CONCERTA® should not be used in patients being treated (currently or within the proceeding 2 weeks) with MAO inhibitors (see CONTRAINDICATIONS, Monoamine Oxidase Inhibitors).
Because of possible increases in blood pressure, CONCERTA® should be used cautiously with vasopressor agents.
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.
Serious adverse events have been reported in concomitant use with clonidine, although no causality for the combination has been established. The safety of using methylphenidate in combination with clonidine or other centrally acting alpha-2 agonists has not been systematically evaluated.
Signs and Symptoms
Signs and symptoms of acute methylphenidate overdosage, resulting principally from overstimulation of the CNS and from excessive sympathomimetic effects, may include the following: vomiting, agitation, tremors, hyperreflexia, muscle twitching, convulsions (may be followed by coma), euphoria, confusion, hallucinations, delirium, sweating, flushing, headache, hyperpyrexia, tachycardia, palpitations, cardiac arrhythmias, hypertension, mydriasis, and dryness of mucous membranes.
Treatment consists of appropriate supportive measures. The patient must be protected against self-injury and against external stimuli that would aggravate overstimulation already present. Gastric contents may be evacuated by gastric lavage as indicated. Before performing gastric lavage, control agitation and seizures if present and protect the airway. Other measures to detoxify the gut include administration of activated charcoal and a cathartic. Intensive care must be provided to maintain adequate circulation and respiratory exchange; external cooling procedures may be required for hyperpyrexia.
Efficacy of peritoneal dialysis or extracorporeal hemodialysis for CONCERTA® overdosage has not been established.
The prolonged release of methylphenidate from CONCERTA® should be considered when treating patients with overdose.
Poison Control Center
As with the management of all overdosage, the possibility of multiple drug ingestion should be considered. The physician may wish to consider contacting a poison control center for up-to-date information on the management of overdosage with methylphenidate.
CONCERTA® is contraindicated in patients with marked anxiety, tension, and agitation, since the drug may aggravate these symptoms.
Hypersensitivity to Methylphenidate
CONCERTA® is contraindicated in patients known to be hypersensitive to methylphenidate or other components of the product.
CONCERTA® is contraindicated in patients with glaucoma.
CONCERTA® is contraindicated in patients with motor tics or with a family history or diagnosis of Tourette's syndrome (see ADVERSE REACTIONS).
Monoamine Oxidase Inhibitors
CONCERTA® is contraindicated during treatment with monoamine oxidase (MAO) inhibitors, and also within a minimum of 14 days following discontinuation of a MAO-inhibitor (hypertensive crises may result) (see PRECAUTIONS, Drug Interactions).
DRUG ABUSE AND DEPENDENCE
Controlled Substance Class
CONCERTA®, like other methylphenidate products, is classified as a Schedule II controlled substance by federal regulation.
Abuse, Dependence, and Tolerance
See WARNINGS for boxed warning containing drug abuse and dependence information.
American Psychiatric Association. Diagnosis and Statistical Manual of Mental Disorders. 4th ed. Washington DC: American Psychiatric Association 1994.
For more information call 1-888-440-7903 or visit www.concerta.net
ALZA Corporation, Mountain View, CA 94043
Distributed and Marketed by
Division of McNeil-PPC, Inc., Fort Washington, PA 19034
An ALZA OROS® Technology Product
CONCERTA® and OROS® are Registered Trademarks of ALZA Corporation.
Edition: March 2007
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