Azstarys

— THERAPEUTIC CATEGORIES —
  • ADHD

Azstarys Generic Name & Formulations

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