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

Mechanism of Action

Serdexmethylphenidate is a prodrug of dexmethylphenidate. Dexmethylphenidate HCl is a central nervous system (CNS) stimulant. The mode of therapeutic action in ADHD is not known.

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, misuse, and addiction.

Azstarys Warnings/Precautions

Warnings/Precautions

High potential for abuse, misuse, and addiction; assess patient's risk before prescribing. Assess for presence of cardiac disease before initiating. Avoid in known structural cardiac abnormalities, cardiomyopathy, serious arrhythmias, coronary artery disease, or other cardiac disease. 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. Risk for acute angle closure glaucoma. History of increased IOP or open angle glaucoma; monitor closely. Assess family history and evaluate for tics or Tourette’s syndrome before initiating; monitor for emergence or worsening, and discontinue if clinically appropriate. Peripheral vasculopathy, including Raynaud's Phenomenon; monitor for digital changes. Monitor BP, HR, growth in children. Reduce dose or discontinue if paradoxical aggravation of symptoms occur. Reevaluate periodically. Pregnancy. Nursing mothers: monitor infants.

Azstarys Pharmacokinetics

Absorption

Median time to reach maximum concentration: ~2 hours.

Distribution

Plasma protein bound: ~56% (serdexmethylphenidate); ~47% (dexmethylphenidate). Mean apparent volume of distribution: 29.3 L/kg (serdexmethylphenidate; after Azstarys administration); 2.65 L/kg (dexmethylphenidate; after IV administration).

Metabolism

Serdexmethylphenidate is likely converted to dexmethylphenidate mainly in the lower gastrointestinal tract. Enzymes involved in the conversion process are not identified.

Dexmethylphenidate is metabolized primarily via de-esterification to d-α-phenyl-piperidine acetic acid (also known as d-ritalinic acid).

Elimination

Renal (62%), fecal (37%). Half-life: 5.7 hours (serdexmethylphenidate); 11.7 hours (dexmethylphenidate).

Azstarys Interactions

Interactions

See Contraindications. Hypertensive crisis with MAOIs (eg, selegiline, tranylcypromine, isocarboxazid, phenelzine, linezolid, IV methylene blue). May antagonize antihypertensives (eg, CCBs, ACE inhibitors, ARBs, K+-sparing diuretics, thiazide diuretics, beta blockers, centrally acting alpha-2 receptor agonists). Concomitant halogenated anesthetics may increase the risk of sudden BP and HR increase during surgery; avoid use. 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, glaucoma, motor/verbal tics.

Azstarys Clinical Trials

See Literature

Azstarys Note

Not Applicable

Azstarys Patient Counseling

See Literature