Aptensio XR Dosage

Pretreatment Screening

​Prior to treating patients with APTENSIO XR, 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 5.2].
• ​the family history and clinically evaluate patients for motor or verbal tics or Tourette's syndrome before initiating APTENSIO XR [see Warnings and Precautions (5.10)].

Recommended Dosage

The recommended starting dose of APTENSIO XR in patients 6 years and older is 10 mg once daily orally in the morning with or without food. Advise patients to establish a routine pattern with regard to meals. The dose should be individualized according to the needs and response of the patient.

The dose may be titrated weekly in increments of 10 mg. Daily doses above 60 mg have not been studied and are not recommended.

Administration Instructions

​APTENSIO XR may be taken whole or the capsule may be opened and the entire contents sprinkled onto applesauce. If the patient is using the sprinkled administration method, the sprinkled applesauce should be consumed immediately; it should not be stored. Patients should take the applesauce with sprinkled beads in its entirety without chewing. The dose of a single capsule should not be divided. The contents of the entire capsule should be taken, and patients should not take anything less than one capsule per day.

Dosage Reduction and Discontinuation

​If paradoxical aggravation of symptoms or other adverse reactions occur; the dosage should be reduced, or, if necessary, discontinue APTENSIO XR.

​If improvement is not observed after appropriate dosage adjustment over a one-month period, discontinue APTENSIO XR.