FDA Approves Methylphenidate Hydrochloride Extended-Release Tablets for ADHD and Narcolepsy
The FDA has approved a generic methylphenidate hydrochloride extended-release tablet for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in pediatric patients 6 years and older and adults, and for narcolepsy. This approval provides an extended-release formulation with an approximate 8-hour duration of action, offering a treatment option that may be used in place of immediate-release methylphenidate hydrochloride tablets when the 8-hour dosage corresponds.
Clinically, this approval adds to the available pharmacologic options for managing ADHD, a common neurodevelopmental disorder. The label carries standard warnings for CNS stimulants, including a boxed warning for abuse and dependence, and contraindicates use with monoamine oxidase inhibitors (MAOIs). The approval is based on an Abbreviated New Drug Application (ANDA), indicating therapeutic equivalence to a previously approved reference listed drug.
Prescribers should note the label's limitation of use, which does not recommend use in pediatric patients younger than 6 years due to higher plasma exposure and a higher incidence of adverse reactions, such as weight loss, compared to older patients at the same dosage.
＋ Clinical Details (Mechanism · Dosing · Trial Data · Warnings)
Not reported in label.
Methylphenidate hydrochloride extended-release tablets are indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in pediatric patients 6 years and older and adults, and for narcolepsy. Use is not recommended in pediatric patients younger than 6 years due to higher plasma exposure and a higher incidence of adverse reactions (e.g., weight loss) than patients 6 years and older at the same dosage.
The tablets have a duration of action of approximately 8 hours. They may be used in place of methylphenidate hydrochloride tablets when the 8-hour dosage corresponds to the titrated 8-hour dosage of the immediate-release tablets. Tablets must be swallowed whole and never crushed or chewed. Prior to treatment, assess for cardiac disease and the risk of abuse. Periodically reevaluate the long-term need for treatment and adjust dosage as needed. If paradoxical worsening of symptoms or other adverse reactions occur, reduce the dosage or discontinue. If no improvement is observed after appropriate dosage adjustment over one month, discontinue the drug.
Trial data not available in label.
The drug carries a boxed warning for abuse and dependence. It is contraindicated in patients with known hypersensitivity to methylphenidate or other product components, and in patients receiving concomitant treatment with monoamine oxidase inhibitors (MAOIs) or within 14 days of discontinuing an MAOI due to risk of hypertensive crises. Warnings and precautions include assessing for cardiac disease prior to treatment, monitoring blood pressure (as it may decrease the effectiveness of antihypertensive drugs), and monitoring for signs of abuse and dependence.
Methylphenidate hydrochloride extended-release tablets are a CNS stimulant indicated for ADHD and narcolepsy. The extended-release formulation provides an approximately 8-hour duration, allowing it to potentially replace immediate-release dosing in corresponding regimens. Treatment may be needed for extended periods, requiring periodic reevaluation.