Exuber 10 Special Precautions

General: Discontinuation of Treatment with Escitalopram Oxalate Tablets: During marketing of Escitalopram oxalate tablets and other SSRIs and SNRIs (serotonin and norepinephrine reuptake inhibitors), there have been spontaneous reports of adverse events occurring upon discontinuation of these drugs, particularly when abrupt, including the following: dysphoric mood, irritability, agitation, dizziness, sensory disturbances (e.g., paresthesias such as electric shock sensations), anxiety, confusion, headache, lethargy, emotional lability, insomnia, and hypomania. While these events are generally self-limiting, there have been reports of serious discontinuation symptoms.
Patients should be monitored for these symptoms when discontinuing treatment with escitalopram oxalate tablets. A gradual reduction in the dose rather than abrupt cessation is recommended whenever possible. If intolerable symptoms occur following a decrease in the dose or upon discontinuation of treatment, then resuming the previously prescribed dose may be considered. Subsequently, the physician may continue decreasing the dose but at a more gradual rate.
Abnormal Bleeding: Published case reports have documented the occurrence of bleeding episodes in patients treated with psychotropic drugs that interfere with serotonin reuptake. Subsequent epidemiological studies, both of the case-control and cohort design, have demonstrated an association between use of psychotropic drugs that interfere with serotonin reuptake and the occurrence of upper gastrointestinal bleeding. In two studies, concurrent use of a Nonsteroidal anti-inflammatory drug (NSAID) or aspirin potentiated the risk of bleeding.
Hyponatremia: Cases of hyponatremia and SIADH (syndrome of inappropriate antidiuretic hormone secretion) have been reported in association with Escitalopram oxalate tablets treatment. All patients with these events have recovered with discontinuation of escitalopram and/or medical intervention. Hyponatremia and SIADH have also been reported in association with other marketed drugs effective in the treatment of major depressive disorder.
Activation of Mania/Hypomania: One additional case of hypomania has been reported in association with Escitalopram oxalate tablets treatment. 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. As with all drugs effective in the treatment of major depressive disorder, escitalopram oxalate tablets should be used cautiously in patients with a history of mania.
Seizures: Although anticonvulsant effects of racemic citalopram have been observed in animal studies, Escitalopram oxalate tablets have not been systematically evaluated in patients with a seizure disorder. In clinical trials of Escitalopram oxalate tablets, cases of convulsion have been reported in association with Escitalopram oxalate tablets treatment.
Interference with Cognitive and Motor Performance: In a study in normal volunteers, Escitalopram oxalate tablets 10 mg/day did not produce impairment of intellectual function or psychomotor performance.
Use in Patients with Concomitant Illness: Clinical experience with Escitalopram oxalate tablets in patients with certain concomitant systemic illnesses is limited. Caution is advisable in using Escitalopram oxalate tablets in patients with diseases or conditions that produce altered metabolism or hemodynamic responses. Patients should be cautioned about the risk of serotonin syndrome with the concomitant use of Escitalopram oxalate tablets and triptans, tramadol or other serotonergic agents. Patients should be cautioned about the concomitant use of escitalopram oxalate tablets and NSAIDs, aspirin, or other drugs that affect coagulation since the combined use of psychotropic drugs that interfere with serotonin reuptake and these agents has been associated with an increased risk of bleeding. Patients should be advised to notify their physician if they become pregnant or intend to become pregnant during therapy. Patients should be advised to notify their physician if they are breastfeeding an infant.
Use in the Elderly: Approximately 6% of the 1144 patients receiving escitalopram in controlled trials of Escitalopram oxalate tablets in major depressive disorder and GAD were 60 years of age or older; elderly patients in these trials received daily doses of escitalopram oxalate tablets between 10 and 20 mg. The number of elderly patients in these trials was insufficient to adequately assess for possible differential efficacy and safety measures on the basis of age. Nevertheless, greater sensitivity of some elderly individuals to effects of Escitalopram oxalate tablets cannot be ruled out.