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OVERDOSAGE and CONTRAINDICATIONS LEXAPRO (Escitalopram)

OVERDOSAGE HUMAN EXPERIENCE

There have been reports of LEXAPRO overdose involving doses of up to 600 mg. All patients recovered and no symptoms associated with the overdoses were reported. In clinical trials of racemic citalopram, there were no reports of fatal citalopram overdose involving overdoses of up to 2000 mg. During the postmarketing evaluation of citalopram, like other SSRIs, a fatal outcome in a patient who has taken an overdose of citalopram has been rarely reported.

Postmarketing reports of drug overdoses involving citalopram have included 12 fatalities, 10 in combination with other drugs and/or alcohol and 2 with citalopram alone (3920 mg and 2800 mg), as well as non-fatal overdoses of up to 6000 mg. Symptoms most often accompanying citalopram overdose, alone or in combination with other drugs and/or alcohol, included dizziness, sweating, nausea, vomiting, tremor, somnolence, sinus tachycardia, and convulsions. In more rare cases, observed symptoms included amnesia, confusion, coma, hyperventilation, cyanosis, rhabdomyolysis, and ECG changes (including QTc prolongation, nodal rhythm, ventricular arrhythmia, and one possible case of torsades de pointes).

MANAGEMENT OF OVERDOSE

Establish and maintain an airway to ensure adequate ventilation and oxygenation. Gastric evacuation by lavage and use of activated charcoal should be considered. Careful observation and cardiac and vital sign monitoring are recommended, along with general symptomatic and supportive care. Due to the large volume of distribution of escitalopram, forced diuresis, dialysis, hemoperfusion, and exchange transfusion are unlikely to be of benefit. There are no specific antidotes for LEXAPRO.

In managing overdosage, consider the possibility of multiple-drug involvement. The physician should consider contacting a poison control center for additional information on the treatment of any overdose.

CONTRAINDICATIONS

Concomitant use in patients taking monoamine oxidase inhibitors (MAOIs) is contraindicated (see WARNINGS).

LEXAPRO is contraindicated in patients with a hypersensitivity to escitalopram or citalopram or any of the inactive ingredients in LEXAPRO.