Serdexmethylphenidate and dexmethylphenidate

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 [see Warnings and Precautions ( 5.7 ), Use in Specific Populations ( 8.4 )]. 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. …

• 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
• Pretreatment Screening Prior to treating patients with AZSTARYS, assess: for the presence of cardiac disease (i.e., perform a careful history, family history of sudden death or ventricular arrhythmia, and physical exam) [see Warnings and Precautions ]. the family history and clinically evaluate patients for motor or verbal tics or Tourette’s syndrome before initiating AZSTARYS [see Warnings and Precautions ]
• Recommended Dosage
• Pediatric Patients 6 to 12 years of age The recommended starting dosage of AZSTARYS is 39.2 mg serdexmethylphenidate/7.8 mg dexmethylphenidate once daily in the morning. …

AZSTARYS capsules are available as: 26.1 mg/5.2 mg (serdexmethylphenidate/dexmethylphenidate) – blue cap/grey body, imprinted with "286" on cap and "KP415" on the body 39.2 mg/7.8 mg (serdexmethylphenidate/dexmethylphenidate) – dark blue cap/grey body, imprinted with "429" on cap and "KP415" on the body 52.3 mg/10.4 mg (serdexmethylphenidate/dexmethylphenidate) – orange cap/grey body, imprinted wi …

• The safety and effectiveness of AZSTARYS have not been established
• In pediatric patients below the age of 6 years. In studies evaluating extended-release methylphenidate products, patients 4 to

Clinical trials of AZSTARYS did not include any patients aged 65 years and over.

• Advise the patient to read the FDA-approved patient labeling (Medication Guide)
• Abuse, Misuse, and Addiction Educate patients and their families about the risks of abuse, misuse, and addiction of AZSTARYS, which can lead to overdose and death, and proper disposal of any unused drug [see Warnings and Precautions , Drug Abuse and Dependence , Overdosage ]
• Advise patients to store AZSTARYS in a safe place, preferably locked, and instruct patients to not give AZSTARYS to anyone else
• Risk to Patients with Serious Cardiac Disease Advise patients that there are potential risks to patients with serious cardiac disease, including sudden death, with AZSTARYS use. …

• 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 [see Adverse Reactions ] . …

Antihypertensive Drugs: Monitor blood pressure. Adjust dosage of antihypertensive drug as needed. ( 7.1 ) 7.1 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 [see Contraindications ( 4 )] . …

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. (5.2) Increased Blood Pressure and Heart Rate : Monitor blood pressure and pulse. (5.3) 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. (5.4) Priapism : If abnormally sustained or frequent and painful erections occur, patients should seek immediate medical attention. …

The following are discussed in more detail in other sections of the labeling: Abuse, Misuse, and Addiction [see Boxed Warning, Warnings and Precautions (5.1) , and Drug Abuse and Dependence (9.2 , 9.3) ] Known hypersensitivity to methylphenidate or other ingredients of AZSTARYS [see Contraindications (4) ] Hypertensive Crisis with Concomitant Use of Monoamine Oxidase Inhibitors [see Contraindications (4) ] Risks to Patients with Serious Cardiac Disease [see Warnings and Precautions (5.2) ] Increased Blood Pressure and Heart Rate [see Warnings and Precautions (5.3) ] Psychiatric Adverse Reactions [see Warnings and Precautions (5.4) ] Priapism [see Warnings and Precautions (5.5) ] Peripheral V …

8.1 Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to ADHD medications, including AZSTARYS, during pregnancy. Healthcare providers are encouraged to register patients by calling the National Pregnancy Registry for Psychostimulants at 1-866-961-2388. …

Clinical Effects of Overdose Overdose of CNS stimulants is characterized by the following sympathomimetic effects: Cardiovascular effects including tachyarrhythmias, and hypertension or hypotension. Vasospasm, myocardial infarction, or aortic dissection may precipitate sudden cardiac death. Takotsubo cardiomyopathy may develop. CNS effects including psychomotor agitation, confusion, and hallucinations. Serotonin syndrome, seizures, cerebral vascular accidents, and coma may occur. Life-threatening hyperthermia (temperatures greater than 104°F) and rhabdomyolysis may develop. …

9.1 Controlled Substance AZSTARYS contains dexmethylphenidate hydrochloride, a Schedule II controlled substance, and serdexmethylphenidate, a Schedule IV controlled substance. 9.2 Abuse AZSTARYS has a high potential for abuse and misuse which can lead to the development of a substance use disorder, including addiction [see Warnings and Precautions (5.1) ] . AZSTARYS can be diverted for non-medical use into illicit channels or distribution. …

Take it when you remember, unless it is nearly time for the next dose. Then skip the missed one. Never take two doses at once to make up for it. Check your leaflet, as some medicines are different.