INDICATION

Aptensio XR® (methylphenidate HCl extended-release) is a central nervous system (CNS) stimulant prescription medicine used for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in people 6 years of age and older.


Limitations of Use
Aptensio XR is not for use in children under 6 years of age because the safety and effectiveness have not been established.

IMPORTANT SAFETY INFORMATION

Aptensio XR is a federally controlled substance (CII) because it contains methylphenidate that can be a target for people who abuse prescription medicines or street drugs. Keep Aptensio XR in a safe place to protect it from theft. Never give your methylphenidate to anyone else, because it may cause death or harm to them. Selling or giving away Aptensio XR may harm others and is against the law. Tell your healthcare provider if you or your child have ever abused or been dependent on alcohol, prescription medicines, or street drugs.

How does Aptensio XR help control my child's ADHD symptoms?

In a study, Aptensio XR® (methylphenidate HCl extended-release) was shown to significantly improve ADHD symptoms in a classroom setting. Patients were tested 1, 2, 3, 4.5, 6, 7.5, 9, 10.5, and 12 hours after taking Aptensio XR. Improvements in symptoms were seen at each of these times.

Aptensio XR can control your child's symptoms during school.

What are the common side effects with Aptensio XR?

The safety of Aptensio XR was shown in studies that lasted up to 2 years. One study included children aged 6-12 years. The second study enrolled children and adolescents aged 6-17 years.

In one of those studies, less than 2% of children stopped taking Aptensio XR because of side effects.

In general, the side effects associated with Aptensio XR are similar to other ADHD medicines that contain the active ingredient methylphenidate. The most common side effects in studies of Aptensio XR were stomach pain, decreased appetite, headache, and trouble sleeping.

IMPORTANT SAFETY INFORMATION

Aptensio XR is a federally controlled substance (CII) because it contains methylphenidate that can be a target for people who abuse prescription medicines or street drugs.