Azstarys Dosage

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).
• ​the family history and clinically evaluate patients for motor or verbal tics or Tourette’s syndrome before initiating AZSTARYS.

2.2 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.
• ​The dosage may be increased after one week to a dosage of 52.3 mg serdexmethylphenidate/10.4 mg dexmethylphenidate per day, or decreased after one week to a dosage of 26.1 mg serdexmethylphenidate/5.2 mg dexmethylphenidate per day, depending on response and tolerability.
• ​Maximum recommended dosage is 52.3 mg serdexmethylphendiate/10.4 mg dexmethyphenidate once daily.

​Adults and Pediatric Patients 13 to 17 years of age

• ​The recommended starting dosage of AZSTARYS is 39.2 mg serdexmethylphenidate/7.8 mg dexmethylphenidate once daily in the morning.
• ​Increase the dosage after one week to a dosage of 52.3 mg serdexmethylphenidate/10.4 mg dexmethylphenidate per day, depending on response and tolerability.
• ​Maximum recommended dosage is 52.3 mg serdexmethylphenidate/10.4 mg dexmethylphenidate once daily.

Administration Instructions

Administer AZSTARYS orally once daily in the morning with or without food.

AZSTARYS capsules may be taken whole, or opened and the entire contents sprinkled into 50 mL of water or over 2 tablespoons of applesauce. Consume all the drug/food mixture immediately or within 10 minutes of mixing; do not store for future use.

Switching from Other Methylphenidate Products

If switching from other methylphenidate products, discontinue that treatment, and titrate with AZSTARYS using the titration schedule described above.

Do not substitute AZSTARYS for other methylphenidate products on a milligram-per-milligram basis because these products have different pharmacokinetic profiles from AZSTARYS and may have different methylphenidate base composition.

Dosage Reduction and Discontinuation

​If paradoxical aggravation of symptoms or other adverse reactions occur, reduce dosage or, if necessary, discontinue AZSTARYS. If improvement is not observed after appropriate dosage adjustment over a one-month period, discontinue AZSTARYS.