Because of possible effects on blood pressure, METADATE CD should be used cautiously with pressor agents.
Human pharmacologic studies have shown that methylphenidate may inhibit the metabolism of coumarin anticoagulants, anticonvulsants (e.g., phenobarbital, phenytoin, primidone), phenylbutazone 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.
In theory, there is a possibility that the clearance of methylphenidate might be affected by urinary pH, either being increased with acidifying agents or decreased with alkalizing agents. This should be considered when methylphenidate is given in combination with agents that alter urinary pH.
There is a risk of sudden blood pressure increase during surgery. If surgery is planned, METADATE CD should not be taken the day of the surgery.
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 METADATE CD overdosage has not been established.
The prolonged release of methylphenidate from METADATE CD 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.
METADATE CD is contraindicated in patients with marked anxiety, tension and agitation, since the drug may aggravate these symptoms.
Hypersensitivity To Methylphenidate Or Other Excipients
METADATE CD is contraindicated in patients known to be hypersensitive to methylphenidate or other components of the product.
METADATE CD contains sucrose. Therefore, patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption, or sucrase-isomaltase insufficiency should not take this medicine.
METADATE CD is contraindicated in patients with glaucoma.
METADATE CD is contraindicated in patients with motor tics or with a family history or diagnosis of Tourette’s syndrome (see ADVERSE REACTIONS).
Monoamine Oxidase Inhibitors
METADATE CD is contraindicated during treatment with monoamine oxidase inhibitors, and also within a minimum of 14 days following discontinuation of a monoamine oxidase inhibitor (hypertensive crises may result).
Hypertension And Other Cardiovascular Conditions
METADATE CD is contraindicated in patients with severe hypertension, angina pectoris, cardiac arrhythmias, heart failure, recent myocardial infarction, hyperthyroidism or thyrotoxicosis (see WARNINGS).
There is a risk of sudden blood pressure increase during surgery. If surgery is planned, METADATE CD should not be taken on the day of the surgery.
DRUG ABUSE AND DEPENDENCE
Controlled Substance Class
METADATE CD, 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. Diagnostic and Statistical Manual of Mental Disorders. American Psychiatric Association 1994. 4th ed. Washington D.C.
For Medical Information
Contact: Medical Affairs Department
Phone: (866) 822-0068
Fax: (770) 970-8859
Marketed by UCB, Inc.
Smyrna, GA 30080
Manufactured by UCB Manufacturing, Inc.
Rochester, NY 14623
Metadate CD is a registered trademark of UCB, Inc.
©2007, UCB, Inc., Smyrna, GA 30080
All rights reserved. Printed in U.S.A.
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