INDICATION

Aptensio XR® (methylphenidate HCl extended-release) is a central nervous system (CNS) stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD).

For US Healthcare Professionals

IMPORTANT SAFETY INFORMATION

WARNING: ABUSE AND DEPENDENCE

CNS stimulants, including Aptensio XR, other methylphenidate-containing products, and amphetamines, have a high potential for abuse and dependence. Assess the risk of abuse prior to prescribing and monitor for signs of abuse and dependence while on therapy.

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PHARMACOKINETICS

Once-daily Aptensio XR has a biphasic concentration time profile1

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Concentration of Aptensio XR peaks twice a day to provide both a rapid initial release of ~40% of methylphenidate and a sustained release of the remaining ~60%1

Following oral administration of Aptensio XR® (methylphenidate HCl extended-release) in adults, plasma methylphenidate concentration increases rapidly, peaking at approximately 2 hours and again at approximately 8 hours.

  • The pharmacokinetic profile of methylphenidate when Aptensio XR is administered as a whole capsule is similar to the pharmacokinetic profile when the contents of the Aptensio XR capsule are sprinkled onto applesauce in subjects under fasting conditions1

Plasma concentration time profile of Aptensio XR 80 mg1

Plasma Concentration Plasma Concentration
  • Daily doses above 60 mg have not been studied and are not recommended1
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IMPORTANT SAFETY INFORMATION

WARNING: ABUSE AND DEPENDENCE

CNS stimulants, including Aptensio XR, other methylphenidate-containing products, and amphetamines, have a high potential for abuse and dependence. Assess the risk of abuse prior to prescribing and monitor for signs of abuse and dependence while on therapy.