However, there are limited in vivo data suggesting a modest CYP2D6 inhibitory effect for escitalopram, i. The clinical significance of this finding is unknown. Nevertheless, caution is indicated in the coadministration of escitalopram and drugs metabolized by CYP2D6. Increased metoprolol plasma levels have been associated with decreased cardioselectivity. Coadministration of escitalopram and metoprolol had no clinically significant effects on blood pressure or heart rate.

Slight maternal toxicity clinical signs and decreased body weight gain and food consumption was seen at this dose. This dose was also associated with maternal toxicity clinical signs, decreased body weight gain. Thus, teratogenic effects of racemic citalopram were observed at a maternally toxic dose in the rat and were not observed in the rabbit. When female rats were treated with racemic citalopram 4. The no-effect dose was A no-effect dose was not determined in that study.

There are no adequate and well-controlled studies in pregnant women; therefore, escitalopram should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Pregnancy-Nonteratogenic Effects Neonates exposed to escitalopram and other SSRIs or serotonin and norepinephrine reuptake inhibitors SNRIs , late in the third trimester have developed complications requiring prolonged hospitalization, respiratory support and tube feeding. Such complications can arise immediately upon delivery.

Reported clinical findings have included respiratory distress, cyanosis, apnea, seizures, temperature instability, feeding difficulty, vomiting, hypoglycemia, hypotonia, hypertonia, hyperreflexia, tremor, jitteriness, irritability, and constant crying.

It should be noted that, in some cases, the clinical picture is consistent with serotonin syndrome [see Warnings and Precautions 5. PPHN occurs in 1 to 2 per 1, live births in the general population and is associated with substantial neonatal morbidity and mortality. Other studies do not show a significant statistical association. Physicians should also note the results of a prospective longitudinal study of pregnant women with a history of major depression, who were either on antidepressants or had received antidepressants less than 12 weeks prior to their last menstrual period, and were in remission.

Women who discontinued antidepressant medication during pregnancy showed a significant increase in relapse of their major depression compared to those women who remained on antidepressant medication throughout pregnancy. When treating a pregnant woman with escitalopram, the physician should carefully consider both the potential risks of taking an SSRI, along with the established benefits of treating depression with an antidepressant.

This decision can only be made on a case by case basis [see Dosage and Administration 2. Labor and Delivery The effect of escitalopram on labor and delivery in humans is unknown.

Nursing Mothers Escitalopram is excreted in human breast milk. Limited data from women taking 10 mg to 20 mg escitalopram showed that exclusively breast-fed infants receive approximately 3. There were two reports of infants experiencing excessive somnolence, decreased feeding, and weight loss in association with breast-feeding from a racemic citalopram-treated mother; in one case, the infant was reported to recover completely upon discontinuation of racemic citalopram by its mother and, in the second case, no follow-up information was available.

Caution should be exercised and breast-feeding infants should be observed for adverse reactions when escitalopram is administered to a nursing woman. Pediatric Use The safety and effectiveness of escitalopram have been established in adolescents 12 to 17 years of age for the treatment of major depressive disorder [see Clinical Studies Although maintenance efficacy in adolescent patients with major depressive disorder has not been systematically evaluated, maintenance efficacy can be extrapolated from adult data along with comparisons of escitalopram pharmacokinetic parameters in adults and adolescent patients.

The safety and effectiveness of escitalopram have not been established in pediatric younger than 12 years of age patients with major depressive disorder. In a week, open-label safety study in children aged 7 to 11 years who had major depressive disorder, the safety findings were consistent with the known safety and tolerability profile for escitalopram.

Safety and effectiveness of escitalopram has not been established in pediatric patients less than 18 years of age with Generalized Anxiety Disorder.

Decreased appetite and weight loss have been observed in association with the use of SSRIs. Consequently, regular monitoring of weight and growth should be performed in children and adolescents treated with an SSRI such as escitalopram. 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 cannot be ruled out.

SSRIs and SNRIs, including escitalopram, have been associated with cases of clinically significant hyponatremia in elderly patients, who may be at greater risk for this adverse event [see Hyponatremia 5. Of 4, patients in clinical studies of racemic citalopram, 1, were 60 and over, 1, were 65 and over, and were 75 and over.

No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but again, greater sensitivity of some elderly individuals cannot be ruled out.

Drug Abuse and Dependence Abuse and Dependence Physical and Psychological Dependence Animal studies suggest that the abuse liability of racemic citalopram is low. Escitalopram has not been systematically studied in humans for its potential for abuse, tolerance or physical dependence.

The premarketing clinical experience with escitalopram did not reveal any drug seeking behavior. Consequently, physicians should carefully evaluate escitalopram patients for history of drug abuse and follow such patients closely, observing them for signs of misuse or abuse e.

Overdosage Human Experience In clinical trials of escitalopram, there were reports of escitalopram overdose, including overdoses of up to mg, with no associated fatalities. During the post-marketing evaluation of escitalopram, escitalopram overdoses involving overdoses of over 1, mg have been reported. As with other SSRIs, a fatal outcome in a patient who has taken an overdose of escitalopram has been rarely reported.

Acute renal failure has been very rarely reported accompanying overdose. 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 escitalopram. 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. Escitalopram is the pure S-enantiomer single isomer of the racemic bicyclic phthalane derivative citalopram. Escitalopram oxalate, USP occurs as a fine, white to slightly-yellow powder and is freely soluble in methanol and dimethyl sulfoxide DMSO , soluble in isotonic saline solution, sparingly soluble in water and ethanol, slightly soluble in ethyl acetate, and insoluble in heptane.

Escitalopram Tablets are film-coated, round tablets containing escitalopram oxalate in strengths equivalent to 5 mg, 10 mg, and 20 mg escitalopram base. Before using this medication , tell your doctor or pharmacist your medical history, especially of: Escitalopram may cause a condition that affects the heart rhythm QT prolongation. The risk of QT prolongation may be increased if you have certain medical conditions or are taking other drugs that may cause QT prolongation.

Before using escitalopram, tell your doctor or pharmacist of all the drugs you take and if you have any of the following conditions: Low levels of potassium or magnesium in the blood may also increase your risk of QT prolongation. Talk to your doctor about using escitalopram safely. This drug may make you dizzy or drowsy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely.

Ask your doctor or pharmacist about using this medication safely. Before having surgery, tell your doctor or dentist about all the products you use including prescription drugs , nonprescription drugs, and herbal products. Older adults may be more sensitive to the side effects of this drug, such as QT prolongation see above , loss of coordination, or bleeding. They may also be more likely to lose too much salt hyponatremia , especially if they are also taking "water pills" diuretics with this medication.

Loss of coordination can increase the risk of falling. Children may be more sensitive to the side effects of this drug, especially loss of appetite and weight loss. Monitor weight and height in children who are taking this drug. During pregnancy , this medication should be used only when clearly needed.

It may harm an unborn baby. If you notice any of these symptoms in your newborn , tell the doctor promptly. If you are planning pregnancy, become pregnant , or think you may be pregnant, immediately discuss with your doctor the benefits and risks of using this medication during pregnancy. This medication passes into breast milk and may have undesirable effects on a nursing infant.

Tell your doctor immediately if you experience these symptoms. These may be increased when first starting antidepressants, since these medicines all take time to work, usually about two weeks but sometimes longer. You may be more likely to think like this: Information from clinical trials has shown an increased risk of suicidal behaviour in adults aged less than 25 years with psychiatric conditions who were treated with an antidepressant.

If you have thoughts of harming or killing yourself at any time, contact your doctor or go to a hospital straight away. You may find it helpful to tell a relative or close friend that you are depressed or have an anxiety disorder, and ask them to read this leaflet. You might ask them to tell you if they think your depression or anxiety is getting worse, or if they are worried about changes in your behaviour.

Children and adolescents under 18 years of age Cipralex should normally not be used for children and adolescents under 18 years. Also, you should know that patients under 18 have an increased risk of side effects such as suicide attempts, suicidal thoughts and hostility predominately aggression, oppositional behaviour and anger when they take this class of medicines.

If your doctor has prescribed Cipralex for a patient under 18 and you want to discuss this, please go back to your doctor. You should inform your doctor if any symptoms listed above develop or worsen when patients under 18 are taking Cipralex. Also, the long term safety effects concerning growth, maturation and cognitive and behavioural development of Cipralex in this age group have not yet been demonstrated.

Other medicines and Cipralex Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Tell your doctor if you are taking any of the following medicines: If you have taken any of these medicines you will need to wait 14 days before you start taking Cipralex.

After stopping Cipralex you must allow 7 days before taking any of these medicines. These increase the risk of side effects. Long-term treatment of responders has been studied for 6 months and can be considered on an individual basis to prevent relapse; treatment benefits should be re-evaluated at regular intervals. Social anxiety disorder is a well-defined diagnostic terminology of a specific disorder, which should not be confounded with excessive shyness.

Pharmacotherapy is only indicated if the disorder interferes significantly with professional and social activities. The place of this treatment compared to cognitive behavioural therapy has not been assessed. Pharmacotherapy is part of an overall therapeutic strategy.

Generalised anxiety disorder Initial dosage is 10 mg once daily. Depending on the individual patient response, the dose may be increased to a maximum of 20 mg daily. Long-term treatment of responders has been studied for at least 6 months in patients receiving 20 mg daily. Treatment benefits and dose should be re-evaluated at regular intervals see Section 5.

Obsessive-Compulsive Disorder Initial dosage is 10 mg once daily. As OCD is a chronic disease, patients should be treated for a sufficient period to ensure that they are symptom free. Treatment benefits and dose should be re-evaluated at regular intervals see section 5.

Depending on individual patient response the dose may be increased to 10 mg daily see section 5. The efficacy of Escitalopram in social anxiety disorder has not been studied in elderly patients. Reduced renal function Dosage adjustment is not necessary in patients with mild or moderate renal impairment. Reduced hepatic function An initial dose of 5 mg daily for the first two weeks of treatment is recommended in patients with mild or moderate hepatic impairment.

Depending on individual patient response, the dose may be increased to 10 mg daily. Caution and extra careful dose titration is advised in patients with severely reduced hepatic function see section 5.

Poor metabolisers of CYP2C19 For patients who are known to be poor metabolisers with respect to CYP2C19, an initial dose of 5 mg daily during the first two weeks of treatment is recommended. Depending on individual patient response, the dose may be increased to 10 mg daily see section 5. Discontinuation symptoms seen when stopping treatment Abrupt discontinuation should be avoided. When stopping treatment with Escitalopram the dose should be gradually reduced over a period of at least one to two weeks in order to reduce the risk of discontinuation symptoms see section 4.

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. For the different dosages, film-coated tablets of 5 mg, 10 mg, 15 mg and 20 mg are available. Paediatric Population Escitalopram should not be used in the treatment of children and adolescents under the age of 18 years.

Patients with these diagnoses were generally excluded from clinical studies during the product's premarketing testing. In subjects with hepatic impairment, clearance of racemic citalopram was decreased and plasma concentrations were increased. Because escitalopram is extensively metabolized, excretion of unchanged drug in urine is a minor route of elimination. Until adequate numbers of patients with severe renal impairment have been evaluated during chronic treatment with escitalopram oxalate, however, it should be used with caution in such patients [ see Dosage and Administration 2.

Clinical Trial Data Sources Pediatrics 6 to 17 years Adverse events were collected in pediatric patients escitalopram oxalate, placebo with major depressive disorder in double-blind placebo-controlled studies.

Safety and effectiveness of escitalopram oxalate in pediatric patients less than 12 years of age has not been established. Adults Adverse events information for escitalopram oxalate was collected from patients with major depressive disorder who were exposed to escitalopram and from patients who were exposed to placebo in double-blind, placebo-controlled trials.

An additional patients with major depressive disorder were newly exposed to escitalopram in open-label trials. The adverse event information for escitalopram oxalate in patients with GAD was collected from patients exposed to escitalopram and from patients exposed to placebo in double-blind, placebo-controlled trials.

Adverse events during exposure were obtained primarily by general inquiry and recorded by clinical investigators using terminology of their own choosing. Consequently, it is not possible to provide a meaningful estimate of the proportion of individuals experiencing adverse events without first grouping similar types of events into a smaller number of standardized event categories.

In the tables and tabulations that follow, standard World Health Organization WHO terminology has been used to classify reported adverse events.

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