Index of drugs

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

1 tabl powl. contains 10 mg of escitalopram (in the form of oxalate).

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. It is also possible to form the metabolite in the form of an N-oxide. Metabolism is mainly mediated by CYP2C19, to a lesser extent CYP3A4 and CYP2D6. 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 the active substance or any of the excipients. Simultaneous treatment with non-selective, irreversible MAO inhibitors (risk of serotonin syndrome). Combination therapy with reversible MAO-A inhibitors (eg, moclobemide) or a reversible non-selective MAO inhibitor linezolid (risk of serotonin syndrome). Patients with known QT prolongation or congenital long QT syndrome. Concomitant use with other drugs that prolong the QT interval. Concomitant use with irreversible selective MAO-B inhibitors.

The preparation should not be used to treat 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, based on clinical indications, however, a decision to treat is made, the patient should be carefully monitored for suicidal tendencies. In addition, the lack of long-term safety data for children and adolescents regarding the impact on growth, maturation and cognitive development and behavioral development. Due to the risk of QT prolongation, caution should be exercised in patients with significant bradycardia and in patients with recent myocardial infarction or decompensated heart failure. Electrolyte disturbances, such as hypokalaemia and hypomagnesaemia, increase the risk of malignant arrhythmias and should be corrected before initiating treatment with escitalopram. Before starting treatment for patients with stable cardiac disease, ECG should be considered. If a patient suffering from escitalopram develops cardiac arrhythmias, treatment should be discontinued and an ECG should be performed. Some patients with panic disorder may experience worsening of anxiety symptoms at the beginning of treatment (this paradoxical response usually disappears within 2 weeks of continued treatment, a low initial dose is recommended to reduce the likelihood of anxiety). The use of the drug should be discontinued in any patient who has seizures. SSRIs should be avoided in patients with uncontrolled epilepsy, and patients with controlled epilepsy should be closely monitored.SSRIs should be discontinued if an increase in seizures occurs. Caution should be exercised when using SSRIs in patients with a history of mania or hypomania. The drug should be discontinued in any patient who develops a manic phase. Psychotic symptoms may deteriorate during the treatment of patients with episodes of psychotic depression. Caution is advised in patients with severe renal impairment (creatinine clearance below 30 ml / min). Caution is advised when increasing the dose in patients with severe hepatic impairment. In patients with diabetes, treatment with SSRIs may affect glycemic control (hypoglycaemia or hyperglycaemia). Dose adjustment of insulin and / or oral hypoglycemic agents may be necessary. Depression is associated with an increased risk of suicidal thoughts, self-harm and suicide (events related to suicide). This risk persists until significant improvement occurs. Patients should be closely monitored until recovery and early recovery from the disease (increased risk of suicide). When treating patients with other mental disorders, the same precautions should be taken as for patients with a major depressive episode. Patients with a history of suicidal ideation or patients exhibiting a significant degree of suicidal tendency before commencing treatment are considered to be at increased risk of suicidal thoughts or suicide attempts and should be closely monitored during treatment, especially those under 25 years of age. During treatment, especially at the beginning of therapy and when the dose is changed, patients should be closely monitored, particularly those at high risk. In patients with symptoms of akathisia, increasing the dose may be harmful. Caution should be exercised in patients at risk for hyponatremia, such as elderly patients, cirrhotic patients or patients treated concurrently with medications that may cause hyponatraemia. Due to the risk of bleeding in the skin, patients treated with SSRIs should be cautious, especially when they are given oral anticoagulants, medicines that affect platelet function (eg atypical neuroleptics and phenothiazine derivatives, the majority of antidepressants on tricyclic structure, Acetylsalicylic acid and NSAIDs, ticlopidine and dipyridamol) and in patients diagnosed with hemorrhagic diathesis. Clinical experience in the concomitant use of SSRIs and electroconvulsive therapy is limited and therefore caution is advised. Due to the risk of serotonin syndrome, caution should be exercised while using escitalopram with serotoninergic drugs such as Sumatriptan or other triptans, tramadol and tryptophan. In case of symptoms of serotonin syndrome, the SSRI drug and the serotoninergic drug should be immediately discontinued and symptomatic treatment initiated. The concomitant use of SSRIs and herbal medicines containing St. John's wort can lead to an increased incidence of side effects. Due to limited clinical experience, caution in patients with ischemic heart disease is recommended. Escitalopram should be used with caution in patients with closed-angle glaucoma or with glaucoma.

Escitalopram should not be used during pregnancy unless absolutely necessary and only after careful consideration of the risk / benefit ratio. Newborns should be observed if the woman continued to use escitalopram later in pregnancy, especially in the third trimester. Avoid sudden drug withdrawal during pregnancy. In neonates whose mothers received SSRI / SRNI in later periods of pregnancy, the following symptoms may occur: respiratory disorders, cyanosis, apnea, convulsions, body temperature fluctuations, feeding difficulties, vomiting, hypoglycaemia, hypertonia, hypotension, hyperreflexia, tremor , trembling, irritability, lethargy, constant crying, drowsiness or difficulty falling asleep. These symptoms may be caused by serotoninergic effects or may occur as withdrawal symptoms. In most cases, these effects appear immediately or soon (<24 hours) after delivery.Epidemiological data allow to conclude that the administration of SSRI during pregnancy, especially in its late period, may increase the risk of persistent pulmonary hypertension of newborns (PPHN). Escitalopram is presumed to be excreted in human milk. For this reason, breast-feeding is not recommended during treatment. 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 common: headache, nausea. Common: reduced appetite, increased appetite, increased body weight, anxiety, nervousness, unusual dreams, decreased libido (women and men), lack of orgasm in women, insomnia, drowsiness, dizziness, paresthesia, tremors, sinusitis, yawning, diarrhea, constipation, vomiting, dry mouth, increased sweating, joint pain, muscle aches, fatigue, fever, men: ejaculation disorders, impotence. Uncommon: weight loss, bruxism, agitation, panic disorder, disorientation, taste disturbances, sleep disturbances, syncope, mydriasis, visual disturbances, tinnitus, tachycardia, nosebleeds, gastrointestinal bleeding (including rectal bleeding ), urticaria, alopecia, rash, erythema, edema, women: uterine haemorrhage, menorrhagia. Rarely: anaphylactic reaction, aggression, depersonalization, hallucinations, serotonin syndrome, bradycardia. Not known: thrombocytopenia, abnormal ADH secretion, hyponatraemia, anorexia, mania, suicidal thoughts and behaviors, dyskinesia, movement disorders, convulsions, psychomotor restlessness (akathisia), QT interval prolongation, ventricular arrhythmia (including ventricular tachycardiatorsade de pointes), orthostatic hypotension, hepatitis, abnormalities in liver function tests, ecchymosis, angioneurotic edema, urinary retention, menstruation, men: priapism. Cases of ventricular arrhythmia, including type disorders, have been reported after marketingtorsade de pointes, mainly in women, in patients with hypokalaemia or in patients with pre-existing QT prolongation or other cardiac conditions. Epidemiological studies, mainly in patients aged 50 and over, have shown an increased risk of bone fractures in the group of patients receiving SSRIs and tricyclic antidepressants. The mechanism of this risk is unknown. Discontinuation of the drug (especially sudden) often leads to withdrawal symptoms: central dizziness, sensory disturbances (including paresthesia and feeling of being electrocuted), sleep disorders (including insomnia, intense dreams), agitation or anxiety, nausea and ( or) vomiting, tremor, confusion, sweating, headache, diarrhea, palpitations, emotional instability, irritability, blurred vision.

Orally. Adults.Big episodes of depression. The usual dose is 10 mg once a day. Depending on the patient's response, the dose may be increased to a maximum of 20 mg per day. The antidepressant effect is usually obtained after 2-4 weeks of treatment. After the symptoms have resolved, treatment should continue for at least 6 months in order to achieve a sustained response to treatment.Panic disorder with agoraphobia or without agoraphobia. For the first week, it is recommended to give an initial dose of 5 mg a day and then increase the daily dose to 10 mg. The dose may then be increased to a maximum of 20 mg per day depending on the individual response of the patient. The maximum effectiveness is achieved after about 3 months of use of the drug. The treatment lasts several months.Social phobia. The usual dose is 10 mg once a day. Usually, it takes 2-4 weeks to improve the patient's condition. The dose may then be reduced to 5 mg or increased to a maximum of 20 mg per day depending on the individual response of the patient to treatment. Social phobia is a chronic disease and it is usually recommended to continue treatment for 12 weeks in order to have a lasting response to therapy. Long-term therapy of people responding to treatment was analyzed for 6 months.and can be considered individually for the purpose of preventing the recurrence of the disease; the benefits of treatment should be evaluated at regular intervals. There are no studies comparing treatment with escitalopram with cognitive-behavioral therapy. Pharmacotherapy is part of comprehensive therapeutic treatment.Generalized anxiety disorder. The starting dose is 10 mg once a day. The daily dose can be increased up to a maximum dose, i.e. 20 mg, depending on the individual response of the patient to treatment. For long-term treatment with 20 mg daily, patients responding to therapy have been observed for at least 6 months. Therapeutic benefits and the dose administered should be evaluated at regular intervals.Obsessive-compulsive disorder. The starting dose is 10 mg once a day. The dose can then be increased to a maximum of 20 mg per day, depending on the individual response of the patient to treatment. Because obsessive-compulsive disorder is a chronic disease, patients need to be cured for long enough to be sure they are free from the symptoms of the disease. Benefits resulting from the therapy should be evaluated at regular intervals. Elderly patients (over 65 years): The starting dose is 5 mg per day. Depending on the patient's individual response to treatment, the dose may be increased to 10 mg per day. The efficacy of escitalopram in the social phobia in elderly patients has not been studied. No dosage adjustment is required in patients with mild or moderate renal impairment. Caution is advised in patients with severe renal impairment (creatinine clearance below 30 ml / min). In patients with mild or moderate hepatic impairment an initial dose of 5 mg daily for the first 2 weeks of treatment is recommended. The dose can then be increased to 10 mg a day depending on the individual response of the patient to the treatment. Caution is advised when increasing the dose in patients with severe hepatic impairment. In patients who are slow metabolizing CYP2C19, the recommended starting dose is 5 mg daily for the first 2 weeks of treatment. The dose can then be increased to 10 mg daily, depending on the individual response of the patient to treatment. The safety of daily doses above 20 mg has not been proven. The preparation can be taken regardless of meals. Table. can be divided into halves.