Hyponatremia: Several cases of hyponatremia or SIADH (syndrome of inappropriate antidiuretic hormone secretion) have been reported in association with racemic citalopram. All patients with these events have recovered with discontinuation of Escitalopram or citalopram and/or medical intervention.
Signs and symptoms of hyponatremia include headache, difficulty concentrating, memory impairment, confusion, weakness, unsteadiness, which may lead to falls. Signs and symptoms associated with more severe and/or acute cases have included hallucination, syncope, seizure, coma, respiratory arrest, and death.
Activation of Mania/Hypomania: Activation of mania/hypomania has also been reported in a small proportion of patients with major affective disorders treated with racemic citalopram and other marketed drugs effective in the treatment of major depressive disorder. Escitalopram should be used cautiously in patients with a history of mania.
Seizures: Escitalopram has not been systemically evaluated in patients with a seizure disorder. Like other drugs effective in the treatment of major depressive disorder, Escitalopram should be introduced with care in patients with a history of seizure disorder.
Use in Patients with Concomitant Illness: Caution is advisable in patients with diseases or conditions that produce altered metabolism or hemodynamic responses. Escitalopram has not been systematically evaluated in patients with a recent history of myocardial infarction or unstable heart disease.
In subjects with hepatic impairment, clearance of racemic citalopram was decreased and plasma concentrations were increased. The recommended dose of Escitalopram in hepatically impaired patients is 10 mg/day.
Abnormal Bleeding: Patients should be cautioned about the risk of bleeding associated with the concomitant use of escitalopram oxalate and NSAIDS, aspirin or other drugs that affect coagulation.
Interference with Cognitive and Motor Performance: Any psychoactive drug may impair judgment, thinking, or motor skills, however, patients should be cautioned about operating hazardous machinery, including automobiles, until they are reasonably certain that escitalopram tablets therapy does not affect their ability to engage susceptible activities.
Angle Closure Glaucoma: The pupillary dilation that occurs following use of many antidepressants drugs including escitalopram oxalate may trigger an angle closure attack in a patient with anatomically narrow angles who does not have a patent iridectomy.
Use in children: Safety and effectiveness in pediatric patients have not been established (younger than 12 years of age with major depressive disorder and less than 18 years of age for generalized anxiety disorder).
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