Methylphenidatedosage

N/A

Prior to initiating methylphenidate hydrochloride extended-release tablets treatment, assess each patient’s risk for: o Abuse, misuse, and addiction o Presence of cardiac disease o Developing a manic episode o A family history of tics or Tourette syndrome and clinically evaluate patients for motor or verbal tics or Tourette syndrome

See the recommended dosage and administration in the Full Prescribing Information

Swallow methylphenidate hydrochloride extended-release tablets whole and do not crush or chew the extended-release tablets.

2.1 Pretreatment

Screening Prior to treating patients with Methylphenidate hydrochloride extended-release tablets, assess:

The risk for abuse, misuse, and addiction.

For the presence of cardiac disease (i.e., perform a careful history, family history of sudden death or ventricular arrhythmia, and physical exam).

The risk for developing a manic episode (e.g., history of depressive symptoms or a family history of suicide, bipolar disorder, or depression).

For a family history for tics or Tourette syndrome and clinically evaluate patients for motor or verbal tics or Tourette’s syndrome

2.2 Recommended

Dosage In pediatric patients 6 years of age and older, start with an immediate-release methylphenidate product 5 mg orally twice daily. Subsequently, switch to methylphenidate hydrochloride extended-release tablets 10 mg once daily. May gradually increase the methylphenidate hydrochloride extended-release tablets dosage. The maximum recommended methylphenidate hydrochloride extended-release tablets dosage in pediatric patients 6 years of age and older is 60 mg per day. In adult patients, the recommended oral dosage of methylphenidate hydrochloride extended-release tablets is 20 mg or 30 mg daily. The maximum recommended methylphenidate hydrochloride extended-release tablets dosage in adults is 60 mg per day. Swallow methylphenidate hydrochloride extended-release tablets whole and do not crush or chew the extended-release tablets.

2.3 Dosage Reduction and

Discontinuation If paradoxical aggravation of ADHD or narcolepsy symptoms or methylphenidate hydrochloride extended-release tablets-associated adverse reactions occur, reduce the methylphenidate hydrochloride extended-release tablets dosage, or, if necessary, discontinue methylphenidate hydrochloride extended-release tablets. If improvement is not observed after appropriate dosage modification over a one-month period, discontinue methylphenidate hydrochloride extended-release tablets.

2.4 Starting

Methylphenidate Hydrochloride Extended-Release Tablets After Use of a Monoamine Oxidase Inhibitor Must wait at least 14 days after stopping a monoamine oxidase (MAO) inhibitor before starting methylphenidate hydrochloride extended-release tablets.