formoterol was approved for use in the European Union in April 2014.<ref name="BiResp Spiromax EPAR">{{cite web | title=BiResp Spiromax EPAR | website=] (EMA) | date=17 September 2018 | url=https://www.ema.europa.eu/en/medicines/human/EPAR/biresp-spiromax | access-date=29 April 2020}}</ref><ref name="DuoResp Spiromax EPAR">{{cite web | title=DuoResp Spiromax EPAR | website=] (EMA) | date=17 September 2018 | url=https://www.ema.europa.eu/en/medicines/human/EPAR/duoresp-spiromax | access-date=29 April 2020}}</ref> |
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There are several patents related to the drug; some of which have expired.<ref>{{cite web | title = Has a generic version of Symbicort been approved? | url = https://www.drugs.com/availability/generic-symbicort.html | work = Drugs.com }}</ref> It was initially marketed by ]. |
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== Brand names == |
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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" /> |
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==External links== |
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== References == |
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{{Reflist}} |
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* |
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{{Asthma and copd rx}} |
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{{Asthma and copd rx}} |
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{{AstraZeneca}} |
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{{Portal bar | Medicine}} |
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{{Authority control}} |
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{{DEFAULTSORT:Budesonide/Formoterol}} |
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{{DEFAULTSORT:Budesonide Formoterol}} |
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