# Azstarys ### (serdexmethylphenidate and dexmethylphenidate)
[**Full Prescribing Information**](https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=00b5e716-5564-4bbd-acaf-df2bc45a5663&type=display)[**DailyMed Drug Information**](https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=00b5e716-5564-4bbd-acaf-df2bc45a5663)
--- **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** 1. AZSTARYS (serdexmethylphenidate and dexmethylphenidate) Prescribing Information, FDA, 2023, [https://www.accessdata.fda.gov/drugsatfda\_docs/label/2023/211555s004lbl.pdf](https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/211555s004lbl.pdf) 2. DailyMed: AZSTARYS, NIH, 2024, [https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=f11dd712-5c66-4c3e-9b2b-14d6e9b2b14d](https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=f11dd712-5c66-4c3e-9b2b-14d6e9b2b14d) 3. UpToDate: Methylphenidate (dexmethylphenidate), 2025, [https://www.uptodate.com/contents/methylphenidate-including-dexmethylphenidate-drug-information](https://www.uptodate.com/contents/methylphenidate-including-dexmethylphenidate-drug-information) 4. Clinical Pharmacology Review: AZSTARYS NDA 211555, FDA, 2021, [https://www.accessdata.fda.gov/drugsatfda\_docs/nda/2021/211555Orig1s000ClinPharmR.pdf](https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/211555Orig1s000ClinPharmR.pdf)