Serdexmethylphenidate and dexmethylphenidate
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Parth Vikram Singh, MBBS[2]
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Black Box Warning
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ABUSE, MISUSE, AND ADDICTION
See full prescribing information for complete Boxed Warning.
Condition Name: (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.
Before prescribing AZSTARYS, assess each patient’s risk for abuse, misuse, and addiction. Educate patients and their families about these risks, proper storage of the drug, and proper disposal of any unused drug. Throughout AZSTARYS treatment, reassess each patient’s risk of abuse, misuse, and addiction and frequently monitor for signs and symptoms of abuse, misuse, and addiction)
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Overview
Serdexmethylphenidate and dexmethylphenidate is a central nervous system (CNS) stimulant that is FDA approved for the treatment of Attention Deficit Hyperactivity Disorde (ADHD) in patients 6 years of age and older.. There is a Black Box Warning for this drug as shown here. Common adverse reactions include appetite decreased, insomnia, nausea vomiting, dyspepsia,abdominal pain, weight decreased, anxiety,dizziness, irritability, affect lability, tachycardia, and blood pressure increased..
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
- 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.
DOSAGE FORMS AND STRENGTHS
- Capsules (serdexmethylphenidate/dexmethylphenidate): 26.1 mg/5.2 mg, 39.2 mg/7.8 mg, 52.3 mg/10.4 mg.
Off-Label Use and Dosage (Adult)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Serdexmethylphenidate and dexmethylphenidate in adult patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Serdexmethylphenidate and dexmethylphenidate in adult patients.
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
There is limited information regarding Serdexmethylphenidate and dexmethylphenidate FDA-Labeled Indications and Dosage (Pediatric) in the drug label.
Off-Label Use and Dosage (Pediatric)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Serdexmethylphenidate and dexmethylphenidate in pediatric patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Serdexmethylphenidate and dexmethylphenidate in pediatric patients.
Contraindications
There is limited information regarding Serdexmethylphenidate and dexmethylphenidate Contraindications in the drug label.
Warnings
|
ABUSE, MISUSE, AND ADDICTION
See full prescribing information for complete Boxed Warning.
Condition Name: (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.
Before prescribing AZSTARYS, assess each patient’s risk for abuse, misuse, and addiction. Educate patients and their families about these risks, proper storage of the drug, and proper disposal of any unused drug. Throughout AZSTARYS treatment, reassess each patient’s risk of abuse, misuse, and addiction and frequently monitor for signs and symptoms of abuse, misuse, and addiction)
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There is limited information regarding Serdexmethylphenidate and dexmethylphenidate Warnings' in the drug label.
Adverse Reactions
Clinical Trials Experience
There is limited information regarding Serdexmethylphenidate and dexmethylphenidate Clinical Trials Experience in the drug label.
Postmarketing Experience
There is limited information regarding Serdexmethylphenidate and dexmethylphenidate Postmarketing Experience in the drug label.
Drug Interactions
There is limited information regarding Serdexmethylphenidate and dexmethylphenidate Drug Interactions in the drug label.
Use in Specific Populations
Pregnancy
Pregnancy Category (FDA):
There is no FDA guidance on usage of Serdexmethylphenidate and dexmethylphenidate in women who are pregnant.
Pregnancy Category (AUS):
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Serdexmethylphenidate and dexmethylphenidate in women who are pregnant.
Labor and Delivery
There is no FDA guidance on use of Serdexmethylphenidate and dexmethylphenidate during labor and delivery.
Nursing Mothers
There is no FDA guidance on the use of Serdexmethylphenidate and dexmethylphenidate in women who are nursing.
Pediatric Use
There is no FDA guidance on the use of Serdexmethylphenidate and dexmethylphenidate in pediatric settings.
Geriatic Use
There is no FDA guidance on the use of Serdexmethylphenidate and dexmethylphenidate in geriatric settings.
Gender
There is no FDA guidance on the use of Serdexmethylphenidate and dexmethylphenidate with respect to specific gender populations.
Race
There is no FDA guidance on the use of Serdexmethylphenidate and dexmethylphenidate with respect to specific racial populations.
Renal Impairment
There is no FDA guidance on the use of Serdexmethylphenidate and dexmethylphenidate in patients with renal impairment.
Hepatic Impairment
There is no FDA guidance on the use of Serdexmethylphenidate and dexmethylphenidate in patients with hepatic impairment.
Females of Reproductive Potential and Males
There is no FDA guidance on the use of Serdexmethylphenidate and dexmethylphenidate in women of reproductive potentials and males.
Immunocompromised Patients
There is no FDA guidance one the use of Serdexmethylphenidate and dexmethylphenidate in patients who are immunocompromised.
Administration and Monitoring
Administration
There is limited information regarding Serdexmethylphenidate and dexmethylphenidate Administration in the drug label.
Monitoring
There is limited information regarding Serdexmethylphenidate and dexmethylphenidate Monitoring in the drug label.
IV Compatibility
There is limited information regarding the compatibility of Serdexmethylphenidate and dexmethylphenidate and IV administrations.
Overdosage
There is limited information regarding Serdexmethylphenidate and dexmethylphenidate overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.
Pharmacology
There is limited information regarding Serdexmethylphenidate and dexmethylphenidate Pharmacology in the drug label.
Mechanism of Action
There is limited information regarding Serdexmethylphenidate and dexmethylphenidate Mechanism of Action in the drug label.
Structure
There is limited information regarding Serdexmethylphenidate and dexmethylphenidate Structure in the drug label.
Pharmacodynamics
There is limited information regarding Serdexmethylphenidate and dexmethylphenidate Pharmacodynamics in the drug label.
Pharmacokinetics
There is limited information regarding Serdexmethylphenidate and dexmethylphenidate Pharmacokinetics in the drug label.
Nonclinical Toxicology
There is limited information regarding Serdexmethylphenidate and dexmethylphenidate Nonclinical Toxicology in the drug label.
Clinical Studies
There is limited information regarding Serdexmethylphenidate and dexmethylphenidate Clinical Studies in the drug label.
How Supplied
There is limited information regarding Serdexmethylphenidate and dexmethylphenidate How Supplied in the drug label.
Storage
There is limited information regarding Serdexmethylphenidate and dexmethylphenidate Storage in the drug label.
Images
Drug Images
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Package and Label Display Panel
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Patient Counseling Information
There is limited information regarding Serdexmethylphenidate and dexmethylphenidate Patient Counseling Information in the drug label.
Precautions with Alcohol
Alcohol-Serdexmethylphenidate and dexmethylphenidate interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
Brand Names
There is limited information regarding Serdexmethylphenidate and dexmethylphenidate Brand Names in the drug label.
Look-Alike Drug Names
There is limited information regarding Serdexmethylphenidate and dexmethylphenidate Look-Alike Drug Names in the drug label.
Drug Shortage Status
Price
References
The contents of this FDA label are provided by the National Library of Medicine.