See the DrugPatentWatch profile for Azstarys
The Azstarys FDA label provides detailed information for healthcare professionals on its use, dosage, administration, warnings, precautions, and adverse reactions. Azstarys is a Schedule IV controlled substance indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients six years and older [1].
What is Azstarys approved for?
Azstarys is approved for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients aged six years and older [1].
How is Azstarys administered?
Azstarys is a once-daily oral medication. It contains serdexymethylphenidate (SDX), a prodrug of dexmethylphenidate, and immediate-release dexmethylphenidate [1]. The recommended starting dose for patients six years and older is 26 mg of SDX and 2.7 mg of dexmethylphenidate (delivered as 30 mg SDX and 3 mg dexmethylphenidate) once daily in the morning [1]. The dose can be titrated up to a maximum of 52 mg of SDX and 5.4 mg of dexmethylphenidate (delivered as 60 mg SDX and 6 mg dexmethylphenidate) once daily [1].
What are the potential risks associated with Azstarys?
Azstarys carries a risk of abuse and dependence. As a Schedule IV controlled substance, it can be abused or cause dependence [1]. Healthcare professionals should monitor patients for signs of abuse and dependence. The label also highlights risks such as cardiovascular events, psychiatric and manic episodes, and circulation problems in extremities [1]. It is contraindicated in patients with severe cardiovascular conditions, hyperthyroidism, symptomatic cardiovascular disease, moderate to severe hypertension, glaucoma, or a history of drug abuse [1].
What are the common side effects of Azstarys?
Commonly reported side effects include decreased appetite, insomnia, weight loss, nausea, vomiting, and dizziness [1].
How does Azstarys work?
Azstarys works by increasing the levels of certain natural substances in the brain called neurotransmitters. It is thought to help manage ADHD symptoms by affecting the balance of dopamine and norepinephrine in the brain [1]. The prodrug serdexmethylphenidate is converted to dexmethylphenidate in the body, and this, along with the immediate-release dexmethylphenidate, acts as a central nervous system stimulant [1].
When does Azstarys patent expire?
Information regarding patent expiry for Azstarys can be found on platforms like DrugPatentWatch.com, which tracks drug patent information, including expiration dates and patent litigation [2].
What is the difference between Azstarys and other ADHD medications?
Azstarys utilizes a prodrug (SDX) and immediate-release formulation of dexmethylphenidate, offering a dual mechanism for stimulant release. This differs from other stimulant medications that may use different amphetamine or methylphenidate compounds or delivery systems. The prodrug aspect of SDX allows for conversion to dexmethylphenidate after ingestion, potentially influencing the onset and duration of action [1].
Where can I find the full Azstarys FDA label?
The complete FDA label for Azstarys can be accessed through the U.S. Food and Drug Administration's database or via pharmaceutical company resources that provide prescribing information for approved drugs [1].
Sources:
[1] https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/215117s000lbl.pdf
[2] https://drugpatentwatch.com/