Serdexmethylphenidate/dexmethylphenidate
In this article, we will explore the impact of Serdexmethylphenidate/dexmethylphenidate on contemporary society. Serdexmethylphenidate/dexmethylphenidate has been the subject of interest and debate in various areas of knowledge, from social sciences to technology. Its influence has transcended geographical and cultural boundaries, and its relevance continues to constantly evolve. Throughout these pages, we will analyze the different aspects that make up the presence of Serdexmethylphenidate/dexmethylphenidate in our current reality, as well as its projection into the future. From its origin to its practical implications, we will delve into a deep analysis that seeks to shed light on a topic that is as relevant as it is unavoidable in contemporary times.
 | |
| Combination of | |
|---|---|
| Serdexmethylphenidate | Prodrug of dexmethylphenidate |
| Dexmethylphenidate | Catecholamine reuptake inhibitor |
| Clinical data | |
| Trade names | Azstarys |
| Other names | KP415 |
| AHFS/Drugs.com | Micromedex Detailed Consumer Information |
| License data | |
| Routes of administration | By mouth |
| ATC code | |
| Legal status | |
| Legal status |
|
| Identifiers | |
| KEGG | |
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.[1][2][3]
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.[4]
It was approved for medical use in the United States in March 2021.[4][5][2]
Medical uses
Serdexmethylphenidate/dexmethylphenidate is indicated for the treatment of attention deficit hyperactivity disorder in people six years of age and older.[4]
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).[4] The four-week trial was conducted at five sites in the United States.[4] 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).[4] The 12-month trial was conducted at 18 sites in the United States.[4]
References
- ^ a b "Azstarys- serdexmethylphenidate and dexmethylphenidate capsule". DailyMed. Archived from the original on 13 July 2021. Retrieved 13 July 2021.
- ^ a b "KemPharm Announces FDA Approval of Azstarys (serdexmethylphenidate and dexmethylphenidate capsules, for oral use, CII), A New Once-Daily Treatment for ADHD" (Press release). KemPharm. 3 March 2021. Archived from the original on 3 March 2021. Retrieved 3 March 2021 – via GlobeNewswire.
- ^ McCuistion LE, Yeager JJ, Winton MB, DiMaggio K (2021). "Chapter 18: Stimulants". Pharmacology E-Book: A Patient-Centered Nursing Process Approach. St. Louis, MO: Elsevier Health Sciences. p. 203. ISBN 978-0-323-79316-2. Archived from the original on 9 January 2022. Retrieved 9 January 2022.
- ^ a b c d e f g "Drug Trials Snapshots Azstarys". U.S. Food and Drug Administration (FDA). 8 March 2023. Retrieved 8 March 2023.
This article incorporates text from this source, which is in the public domain.
- ^ "Drug Approval Package: Azstarys". U.S. Food and Drug Administration (FDA). 1 April 2021. Retrieved 8 March 2023.
