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Escitalopram Capsules are indicated:
Escitalopram is contraindicated in patients
Serotonin Syndrome: Escitalopram can precipitate serotonin syndrome, a potentially life-threatening condition. The risk is increased with concomitant use of other serotonergic drugs (including triptans, tricyclic antidepressants, fentanyl, meperidine, methadone, lithium, tramadol, tryptophan, buspirone, amphetamines, and St. John’s Wort) and with drugs that impair metabolism of serotonin, i.e., MAOIs. Serotonin syndrome can also occur when these drugs are used alone.
Discontinuation Syndrome: Adverse reactions after discontinuation of serotonergic antidepressants, particularly after abrupt discontinuation, include: nausea, sweating, dysphoric mood, irritability, agitation, dizziness, sensory disturbances (e.g., paresthesia, such as electric shock sensations), tremor, anxiety, confusion, headache, lethargy, emotional lability, insomnia, hypomania, tinnitus, and seizures. A gradual reduction in dosage rather than abrupt cessation is recommended whenever possible.
Seizures: In clinical trials of another escitalopram product, cases of convulsion have been reported in association with escitalopram treatment. Like other drugs effective in the treatment of MDD, Escitalopram Capsules should be introduced with care in patients with a history of seizure disorder.
Activation of Mania or Hypomania: In patients with bipolar disorder, treating a depressive episode with Escitalopram Capsules or another antidepressant may precipitate a mixed/manic episode.
Hyponatremia: Hyponatremia may occur as a result of treatment. In many cases, this hyponatremia appears to be the result of the syndrome of inappropriate antidiuretic hormone secretion (SIADH) and was reversible when escitalopram was discontinued. Cases with serum sodium lower than 110 mmol/L have been reported with another escitalopram product. Geriatric patients may be at greater risk of developing hyponatremia with SSRIs and SNRIs (Escitalopram Capsules are not indicated in geriatric patients). Also, patients taking diuretics or who are otherwise volume depleted may be at greater risk. Consider discontinuing Escitalopram Capsules in patients with symptomatic hyponatremia and institute appropriate medical intervention.
Increased Risk of Bleeding: Escitalopram Capsules increase the risk of bleeding events. Concomitant use of aspirin, nonsteroidal anti-inflammatory drugs (NSAIDs), other antiplatelet drugs, warfarin, and other anticoagulants may add to the risk. Case reports and epidemiological studies (case-control and cohort design) have demonstrated an association between use of drugs that interfere with serotonin reuptake and the occurrence of gastrointestinal bleeding. Based on data from the published observational studies, exposure to SSRIs, particularly in the month before delivery, has been associated with a less than 2-fold increase in the risk of postpartum hemorrhage. Bleeding events related to drugs that interfere with serotonin reuptake have ranged from ecchymoses, hematomas, epistaxis, and petechiae to life-threatening hemorrhages.
Interference with Cognitive and Motor Performance: Because any psychoactive drug may impair judgment, thinking, or motor skills, patients should be cautioned about operating hazardous machinery, including automobiles, until they are reasonably certain that Escitalopram Capsules do not affect their ability to engage in such activities.
Angle Closure Glaucoma: The pupillary dilation that occurs following use of many antidepressant drugs, including Escitalopram Capsules, may trigger an angle closure attack in a patient with anatomically narrow angles who does not have a patent iridectomy. Avoid use of antidepressants, including Escitalopram Capsules, in patients with untreated anatomically narrow angles.
Use in Patients with Concomitant Illness: Caution is advisable in using escitalopram in patients with diseases or conditions that produce altered metabolism or hemodynamic responses.
In subjects with hepatic impairment, clearance of racemic citalopram was decreased and plasma concentrations were increased. Escitalopram Capsules are not recommended in patients with hepatic impairment.
Pharmacokinetics of escitalopram in patients with a creatinine clearance less than 20 mL/minute has not been evaluated, however, it should be used with caution in such patients.
Sexual Dysfunction: Use of SSRIs, including Escitalopram Capsules, may cause symptoms of sexual dysfunction. In male patients, SSRI use may result in ejaculatory delay or failure, decreased libido, and erectile dysfunction. In female patients, SSRI use may result in decreased libido and delayed or absent orgasm.
The most common adverse reactions in clinical trials included: insomnia, ejaculation disorder (primarily ejaculatory delay), nausea, increased sweating, fatigue and somnolence, decreased libido, and anorgasmia.
Consider the risk of untreated depression when discontinuing or changing treatment with antidepressant medication during pregnancy and postpartum.
Use of Escitalopram Capsules in the month before delivery may be associated with an increased risk of postpartum hemorrhage.
Neonates exposed to SSRIs or SNRIs, including Escitalopram Capsules, late in third trimester have developed complications requiring prolonged hospitalization, respiratory support, and tube feeding. Such complications can arise immediately upon delivery.
Infants exposed to Escitalopram Capsules should be monitored for excess sedation, restlessness, agitation, poor feeding and poor weight gain.
The safety and effectiveness of Escitalopram Capsules for the treatment of MDD have not been established in pediatric patients younger than 12 years of age.
Escitalopram Capsules are not recommended in patients with hepatic impairment.
For additional safety information about Escitalopram Capsules, please see the Full Prescribing Information including Boxed Warning and Medication Guide.
