SERDEXMETHYLPHENIDATE AND DEXMETHYLPHENIDATE

CNS Stimulant

Oral

Mechanism of Action

12.1 Mechanism of Action 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.

Indications

weight loss) than patients 6 years and older at the same dosage [see Warnings and Precautions ( 5.7 )

weight loss) than patients 6 years and older at the same dosage (5.7

8.4).

Contraindications

• 4 CONTRAINDICATIONS AZSTARYS is contraindicated in patients: with known hypersensitivity to serdexmethylphenidate
• methylphenidate
• or other components of AZSTARYS. Bronchospasm
• rash
• or within 14 days following discontinuation of treatment with an MAOI

FDA Warnings

5 WARNINGS AND PRECAUTIONS 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
3) Psychiatric Adverse Reactions : Prior to initiating AZSTARYS, screen patients for risk factors for developing a manic episode
7) Acute Angle Closure Glaucoma : AZSTARYS-treated patients considered at risk for acute angle closure glaucoma (e
8) Increased Intraocular Pressure (IOP) and Glaucoma : Prescribe AZSTARYS to patients with open-angle glaucoma or abnormally increased IOP only if the benefit of treatment is considered to outweigh the risk

Known Side Effects

8 documented side effects by frequency

Drug Not Working

>10%

Anxiety

1-10%

Headache

1-10%

Insomnia

1-10%

Decreased Appetite

1-10%

Nausea

1-10%

Fatigue

1-10%

Depression

0.1-1%

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Compare With

14 available comparisons

Formulations

Dosage Forms

Tablet

Route

Oral