Azstarys

(serdexmethylphenidate and dexmethylphenidate) 

 

 

 

 Full Prescribing Information 

 DailyMed Drug Information 

 

 

 

 

 Forms/Strengths 

 

 Capsules: 26.1 mg/5.2 mg, 39.2 mg/7.8 mg, 52.3 mg/10.4 mg  

 

 

 Dosing 

 

 Age: ≥ 6 y/o 

 Onset:  ~ 30 min 

 Duration: 12-14 hours 

 Release Profile: 30% IR, 70% ER 

 Considerations: Administer once daily in the morning, with or without food; capsules can be taken whole or opened and sprinkled onto applesauce or mixed with water. 

 Initial Dose: 39.2/7.8 mg 

 Titration: Increase to 52.3/10.4 mg or decrease to 26.1/5.2 mg after one week 

 Max Dose: 52.3/10.4 mg daily 

 

 

 Quick Facts 

 

 Prodrug formulation : 30% immediate-release dexmethylphenidate + 70% delayed-release serdexmethylphenidate (converted to dexmethylphenidate in lower GI tract) for rapid onset and sustained 13-hour effect 

 Blocks reuptake of dopamine and norepinephrine into presynaptic neurons, increasing synaptic concentrations 

 FDA-approved for ADHD in patients ≥6 years; no generic available 

 CII controlled substance with high abuse potential; monitor for misuse 

 Common side effects include appetite suppression , insomnia , and increased BP/HR 

 Low incidence of next-day rebound vs. other stimulants due to extended PK profile 

 

 

 Indications 

 

   ADHD (ICD-10: F90.0) 

 

 

 Off-Label Uses 

 

  N/A 

 

 

 How to Take 

 

 Take once daily in the morning to reduce the risk of insomnia. 

 Can be taken with or without food . 

 Swallow the capsule whole ; do not crush or chew. 

 If needed, the capsule can be opened, and contents sprinkled on applesauce or water —consume immediately without chewing. 

 

 

 Side Effects 

 

 

 Common : 

 

 Decreased appetite, weight loss 

 Insomnia 

 Headache 

 Nausea, stomach pain 

 Increased heart rate or blood pressure 

 

 

 

 Serious : 

 

 Cardiovascular events: Sudden death in patients with pre-existing structural cardiac abnormalities or arrhythmias. 

 Psychiatric symptoms: New or worsening anxiety, psychosis, or manic symptoms. 

 Peripheral vasculopathy, including Raynaud’s phenomenon. 

 

 

 

 

 Monitoring / Labs 

 

 Cardiovascular : Baseline and routine monitoring of heart rate and blood pressure. 

 Growth in Pediatrics : Regular monitoring of height and weight to detect growth suppression. 

 Psychiatric Symptoms : Observe for mood changes, anxiety, or psychosis. 

 Abuse Potential : Monitor for misuse or diversion. 

 

 

 Education 

 

 

 When to Call the Doctor: 

 

 Severe mood changes, aggression, or suicidal thoughts . 

 Chest pain, rapid heartbeat, shortness of breath ( cardiovascular concerns ). 

 Uncontrolled movements, tics, or worsening anxiety. 

 Numbness, coldness, or color changes in fingers or toes ( circulatory issues ). 

 Unexplained weight loss or delayed growth in pediatric patients . 

 

 

 

 Safety Tips: 

 

 Monitor blood pressure and heart rate , especially in patients with cardiovascular risk. 

 Use caution in patients with anxiety, bipolar disorder, or psychosis , as symptoms may worsen. 

 Avoid caffeine and other stimulants , which may amplify side effects. 

 Ensure adequate hydration and nutrition , as appetite suppression is common. 

 Tapering may be required if discontinuing after long-term use. 

 

 

 

 Parent Tips for Pediatric Patients: 

 

 Encourage a nutrient-dense diet to counteract appetite suppression. 

 Administer in the morning before school for optimal effect. 

 Monitor school performance and behavioral changes . 

 Observe for sleep disturbances ; adjust timing if necessary. 

 Communicate regularly with teachers and caregivers about medication effects. 

 

 

 

 

 Additional Information 

 

 

 Contraindications: 

 

 Hypersensitivity to serdexmethylphenidate, dexmethylphenidate, or formulation components. 

 Use within 14 days of MAOI therapy (risk of hypertensive crisis). 

 Symptomatic cardiovascular disease, moderate-to-severe hypertension, hyperthyroidism, glaucoma . 

 History of substance use disorder , unless benefits outweigh risks. 

 

 

 

 Pregnancy: 

 

 Category C ; use only if benefits outweigh risks. 

 May cause neonatal withdrawal symptoms or low birth weight . 

 

 

 

 Lactation: 

 

 Excreted in breast milk ; not recommended due to potential infant exposure. 

 

 

 

 Drug Interactions: 

 

 Serotonergic drugs (e.g., SSRIs, SNRIs, MAOIs) increase serotonin syndrome risk . 

 Acidifying agents (e.g., ascorbic acid) may reduce drug absorption. 

 Alkalinizing agents (e.g., sodium bicarbonate) may increase dexmethylphenidate levels. 

 May potentiate hypertensive effects of certain medications (e.g., decongestants, beta-agonists). 

 

 

 

 References 

 

 AZSTARYS (serdexmethylphenidate and dexmethylphenidate) Prescribing Information, FDA, 2023, https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/211555s004lbl.pdf 

 DailyMed: AZSTARYS, NIH, 2024, https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=f11dd712-5c66-4c3e-9b2b-14d6e9b2b14d 

 UpToDate: Methylphenidate (dexmethylphenidate), 2025, https://www.uptodate.com/contents/methylphenidate-including-dexmethylphenidate-drug-information 

 Clinical Pharmacology Review: AZSTARYS NDA 211555, FDA, 2021, https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/211555Orig1s000ClinPharmR.pdf