Generic Name: serdexmethylphenidate and dexmethylphenidate capsules
What is Azstarys?
Azstarys is a once-daily central nervous system (CNS) stimulant ADHD medication approved for the treatment of ADHD symptoms in patients 6 years of age and older. Formerly referred to as KP415, Azstarys comprises serdexmethylphenidate (SDX), KemPharm’s prodrug of d-methylphenidate (d-MPH), co-formulated with immediate-release d-MPH. Like all methylphenidate-containing products, Azstarys is a federally controlled substance (CII) because it can be abused or lead to dependence.
Azstarys Dosages Explained
Patients 6 to 12 years: The recommended starting dosage is 39.2mg/7.8mg orally once daily in the morning. Dosage may be increased to 52.3mg/10.4mg daily or decreased to 26.1mg/5.2mg daily after one week. Maximum recommended dosage is 52.3mg/10.4mg once daily.
Adults and Patients 13 to 17 years: The recommended starting dosage is 39.2mg/7.8mg orally once daily in the morning. Dosage may be increased after one week to 52.3mg/10.4mg once daily.
Azstarys can be taken with or without food. Patients may swallow capsules whole or open and sprinkle onto applesauce or add to water.
What are the Side Effects of Azstarys?
The most common side effects of Azstarys include:
- decreased appetite
- nausea or indigestion
- weight loss
- mood swings
- increased blood pressure
- trouble sleeping
- vomiting or stomach pain
- increased heart rate
Azstarys and Heart Problems
If you or your child has heart problems, heart defects, high blood pressure, or a family history of these problems, your doctor should check you or your child before and during taking Azstarys; increases in blood pressure and heart rate may occur. Call your healthcare provider right away or go to the nearest hospital emergency room if you or your child experience chest pain, shortness of breath, or fainting while taking Azstarys.
Azstarys and Mental Illness
If you or your child has psychiatric problems, or a family history of suicide, bipolar illness, or depression, tell your doctor before starting Azstarys. New or worse behavior and thought problems may occur, as well as new psychotic or manic symptoms. Call your healthcare provider right away if there are any new or worsening mental symptoms or problems during treatment.
Azstarys and Circulation Problems
Talk to your doctor before starting Azstarys if you or your child has circulation problems in fingers and toes. Fingers or toes may feel numb, cool, painful, sensitive to temperature, and/or change color from pale, to blue, to red. Call your healthcare provider right away if any signs of unexplained wounds appear on fingers or toes while taking Azstarys.
Azstarys and Growth in Children
There has been some concern that stimulants may cause a slowing of growth in children and adolescents, however research findings are mixed. Some studies show no impact on growth at all,1 while others find what is considered “negligible” slowing of growth.2 If you find evidence of suppressed growth in your child, talk to your doctor about what steps might help.
Azstarys and Pregnancy
Let your doctor know if you or your child is pregnant or plan to become pregnant. It is not known if Azstarys may harm your unborn baby. Azstarys passes into breast milk – talk to your healthcare provider about the best way to feed your baby if you take Azstarys.
Precautions Associated with Azstarys
Do not take Azstarys if your or your child is allergic to any of the ingredients, including serdexmethylphenidate or methylphenidate. Azstarys should not be taken if you or your child is taking or have stopped taking within the past 14 days a medicine used to treat depression called a monoamine oxidase inhibitor (MAOI).
Interactions Associated with Azstarys
Those taking antihypertensive drugs in additional to Azstarys should have their blood pressure monitored. The use of Azstarys should be avoided on the day of surgery if halogenated anesthetics will be used.
Azstarys: Next Steps
- Free Download:A Parent’s Guide to ADHD Medications
- Free Download: Medication Monitoring Log
- Read: A Patient’s Primer on the Stimulant Medications Used to Treat ADHD
- Find: ADHD Specialists and Clinics Near You
View Article Sources
1Pediatrics (2014.) “ADHD, Stimulant Treatment, and Growth: A Longitudinal Study.” https://publications.aap.org/pediatrics/article-abstract/134/4/e935/77034/ADHD-Stimulant-Treatment-and-Growth-A-Longitudinal
2Journal of the American Academy of Child & Adolescent Psychiatry. (2019.) “Trajectories of Growth Associated With Long-Term Stimulant Medication in the Multimodal Treatment Study of Attention-Deficit/Hyperactivity Disorder.” https://www.jaacap.org/article/S0890-8567(19)31443-1/fulltext