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Azstarys Generic Name & Formulations
Legal Class
CII
General Description
Serdexmethylphenidate, dexmethylphenidate; 26.1mg/5.2mg, 39.2mg/7.8mg, 52.3mg/10.4mg; caps.
Pharmacological Class
CNS stimulant.
How Supplied
Caps—100
Manufacturer
Generic Availability
NO
Azstarys Indications
Indications
Attention deficit hyperactivity disorder (ADHD).
Azstarys Dosage and Administration
Adults and Children
<6yrs: not established. Take in the AM. Swallow whole or may open caps and sprinkle contents into 50mL of water or over 2 tablespoons of applesauce (consume immediately). 6–12yrs: initially 39.2mg/7.8mg once daily; may increase to 52.3mg/10.4mg per day or decrease to 26.1mg/5.2mg per day after 1 week depending on response and tolerability; max 52.3mg/10.4mg once day. ≥13yrs: initially 39.2mg/7.8mg once daily; may increase to 52.3mg/10.4 per day after 1 week; max 52.3mg/10.4mg once day. Switching from other methylphenidate products: discontinue and follow Azstarys titration schedule. Not interchangeable on a mg-per-mg basis.
Azstarys Contraindications
Contraindications
During or within 14 days of MAOIs.
Azstarys Boxed Warnings
Boxed Warning
Abuse and dependence.
Azstarys Warnings/Precautions
Warnings/Precautions
High potential for abuse and dependence; monitor. Increased risk of sudden death, stroke, and MI; assess for presence of cardiac disease before initiating. Avoid in known structural cardiac abnormalities, cardiomyopathy, serious arrhythmias, coronary artery disease, and other cardiac problems. Pre-existing psychotic disorder. Bipolar disorder. Screen for risk factors of developing a manic episode prior to initiation. Consider discontinuing if new psychotic/manic symptoms occur. Peripheral vasculopathy, including Raynaud's Phenomenon; monitor for digital changes. Monitor growth (esp. children), BP, HR. Reduce dose or discontinue if paradoxical aggravation of symptoms occur. Reevaluate periodically. Pregnancy. Nursing mothers: monitor infants.
Azstarys Pharmacokinetics
See Literature
Azstarys Interactions
Interactions
See Contraindications. Hypertensive crisis with MAOIs (eg, selegiline, tranylcypromine, isocarboxazid, phenelzine, linezolid, IV methylene blue). Avoid concomitant use with halogenated anesthetics (eg, halothane, isoflurane, enflurane, desflurane, sevoflurane). May antagonize antihypertensives (eg, CCBs, ACE inhibitors, ARBs, K+-sparing diuretics, thiazide diuretics, beta blockers, centrally acting alpha-2 receptor agonists). Increased risk of extrapyramidal symptoms with risperidone; monitor.
Azstarys Adverse Reactions
Adverse Reactions
Appetite decreased, insomnia, nausea, vomiting, dyspepsia, abdominal pain, weight decreased, anxiety, dizziness, irritability, affect lability, tachycardia, BP increased; priapism, hypersensitivity, cardiovascular reactions.
Azstarys Clinical Trials
See Literature
Azstarys Note
Not Applicable
Azstarys Patient Counseling
See Literature
