Concerta (methylphenidate)

Concerta (methylphenidate) extended release tablets is a prescription medicine used to treat the symptoms of attention deficit disorder (ADD), attention deficit hyperactivity disorder (ADHD) and narcolepsy. Concerta may be used alone or with other medications.

Concerta is a central nervous system stimulant.

It is not known if Concerta is safe and effective in children younger than 6 years of age.

WARNING

DRUG DEPENDENCE

Concerta should be given cautiously to patients with a history of drug dependence or alcoholism. Chronic abusive use can lead to marked tolerance and psychological dependence with varying degrees of abnormal behavior. Frank psychotic episodes can occur, especially with parenteral abuse. Careful supervision is required during withdrawal from abusive use since severe depression may occur. Withdrawal following chronic therapeutic use may unmask symptoms of the underlying disorder that may require follow-up.

Concerta may cause serious side effects including:

• chest pain,
• trouble breathing,
• lightheadedness,
• hallucinations,
• new behavioral problems,
• aggression,
• hostility,
• paranoia
• numbness,
• pain,
• cold feeling,
• unexplained wounds,
• skin color changes in your hands or feet (pale, red or blue), and
• painful erection or an erection lasting over 4 hours

Get medical help right away, if you have any of the symptoms listed above.

The most common side effects of Concerta include:

• excessive sweating,
• mood changes,
• nervousness or irritability,
• sleep problems (insomnia),
• fast heart rate,
• pounding heartbeat or fluttering in your chest,
• increased blood pressure,
• loss of appetite,
• weight loss,
• dry mouth,
• nausea,
• stomach pain, and
• headache

Get medical help right away, if you have any of the symptoms listed above.

These are not all the possible side effects of Concerta. For more information, ask your doctor or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Controlled Substance

Methylphenidate is a Schedule II controlled substance under the Controlled Substances Act.

Abuse

Concerta should be given cautiously to patients with a history of drug dependence or alcoholism. Chronic abusive use can lead to marked tolerance and psychological dependence with varying degrees of abnormal behavior. Frank psychotic episodes can occur, especially with parenteral abuse.

Dependence

Careful supervision is required during withdrawal from abusive use since severe depression may occur. Withdrawal following chronic therapeutic use may unmask symptoms of the underlying disorder that may require follow-up.

General Dosing Information

Concerta should be administered orally once daily in the morning with or without food.

Concerta must be swallowed whole with the aid of liquids, and must not be chewed, divided, or crushed.

Patients New To Methylphenidate

The recommended starting dose of Concerta for patients who are not currently taking methylphenidate or stimulants other than methylphenidate is 18 mg once daily for children and adolescents and 18 or 36 mg once daily for adults (see Table 1).

Table 1. Concerta Recommended Starting Doses and Dose Ranges

Patients Currently Using Methylphenidate

The recommended dose of Concerta for patients who are currently taking methylphenidate twice daily or three times daily at doses of 10 to 60 mg/day is provided in Table 2. Dosing recommendations are based on current dose regimen and clinical judgment. Conversion dosage should not exceed 72 mg daily.

Table 2. Recommended Dose Conversion from Methylphenidate Regimens to Concerta

Other methylphenidate regimens: Clinical judgment should be used when selecting the starting dose.

Dose Titration

Doses may be increased in 18 mg increments at weekly intervals for patients who have not achieved an optimal response at a lower dose. Daily dosages above 54 mg in children and 72 mg in adolescents have not been studied and are not recommended. Daily dosages above 72 mg in adults are not recommended.

A 27 mg dosage strength is available for physicians who wish to prescribe between the 18 mg and 36 mg dosages.

Maintenance/Extended Treatment

There is no body of evidence available from controlled trials to indicate how long the patient with ADHD should be treated with Concerta. It is generally agreed, however, that pharmacological treatment of ADHD may be needed for extended periods.

The effectiveness of Concerta for long-term use, i.e., for more than 7 weeks, has not been systematically evaluated in controlled trials. The physician who elects to use Concerta for extended periods in patients with ADHD should periodically re-evaluate the long-term usefulness of the drug for the individual patient with trials off medication to assess the patient’s functioning without pharmacotherapy. Improvement may be sustained when the drug is either temporarily or permanently discontinued.

Dose Reduction and Discontinuation

If paradoxical aggravation of symptoms or other adverse events occur, the dosage should be reduced, or, if necessary, the drug should be discontinued.

If improvement is not observed after appropriate dosage adjustment over a one-month period, the drug should be discontinued.

MAO Inhibitors

Concerta should not be used in patients being treated (currently or within the preceding 2 weeks) with MAO inhibitors.

Vasopressor Agents

• Because of possible increases in blood pressure, Concerta should be used cautiously with vasopressor agents.

Coumarin Anticoagulants, Antidepressants, And Selective Serotonin Reuptake Inhibitors

• Human pharmacologic studies have shown that methylphenidate may inhibit the metabolism of coumarin anticoagulants, anticonvulsants (eg, phenobarbital, phenytoin, primidone), and some antidepressants (tricyclics and selective serotonin reuptake inhibitors).
• Downward dose adjustment of these drugs may be required when given concomitantly with methylphenidate. It may be necessary to adjust the dosage and monitor plasma drug concentrations (or, in the case of coumarin, coagulation times), when initiating or discontinuing concomitant methylphenidate.

Risperidone

• Combined use of methylphenidate with risperidone when there is a change, whether an increase or decrease, in dosage of either or both medications, may increase the risk of extrapyramidal symptoms (EPS). Monitor for signs of EPS.

• The safety of methylphenidate for use during human pregnancy has not been established. There are no adequate and well-controlled studies in pregnant women. Concerta should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
• It is not known whether methylphenidate is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised if Concerta is administered to a nursing woman.