Index of drugs

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

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. 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 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 linezolid (a reversible, non-selective MAO inhibitor). Patients with diagnosed QT prolongation or congenital long QT syndrome. Simultaneous use with other drugs that prolong the QT interval.

The preparation 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. In addition, there are no long-term data on the safety of children and adolescents regarding growth, maturation and cognitive development and behavioral development. In some patients with panic disorder, anxiety symptoms may develop during the initial treatment period (this paradoxical response usually disappears within 2 weeks of continued treatment, a low starting dose is recommended to reduce the likelihood of anxiety). Use should be discontinued if you experience seizures during the first period of use or if the frequency of convulsions increases (in patients with previously diagnosed epilepsy). In patients with unstable epilepsy, SSRIs should be avoided and patients with controlled epilepsy should remain under special control. Caution should be exercised when using SSRIs in patients with a history of mania or hypomania; the preparation should be discontinued in every patient who develops a manic phase. In patients with diabetes, treatment with SSRIs may interfere with blood Glucose control (hypoglycaemia or hyperglycaemia) - it may be necessary to adjust the insulin dose and / or oral hypoglycemic agents. Depression is associated with an increased risk of suicidal thoughts, self-injury and suicide (suicide related events). This threat persists until significant remission is achieved. The patient should be closely monitored until the appearance of improvement and in the early period of the disappearance of the symptoms of the disease (increased risk of suicide).When treating patients with other mental disorders, therefore, the same precautions should be taken as when treating patients with major depressive disorder. Patients with a history of suicide or a high degree of suicidal thoughts prior to treatment are more at risk of suicidal ideation or attempts and should therefore be carefully monitored during treatment, particularly patients under 25 years of age. In patients with akathisia, increasing the dose may be detrimental . Caution should be exercised in patients at increased risk of hyponatraemia (elderly patients, patients with cirrhosis and using drugs that cause hyponatraemia). Because of the risk of bleeding in the skin, caution should be exercised in patients who are also taking oral anticoagulants, medicines that affect platelet function (eg atypical antipsychotics, phenothiazine derivatives, most tricyclic antidepressants, Acetylsalicylic acid, NSAIDs, ticlopidine, dipyridamole) and in patients with haemorrhagic diathesis. 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 in combination with serotoninergic agents (eg Sumatriptan or other triptans, tramadol and tryptophan); in case of symptoms of serotonin syndrome (agitation, muscle tremors, muscle clonic convulsions and hyperthermia), escitalopram and a serotoninergic drug should be immediately discontinued and symptomatic treatment initiated. When taking concomitant preparations with St John's wort, the incidence of side effects may increase. Due to limited clinical experience, caution in patients with ischemic heart disease is recommended. Due to the risk of QT interval prolongation, special care should be taken in patients with significant bradycardia or in patients with a recent myocardial infarction or decompensated heart failure. Electrolyte abnormalities such as hypokalaemia and hypomagnesaemia increase the risk of malignant arrhythmias and should be corrected before initiating treatment with escitalopram. When using escitalopram in patients with stabilized cardiac disease, an ECG should be performed before treatment. If arrhythmias develop during treatment with es citalopram, treatment should be discontinued and an ECG should be performed.

It should not be used during pregnancy unless clearly necessary and only after careful consideration of the risks and benefits. The newborn should be monitored if the mother continues to use the product at later stages of pregnancy, especially in the third trimester. During pregnancy, sudden withdrawal of the drug should be avoided. If the mother used SSRI / SNRI in the later stages of pregnancy, the following symptoms may occur in the newborn: respiratory disorders, cyanosis, apnea, seizures, body temperature fluctuations, difficulty in feeding, vomiting, hypoglycaemia, increased muscle tone, decreased tension muscular, hyperreflexia, tremor, jittery, irritability, lethargy, constant crying, difficulty sleeping. These symptoms may be due to serotoninergic or withdrawal reactions. In most cases, complications appear immediately or soon (<24 h) 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). It is believed that escitalopram is excreted in breast milk - breast-feeding is not recommended during treatment. Animal studies show that citalopram can affect sperm quality. Human studies on certain SSRIs show that the effects on semen are reversible. So far, no effects on human fertility have been observed.

Adverse reactions usually occur in the first or second week of treatment, and their severity and frequency generally decrease with continuation of treatment. Very often: nausea.Common: insomnia, drowsiness, dizziness, paresthesia, tremors, sinusitis, yawning, diarrhea, constipation, vomiting, dry mouth, increased sweating, joint pain, muscle aches, reduced appetite, increased appetite, increased body weight, feeling fatigue, fever, improper ejaculation and impotence in men, anxiety, psychomotor anxiety, abnormal dreams, decreased libido (women and men), lack of orgasm in women. Uncommon: tachycardia, dysgeusia, sleep disturbance, syncope, mydriasis, tinnitus, nosebleeds, gastrointestinal bleeding (including rectal bleeding), urticaria, alopecia, rash, pruritus, weight loss, edema , uterine hemorrhage and menstrual bleeding in women, bruxism, agitation, nervousness, panic attacks, confusional states. Rarely: bradycardia, serotonin syndrome, anaphylactic reactions, aggression, depersonalization, hallucinations. Not known: QT prolongation in ECG, ventricular arrhythmia (incltorsade de pointes), thrombocytopenia, dyskinesia, movement disorders, convulsions, akathisia, restlessness, urinary retention, bruising, angioneurotic edema, inadequate antidiuretic hormone secretion, hyponatremia, anorexia, orthostatic hypotension, hepatitis, abnormal results of liver function tests, galactorrhea, priapism, mania , suicidal thoughts, suicidal behavior.
Following post-marketing experience, cases of QT prolongation and ventricular arrhythmia were reportedtorsade de pointes, mainly in women with hypokalemia or previous 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 (SSRIs) and tricyclic antidepressants (a mechanism that increases this risk is not known). Discontinuation of SSRI / SNRIs (especially abrupt) often leads to withdrawal symptoms; the most frequently reported reactions 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, tremor, confusion, sweating, headaches, diarrhea, palpitations, emotional instability, irritability and blurred vision.

Orally. Adults.Episodes of severe depression. The usual dose is 10 mg once a day. Depending on the patient's individual 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 using the drug. After symptoms have resolved, treatment should be continued for at least 6 months to consolidate response to treatment.Panic disorder with agoraphobia or without agoraphobia. In the first week, an initial dose of 5 mg is recommended, followed by increasing the dose to 10 mg daily. The dose may then be increased, up to a maximum of 20 mg daily, depending on the patient's individual response. Maximum effectiveness is achieved after approx. 3 months of use. The treatment lasts several months.Social phobia. The usual dose is 10 mg once a day. In general, clinical improvement is achieved after 2-4 weeks of treatment. The dose can then be reduced to 5 mg or increased to a maximum of 20 mg a day, depending on the patient's individual response. Social phobia is a chronic disease and it is recommended to continue treatment for 12 weeks in order to obtain a lasting response to treatment. Long-term therapy for people responding to treatment has been analyzed for 6 months, and can be considered individually to prevent the recurrence of the disease; the effects of therapy should be regularly evaluated. There are no studies comparing the discussed therapy with cognitive behavioral therapy. 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 individual response, the dose may be increased to a maximum of 20 mg per day. Obsessive-compulsive disorder is a chronic disease and patients should be treated long enough to be sure that their symptoms have gone away. 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 to treatment, the dose may be increased to 10 mg once a day. The efficacy of the preparation in social phobia in elderly patients has not been studied. No dosage adjustment is necessary for patients with mild or moderate renal impairment. Caution is advised in patients with severe renal impairment (creatinine clearance less than 30 ml / min). In patients with mild to moderate hepatic impairment and in patients known to be able to metabolize CYP2C19 medication, an initial 5 mg dose is recommended in the first 2 weeks of treatment; depending on the patient's individual response, the dose may be increased to 10 mg daily. Severe caution is recommended in patients with severe hepatic impairment, including during dose adjustment. The safety of daily doses of over 20 mg has not been demonstrated. The preparation can be taken with or without food.