Azstarys

FDA label

Read the full label on DailyMed ↗

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.