Index of drugs

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

1 tabl powl. contains 5 mg, 10 mg or 20 mg of escitalopram (in the form of oxalate). 1 tabl orally disintegrating contains 5 mg, 10 mg, 15 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. 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. Metabolism is mainly mediated by the CYP2C19 isoenzyme, to a lesser extent CYP3A4 and CYP2D6. T_0,5 escitalopram in the elimination phase after repeated administration is about 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 other ingredients of the preparation. Simultaneous treatment with non-selective, irreversible MAO inhibitors. Concomitant treatment with reversible MAO-A inhibitors (e.g., moclobemide) or reversible, non-selective MAO inhibitors (e.g., linezolidem). Patients with known or congenital QT prolongation syndrome. Simultaneous use with drugs that prolong the QT interval.

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 is made on the basis of existing clinical need to initiate treatment, the patient should be closely monitored for signs of suicidal tendencies. The lack of long-term data on the safety of the medicine in children and adolescents, affecting the growth, maturation and cognitive, emotional 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 that can occur within 2 weeks of uninterrupted treatment. The use of escitalopram should be discontinued if the patient experiences convulsions for the first time or there is an increased frequency of seizures (in patients with diagnosed epilepsy).In patients with uncontrolled epilepsy, SSRIs should be avoided and patients with controlled epilepsy should remain under strict 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 - you may need to adjust your insulin dose 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). Caution is advised with simultaneous treatment with escitalopram and electroconvulsive therapy. Due to the risk of serotonin syndrome, caution should be exercised when using escitalopram with serotoninergic agents; drug should be discontinued if symptoms of serotonin syndrome appear (agitation, muscle tremors, myoclonic seizures and hyperthermia). When taking concomitant preparations with St John's wort, the incidence of side effects may increase. 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. Escitalopram causes a dose-dependent prolongation of the QT interval. There have been post-marketing reports of QT prolongation and ventricular arrhythmia, including type-related disorderstorsade de pointes, especially in women with hypokalemia or with pre-existing QT prolongation or other heart diseases. Caution should be exercised in patients with significant bradycardia and in patients who have recently had an acute myocardial infarction or decompensated heart failure. Electrolyte disturbances, such as hypokalaemia and hypomagnesaemia, increase the risk of malignant arrhythmias and should be compensated before treatment with escitalopram. In patients with chronic cardiac disease, ECG should be considered before starting treatment. If signs of cardiac arrhythmias occur during treatment with es citalopram, treatment should be discontinued and an ECG should be performed. Due to the risk of mydriasis, caution should be exercised when using escitalopram in patients with closed-angle glaucoma or with glaucoma. The preparation contains lactose and should not be used in patients with hereditary galactose intolerance, Lapp lactase deficiency 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. Avoid sudden interruption of treatment during pregnancy. Newborns should be observed whose mothers took the drug later in pregnancy; these newborns may have symptoms caused by serotonergic effects or withdrawal symptoms; in most cases, complications appear directly or <24 h after delivery. The use of SSRIs during pregnancy, especially in the late period, may increase the risk of persistent pulmonary hypertension in newborns. Escitalopram is presumed to be excreted in human milk - breast-feeding is not recommended. Animal studies have shown that citalopram can affect the quality of semen. From the case reports of some SSRIs in humans, the effect on sperm quality is transient. No effects on human fertility have been observed so far.

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 often: nausea, headache.Common: decreased appetite, increased appetite, increased body weight, anxiety, anxiety, unusual dreams, decreased libido, lack of orgasm in women, insomnia, drowsiness, dizziness, paresthesia, tremors, sinusitis, yawning, diarrhea, constipation, vomiting, dryness in the mouth, increased sweating, joint pain, muscle pain; ejaculation and impotence disorders in men, feeling tired, fever. Uncommon: weight loss, bruxism, agitation, nervousness, panic attacks, confusion, taste disturbances, sleep disorders, syncope, mydriasis, visual disturbances, tinnitus, tachycardia, nosebleeds, gastrointestinal bleeding (including bleeding from the anus), hepatitis, abnormal liver function tests, urticaria, alopecia, rash, pruritus, edema; Uterine haemorrhage and menorrhagia in women. Rarely: anaphylactic reaction, 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 prolongation in ECG, ventricular arrhythmia (incl.torsade de pointes), orthostatic hypotension, subcutaneous haemorrhage, angioneurotic edema, urinary retention, amlectomy; priapism in men. Cases of QT prolongation and ventricular arrhythmia, includingtorsade de pointes, especially in women with hypokalemia or with pre-existing QT prolongation or other heart diseases. Epidemiological studies, conducted mainly in patients from 50 years of age, showed an increased risk of bone fractures in the group of patients receiving SSRIs 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 (insomnia, expressive dreams), agitation or anxiety, nausea and / or vomiting, trembling, confusion, excessive sweating, headache, diarrhea, palpitations, emotional instability, irritability, blurred vision.

Orally. Adults.Major depressive disorders: usually 10 mg once a day. Depending on the patient's response, the dose may be increased up to a maximum 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. The dose can then be increased to a maximum of 20 mg daily, depending on the patient's response. The maximum effectiveness is achieved after about 3 months of use of the preparation; the treatment lasts several months.Social phobia: usually 10 mg once a day. Symptoms usually resolve after 2-4 weeks of treatment. The dose can then be reduced to 5 mg / day or increased to a maximum of 20 mg / day, depending on the patient's response. Treatment should be continued for at least 12 weeks to help maintain a response. Individually, 6-month therapy can be considered for the purpose of preventing the recurrence of the disease.Generalized anxiety disorder: initially 10 mg once a day. Depending on the patient's response, the dose may be increased up to a maximum of 20 mg per day. The treatment lasts several months.Obsessive-compulsive disorder: initially 10 mg once a day. Depending on the patient's response, the dose may be increased up to a maximum of 20 mg per day. Treatment should be continued for a long time to ensure that the symptoms of the disease are gone.Special groups of patients. In elderly patients, at the initial stage of treatment, half of the usual recommended dose and administration of a lower maximum dose should be considered; the efficacy of escitalopram in the treatment of social phobia in the elderly has not been studied. There is no need to modify the dosage in patients with mild or moderate renal impairment. In patients with mild to moderate hepatic impairment and in patients who metabolise CYP2C19 slowly, in the first 2 weekstreatment is recommended to use an initial dose of 5 mg per day; depending on the patient's response to treatment, the dose can be increased to 10 mg daily. Do not use in children and adolescents <18 years.Way of giving. Table. powl. can be taken with or without food. Table. disintegrating in the mouth should not be taken with a meal. The orodispersible tablet should be placed in the mouth, on the tongue, where it will quickly disintegrate and can easily be swallowed without drinking water. The tablet is brittle and must be handled with care; there is no dividing line and it can not be divided into equal doses. Orally disintegrating tablets are the preferred pharmaceutical form for patients who have trouble swallowing traditional tablets or in situations where there is no fluid to break the tablet. Escitalopram in the form of orally disintegrating tablets is bioequivalent to escitalopram in the form of coated tablets, showing a similar rate and extent of absorption (these forms may be used interchangeably).