Serdexmethylphenidate/dexmethylphenidate
{{Short description|A combination of CNS Stimulants}}
{{Distinguish|serdexmethylphenidate}}
{{Use American English|date=March 2021}}
{{Use dmy dates|date=March 2021}}
{{Infobox drug
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| type = combo
| image = Dexmethylphenidate and serdexmethylphenidate.svg
| width = 250
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| component1 = Serdexmethylphenidate
| class1 = Prodrug of dexmethylphenidate
| component2 = Dexmethylphenidate
| class2 = Catecholamine reuptake inhibitor
| tradename = Azstarys
| Drugs.com = {{drugs.com|cons|serdexmethylphenidate-and-dexmethylphenidate}}
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| DailyMedID = Azstarys
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| routes_of_administration = By mouth
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| ATC_prefix = N06
| ATC_suffix = BA15
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| legal_US = Schedule II
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| KEGG = D11989
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| synonyms = KP415
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Serdexmethylphenidate/dexmethylphenidate, sold under the brand name Azstarys, is a fixed-dose combination medication containing serdexmethylphenidate, a prodrug of dexmethylphenidate, and dexmethylphenidate, a d-threo enantiomer of racemic methylphenidate, which is used to treat attention deficit hyperactivity disorder (ADHD) in people aged six years and older.{{cite press release|title=KemPharm Announces FDA Approval of Azstarys (serdexmethylphenidate and dexmethylphenidate capsules, for oral use, CII), A New Once-Daily Treatment for ADHD|publisher=KemPharm|via=GlobeNewswire|date=3 March 2021|url=http://www.globenewswire.com/news-release/2021/03/03/2185820/0/en/KemPharm-Announces-FDA-Approval-of-AZSTARYS-serdexmethylphenidate-and-dexmethylphenidate-capsules-for-oral-use-CII-A-New-Once-Daily-Treatment-for-ADHD.html|access-date=3 March 2021|archive-date=3 March 2021|archive-url=https://web.archive.org/web/20210303043638/https://www.globenewswire.com/news-release/2021/03/03/2185820/0/en/KemPharm-Announces-FDA-Approval-of-AZSTARYS-serdexmethylphenidate-and-dexmethylphenidate-capsules-for-oral-use-CII-A-New-Once-Daily-Treatment-for-ADHD.html|url-status=live}}{{cite book|vauthors=McCuistion LE, Yeager JJ, Winton MB, DiMaggio K|chapter=Chapter 18: Stimulants|title=Pharmacology E-Book: A Patient-Centered Nursing Process Approach|date=2021|location=St. Louis, MO|publisher=Elsevier Health Sciences|isbn=978-0-323-79316-2|page=203|chapter-url=https://books.google.com/books?id=9HVWEAAAQBAJ&pg=PA203|access-date=9 January 2022|archive-date=9 January 2022|archive-url=https://web.archive.org/web/20220109123957/https://books.google.com/books?id=9HVWEAAAQBAJ&pg=PA203|url-status=live}}
Side effects include decreased appetite, nausea, indigestion, weight loss, dizziness, mood swings, increased blood pressure, trouble sleeping, vomiting, stomach pain, anxiety, irritability, and increased heart rate.
It was approved for medical use in the United States in March 2021.{{cite web | title=Drug Approval Package: Azstarys | website=U.S. Food and Drug Administration (FDA) | date=1 April 2021 | url=https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/212994Orig1s000TOC.cfm | access-date=8 March 2023}}
Medical uses
File:Azstarys-52 3-10 4-capsules.jpg
Serdexmethylphenidate/dexmethylphenidate is indicated for the treatment of attention deficit hyperactivity disorder in people six years of age and older.{{cite web | title=Drug Trials Snapshots Azstarys | website=U.S. Food and Drug Administration (FDA) | date=8 March 2023 | url=https://www.fda.gov/drugs/drug-approvals-and-databases/drug-trials-snapshots-azstarys | access-date=8 March 2023}} {{PD-notice}}
History
The US Food and Drug Administration (FDA) approved serdexmethylphenidate/dexmethylphenidate based on evidence from one clinical trial of 150 participants with attention deficit hyperactivity disorder 6 to 12 years of age (Study 1). The four-week trial was conducted at five sites in the United States. The safety and tolerability of serdexmethylphenidate/dexmethylphenidate was examined in an open-label trial of 238 participants with attention deficit hyperactivity disorder 6 to 12 years of age (Study 2). The 12-month trial was conducted at 18 sites in the United States.
References
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{{Psychostimulants, agents used for ADHD and nootropics}}
{{ADHD pharmacotherapies}}
{{Monoamine reuptake inhibitors}}
{{Portal bar | Medicine}}
{{DEFAULTSORT:Serdexmethylphenidate Dexmethylphenidate}}
Category:Combination psychiatric drugs