Index of drugs

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

1 tabl powl. contains 5 mg or 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. 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 to 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 reversible, non-selective MAO inhibitors (e.g., 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.

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 remission 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 with other psychiatric disorders, the same precautions should be taken as in patients with major depressive disorder. 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. For patients with panic disorder, a low starting 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 incidence of seizures is increased. Avoid using the drug in patients with unstable epilepsy, patients with controlled epilepsy should be closely monitored. Exercise caution in patients with a history of mania 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 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 with diagnosed hemorrhagic diathesis. Due to limited clinical experience, 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 drugs (eg Sumatriptan and other triptans, tramadol, tryptophan); drug should be discontinued if symptoms of serotonin syndrome appear (agitation, muscle tremors, myoclonus and hyperthermia). Caution should be exercised in patients with ischemic heart disease and in patients with severe renal impairment (creatinine clearance below 30 ml / min). Take special care when adjusting the dose in patients with severe hepatic impairment. The efficacy of escitalopram in the treatment of social phobia in elderly patients has not been studied. 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 recommended in patients with significant bradyarrhythmia, in patients who have recently had an acute myocardial infarction or with decompensated heart failure. Electrolyte abnormalities such as hypokalaemia and hypomagnesaemia increase the risk of malignant arrhythmia and should be corrected before initiating therapy with escitalopram. In patients with stable cardiac disease, ECG should be considered before commencing treatment with escitalopram. If signs of arrhythmia occur during treatment with es citalopram, discontinue use and ECG.

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, especially in the third trimester; 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 late pregnancy, may increase the risk of persistent neonatal hypertension (PPHN). Escitalopram is presumed to be excreted in human milk - breast-feeding is not recommended. Animal studies have shown that citalopram can affect sperm quality. From the case reports of the use of certain 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. Common: decreased appetite, increased appetite, increased body weight, anxiety, anxiety (especially motor), unusual dreams, decreased libido (women and men), women: lack of orgasm, insomnia, drowsiness, dizziness, paresthesia, tremors, sinusitis , yawning, diarrhea, constipation, vomiting, dry mouth, increased sweating, pain in the joints, muscle aches, men: ejaculation problems, impotence, tiredness, fever.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, women: uterine haemorrhage, menorrhagia, edema. Rare: anaphylactic reactions, aggression, depersonalization, hallucinations, suicide-related events, serotonin syndrome, and bradycardia. Not known: thrombocytopenia, abnormal secretion of antidiuretic hormone, hyponatraemia, anorexia, mania, suicidal thoughts and behaviors, dyskinesia, movement disorders, convulsions, restlessness / akathisia, QT interval prolongation, ventricular arrhythmia (includingtorsade de pointes), orthostatic hypotension, hepatitis, abnormal results of liver function tests, ecchymosis, angioneurotic edema, urinary retention, menstruation, men: priapism. Epidemiological studies conducted in patients aged 50 and older indicate an increased risk of bone fractures in patients using SSRIs or tricyclic antidepressants. There have been post-marketing reports of QT prolongation and ventricular arrhythmias, including type-related disorderstorsade de pointes, mainly in female patients, in people with hypokalaemia, and in patients with known prolongation of QT or other heart diseases. Discontinuation of the drug (especially sudden) may lead to withdrawal symptoms: dizziness, sensory disturbances (including paresthesia and sensation of electric shock), sleep disturbances (insomnia, expressive dreams), agitation or anxiety, nausea and / or vomiting, tremor , confusion, excessive sweating, headache, diarrhea, palpitations, emotional instability, irritability, blurred vision.

Oral: Adults.Big episodes of depression: 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. The antidepressant effect is usually obtained after 2-4 weeks of using the drug. After the symptoms have resolved, treatment should be continued for at least 6 months to consolidate the response to treatment.Panic disorder (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 per day, depending on the patient's individual 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. The improvement of the clinical condition is generally obtained 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. It is recommended to continue treatment for 12 weeks to obtain a lasting response to treatment. Individually, 6-month therapy can be considered for the purpose of preventing the recurrence of the disease. The effects of therapy should be regularly evaluated. Pharmacotherapy is part of a comprehensive therapeutic treatment.Obsessive-compulsive disorder: the starting dose is 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. Therapeutic benefits and the dose used should be regularly evaluated. In elderly patients (> 65 years), the starting dose is 5 mg once a day. Depending on the patient's individual response, the dose may be increased to 10 mg daily. The effectiveness of the drug in social phobia in elderly patients 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 are slowly metabolised by CYP2C19, a first 5 mg / day dosing is recommended during the first 2 weeks of treatment; depending on the patient's response to treatment, the dose can be increased to 10 mg / day. In patients with severe hepatic impairment, special care should be taken when adjusting the dose. The tablets can be taken with or without food. Table. 10 mg are divisible.