Mometasone/formoterol: Difference between revisions

{{Short description|Combination drug}}

{{Use dmy dates|date=March 2024}}

| Verifiedfields = changed

| Watchedfields = changed

| verifiedrevid = 445543421

| image = Mometasone furoate and formoterol.svg

| width = 275

| type = combo

| component1 = Mometasone furoate

| class1 = [[Corticosteroid]]

| component2 = Formoterol fumarate

| class2 = [[Long-acting beta-adrenoceptor agonist|Long-acting β₂ adrenoreceptor agonist]] (LABA)

| tradename = Zenhale, Dulera, others

| Drugs.com = {{drugs.com|ppa|mometasone-and-formoterol}}

| DailyMedID = Dulera

| pregnancy_category =

| routes_of_administration = Inhalation ([[Metered-dose inhaler]] MDI)

| ATC_prefix = R03

| ATC_suffix = AK09

<!--Identifiers-->

| CAS_number_Ref =

| CAS_number = 1609016-84-3

| CAS_supplemental =

| KEGG_Ref = {{keggcite|changed|kegg}}

| KEGG = D10295

<!-- Definition and medical use -->

'''Mometasone/formoterol''', sold under the brand name '''Dulera''' among others, is a [[fixed-dose combination]] medication used in the long-term treatment of [[asthma]].<ref name="Dulera FDA label"/> It contains [[mometasone]] a [[corticosteroid|steroid]] and [[formoterol]] a [[long-acting beta agonist]].<ref name="Dulera FDA label"/> It is only recommended in those for whom an inhaled steroid is not sufficient.<ref name="Dulera FDA label"/> It is used by [[inhalation]].<ref name="Dulera FDA label"/>

<!-- Side effects and mechanism -->

Common side effect include headache and [[sinusitis]].<ref name="Dulera FDA label">{{cite web | title=Dulera- mometasone furoate and formoterol fumarate dihydrate aerosol | website=DailyMed | date=12 August 2019 | url=https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=116464ce-cfd8-4b9f-8b5a-3a114b6ff2b1 | access-date=29 April 2020}}</ref> More serious side effects may include [[Oral candidiasis|thrush]], [[immunosuppression]], [[allergic reactions]], and [[cataracts]].<ref name="Dulera FDA label"/> Use is not recommended in those less than twelve years of age.<ref name="Dulera FDA label"/> It has not been studied during [[pregnancy]] or [[breastfeeding]].<ref name="Dulera FDA label"/> Mometasone works by decreasing inflammation while formoterol works by relaxing smooth muscle in the airways.<ref name="Dulera FDA label"/>

<!-- History and culture -->

The combination was approved for medical use in the United States in 2010.<ref name="Dulera FDA label"/> No [[generic medication|generic version]] is available {{as of|2019|lc=yes}}. In 2021, it was the 215th most commonly prescribed medication in the United States, with more than 1{{nbsp}}million prescriptions.<ref>{{cite web | title=The Top 300 of 2021 | url=https://clincalc.com/DrugStats/Top300Drugs.aspx | website=ClinCalc | access-date=14 January 2024 | archive-date=15 January 2024 | archive-url=https://web.archive.org/web/20240115223848/https://clincalc.com/DrugStats/Top300Drugs.aspx | url-status=live }}</ref><ref>{{cite web | title = Formoterol; Mometasone - Drug Usage Statistics | website = ClinCalc | url = https://clincalc.com/DrugStats/Drugs/FormoterolMometasone | access-date = 14 January 2024}}</ref> It is on the [[WHO Model List of Essential Medicines|World Health Organization's List of Essential Medicines]].<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>

==Medical use==

It is used in the long-term treatment of [[asthma]].<ref name="Dulera FDA label"/>

It is not for the treatment of acute [[bronchospasm]].<ref name="medscape">{{cite web| vauthors = Waknine Y |title=FDA Approves Mometasone-Formoterol Combo for Asthma|url=http://www.medscape.com/viewarticle/724189|work=Medscape Today FDA Approvals|publisher=Medscape|accessdate=16 August 2011}}</ref> To relieve acute symptoms, a rapid-onset short-duration inhaled bronchodilator (such as [[salbutamol]]) should be available.<ref name="monograph">{{cite web|title=Zenhale product monograph|url=http://www.merck.ca/assets/en/pdf/products/ci/Zenhale-CI_E.pdf|publisher=Merck Canada|accessdate=16 August 2011}}</ref>

== Warnings and precautions ==

[[Long-acting beta-adrenoceptor agonist|Long-acting β adrenoreceptor agonist]]s (LABAs) are subject to a [[boxed warning]] against the possibility of an increased risk of asthma-related death.<ref name=monograph /> [[Formoterol]] belongs to the LABA class of drugs. As there does not exist at the time of the monograph's publication adequate research to determine whether the rate of asthma-related death is increased with formoterol, it is therefore recommended by the FDA that LABAs only be used for patients not adequately controlled on other asthma controlling medications or whose disease severity clearly warrants initiation of dual therapy.<ref name="black box">{{cite web| vauthors = Donohue JF |title=Asthma Medications: Black Box Warnings -- Where Do We Go From Here?|url=http://www.medscape.org/viewarticle/555291|publisher=Medscape|accessdate=16 August 2011}}</ref>

== Side effects ==

The most commonly reported side effects were: oral [[Candidiasis|thrush]], [[nausea]], [[headache]], and pain in the [[pharynx]] or [[larynx]]. More rarely reported side effects (occurring in <1% of patients during the clinical trial) include: [[tachycardia]], [[palpitations]], [[Xerostomia|dry mouth]], [[Allergy|allergic reaction]] ([[bronchospasm]], [[dermatitis]], [[Urticaria|hives]]), [[pharyngitis]], [[Spasm|muscle spasms]], [[tremor]], [[dizziness]], [[insomnia]], [[Anxiety|nervousness]], and [[hypertension]]. Patients experiencing an allergic reaction or increase in difficulty breathing while using this medication should immediately discontinue its use and contact their physician.<ref name="pt info">{{cite web|title=Zenhale Patient Information|url=http://www.merck.ca/assets/en/pdf/products/ci/Zenhale-CI_E.pdf|work=Zenhale Product Monograph|publisher=Merck & Co.|accessdate=16 August 2011}}</ref>

==Society and culture==

=== Legal status ===

Zenhale was approved in Canada in 2011.<ref name="BC DPIC">{{cite web|title=British Columbia Drug and Poison Information Center|url=http://dpic.org/druglisting/mometasone-formoterol|publisher=BC DPIC}}</ref> Dulera was approved by the [[Food and Drug Administration]] (FDA) in the United States in June 2010.<ref name="FDA-date">{{cite web|title=Merck's Dulera Inhalation Aerosol for asthma receives FDA approval|date=24 June 2010 |url=http://www.news-medical.net/news/20100624/Mercks-DULERA-Inhalation-Aerosol-for-asthma-receives-FDA-approval.aspx|publisher=News-Medical.net}}</ref> Zenhale's marketing application was voluntarily withdrawn from the EU due to the manufacturer's inability to provide additional information in the necessary timeframe.<ref name=EMA2010>{{cite web|title=Withdrawal of the marketing authorisation application for Zenhale (mometasone furoate/formoterol fumarate) Questions and Answers|url=http://www.ema.europa.eu/docs/en_GB/document_library/Medicine_QA/2010/11/WC500099298.pdf|publisher=[[European Medicines Agency]] (EMA)}}</ref>

=== Formulation ===

Mometasone/formoterol is available in a pressurized [[Metered-dose inhaler|MDI]] (pMDI) in three strengths (in [[micrograms]] of mometasone/micrograms of formoterol): 50/5, 100/5, and 200/5.

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[[Category:Wikipedia medicine articles ready to translate]]

[[Category:Antiasthmatic drugs]]

[[Category:Combination asthma drugs]]

[[Category:Drugs developed by Merck & Co.]]