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 ml of solution contains 20 mg of escitalopram (in the form of oxalate). One drop contains 1 mg escitalopram. 1 drop of the solution contains 4.7 mg of ethanol

Antidepressant - a selective serotonin reuptake inhibitor (5-HT) with high affinity to the primary binding site. It also binds to the allosteric site of the serotonin transporter with 1,000-fold lower affinity. Escitalopram has no or very 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, escitalopram is absorbed almost completely, regardless of food intake (bioavailability is about 80%), reaching a maximum blood concentration after about 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 metabolites and the didemetylated, pharmacologically active metabolites. Biotransformation takes place mainly with the participation of CYP2C19; CYP3A4 and CYP2D6 are possible. T_0,5 drug 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 any of the excipients. Simultaneous treatment with non-selective, irreversible MAO inhibitors - the risk of serotonin syndrome. Concomitant treatment with reversible MAO-A inhibitors (eg, moclobemide) or a reversible non-selective MAO inhibitor (linezolidem) - risk of serotonin syndrome. Patients with known QT prolongation or congenital long QT syndrome. Concomitant use with other drugs that prolong the QT interval.

The drug should not be used to treat children and adolescents under 18 years of age. In the course of clinical trials, suicidal behavior (suicide attempts and suicidal thoughts) and hostility (especially aggression, rebel behavior and anger) were more frequently observed in children and adolescents treated with antidepressants than in the placebo group. If, however, based on the existing clinical need, a decision to treat is made, the patient should be carefully monitored for signs of suicide. Lack of long-term safety data for children and adolescents regarding effects on growth, maturation and cognitive development and behavioral development. Depression is associated with an increased risk of suicidal thoughts, self-mutilation and suicide (suicide behavior). This risk persists until full remission is achieved. 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 severe depressive disorder. 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, particularly patients under 25 years of age. At the beginning of therapy and after dose adjustment, patients should be closely monitored, particularly those at high risk. For patients with panic disorder, a low initial dose is recommended to reduce the likelihood of anxiety symptoms at the beginning of treatment. Treatment should be discontinued if seizures occur for the first time or if the frequency of seizures increases.Avoid using the drug in patients with unstable epilepsy, patients with controlled epilepsy should remain under strict control. Caution should be exercised in patients with a history of mania or hypomania. The drug should be discontinued in the event of a manic phase. In diabetic patients, the drug may affect glycemic control - a change in insulin dosage and / or oral antidiabetic medications may be required. In patients with symptoms of akathisia, increasing the dose may be harmful. Caution should be exercised in patients at increased risk of hyponatraemia (elderly, cirrhotic patients or those receiving concomitant medications that may cause hyponatraemia). Because of the risk of bleeding, caution should be used when taking oral anticoagulants, medicines that affect platelet function (eg atypical neuroleptics and phenothiazine derivatives, most antidepressants with tricyclics, Acetylsalicylic acid and NSAIDs, ticlopidine and dipyridamol) and patients diagnosed with hemorrhagic diathesis. Due to limited clinical experience, caution should be exercised when using escitalopram and electroconvulsive therapy in patients. Due to the possibility of serotonin syndrome, caution should be exercised when using escitalopram with serotonergic drugs (eg Sumatriptan or other triptans, tramadol and tryptophan); drug should be discontinued in case of symptoms of serotonin syndrome (agitation, muscle tremors, muscle clonic convulsions and hyperthermia). The efficacy of escitalopram in social phobia in elderly patients has not been studied. Caution is advised in patients with ischemic heart disease and in patients with severe renal impairment (CCr below 30 ml / min). Special care should be taken when adjusting the dose in patients with severe hepatic impairment. Due to the increased risk of QT prolongation and ventricular arrhythmia, including type-related disorderstorsade de pointes (mainly in women, patients with hypokalemia or patients with existing QT prolongation or other cardiac diseases) caution is advised in patients with significant bradycardia, patients who have had a history of myocardial infarction or decompensated heart failure. Electrolyte abnormalities such as hypokalemia or hypomagnesaemia increase the risk of malignant arrhythmias and should be compensated before initiating treatment with escitalopram. For patients with stable cardiac disease, ECG should be considered before starting escitalopram. If a heart rhythm occurs during treatment with es citalopram, treatment should be discontinued and an ECG should be performed. The product contains small amounts of ethanol, less than 100 mg per dose.

drug should not be used during pregnancy unless clearly necessary and only after careful consideration of the benefit / risk ratio. Avoid sudden withdrawal during pregnancy. Newborns should be observed whose mothers took the drug later in pregnancy, especially in the third trimester; these newborns may experience symptoms caused by serotonergic effects or withdrawal symptoms (breathing disorders, cyanosis, apnea, seizures, body temperature fluctuations, difficulty in feeding, vomiting, hypoglycaemia, increased muscle tone, decreased muscle tone, hyperreflexia, tremors, jitter , irritability, lethargy, constant crying, drowsiness and difficulty falling asleep). Most complications appear immediately or up to 24 hours after delivery. The use of SSRIs in pregnant women, especially in the third trimester, may increase the risk of persistent pulmonary hypertension of the newborn (PPHN). It is believed that escitalopram is excreted in breast milk, therefore it is not recommended for use during lactation. Animal studies have shown that citalopram can affect sperm quality. Based on human data for some SSRIs, this effect was shown to be transient. So far, no effects on human fertility have been observed.

Adverse reactions usually occur in the first or second week of treatment and usually their severity and frequency decreases with continuation of treatment. Very often: nausea.Common: decreased appetite, increased appetite, weight gain, anxiety, nervousness, abnormal dreams, decreased libido (men and women), anorgasmia (female), insomnia, drowsiness, dizziness, paraesthesia, tremor, sinusitis, yawning, diarrhea, constipation, vomiting, dry mouth, increased sweating, arthritis, muscle inflammation, abnormal ejaculation, impotence (men), fatigue, fever. Uncommon: weight loss, bruxism, agitation, anxiety, panic attack, taste dysfunction, sleep disorders, syncope, mydriasis, blurred vision, tinnitus, tachycardia, epistaxis, gastrointestinal bleeding (including rectal bleeding) , hives, alopecia, rash, erythema, women: uterine haemorrhage, menorrhagia, edema. Rarely: anaphylactic reaction, aggression, depersonalization, hallucinations, serotonin syndrome, bradycardia. Known: thrombocytopenia, inappropriate secretion of antidiuretic hormone, hyponatremia, anorexia, mania, suicidal ideation, suicidal behavior, dyskinesia, movement disorders, seizures, psychomotor restlessness / akathisia, prolongation of the QT interval of the ECG, ventricular arrhythmias (including disorder typetorsade de pointes), orthostatic hypotension, hepatitis, abnormal liver function tests, petechiae, angioneurotic edema, urinary retention, galactorrhoea, men: priapism. Discontinuation of treatment, especially sudden, can lead to withdrawal symptoms: dizziness central origin, sensory disturbances (including paraesthesia and feeling of electric shock), sleep disturbances (including insomnia and intense dreams), agitation or anxiety, nausea and (or ) vomiting, trembling, confusion, sweating, headache, diarrhea, palpitations, emotional instability, irritability and blurred vision.

Oral: Adults.Episodes of severe depression: usually 10 mg (10 drops) per day. Depending on the patient's response, the dose may be increased to a maximum of 20 mg (20 drops) per day. It usually takes 2-4 weeks to get antidepressant effect. After the symptoms have resolved, treatment should continue for at least 6 months to consolidate the response to treatment.Panic disorder with agoraphobia or without agoraphobia: recommended starting dose of 5 mg (5 drops) for the first week of treatment before increasing the dose to 10 mg (10 drops) per day; the dose can then be increased to a maximum of 20 mg (20 drops) per day, depending on the patient's individual response. Maximum effectiveness is achieved after approx. 3 months of use; the treatment lasts several months.Social phobia: usually 10 mg (10 drops) per day. Usually, it takes 2-4 weeks to improve the patient's condition. The dose can then be reduced to 5 mg (5 drops) or increased to a maximum of 20 mg (20 drops) per day, depending on the patient's individual response. It is usually recommended to continue treatment for 12 weeks in order to have a lasting response to therapy. Individually, 6-month therapy can be considered to prevent relapse. The effects of therapy should be regularly evaluated. Pharmacotherapy is part of comprehensive therapeutic treatment. Generalized anxiety disorder: the starting dose is 10 mg (10 drops) per day. Depending on the patient's individual response, the dose may be increased to a maximum of 20 mg (20 drops) per day. The benefits of therapy and the dose used should be regularly evaluated.Obsessive-compulsive disorder: the starting dose is 10 mg (10 drops) per day. The dose can then be increased to a maximum of 20 mg (20 drops) per day, depending on the patient's individual response. Treatment should be continued for a long time to ensure that the symptoms of the disease are gone. The benefits of therapy and the dose used should be regularly evaluated. Special patient groups: In elderly patients (> 65 years) the starting dose is 5 mg (5 drops) per day. Depending on the patient's individual response, the dose may be increased to 10 mg (10 drops) per day. The efficacy of escitalopram in 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 (CCr below 30 ml / min).In patients with mild to moderate hepatic impairment and in patients who are slow metabolisers with CYP2C19, the initial dose of 5 mg (5 drops) per day is recommended during the first two weeks of treatment. The dose can then be increased to 10 mg (10 drops) per day, depending on the patient's individual response. Caution is advised when adjusting the dose in patients with severe hepatic impairment. The preparation is given as a single daily dose and can be taken with or without food. It can be mixed in water, orange juice or apple juice.