Dexmethylphenidate and Serdexmethylphenidate

AZSTARYS is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients 6 years of age and older. Limitations of Use The use of AZSTARYS is not recommended in pediatric patients younger than 6 years of age because they had higher plasma exposure and a higher incidence of adverse reactions (e.g., weight loss) than patients 6 years and older at the same dosage. AZSTARYS is a central nervous system (CNS) stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients 6 years of age and older.

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.

Pediatric Patients 6 to 12 years: Recommended starting dosage is 39.2 mg/7.8 mg orally once daily in the morning. Dosage may be increased to 52.3 mg/10.4 mg daily or decreased to 26.1 mg/5.2 mg daily after one week. Maximum recommended dosage is 52.3 mg/10.4 mg once daily. Adults and Pediatric Patients 13 to 17 years: Recommended starting dosage is 39.2 mg/7.8 mg orally once daily in the morning. Increase the dosage after one week to 52.3 mg/10.4 mg once daily depending on response and tolerability. Administer with or without food. Swallow capsules whole or open and sprinkle onto applesauce or add to water. To avoid substitution errors and overdosage, do not substitute for other methylphenidate products on a milligram-per-milligram basis.

AZSTARYS is contraindicated in patients: with known hypersensitivity to serdexmethylphenidate, methylphenidate, or other components of AZSTARYS. Bronchospasm, rash, and pruritus have been reported in patients who received AZSTARYS. Hypersensitivity reactions such as angioedema and anaphylactic reactions have been reported in patients treated with other methylphenidate products. receiving concomitant treatment with monoamine oxidase inhibitors (MAOIs), or within 14 days following discontinuation of treatment with an MAOI, because of the risk of hypertensive crisis. Known hypersensitivity to serdexmethylphenidate, methylphenidate, or product components.

Boxed warning (abuse, misuse, and addiction azstarys): has a high potential for abuse and misuse, which can lead to the development of a substance use disorder, including addiction. Misuse and abuse of CNS stimulants, including AZSTARYS, can result in overdose and death, and this risk is increased with higher doses or unapproved methods of administration, such as snorting or injection. Risks to Patients with Serious Cardiac Disease: Avoid use in patients with known structural cardiac abnormalities, cardiomyopathy, serious cardiac arrhythmias, coronary artery disease, or other serious cardiac disease. Increased Blood Pressure and Heart Rate: Monitor blood pressure and pulse. Psychiatric Adverse Reactions: Prior to initiating AZSTARYS, screen patients for risk factors for developing a manic episode. If new psychotic or manic symptoms occur, consider discontinuing AZSTARYS.

The following are discussed in more detail in other sections of the labeling: Abuse, Misuse, and Addiction Known hypersensitivity to methylphenidate or other ingredients of AZSTARYS Hypertensive Crisis with Concomitant Use of Monoamine Oxidase Inhibitors Risks to Patients with Serious Cardiac Disease Increased Blood Pressure and Heart Rate Psychiatric Adverse Reactions Priapism Peripheral Vasculopathy, including Raynaud's Phenomenon Long-Term Suppression of Growth in Pediatric Patients Acute Angle Closure Glaucoma Increased Intraocular Pressure and Glaucoma Motor and Verbal Tics, and Worsening of Tourette’s Syndrome Based on accumulated data from other methylphenidate products, the most common (>5% and twice the rate of placebo) adverse reactions are appetite decreased, insomnia, nausea, vomiting, dyspepsia, abdominal pain, weight decreased, anxiety, dizziness, irritability, affect…

Antihypertensive Drugs: Monitor blood pressure. Adjust dosage of antihypertensive drug as needed. Clinically Important Interactions with AZSTARYS Table 1 presents clinically important drug interactions with AZSTARYS. Table 1: Clinically Important Drug Interactions with AZSTARYS Monoamine Oxidase Inhibitors (MAOIs) Clinical Impact Concomitant use of MAOIs and CNS stimulants, including AZSTARYS, can cause hypertensive crisis. Potential outcomes include death, stroke, myocardial infarction, aortic dissection, ophthalmological complications, eclampsia, pulmonary edema, and renal failure. Intervention Do not administer AZSTARYS concomitantly with MAOIs or within 14 days after discontinuing MAOI treatment Antihypertensive Drugs Clinical Impact AZSTARYS may decrease the effectiveness of drugs used to treat hypertension.

Storage Store at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C to 30°C (59°F to 86°F). Protect from moisture.