Methylphenidate Hydrochloride

What it is and how it works

Mechanism of Action Methylphenidate hydrochloride is a central nervous system (CNS) stimulant. The mode of therapeutic action in ADHD is not known.

Indications

Methylphenidate hydrochloride extended-release capsules are indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in pediatric patients 6 to 15 years of age. Limitations of Use The use of methylphenidate hydrochloride extended-release capsules is not recommended in pediatric patients younger than 6 years of age because they had higher plasma exposure and a higher incidence of adverse reactions (e.g. weight loss) than patients 6 years and older at the same dosage . Methylphenidate hydrochloride extended-release capsules are a central nervous system (CNS) stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in pediatric patients 6 to 15 years of age. Limitations of Use The use of methylphenidate hydrochloride extended-release capsules is not recommended in pediatric patients younger than 6 years of age because they had higher exposure and a higher incidence of adverse reactions (e.g., weight loss) than patients 6 years and older at the same dosage. (5.7 , 8.4)

Dosage and administration (summary)

Take orally once daily in the morning, before breakfast. Swallow whole with the aid of liquids, or sprinkle contents onto a small amount of applesauce and give immediately. Do not crush or chew the capsule or capsule contents. Recommended starting dose is 20 mg once daily. Dosage may be increased 10 mg to 20 mg at weekly intervals; do not exceed 60 mg per day. Pretreatment Screening Prior to treating patients with methylphenidate hydrochloride extended-release capsules, assess: for the presence of cardiac disease (i.e., perform a careful history, family history of sudden death or ventricular arrhythmia, and physical exam) .

Contraindications

Methylphenidate hydrochloride extended-release capsules are contraindicated in patients with: known hypersensitivity to methylphenidate or other component of methylphenidate hydrochloride extended-release capsules. Angioedema has been reported in patients treated with methylphenidate hydrochloride extended-release capsules. Anaphylactic reactions have been reported in patients treated with other methylphenidate products .

Warnings and precautions

Risks to Patients with Serious Cardiac Disease: Avoid use in patients with known structural cardiac abnormalities, cardiomyopathy, serious cardiac arrhythmias, coronary artery disease, or other serious cardiac disease. Increased Blood Pressure and Heart Rate: Monitor blood pressure and pulse. Psychiatric Adverse Reactions: Prior to initiating methylphenidate hydrochloride extended-release, screen patients for risk factors for developing a manic episode. If new psychotic or manic symptoms occur, consider discontinuing methylphenidate hydrochloride extended-release.

Pregnancy

Pregnancy There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to ADHD medications, including methylphenidate hydrochloride extended-release, during pregnancy. Healthcare providers are encouraged to register patients by calling the National Pregnancy Registry for Psychostimulants at 1-866-961-2388.

Storage and supply

How Supplied Methylphenidate hydrochloride extended-release capsules are available in six strengths: Methylphenidate hydrochloride extended-release capsules, 10 mg are green cap and white body, opaque capsules, imprinted with ‘CP’ over ‘401’ on the cap and ‘10 mg’ on the body.

Source: Methylphenidate Hydrochloride (Methylphenidate Hydrochloride) — US FDA prescribing information, 2026-05-27, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.