Azstarys
Combination product
Pronunciation: ser-dex-meth-il-FEN-i-dayt and dex-meth-il-FEN-i-dayt (az-STAR-is)
Combination of serdexmethylphenidate (prodrug, 70%) and dexmethylphenidate (30%) — extended + immediate d-MPH in one capsule (2021).
Each component keeps its own pharmacology page; the combination itself adds no new mechanism.
Components (2)
FDA label
Read the full label on DailyMed ↗
| FDA dosing | Population | Start | Target | Max |
|---|---|---|---|---|
| ADHD | Adults & pediatric 13–17 yr | 39.2/7.8 mg QAM | 52.3/10.4 mg QD (after 1 wk) | 52.3/10.4 mg QD |
| ADHD | Pediatric 6–12 yr | 39.2/7.8 mg QAM | increase to 52.3/10.4 or decrease to 26.1/5.2 mg QD after 1 wk | 52.3/10.4 mg QD |
Titration May adjust after 1 week
Renal Undefined
Hepatic Undefined
Not recommended below 6 years of age (higher exposure, more adverse reactions e.g. weight loss)
Instructions
- Once daily in the morning, with or without food
- Swallow whole, or open and sprinkle on applesauce or in water; consume within 10 min
- Do not substitute for other methylphenidate products on a mg-per-mg basis
Available strengths
- cap 26.1/5.2, 39.2/7.8, 52.3/10.4 mg
Contraindications
- Concurrent MAOI use, or use of an MAOI within the preceding 14 days (hypertensive-crisis risk)
Cautions
- Serious cardiac disease (avoid in structural cardiac abnormalities/serious arrhythmia)
- Increased blood pressure and heart rate
- Psychiatric reactions (mania, new psychotic/manic symptoms)
- Priapism
- Peripheral vasculopathy including Raynaud's phenomenon
- Long-term growth suppression in pediatric patients
- Acute angle-closure glaucoma; increased intraocular pressure
- Motor/verbal tics and worsening of Tourette's syndrome
Adverse reactions
- Decreased appetite
- Insomnia
- Nausea/vomiting
- Dyspepsia
- Abdominal pain
- Weight decreased
- Anxiety
- Dizziness
- Irritability
- Affect lability
- Tachycardia
- Blood pressure increased
Pregnancy No AZSTARYS-specific human data; methylphenidate data show no clear malformation risk. Registry available.
Lactation Methylphenidate present in human milk (low infant dose); monitor infant for agitation, poor weight gain.
Cost
| Strength | #/mo | generic $/mo | brand $/mo | CostPlus | |
|---|---|---|---|---|---|
| 26.1/5.2 mg | cap | 30 qd | — | $432.03 | not offered |
| 39.2/7.8 mg | cap | 30 qd | — | $432.55 | not offered |
| 52.3/10.4 mg | cap | 30 qd | — | $432.38 | not offered |
Part D rank #469.