Azstarys Generic Name & Formulations
Legal Class
General Description
Pharmacological Class
How Supplied
Manufacturer
Generic Availability
Mechanism of Action
Azstarys Indications
Indications
Azstarys Dosage and Administration
Adults and Children
Azstarys Contraindications
Contraindications
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).
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