Serdexmethylphenidate and dexmethylphenidate (Azstarys®) is a central nervous stimulant.
On this page, we will provide basic prescribing information about this medication. Links to other articles on this website with more advanced information and tips related to this medication and/or related topics are provided below—under Related Pages
FDA-approved indications
Treatment of attention deficit hyperactivity disorder (ADHD) in patients 6 years of age and older.
Mechanism of action/ Pharmacodynamics
Serdexmethylphenidate is a prodrug of dexmethylphenidate, a central nervous stimulant.
Contraindications
1. Hypersensitivity to serdexmethylphenidate, methylphenidate, or their components.
2. Concurrent treatment with monoamine oxidase inhibitor (MAOI) or use of an MAOI within the preceding 14 days.
Warnings and Precautions
- Serious cardiac diseases such as structural cardiac abnormalities, cardiomyopathy, serious cardiac arrhythmias, coronary artery disease
- Increased blood pressure and heart rate
- Psychotic or manic symptoms
- Priapism: seek immediate medical attention
- Peripheral vasculopathy, including Raynaud’s Phenomenon
- Long-term suppression of growth in pediatric patients
- Acute angle-closure glaucoma
- Motor and verbal tics, and worsening of Tourette’s Syndrome
Boxed warnings
Side effects
The commonest side effects of Azstarys® (occurring in 5% or more of patients and at least twice the rate of placebo) were:
Decreased appetite, insomnia, nausea, vomiting, dyspepsia, abdominal pain, weight loss, anxiety, dizziness, irritability, affect lability, tachycardia, and increased blood pressure.
Potential drug interactions
May decrease the effectiveness of antihypertensives.
Dosage and administration
Serdexmethylphenidate/dexmethylphenidate is given once daily in the morning with or without food. Capsules may either be swallowed whole or opened and sprinkled onto applesauce or added to water
1. Recommended dose of serdexmethylphenidate/dexmethylphenidate in pediatric patients 6-12 years of age:
Initial: 39.2 mg/7.8 mg
After 1 week: Depending on response and tolerability either increase to 52.3 mg/10.4 mg or decrease to 26.1 mg/5.2 mg
Maximum: 52.3 mg/10.4 mg
2. Recommended dose of serdexmethylphenidate/dexmethylphenidate in adults and pediatric patients 13-17 years of age:
Initial: 39.2 mg/7.8 mg
After 1 week: Depending on response and tolerability increase to 52.3 mg/10.4 mg
Maximum: 52.3 mg/10.4 mg
Dosage forms and strengths
Capsules (serdexmethylphenidate/dexmethylphenidate): 26.1 mg/5.2 mg, 39.2 mg/7.8 mg, 52.3 mg/10.4 mg
Important! This page does not provide all the information needed to prescribe this medication. Please refer to the full Prescribing Information (see the link below) before prescribing this medication.
Related Pages
Dexmethylphenidate preparations
Methylphenidate/ dexmethylphenidate preparations: Index and links
How to choose between generic, long-acting methylphenidate/ dexmethylphenidate preparations
Should we prescribe dexmethylphenidate (Focalin) rather than methylphenidate (Ritalin)?
Dexmethylphenidate (Focalin®, Focalin XR®): Basic Information
Does serdexmethylphenidate+dexmethylphenidate (Azstarys®) have significant advantages?
Stimulants—General
What are the closest alternatives when forced to switch a stimulant?
A dozen tips to manage loss of appetite due to a stimulant (in adults)
Converting stimulants: Equivalent doses
Pros and cons of short-acting preparations of psychostimulants
Tips for managing abuse potential of medications for ADHD
Stimulant medications and irritability in children with ADHD
Stimulants for ADHD with a history of a substance use disorder?
Don’t change the stimulant medication without first asking about this
What if you refuse an early refill of a stimulant medication?
What to look for in stimulant withdrawal (including a physical sign that is little known)
Stimulant “holidays” (breaks) in adults with ADHD?
How to get full-day coverage with stimulants
Do stimulants need to be titrated up again after an interruption?
Do we need to worry about stimulant medications as our patients become older adults?
Clinical recommendations: What to do about stimulant medications in older adults
Can patients with ADHD develop tolerance to stimulant medications?
Can psychostimulant medications cause or worsen Raynaud’s phenomenon?
What can we do about the shortage of stimulant medications?
Laws about prescriptions for psychostimulants
Are stimulants useful after traumatic brain injury?
What to do about stimulant medications for surgery or other procedures under anesthesia
Laws about prescriptions for psychostimulants
How are methylphenidate and amphetamines metabolized?
Four kinds of atypical responses to stimulant medications
Can I take my medication with me when I travel to another country?
What to do about medications when traveling to Japan
Treatments (Main menu)
References
Serdexmethylphenidate and dexmethylphenidate (Azstarys®) Prescribing information
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