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OROS methylphenidate extended-release (Concerta®) : Basic information

OROS methylphenidate extended-release (US brand name Concerta® and generic) is a central nervous system stimulant.


On this page, we present some basic information about this medication. Other articles on this website with more advanced information and tips related to this medication are linked to under Related Pages below.


FDA-approved indications

Treatment of attention deficit hyperactivity disorder (ADHD) in children (6-12 years), adolescents (13-17 years), and adults (18-65 years)


Mechanism of action/ Pharmacodynamics

Methylphenidate is a central nervous stimulant. The exact mode of therapeutic action on ADHD is known though it is hypothesized that it blocks the reuptake of norepinephrine and dopamine in presynaptic neurons and increases the release of these monoamines in the extraneuronal space. Methylphenidate is a racemic mixture of d- and l-isomers. The d-isomer is more pharmacologically active than the l-isomer.


Pharmacokinetics

The peak plasma concentration of OROS methylphenidate extended-release occurs between 6 to 10 hours.

Methylphenidate is primarily (90%) excreted in the urine.


Warnings and Precautions

a) Serious cardiovascular events: Sudden death has been reported with the use of methylphenidate in patients with cardiac problems. It should be avoided in structural cardiac abnormalities, coronary artery disease, and other heart problems.

b) Increased blood pressure: Monitor for changes in heart rate or blood pressure

c) Psychiatric adverse events: May aggravate psychotic or manic symptoms

d) Seizures: Discontinue in presence of seizures since it may lower the seizure threshold

e) Priapism

f) Peripheral vasculopathy including Raynaud’s phenomenon

g) Visual disturbance: Difficulties with accommodation and blurring of vision have been reported

h) Suppression of growth: Monitor height and weight in children and adolescents

i) Gastrointestinal obstruction with preexisting gastrointestinal narrowing

j) Hematologic monitoring: Periodic blood counts are advised


Contraindications

1. Patients with marked anxiety, tension, and agitation

2. Glaucoma

3. History of motor tics or family history of Tourette’s syndrome

4. Concurrent use of monoamine oxidase (MAO) inhibitors or within 14 days after discontinuation of MAO inhibitors

5. Hypersensitivity to methylphenidate or its components


Side effects

Please see THIS PAGE for a handout listing both the common and less common side effects of this medication along with the percentages of patients who report them.


Dosage

a) Children (ages 6-12) and adolescents (ages 13-18) who are new to methylphenidate

Starting: 18 mg once daily in the morning
Titration: 18 mg increments weekly
Maximum: 54 mg/day (children) and 72 mg/day (adolescents)

b) Adults who are new to methylphenidate

Starting: 18 or 36 mg once daily with or without food
Titration: 18 mg increments weekly
Maximum: 72 mg/day

c) For patients currently using methylphenidate

Dosing is based on dosing regimen and clinical judgment

Concerta® tablets should not be chewed or crushed and swallowed whole with the aid of liquids


Dosage forms and strengths

Extended-release tablets (Concerta® and generic): 18 mg, 27 mg, 36 mg, and 54 mg


Important! Please refer to the full Prescribing Information (see link below) before prescribing this medication.


Related Pages

Methylphenidate preparations

Should we prescribe dexmethylphenidate (Focalin) rather than methylphenidate (Ritalin)?

Should we combine methylphenidate and guanfacine? 

Tips for managing abuse potential of medications for ADHD

Does lisdexamfetamine really have lower abuse potential? 

Triple-bead preparation of mixed amphetamine salts (Mydayis®)

How are methylphenidate and amphetamines metabolized?

Converting from OROS methylphenidate to amphetamine is a two-step process

Methylphenidate (Ritalin, Ritalin SR®, Ritalin LA®): Basic information

Dexmethylphenidate (Focalin®, Focalin XR®): Basic Information

First ADHD medication to be taken at *bedtime*–Why? How?

A dozen tips to manage loss of appetite due to a stimulant (in adults)

Converting stimulants: Equivalent doses

Combine a stimulant and atomoxetine?

Stimulant medications and irritability in children with ADHD

Stimulants for ADHD with a history of a substance use disorder?

What if you refuse an early refill of a stimulant medication?

What to look for in stimulant withdrawal (including a physical sign that is little known)

Stimulant “holidays” (breaks) in adults with ADHD?

Be careful if a person is on both a stimulant and an antipsychotic

What could happen when changing from an antipsychotic to a stimulant?

Laws about prescriptions for psychostimulants


References

Prescribing information for methylphenidate (Concerta®) extended-release


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Disclaimer: The material on this website is provided as general education for medical professionals. It is not intended or recommended for patients or other laypersons or as a substitute for medical advice, diagnosis, or treatment. Patients must always consult a qualified healthcare professional regarding their diagnosis and treatment. Healthcare professionals should always check this website for the most recently updated information.

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