Index of drugs

Major depressive episodes. Panic disorder with agoraphobia or without agoraphobia. Social phobia. Obsessive-compulsive disorder.

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

Antidepressant - a selective serotonin reuptake inhibitor (SSRI). Escitalopram has no affinity or shows very low, no clinical significance, affinity for a number of receptors, including 5-HT receptors_1A, 5-HT₂, dopaminergic D₁ and D₂, adrenergic α-₁, α-₂ and β and histamine H receptors₁, muscarinic cholinergic, benzodiazepine and opioid. After oral administration, the drug is absorbed almost completely, regardless of food intake (bioavailability is about 80%), reaching C_max within 4 hours. Escitalopram and its major metabolites bind to plasma proteins in less than 80%. Escitalopram 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. Escitalopram and its metabolites are removed from the body via both metabolic (hepatic) and renal pathways. In patients with hepatic impairment and in the elderly, the elimination of escitalopram is slower and the drug exposure is about 50-60% higher. In patients with impaired renal function T_0,5 racemic citalopram is longer, while the increase in exposure is small; blood metabolites have not been tested - they can be increased.

Hypersensitivity to escitalopram or other components of the drug. Concomitant treatment with non-selective, irreversible MAO inhibitors and reversible MAO-A inhibitors (eg, moclobemide) or reversible, non-selective MAO inhibitors (e.g., linezolidem) due to the risk of serotonin syndrome. Patients with known QT prolongation or congenital long QT syndrome. Simultaneous treatment with medicinal products that cause QT prolongation.

The drug should not be used in children and adolescents under 18 (no long-term studies on safety, mainly growth, maturation, cognitive development and behavior development, and an increased risk of hostility and suicidal behavior in this age group). All patients treated with escitalopram should be monitored for signs of suicidal ideation and behavior (especially in the early period of treatment and after the change of the dose). This applies especially to people under 25 years of age and patients with behavior or suicidal thoughts in an interview. When treating patients with other mental disorders, the same precautions should be taken as when treating patients with major depressive disorder. Caution should be used in patients with: hepatic insufficiency; with severe renal impairment (creatinine clearance <30 ml / min); with stable epilepsy (avoid use in patients with unstable epilepsy); with history of mania or hypomania; with diabetes (you may need to adjust your insulin dose or oral antidiabetic medicines); with narrow-angle glaucoma or glaucoma in an interview; with the risk of hyponatremia (patients with liver cirrhosis, in the elderly or taking drugs that cause hyponatraemia); the risk of bleeding (patients taking oral anticoagulants, medicines that affect platelet function, and patients with bleeding diathesis); with coronary disease. Caution is advised in patients with severe bradycardia or in patients who have recently had an acute myocardial infarction or with decompensated heart failure. Electrolyte abnormalities, such as hypokalemia and hypomagnesaemia, increase the risk of severe arrhythmias and should be compensated before initiating treatment with escitalopram.If symptoms of cardiac arrhythmia occur during treatment, treatment should be discontinued and an ECG should be performed. Caution should be exercised when using escitalopram in combination with serotoninergic agents (risk of serotonin syndrome). Clinical experience with concomitant use of escitalopram and electroconvulsive therapy is very limited - caution is advised. For patients with panic disorder, a low starting dose is recommended to reduce the likelihood of paradoxical anxiety. In patients with symptoms of akathisia, increasing the dose may be harmful. The use of the drug should be discontinued in any patient experiencing convulsions or if the frequency of seizures is increased in patients with controlled epilepsy; in every patient who develops a manic phase and in the case of a serotonin syndrome (manifested by stimulation, muscle tremor, muscle clonic convulsions and hyperthermia). Due to the lactose content, do not use in patients with hereditary galactose intolerance, Lapp lactase deficiency or malabsorption of glucose-galactose.

Do not use during pregnancy unless clearly necessary and only after careful consideration of the risks and expected benefits. Avoid sudden interruption of treatment during pregnancy. When using the drug in the final stage of pregnancy, the risk of persistent pulmonary hypertension of newborns (PPHN) may increase, in the newborn the withdrawal symptoms and side effects resulting from serotoninergic effects may occur. Newborns should be observed whose mothers took the drug in advanced pregnancy, especially in the third trimester. Escitalopram is presumed to be excreted in human milk - the drug should not be used during breastfeeding.

Most often they occur in 1-2 weeks of treatment, and their severity and incidence generally decrease during treatment. Very common: headache, nausea. Common: decrease or increase in appetite, weight gain, anxiety, anxiety, unusual dreams, decreased libido, lack of orgasm in women, insomnia, drowsiness, dizziness, paresthesia, tremor, sinusitis, yawning, diarrhea, constipation, vomiting, dry membrane mucous oral cavity, hyperhidrosis, joint pain, muscle pain, ejaculation disorders and impotence in men, fatigue, fever. Uncommon: weight loss, bruxism, agitation, nervousness, panic attacks, confusion, taste disorders, sleep disorders, syncope, mydriasis, visual disturbances, tinnitus, tachycardia, gastrointestinal bleeding (including rectum), bleeding from the nose, urticaria, alopecia, rash, pruritus, uterine haemorrhage, menorrhagia, edema. Rarely: anaphylactic reaction, aggression, depersonalization, hallucinations, serotonin syndrome, bradycardia. In addition: thrombocytopenia, abnormal secretion of antidiuretic hormone, hyponatraemia, anorexia, manic state, suicidal thoughts, suicidal behavior, dyskinesia, movement disorders, seizures, akathisia, QT prolongation, ventricular arrhythmiatorsade de pointes, orthostatic hypotension, hepatitis, abnormal liver function tests, ecchymosis, angioneurotic edema, urinary retention, amlectomy, priapism. In some patients with panic disorder, paradoxical anxiety symptoms may occur in the initial period of treatment. In patients taking SSRIs and tricyclic antidepressants, an increased risk of bone fractures (a mechanism that increases this risk is not known). Withdrawal of the drug (especially sudden) may lead to withdrawal symptoms: dizziness, sensory disturbances (including paresthesia and feelings reminiscent of electric shock), sleep disorders (insomnia, intense dreams), agitation, anxiety, nausea, vomiting, tremor, confusion, excessive sweating, headache, diarrhea, palpitations, emotional instability, irritability, blurred vision.

Oral: Adults.Major depressive episodes: usually 10 mg / day. Depending on the patient's response, the dose may be increased up to a maximum of 20 mg / day. Antidepressant effect usually occurs after 2-4 weeks of use of the drug.After symptoms have resolved, treatment should continue 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 / day is recommended, followed by an increase of up to 10 mg / day. The dose may then be increased up to a maximum of 20 mg / day, depending on the patient's response. The maximum effectiveness is achieved after about 3 months of use of the drug; the treatment lasts several months.Social phobia: usually 10 mg / 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.Obsessive-compulsive disorder: initially 10 mg / day. Depending on the patient's response, the dose may be increased up to a maximum of 20 mg / day. Treatment should be continued for a long time to ensure that the symptoms are completely resolved.Special groups of patients. In elderly patients, the starting dose is 5 mg, and the maximum dose is 10 mg per day; 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 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.Way of giving.The drug should be administered in a single daily dose, with or without a meal.