Serdexmethylphenidate and dexmethylphenidate

Serdexmethylphenidate and dexmethylphenidate
Black Box Warning
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

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

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)

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)

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.