Index of drugs

Treatment of major depressive episodes. Treatment of panic disorders with agoraphobia or without agoraphobia. Treatment of social anxiety disorder (social phobia). Treatment of obsessive-compulsive disorders.

1 tabl powl. contains 10 mg or 20 mg of escitalopram (in the form of oxalate). The preparation contains lactose.

Antidepressant - a selective serotonin reuptake inhibitor with high affinity to the primary binding site. It also binds to the allosteric site on the serotonin transporter, with a 1000-fold lower affinity. Escitalopram has no affinity or has low affinity for many receptors, including 5-HT receptors_1A, 5-HT₂, DA, D₁ and D₂, α receptors₁-, α₂- and β-adrenergic and histamine H-receptors₁, cholinergic muscarinic receptors, benzodiazepine receptors and opioid receptors. After oral administration, the drug is absorbed almost completely, regardless of food intake (bioavailability is about 80%), reaching a maximum concentration in the blood within 4 hours after repeated administration. Escitalopram and its major metabolites bind to plasma proteins in less than 80%. The drug is metabolized in the liver to the demethylated and didemethylated metabolites, which are pharmacologically active; or a metabolite in the form of an N-oxide may be formed. Metabolism is mainly mediated by the CYP2C19 isoenzyme, CYP3A4 and CYP2D6 are also possible. T_0,5 escitalopram in the elimination phase after repeated administration is approx. 30 h. T_0,5 major metabolites are significantly longer. Most of the dose is excreted in the form of metabolites in the urine.

Hypersensitivity to escitalopram or any of the excipients. Simultaneous treatment with non-selective, irreversible MAO inhibitors. Concomitant treatment with reversible MAO-A inhibitors (e.g., moclobemide) or a reversible, non-selective MAO inhibitor (e.g., linezolidem). Patients with known QT prolongation or congenital long QT syndrome. Simultaneous treatment with other drugs that cause QT prolongation.

It should not be used in children and adolescents under 18 years of age. Suicidal behaviors (suicide attempts and suicidal thoughts) and hostility (especially aggression, rebel behavior, anger symptoms) were more frequently observed in clinical trials in children and adolescents treated with antidepressants than in the placebo group. If a decision to treat is made based on an existing clinical need, the patient should be closely monitored for suicidal tendencies. There are no long-term data on the safety of the medicine in children and adolescents regarding the impact on growth, maturation and cognitive development and behavioral development. Depression is associated with an increased risk of suicidal thoughts, self harm and suicide. This risk persists until significant improvement occurs. The patient should be closely monitored until the appearance of improvement and in the early stages of recovery (increased risk of suicide). In patients treated for other psychiatric disorders, the same precautions should be taken as in patients with a major episode of depression. Patients with a history of suicide-related events or patients exhibiting a significant degree of suicidal ideation prior to commencement of treatment are considered to be at increased risk of suicidal thoughts or suicide attempts and should be closely monitored during treatment, particularly in patients below 25 years of age. In patients with panic disorder, a low starting dose is recommended to reduce the likelihood of anxiety (a paradoxical reaction that usually disappears within 2 weeks of uninterrupted treatment). The use of escitalopram should be discontinued in any patient who experiences a first convulsive seizure or if the frequency of seizures increases in patients with previously diagnosed epilepsy.In patients with uncontrolled epilepsy, SSRIs should be avoided and patients with controlled epilepsy should remain under careful control. Exercise caution in patients with a history of mania and / or hypomania; drug should be discontinued if a manic phase occurs. In diabetic patients, the drug may affect glycemic control - it may be necessary to adjust the dosage of insulin and / or oral hypoglycemic agents. In patients with symptoms of akathisia, increasing the dose may be harmful. Exercise caution in patients at increased risk of hyponatraemia (elderly patients, patients with liver cirrhosis, and those using medicines that may cause hyponatraemia). Because of the risk of bleeding, caution should be exercised when co-administering oral anticoagulants, drugs that affect platelet function (eg atypical antipsychotics, phenothiazine derivatives, most tricyclic antidepressants, Acetylsalicylic acid, NSAIDs, ticlopidine, dipyridamole) and in patients diagnosed with tendency to bleed. Caution is advised with simultaneous treatment with escitalopram and electroconvulsive therapy (limited clinical experience). Due to the risk of serotonin syndrome, caution should be exercised when using escitalopram with serotonergic agents (eg: Sumatriptan, other triptans, tramadol, tryptophan); drug should be discontinued if symptoms of serotonin syndrome appear (agitation, muscle tremors, myoclonic seizures and hyperthermia). Caution should be exercised in patients with ischemic heart disease and in patients with severe renal impairment (creatinine clearance less than 30ml / min). Take special care when adjusting the dose in patients with severe hepatic impairment. There have been post-marketing reports of QT prolongation and ventricular anomalies, including type-related disorderstorsade de pointes, mainly in women, in patients with hypokalemia and in patients with pre-existing QT prolongation or other heart diseases. Caution should be exercised when using escitalopram in patients with significant bradycardia, recent acute myocardial infarction or uncompensated heart failure. Electrolyte abnormalities such as hypokalemia and hypomagnesaemia increase the risk of malignant arrhythmias and should be compensated before starting treatment. In patients with stable cardiac disease, ECG should be performed prior to initiating treatment with escitalopram. If cardiac arrhythmia occurs during use of es citalopram, discontinue treatment and ECG. In patients with a history of glaucoma and patients with closed-angle glaucoma, escitalopram should be used with caution. The preparation contains lactose - should not be used in patients with rare hereditary galactose intolerance, lactase deficiency (Lapp type) or malabsorption of glucose-galactose.

It should not be used during pregnancy unless clearly necessary and only after careful consideration of the risk / benefit ratio. The newborn should be observed if the woman continued to use the product later in pregnancy, especially in the third trimester. Avoid stopping the drug during pregnancy. Maternal use of an SSRI / SNRI drug in later pregnancy may cause the following symptoms in the newborn: respiratory disorders, cyanosis, apnea, convulsions, body temperature fluctuations, feeding difficulties, vomiting, hypoglycaemia, increased or decreased muscle tone, hyperreflexia, tremor muscular, agitated, irritable, lethargic, continuous crying, drowsiness and difficulty falling asleep. These symptoms may result from both serotoninergic and withdrawal effects. In most cases, they occur directly or soon (<24 hours) after delivery. The results of epidemiological studies indicate that the use of SSRI in pregnant women, especially in the third trimester, may increase the risk of persistent pulmonary hypertension of the newborn (PPHN). Escitalopram is presumed to be excreted in human breast milk - breast-feeding is not recommended during treatment.

Side effects are most common during the first or second week of treatment and usually their severity and incidence decreases with continuation of treatment.Very common: headache, nausea. Common: reduced appetite, increased appetite, increased body weight, anxiety, restlessness, unusual dreams, decreased sex drive in men and women, lack of orgasm in women, insomnia, drowsiness, dizziness, paresthesia, muscle tremors, sinusitis, yawning, diarrhea, constipation, vomiting, dry mouth, increased sweating, joint pain, muscle pain, fatigue, fever, men: ejaculation disorders, impotence. Uncommon: weight loss, bruxism, agitation, nervousness, panic attacks, confusion, taste disturbances, sleep disturbances, fainting, mydriasis, visual disturbances, tinnitus, tachycardia, nosebleeds, gastrointestinal bleeding (including bleeding from the anus), urticaria, alopecia, rash, pruritus, edema, women: uterine haemorrhage, menorrhagia. Rare: anaphylactic reactions, aggression, depersonalization, hallucinations, serotonin syndrome, bradycardia. Not known: thrombocytopenia, abnormal ADH secretion, hyponatremia, anorexia, mania, suicidal thoughts and behaviors, dyskinesia, movement disorders, convulsions, psychomotor anxiety / akathisia, QT interval prolongation, ventricular arrhythmia (alsotorsade de pointes), orthostatic hypotension, hepatitis, abnormal liver test results, petechiae, angioneurotic edema, urinary retention, galactorrhea, men: priapism. There have been post-marketing reports of QT prolongation and ventricular anomalies, including type disorderstorsade de pointes, mainly in women, in people with hypokalemia and in patients with pre-existing QT prolongation or other heart diseases. The results of epidemiological studies conducted mainly among patients aged 50 and more indicate an increased risk of bone fractures in patients taking serotonin reuptake inhibitors and tricyclic antidepressants.
Discontinuation of the drug (especially sudden) often leads to withdrawal symptoms. The most common are: dizziness, sensory disturbances (including paresthesia and the sensation of electric shock), sleep disorders (including insomnia and expressive dreams), agitation or anxiety, nausea and / or vomiting, muscle tremor, confusion, excessive sweating, pain headaches, diarrhea, palpitations, emotional instability, irritability and blurred vision.

Oral: Adults.Big episodes of depression: usually 10 mg once a day. Depending on the patient's individual response, the dose can be increased up to a maximum dose of 20 mg per day. Antidepressant effect usually occurs after 2-4 weeks of use of the drug. After symptoms have resolved, treatment should be continued for at least 6 months to help maintain response.Panic disorder with agoraphobia or without agoraphobiaIn the first week of treatment, an initial dose of 5 mg once a day is recommended, followed by an increase of up to 10 mg daily. Depending on the patient's individual response, the dose can be increased up to a maximum dose of 20 mg per day. The highest effectiveness is achieved after about 3 months of use of the preparation; the treatment lasts several months.Social anxiety disorder: usually 10 mg once a day. The improvement of the clinical condition usually takes after 2-4 weeks of treatment. Depending on the patient's individual response, the dose may then be reduced to 5 mg or increased to a maximum dose of 20 mg per day. It is recommended to continue treatment for at least 12 weeks in order to consolidate the response to treatment. Long-term treatment of patients responding to treatment has been studied for 6 months and may be considered individually to prevent the recurrence of the disease; the effects of treatment should be regularly evaluated. The position of the treatment in question in relation to cognitive-behavioral therapy has not been evaluated. Pharmacotherapy is part of comprehensive therapeutic treatment.Obsessive-compulsive disorderThe starting dose is 10 mg once a day. Depending on the patient's individual response, the dose can be increased up to a maximum dose of 20 mg per day. Patients should be treated for a sufficiently long period of time to ensure that their symptoms are gone. Therapeutic benefits and the dose used should be regularly evaluated. In elderly patients (> 65 years), the initial dose is 5 mg once a day.Depending on the patient's individual response, the dose may be increased up to a maximum dose of 10 mg per day. The efficacy of the preparation in panic disorder in elderly patients has not been studied. No dosage adjustment is necessary in patients with mild or moderate renal impairment. In patients with mild or moderate hepatic impairment an initial dose of 5 mg daily for the first 2 weeks of treatment is recommended. Depending on the patient's individual response, the dose may be increased to 10 mg daily. In patients with severe hepatic impairment, caution should be exercised when adjusting the dose. Patients known to be slow metabolizing CYP2C19 medication should receive an initial dose of 5 mg daily for the first 2 weeks of treatment. Depending on the patient's individual response, the dose may be increased to 10 mg daily.
The safety of using a daily dose of more than 20 mg has not been demonstrated. The preparation can be taken with or without food.