In 2014, the FDA revised its guidelines for new methylphenidate ER alternatives. Methylphenidate ER 72-mg tablets met these stricter guidelines to demonstrate equivalence to branded methylphenidate HCl extended-release tablets.
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.
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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.
Methylphenidate ER 72-mg should not be taken by patients who have:
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.
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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.