Common (≥1/100 to <1/10) side effects include candidiasis, headache, tremor, palpitations, throat irritation, coughing, and dysphonia.[6] Pneumonia is a common side effect in people with COPD, and other, less common side effects have been documented.[2][3] There were concerns that the LABA component increases the risk of death in children with asthma, however these concerns were removed in 2017.[7] Therefore, this combination is only recommended in those who are not controlled on an inhaled steroid alone.[2] There is tentative evidence that typical doses of inhaled steroids and LABAs are safe in pregnancy.[8] Both formoterol and budesonide are excreted in breast-milk.[1]
Budesonide/formoterol has shown efficacy to prevent asthma attacks.[5] It is unclear if the efficacy of budesonide/formoterol differs from that of fluticasone and salmeterol in chronic asthma.[15]
Exacerbation
The combination is approved in the United States only as a maintenance medication in asthma and chronic obstructive pulmonary disease (COPD).[2] 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.[5]
Use for both maintenance and as-needed treatment is also known as single maintenance and reliever therapy (SMART) and is a well-established treatment.[16][17] 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.[16][17]
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)
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.)[19]
Society and culture
Legal status
It was approved for use in the United States in July 2006.[9][20]
Budesonide/formoterol was approved for use in the European Union in April 2014.[4][21]
There are several patents related to the drug; some of which have expired.[22] It was initially marketed by AstraZeneca.
References
^ ab"Budesonide / formoterol (Symbicort) Use During Pregnancy". Drugs.com. 28 August 2019. Retrieved 13 April 2020.
^ abcdefghij"Symbicort- budesonide and formoterol fumarate dihydrate aerosol". DailyMed. 24 July 2019. Retrieved 29 April 2020.
^ ab"Symbicort Turbohaler 200/6 Inhalation powder - Summary of Product Characteristics (SmPC)". (emc). 30 August 2019. Retrieved 13 April 2020.
^ abcJenkins, CR; Bateman, ED; Sears, MR; O'Byrne, PM (31 March 2020). "What have we learnt about asthma control from trials of budesonide/formoterol as maintenance and reliever?". Respirology. 25 (8): 804–815. doi:10.1111/resp.13804. PMID 32237004.
^"Symbicort Turbohaler 100/6 Summary of Product Characteristics". Medicines.ie. Irish Pharmaceutical Healthcare Association. 2 February 2021. Retrieved 2 July 2021.
^"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.
^"Global Strategy for Asthma Management and Prevention" (PDF). Ginasthma.org. 2020. p. 90. Retrieved 9 May 2020. evidence for safety of usual doses of ICS and LABA
^ ab"Drug Approval Package: Symbicort (budesonide/formoterol fumarate dihydrate) NDA #021929". U.S. Food and Drug Administration (FDA). 30 October 2008. Retrieved 29 April 2020.
^World Health Organization (2019). World Health Organization model list of essential medicines: 21st list 2019. Geneva: World Health Organization. hdl:10665/325771. WHO/MVP/EMP/IAU/2019.06. License: CC BY-NC-SA 3.0 IGO.
^World Health Organization (2021). World Health Organization model list of essential medicines: 22nd list (2021). Geneva: World Health Organization. hdl:10665/345533. WHO/MHP/HPS/EML/2021.02.
^"FDA Approves First Generic of Symbicort to Treat Asthma and COPD". U.S. Food and Drug Administration (Press release). 15 March 2022. Retrieved 15 March 2022.
^"The Top 300 of 2020". ClinCalc. Retrieved 7 October 2022.
^"Budesonide; Formoterol - Drug Usage Statistics". ClinCalc. Retrieved 7 October 2022.
^Lasserson, Toby J; Ferrara, Giovanni; Casali, Lucio (7 December 2011). Cochrane Airways Group (ed.). "Combination fluticasone and salmeterol versus fixed dose combination budesonide and formoterol for chronic asthma in adults and children". Cochrane Database of Systematic Reviews (12): CD004106. doi:10.1002/14651858.CD004106.pub4. PMID 22161385.
^ abKew KM, Karner C, Mindus SM, Ferrara G, et al. (Cochrane Airways Group) (December 2013). "Combination formoterol and budesonide as maintenance and reliever therapy versus combination inhaler maintenance for chronic asthma in adults and children". The Cochrane Database of Systematic Reviews. 2013 (12): CD009019. doi:10.1002/14651858.CD009019.pub2. PMC8949777. PMID 24343671.
^ abSobieraj DM, Weeda ER, Nguyen E, Coleman CI, White CM, Lazarus SC, et al. (April 2018). "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". JAMA. 319 (14): 1485–1496. doi:10.1001/jama.2018.2769. PMC5876810. PMID 29554195.
^"Symbicort Turbohaler 100/6, Inhalation powder - Patient Information Leaflet". Electronic Medicines Compendium. September 2020. Retrieved 9 September 2021.
^"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. (PDF) from the original on 9 August 2018.
^Haber G (19 November 2006). . Delaware News-Journal (delawareonline). Archived from the original on 30 September 2007. Retrieved 9 July 2020.
budesonide, formoterol, sold, under, brand, name, symbicort, among, others, fixed, dose, combination, medication, used, management, asthma, chronic, obstructive, pulmonary, disease, copd, contains, budesonide, steroid, formoterol, long, acting, agonist, laba, . 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 2 It contains budesonide a steroid and formoterol a long acting b2 agonist LABA 2 The product monograph does not support its use for sudden worsening or treatment of active bronchospasm 2 However a 2020 review of the literature does support such use 5 It is used by breathing in the medication 2 Budesonide formoterolCombination ofBudesonideGlucocorticoidsFormoterolLong acting beta adrenoceptor agonistClinical dataTrade namesSymbicort DuoResp Spiromax BiResp Spiromax othersAHFS Drugs comProfessional Drug FactsLicense dataEU EMA by INN US DailyMed Budesonide and formoterol US FDA SymbicortPregnancycategoryAU B3 1 Routes ofadministrationInhalation 2 ATC codeR03AK07 WHO Legal statusLegal statusAU S4 Prescription only UK POM Prescription only 3 US only 2 EU Rx only 4 In general Prescription only IdentifiersCAS Number150693 37 1 NKEGGD09595CompTox Dashboard EPA DTXSID80872449Chemical and physical dataFormulaC 44H 58N 2O 10Molar mass774 952 g mol 13D model JSmol Interactive imageSMILES CCCC1OC2CC3C4CCC5 CC O C CC5 C4C CC3 C2 O1 C O CO C O C CC CC1 CC C C C1 OC NCC C2 CC C C C2 O NC O OInChI InChI 1S C25H34O6 C19H24N2O4 c1 4 5 21 30 20 11 17 16 7 6 14 10 15 27 8 9 23 14 2 22 16 18 28 12 24 17 3 25 20 31 21 19 29 13 26 1 13 9 14 3 6 16 25 2 7 4 14 20 11 19 24 15 5 8 18 23 17 10 15 21 12 22 h8 10 16 18 20 22 26 28H 4 7 11 13H2 1 3H3 3 8 10 12 13 19 20 23 24H 9 11H2 1 2H3 H 21 22 t16 17 18 20 21 22 23 24 25 13 19 m00 s1Key PJFHZKIDENOSJB JIVDDGRNSA N verify Common 1 100 to lt 1 10 side effects include candidiasis headache tremor palpitations throat irritation coughing and dysphonia 6 Pneumonia is a common side effect in people with COPD and other less common side effects have been documented 2 3 There were concerns that the LABA component increases the risk of death in children with asthma however these concerns were removed in 2017 7 Therefore this combination is only recommended in those who are not controlled on an inhaled steroid alone 2 There is tentative evidence that typical doses of inhaled steroids and LABAs are safe in pregnancy 8 Both formoterol and budesonide are excreted in breast milk 1 Budesonide formoterol was approved for medical use in the United States in 2006 2 9 It is on the World Health Organization s List of Essential Medicines 10 11 It is available as a generic medication 12 In 2020 it was the 61st most commonly prescribed medication in the United States with more than 11 million prescriptions 13 14 Contents 1 Medical uses 1 1 Maintenance 1 2 Exacerbation 2 Side effects 2 1 Common up to 1 in 10 people 2 2 Uncommon up to 1 in 100 people 2 3 Rare up to 1 in 1 000 people 2 4 Very rare up to 1 in 10 000 people 2 5 Other 2 6 Allergic reaction 3 Society and culture 3 1 Legal status 4 References 5 External linksMedical uses EditMaintenance Edit Budesonide formoterol has shown efficacy to prevent asthma attacks 5 It is unclear if the efficacy of budesonide formoterol differs from that of fluticasone and salmeterol in chronic asthma 15 Exacerbation Edit The combination is approved in the United States only as a maintenance medication in asthma and chronic obstructive pulmonary disease COPD 2 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 5 Use for both maintenance and as needed treatment is also known as single maintenance and reliever therapy SMART and is a well established treatment 16 17 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 16 17 Side effects EditCommon up to 1 in 10 people Edit Mild throat irritation Coughing Hoarseness Oral candidiasis thrush significantly less likely if the patient rinses their mouth out with water after inhalations HeadacheOften mild and usually disappear as the medication continues to be used Heart palpitations TremblingUncommon up to 1 in 100 people Edit Feeling restlessness nervous or agitated Disturbed sleep Feeling dizzy Nausea Tachycardia fast heart rate Bruising of the skin Muscle crampsRare up to 1 in 1 000 people Edit 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 arrhythmiaVery rare up to 1 in 10 000 people Edit Depression Changes in behaviour especially in children Chest pain or tightness in chest Increase in blood glucose levels Taste changes such as an unpleasant taste in the mouth Changes in blood pressureOther Edit With high doses for a long period of time Reduced bone mineral density causing osteoporosis Cataracts Glaucoma Slowed rate of growth in children and adolescents Dysfunction of the adrenal gland which affects the production of various hormones 18 Allergic reaction Edit 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 19 Society and culture EditLegal status Edit It was approved for use in the United States in July 2006 9 20 Budesonide formoterol was approved for use in the European Union in April 2014 4 21 There are several patents related to the drug some of which have expired 22 It was initially marketed by AstraZeneca References Edit a b Budesonide formoterol Symbicort Use During Pregnancy Drugs com 28 August 2019 Retrieved 13 April 2020 a b c d e f g h i j Symbicort budesonide and formoterol fumarate dihydrate aerosol DailyMed 24 July 2019 Retrieved 29 April 2020 a b Symbicort Turbohaler 200 6 Inhalation powder Summary of Product Characteristics SmPC emc 30 August 2019 Retrieved 13 April 2020 a b BiResp Spiromax EPAR European Medicines Agency EMA Retrieved 29 April 2020 a b c Jenkins CR Bateman ED Sears MR O Byrne PM 31 March 2020 What have we learnt about asthma control from trials of budesonide formoterol as maintenance and reliever Respirology 25 8 804 815 doi 10 1111 resp 13804 PMID 32237004 Symbicort Turbohaler 100 6 Summary of Product Characteristics Medicines ie Irish Pharmaceutical Healthcare Association 2 February 2021 Retrieved 2 July 2021 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 Global Strategy for Asthma Management and Prevention PDF Ginasthma org 2020 p 90 Retrieved 9 May 2020 evidence for safety of usual doses of ICS and LABA a b Drug Approval Package Symbicort budesonide formoterol fumarate dihydrate NDA 021929 U S Food and Drug Administration FDA 30 October 2008 Retrieved 29 April 2020 World Health Organization 2019 World Health Organization model list of essential medicines 21st list 2019 Geneva World Health Organization hdl 10665 325771 WHO MVP EMP IAU 2019 06 License CC BY NC SA 3 0 IGO World Health Organization 2021 World Health Organization model list of essential medicines 22nd list 2021 Geneva World Health Organization hdl 10665 345533 WHO MHP HPS EML 2021 02 FDA Approves First Generic of Symbicort to Treat Asthma and COPD U S Food and Drug Administration Press release 15 March 2022 Retrieved 15 March 2022 The Top 300 of 2020 ClinCalc Retrieved 7 October 2022 Budesonide Formoterol Drug Usage Statistics ClinCalc Retrieved 7 October 2022 Lasserson Toby J Ferrara Giovanni Casali Lucio 7 December 2011 Cochrane Airways Group ed Combination fluticasone and salmeterol versus fixed dose combination budesonide and formoterol for chronic asthma in adults and children Cochrane Database of Systematic Reviews 12 CD004106 doi 10 1002 14651858 CD004106 pub4 PMID 22161385 a b Kew KM Karner C Mindus SM Ferrara G et al Cochrane Airways Group December 2013 Combination formoterol and budesonide as maintenance and reliever therapy versus combination inhaler maintenance for chronic asthma in adults and children The Cochrane Database of Systematic Reviews 2013 12 CD009019 doi 10 1002 14651858 CD009019 pub2 PMC 8949777 PMID 24343671 a b Sobieraj DM Weeda ER Nguyen E Coleman CI White CM Lazarus SC et al April 2018 Association of Inhaled Corticosteroids and Long Acting b Agonists as Controller and Quick Relief Therapy With Exacerbations and Symptom Control in Persistent Asthma A Systematic Review and Meta analysis JAMA 319 14 1485 1496 doi 10 1001 jama 2018 2769 PMC 5876810 PMID 29554195 Symbicort Turbohaler 100 6 Inhalation powder Patient Information Leaflet Electronic Medicines Compendium September 2020 Retrieved 9 September 2021 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 Haber G 19 November 2006 AstraZeneca banking on asthma inhaler Delaware News Journal delawareonline Archived from the original on 30 September 2007 Retrieved 9 July 2020 DuoResp Spiromax EPAR European Medicines Agency EMA Retrieved 29 April 2020 Has a generic version of Symbicort been approved Drugs com External links Edit Budesonide mixture with formoterol Drug Information Portal U S National Library of Medicine Budesonide Oral Inhalation MedlinePlus Formoterol Oral Inhalation MedlinePlus Portal Medicine Retrieved from https en wikipedia org w index php title Budesonide formoterol amp oldid 1142897238, wikipedia, wiki, book, books, library,
