Indication and Important Safety Information
The 72-mg methylphenidate hydrochloride extended-release tablet is a prescription medication approved for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in adolescents 13 years of age and older, and adults up to the age of 65.
WARNING: DRUG DEPENDENCE
See full prescribing information for complete boxed warning.
Abuse of methylphenidate may lead to dependence. Tell your healthcare professional if you or your child has had prior issues of abuse or dependence with alcohol or drugs. Keep Methylphenidate ER 72-mg tablets in a safe place to prevent misuse and abuse by others.
Who should not take Methylphenidate ER 72-mg?
Methylphenidate ER 72-mg should not be taken by patients who have:
- allergies to methylphenidate or other ingredients in Methylphenidate ER 72-mg
- significant anxiety, tension, or agitation
- tics, Tourette’s syndrome, or family history of Tourette’s syndrome
- current or past use of monoamine oxidase inhibitor (MAOI)
- esophagus, stomach, or intestinal narrowing
Children under 13 years of age should not take 72-mg Methylphenidate ER tablets.
Tell your healthcare professional if you or your child has had:
- any heart problems, heart defects, high blood pressure, or a family history of these problems
- has had depression, abnormal thoughts or visions, bipolar disorder, or seizures
- numbness, pain, skin color change, or sensitivity to temperature in fingers or toes
Contact your healthcare professional immediately if you or your child:
- develops abnormal thinking or hallucinations, abnormal or extreme moods, and/or excessive activity
- if aggressive behavior or hostility develops or worsens while taking Methylphenidate ER 72-mg
Painful and prolonged erections (priapism) have occurred with methylphenidate. If you or your child develop priapism, seek medical help right away. Because of the potential for permanent damage, priapism should be evaluated by a doctor immediately.
Your child’s healthcare professional should check height and weight often and may interrupt Methylphenidate ER 72-mg treatment if your child is not growing or gaining weight as expected.
Stimulants may impair the ability of a patient to operate potentially hazardous machinery or vehicles. Caution should be used accordingly until you are reasonably certain that Methylphenidate ER 72-mg tablets do not adversely affect your or your child’s ability to engage in such activities.
The most common adverse reactions in double-blind clinical trials (>5%) reported:
- in children and adolescents, upper abdominal pain
- in adult patients, decreased appetite, headache, dry mouth, nausea, trouble sleeping, anxiety, dizziness, weight decrease, irritability, and increased sweating
Please click here for full Prescribing Information, including Boxed Warning.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.