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Focalin XR

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Focalin XR

Focalin XR

OVERDOSE

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.

Poison Control Center

The physician may wish to consider contacting a poison control center for up-to-date information on the management of overdosage with methylphenidate.

Recommended Treatment

As with the management of all overdosage, the possibility of multiple drug ingestion should be considered.

When treating overdose, practitioners should bear in mind that there is a prolonged release of dexmethylphenidate from Focalin XR.

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 for Focalin overdosage has not been established.

CONTRAINDICATIONS

Agitation

Focalin XR is contraindicated in patients with marked anxiety, tension, and agitation, since the drug may aggravate these symptoms.

Hypersensitivity To Methylphenidate

Focalin XR is contraindicated in patients known to be hypersensitive to methylphenidate, or other components of the product. Hypersensitivity reactions, including angioedema and anaphylactic reactions, have been observed in patients treated with methylphenidate [see ADVERSE REACTIONS].

Glaucoma

Focalin XR is contraindicated in patients with glaucoma.

Tics

Focalin XR is contraindicated in patients with motor tics or with a family history or diagnosis of Tourette's syndrome [see ADVERSE REACTIONS].

Monoamine Oxidase Inhibitors

Focalin XR is contraindicated during treatment with monoamine oxidase inhibitors, and also within a minimum of 14 days following discontinuation of treatment with a monoamine oxidase inhibitor (hypertensive crises may result).

Last reviewed on RxList: 1/21/2014
This monograph has been modified to include the generic and brand name in many instances.

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Focalin XR - User Reviews

Focalin XR User Reviews

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Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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