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
Extended-release formulation combining immediate-release dexmethylphenidate with a delayed-release prodrug (serdexmethylphenidate) for rapid and sustained effect
Increases synaptic dopamine and norepinephrine by inhibiting reuptake
Enhances focus, attention, and impulse control
Side effects: decreased appetite, insomnia, elevated blood pressure

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).