Azstarys

Forms/Strengths

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

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

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.

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.

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.

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.

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).