Product Overview
Composition
per 1 tablet 5 mg/10 mg/20 mg
Active substance:
Escitalopram oxalate 6.39 mg/12.78 mg/25.55 mg, equivalent to escitalopram 5.00 mg/10.00 mg/20.00 mg
Excipients: potassium polycryline, lactose monohydrate, microcrystalline cellulose (type 102), sodium crosscarmellose, potassium acesulfame, neohesperidine-dihydrochalcon, peppermint flavoring1, magnesium stearate
1 Peppermint flavor contains: maltodextrin (corn), modified starch (corn), mint field leaf oil, plegon.
Pharmacological action
antidepressant
Clinical pharmacology
Pharmacodynamics
Escitalopram is an antidepressant, a selective serotonin reuptake inhibitor with high affine to the primary binding site. Escitalopram also binds to the allosteric binding site of the transporter protein, with affineness a thousand times less. Allosteric modulation of the transporter protein enhances the binding of escitalopram at the primary binding site, which leads to a fuller inhibition of serotonin reuptake.
Escitalopram does not have at all or has a very weak ability to bind to a number of receptors, including: serotonin 5-HT1A, 5-HT2 receptors, dopamine D1 and D2 receptors, α1-, α2-, β-adrenergic receptors, H1-histamine receptors, m-choline receptors, benzodiazepine and opioid receptors.
Pharmacokinetics
Suction
The suction is almost complete and does not depend on the time of meals. The average time to reach maximum plasma concentration (TCmax) is 4 hours after repeated use. The absolute bioavailability of escitalopram is about 80%.
Distribution
The estimated volume of distribution (Vd,β/F) after ingestion is from 12 to 26 l/kg. Binding of escitalopram and its main metabolites to plasma proteins below 80%. The escitalopram kinetics are linear. Equilibrium concentration (Css) is reached after about 1 week, the average Css - 50 nmol/l (from 20 to 125 nmol/l) is achieved at a daily dose of 10 mg.
Metabolism
Escitalopram is metabolized in the liver to demethylated and didemethylated metabolites. They are both pharmacologically active. Nitrogen can be oxidized to N-oxide metabolite. The main substance and its metabolites are partially excreted in the form of glucuronides. After repeated use, the average concentrations of demethylated and dideethylated metabolites are 28-31% and less than 5%, respectively, of the concentration of escitalopram. Biotransformation of escitalopram into demethylated metabolite occurs mainly with the help of the isoenzyme СYP2C19, some participation of the isoenzymes CYP3A4 and CYP2D6 isoenzymes.
Withdignment
The half-life (T1/2) after repeated use is about 30 hours.
Clearance when taken orally (Cloral) is 0.6 l/min. In the main metabolites, escitalopram T1/2 is more long. Escitalopram and its main metabolites are excreted by the liver (metabolic pathway) and kidneys, most of them are excreted in the form of metabolites with urine.
Special groups of patients
Elderly patients (over 65 years old)
In elderly patients (over 65 years old), escitalopram is excreted more slowly than in younger patients. The number of escitalopram in the systemic blood flow, calculated using the pharmacokinetic indicator, the area under the concentration-time curve (AUC) in elderly patients is 50% higher than in young healthy volunteers.
Polymorphism (in persons with low activity of isoenzymes СYP2C19 or CYP2D6)
In patients with low activity of the isoenzyme СYP2C19, the concentration of escitalopram in blood plasma may be 2 times higher than in patients with high activity of this isoenzyme. No significant changes in the concentration of escitalopram in blood plasma at low activity of the CYP2D6 isoenzyme were found.
Indications
- Depressive episodes of any severity.
- Panic disorders with/without agoraphobia.
- Obsessive-compulsive disorder.
Use during pregnancy and breastfeeding
There is limited data on the use of escitalopram during pregnancy.
Studies of escitalopram on animals have demonstrated reproductive toxicity.
Escitalopram during pregnancy should be taken only in cases of emergency and after a careful assessment of the benefit/risk ratio.
If escitalopram continued in late pregnancy, especially in the third trimester, the newborn should be monitored. If escitalopram administration continued until childbirth or was discontinued shortly before childbirth, the newborn may develop symptoms of "cancellation".
In the case of a mother taking SSRI/SIOZSN (selective serotonin reuptake inhibitors/selective serotonin and norepinephrine reuptake inhibitors) at late stages of pregnancy, the newborn may develop the following side effects: respiratory depression, cyanosis, apnea, convulsive disorders, temperature spikes, feeding difficulties, vomiting, hypoglycemia, muscle hypertension, muscle hypotension, hyperreflection, tremor, increased neuroreflex excitability, irritability, lethargy, constant crying, drowsiness and bad sleep. These symptoms may occur due to the development of "cancellation" syndrome or serotonergic action. In most cases, such complications occur within 24 hours after birth.
Epidemiological studies suggest that the use of SSRIs during pregnancy, especially in late stages, can increase the risk of persistent pulmonary hypertension in newborns (PPHN). The observed risk was 5 cases per 1,000 pregnancies. In the general population, there are 1-2 cases of PPHN per 1,000 pregnancies.
It is expected that escitalopram will be released with breast milk, so breastfeeding is not recommended during escitalopram treatment.
Animal research data have shown that some SSRIs can affect sperm quality. There are no data on this aspect on animals for escitalopram. Reports of the use of some SSRIs in humans have shown that the effect of these drugs on sperm quality is reversible. So far, there has been no effect of escitalopram on fertility in humans.
Contraindications
- Hypersensitivity to escitalopram and other components of the drug.
- Simultaneous administration of non-selective irreversible monoamine oxidase inhibitors (MAO).
- Simultaneous administration of reversible MAO A inhibitors (moclobemide), reversible non-selective MAO inhibitors (linezolid).
- Lengthening the QT interval in the history, including congenital QT extended interval syndrome.
- Simultaneous administration of medicines that extend the QT interval (see the section "Interaction with other medicines").
- Simultaneous administration of the pymosis.
- Child and adolescence under 18 years of age (efficiency and safety of use have not been studied).
- Lactose intolerance, lactase deficiency or glucose-galactose malabsorption syndrome (Elycea® Ku-tab® contains lactose).
Side effects
Side effects most often develop in the first or second week of therapy, then usually become less intense and occur less often when continuing therapy.
The following side effects occur when taking SSRI drugs and noted when taking escitalopram. The information is provided on the basis of placebo-controlled clinical trials and spontaneous reports.
The frequency is indicated as: very often (≥ 1/10), often (≥ 1/100 to < 1/10), infrequently
(from ≥ 1/1000 to < 1/100), rarely (from ≥ 1/10000 to < 1/1000), very rarely (< 1/10000), frequency unknown (the frequency of occurrence cannot be estimated based on existing data).
Blood and lymphatic disorders:
frequency unknown: thrombocytopenia.
Immune system disorders:
rarely: anaphylactic reactions.
Endocrine system disorders:
frequency unknown: insufficient secretion of the antidiuretic hormone (ADH).
Metabolic and nutritional disorders:
often: decreased appetite, increased appetite, increased body weight;
infrequently: weight loss;
frequency unknown: hyponatremia, anorexia.
Mental disorders:
often: anxiety, anxiety, unusual dreams, decreased libido, anorgasmia (in women);
infrequently: bruxism, agitation, nervousness, panic attacks, confusion;
rarely: aggression, depersonalization, hallucinations;
frequency unknown: mania, suicidal thoughts, suicidal behavior.
Cases of suicidal thoughts and behavior were noted when taking escitalopram and immediately after the cancellation of therapy.
Nervous system disorders:
very often: headache
often: insomnia, drowsiness, dizziness, paresthesia, tremors;
infrequently: taste disorders, sleep disorders, fainting;
rarely: serotonin syndrome;
frequency unknown: dyskinesia, motor disorders, convulsive disorders, psychomotor arousal/acathy.
Visual impairments:
infrequently: midriasis (pupil dilation), visual impairment.
Hearing disorders and labyrinthic disorders:
infrequently: tinnitus (tinnitus).
Disorders from the cardiovascular system:
infrequently: tachycardia;
rarely: bradycardia;
frequency unknown: elongation of the QT interval on the electrocardiogram (ECG), orthostatic hypotension.
Disorders from the respiratory system, chest and mediastinum:
often: sinusitis, yawning;
infrequently: nasal bleeding.
Disorders of the gastrointestinal tract:
very often: nausea;
often: diarrhea, constipation, vomiting, dry oral mucosa;
infrequently: gastrointestinal bleeding (including rectal bleeding).
Liver and biliary tract disorders:
frequency unknown: hepatitis, increased activity of "liver" enzymes.
Skin and subcutaneous tissue disorders:
often: increased sweating;
infrequently: hives, alopecia, skin rash, itching;
frequency unknown: ecchymosis, angioedema.
Musculoskeletal and connective tissue disorders:
often: arthralgia, myalgia.
Kidney and urinary tract disorders:
frequency unknown: urine retention.
Sexual and breast disorders:
often: impotence, ejaculation disorders;
infrequently: menorragia, metrorragia;
frequency unknown: galatorea, primasism.
General disorders and disorders at the place of administration:
often: weakness, hyperthermia;
infrequently: swelling.
In the post-registration period, there were cases of elongation of the QT interval, mainly in patients with previously existing heart diseases. In double-blind placebo-controlled ECG studies in healthy volunteers, the change from the base value of QTc (correction according to the Fredericia formula) was 4.3 ms at a dose of 10 mg/day and 10.7 ms at 30 mg/day.
Epidemiological studies involving patients aged 50 years and older have shown an increased risk of bone fracture in patients taking SSRIs and tricyclic antidepressants. The mechanism for this risk has not been established.
Cancellation of SSRI/SIHOS group drugs (especially sharp) often leads to "cancellation" syndrome. The most common are dizziness, sensitivity disorders (including paresthesia and current sensation), sleep disorders (including insomnia and intense dreams), agitation or anxiety, nausea and/or vomiting, tremors, confusion, increased sweating, headache, diarrhea, heartbeat, emotional instability, irritability, visual impairments As a rule, these effects are mildly or moderate and pass quickly, but in some patients they may manifest themselves in an acute form and/or longer. It is recommended to gradually cancel the drug by reducing its dose.
Interaction
Pharmacodynamic interaction
Non-selective irreversible MAO inhibitors
Serious adverse reactions were reported when taking SSRIs and non-selective irreversible MAO inhibitors were reported, as well as when patients who had recently stopped taking SSRIs shortly before. In some cases, patients developed serotonin syndrome.
It is contraindicated to use escitalopram simultaneously with non-selective irreversible MAO inhibitors. Escitalopram can be taken 14 days after the cancellation of non-selective irreversible MAO inhibitors. At least 7 days after taking escitalopram must pass before taking non-selective irreversible MAO inhibitors.
Reversible selective inhibitor MAO A (moclobemide)
Due to the risk of serotonin syndrome, it is not recommended to use escitalopram simultaneously with the MAO A inhibitor moclobemide. If taking such a combination of drugs is considered clinically necessary, it is recommended to start with the minimum possible doses, as well as to conduct constant clinical monitoring of the patient's condition. Escitalopram can be taken at least one day after the cancellation of the reversible MAO A moclobemid inhibitor.
Reversible non-selective MAO inhibitor (linezolid)
The antibiotic linezolid is a reversible non-selective MAO inhibitor and should not be used in patients receiving escitalopram therapy. If taking such a combination of drugs is considered clinically necessary, it is recommended to start with the minimum possible doses, as well as to conduct constant clinical monitoring of the patient's condition.
Irreversible selective inhibitor MAO B (selegilin)
Due to the risk of serotonin syndrome, care should be taken when taking escitalopram simultaneously with the irreversible MAO B inhibitor with selegilin.
Medicines that lengthen the QT interval
Pharmacokinetic and pharmacodynamic studies of the use of escitalopram in combination with other drugs that extend the QT interval have not been carried out. The additive effect of escitalopram and these drugs cannot be excluded. Consequently, simultaneous use of escitalopram and drugs that lengthen the QT interval, such as antiarrhythmic drugs of classes IA and III, neuroleptics (e.g. phenothiazine derivatives, pymozide, haloperidol), tricyclic antidepressants, some anti
Serotonergic drugs
Simultaneous use with serotonergic drugs (e.g. tramadol, sumatriptan and other tryptanes) can lead to the development of serotonin syndrome.
Medicines that reduce the threshold of convulsive readiness
SSRIs can lower the threshold of convulsive readiness. Care must be taken when using other drugs that reduce the threshold of convulsive readiness (tricyclic antidepressants, SSRIs, antipsychotic drugs (neuroleptics) - derivatives of phenothiazine, thioxanthen, and butyrophenone, mefloquine, bupropion and tram
Lithium, tryptophan
Since there have been cases of increased action with simultaneous use of SSRIs and lithium or tryptophane, caution is recommended when using escitalopram with these drugs at the same time.
St. turf holed
Simultaneous use of SSRIs and drugs containing St. erty erty can lead to an increase in the number of side effects.
Anticoagulants and means affecting blood clotting
Blood clotting disorders can occur with simultaneous use of escitalopram with oral anticoagulants and drugs that affect blood clotting (e.g. atypical neuroleptics and phenothiazine derivatives, most tricyclic antidepressants, acetylsalicylic acid and nonsteroidal anti-inflammatory drugs, ticlopidine and dipyridamol). In such cases, careful monitoring of blood clotting rates is necessary at the beginning or end of escitalopram therapy. Simultaneous administration with non-steroidal anti-inflammatory drugs can lead to an increase in the number of bleeding.
Ethanol
Escitalopram does not enter into a pharmacodynamic or pharmacokinetic interaction with ethanol. However, as with other psychotropic drugs, simultaneous use of escitalopram and ethanol is not recommended.
Medicines that cause hypokalemia/hypomagnesia
Care must be taken when using drugs that cause hypokalemia/hypomagnesia at the same time, as these conditions increase the risk of malignant arrhythmias.
Pharmacokinetic interaction
Effect of other drugs on escitalopram pharmacokinetics
Escitalopram metabolism is mainly carried out with the participation of the isoenzyme CYP2C19. To a lesser extent, the isoenzymes CYP3A4 and CYP2D6 can take part in metabolism. The metabolism of the main metabolite - demethylated escitalopram, seems to be partially catalyzed by the isoenzyme CYP2D6.
Simultaneous use of escitalopram and omeprazole (inhibitor of the isoenzyme CYP2C19) leads to a moderate (approximately 50%) increase in the concentration of escitalopram in blood plasma.
Simultaneous administration of escitalopram and cimetidine (inhibitor of isoenzymes CYP2D6, CYP3A4 and CYP1A2) leads to an increase (about 70%) in the concentration of escitalopram in blood plasma.
Thus, the maximum possible doses of escitalopram should be used simultaneously with the inhibitors of the isoenzyme CYP2C19 (e.g. omeprazole, fluconazole, fluoxetine, fluvoxamine, lansoprazole, ticlopidine) and cimetidine should be carefully. Simultaneous administration of escitalopram and the above drugs on the basis of clinical assessment may require a decrease in the dose of escitalopram.
Effect of escitalopram on the pharmacokinetics of other drugs
Escitalopram is an inhibitor of the CYP2D6 isoenzyme.
Care should be taken when simultaneously using escitalopram and drugs metabolized with this isoenzyme and have a small therapeutic index, such as phlekainide, propaphenone and metoprolol (in cases of use in heart failure) or medicines mainly metabolized by the isoenzyme CYP2D6 and acting on the central nervous system, such as antidepressants: desipramine, clomipramine, nortriptyline or antipsychotic drugs: risperidone, thioridazine, haloperidol. In these cases, dose correction may be required.
Simultaneous use of escitalopram and desipramine or metoprolol leads to a double increase in the concentration of the last two drugs.
Escitalopram may slightly inhibit the isoenzyme CYP2C19. Therefore, it is recommended to be careful when using escitalopram and drugs metabolized with the CYP2C19 isoenzyme at the same time.
How to take, course of administration and dosage
Inside, once a day. Do not mix the tablet in your mouth with food.
The tablet is put on the tongue, after rapid dissolution it is swallowed without drinking water.
Tablets dispersed in the oral cavity are not divided.
Tablets dispersed in the oral cavity are fragile, should be treated with caution.
Remove the tablet as follows:
- Bend the blister along the break line.
- Open the blister by gently pulling the edge of the foil.
- Carefully remove the tablet.
- Then the tablet should be immediately put on the tongue and kept in the mouth for a few seconds until completely dissolved.
Tablets dispersed in the oral cavity can be used as an alternative to film-coated tablets in patients who have difficulty swallowing the tablet or in the absence of drinking liquid.
Elicea® Ku-tab®, tablets dispersed in the oral cavity, bioequivalent to escitalopram in film-coated tablets, has a similar rate and degree of absorption. Doses and dosage regimen also correspond.
Elicea® Ku-tab®, tablets dispersed in the oral cavity, can be used as an alternative to escitalopram in film-coated tablets.
Depressive episodes
Usually 10 mg is prescribed once a day. Depending on the patient's individual reaction, the dose can be increased to a maximum of 20 mg/day.
The antidepressive effect develops 2-4 weeks after the start of treatment. After the symptoms of depression disappear, at least, therapy should continue for another 6 months to consolidate the effect.
Panic disorders with/without agoraphobia
During the first week, the recommended dose is 5 mg/day, which then increases to 10 mg/day. Depending on the patient's individual reaction, the dose can be increased to a maximum of 20 mg/day.
Usually 10 mg is prescribed once a day. Depending on the patient's individual reaction, the dose can be increased to a maximum of 20 mg/day.
Elderly patients (over 65 years old)
It is recommended to use half of the usually recommended dose (i.e. 5 mg/day) and a lower maximum dose (10 mg/day).
Children and adolescents (under 18 years old)
Elicea® Ku-tab® should not be used in children and adolescents under 18 years of age (see "Special instructions"). In addition, there is not enough data on long-term studies on the safety of escitalopram use in children and adolescents related to growth, maturation, cognitive and behavioral development.
Kidney dysfunction
In mild to moderate renal failure, dose correction is not required.
In case of severe renal failure (CC less than 30 ml/min), Elicea® Ku-tab® should be prescribed with caution.
Liver dysfunction
The recommended initial dose during the first two weeks of treatment is 5 mg/day. Depending on the patient's individual reaction, the dose can be increased to 10 mg/day.
Reduced activity of the CYP2C19 isoenzyme
For patients with weak activity of the CYP2C19 isoenzyme, the recommended initial dose during the first two weeks of treatment is 5 mg/day. Depending on the patient's individual reaction, the dose can be increased to 10 mg/day.
Termination of treatment
If treatment with Elicea® Ku-tab® is discontinued, the dose should be reduced gradually within 1-2 weeks to avoid "cancellation" syndrome.
Overdose
Data on escitalopram overdose are limited, in many such cases there was an overdose with other drugs. In most cases, the symptoms of overdose do not manifest themselves or are weak.
Cases of death overdose with escitalopram (without taking other drugs) are isolated, in most cases there is also an overdose with other drugs. When taking escitalopram in the dose range of 400-800 mg in monotherapy, there were no clinically significant symptoms of overdose.
Symptoms
Escitalopram overdose mainly causes symptoms from the central nervous system (from dizziness, tremors and agitation to rare cases of serotonin syndrome, convulsive disorders and coma), from the gastrointestinal tract (nausea/vomiting), cardiovascular system (arterial hypotension, tachycard
Treatment
There is no specific antidote. Normal patency of the respiratory tract, oxygenation and ventilation of the lungs should be ensured. Wash your stomach and assign activated carbon. Stomach rinsing should be carried out as quickly as possible after taking the drug. It is recommended to monitor the performance of the heart and other vital organs and carry out symptomatic and supportive therapy.
Description
Tablets 5 mg:
Round, flat-cylindrical tablets of white or almost white color, chamfered and engraved "5" on one side.
Tablets 10 mg:
Round, flat-cylindrical tablets of white or almost white color, chamfered and engraved "10" on one side.
Tablets 20 mg:
Round, flat-cylindrical tablets of white or almost white color, chamfered and engraved "20" on one side.
Special instructions
Severe renal failure (creatinine clearance (CC) less than 30 ml/min), mania/hypomania, pharmacologically uncontrolled epilepsy, pronounced suicidal behavior, diabetes mellitus, liver cirrhosis, propensity to bleeding, simultaneous administration with MAO B inhibitor (selegilin), serotonergic drugs, drugs that reduce the threshold of convulsive readiness, lithium, tryptophan, drugs containing gested ant ant, anticoagulants for oral administration and drugs that affect blood clotting, drugs that can cause hyponatremia, drugs, drugs, metabolizing in the ageing, CIES, in the participation of the thoracic period, isopherment, isopherment.
Elicea® Ku-tab® should not be used in children and adolescents under 18 years of age.
Kidney dysfunction
In mild to moderate renal failure, dose correction is not required.
In case of severe renal failure (CC less than 30 ml/min), Elicea® Ku-tab® should be prescribed with caution.
Liver dysfunction
The recommended initial dose during the first two weeks of treatment is 5 mg/day. Depending on the patient's individual reaction, the dose can be increased to 10 mg/day.
Antidepressants should not be prescribed to children and adolescents under 18 years of age due to the increased risk of suicidal behavior (suicide attempts and suicidal thoughts), hostility (with a predominance of aggressive behavior, a tendency to confrontation and irritation). If a decision is made on the basis of a clinical assessment to start antidepressant therapy, the patient should be closely monitored.
When using drugs belonging to the therapeutic group of SSRIs, including escitalopram, the following should be taken into account
Some patients with panic disorder may experience increased anxiety at the beginning of antidepressant treatment. Such a paradoxical reaction usually disappears during the first two weeks of treatment. To reduce the likelihood of anxiogenic effect, low initial doses are recommended.
Escitalopram should be abolished in case of primary development of seizures or in case of increased frequency (in patients with previously diagnosed epilepsy). SSRIs should not be used in patients with unstable epilepsy, with controlled seizures careful monitoring is necessary.
Escitalopram should be used with caution in patients with a history of mania/hypomania. In case of developing a manic state, escitalopram should be canceled.
In patients with diabetes mellitus, treatment with escitalopram can change the concentration of glucose in blood plasma. Therefore, correction of doses of insulin and/or hypoglycemic drugs may be required for oral administration.
Depression is associated with an increased risk of suicidal thoughts, bodily harm and suicide (suicidal phenomena). This risk remains until pronounced remission occurs. Since improvements may not be observed during the first few weeks of therapy or even for more time, patients should be constantly monitored until their condition improves.
General clinical practice shows that in the early stages of recovery, the risk of suicide may increase.
Other mental conditions for which escitalopram is prescribed may also be associated with an increased risk of suicidal events and phenomena. In addition, these conditions can be a concomitant pathology in relation to the depressive episode. The same precautions should be taken in the treatment of patients with other mental disorders as in the treatment of patients with a depressive episode.
Patients with a history of suicidal behavior or patients with a significant level of reflection on suicidal topics before treatment are more at risk of suicidal thoughts or suicide attempts, so they should be closely monitored during treatment.
Meta-analysis of placebo-controlled clinical trials of antidepressants involving adult patients with mental disorders showed that when taking antidepressants in patients under 25 years of age, there is an increased risk of suicidal behavior compared to taking placebo. Drug treatment of these patients, and in particular patients with a high risk of suicide, should be accompanied by careful observation, especially at an early stage of treatment and in case of dose changes.
Patients (and caregivers) should be warned of the need to monitor any manifestations of clinical deterioration, suicidal behavior or thoughts, as well as unusual behavioral changes, and immediately seek medical advice if these symptoms occur.
The use of SSRI/SIHOS is associated with the development of akatizia, characterized by the development of subjectively unpleasant or depressing anxiety and the need for constant movement, often combined with the inability to sit or stand quietly. This most often manifests itself during the first few weeks of treatment. In patients with such symptoms, an increase in dose can lead to deterioration.
Hyponatremia, possibly associated with impaired ADH secretion, rarely occurs against the background of SSRI administration and usually disappears when therapy is canceled. Care should be taken when using escitalopram and other SSRIs to persons at risk of hyponatremia: elderly patients, patients with liver cirrhosis and taking drugs that can cause hyponatremia.
When taking SSRIs, there were cases of skin hemorrhages (ecchymosis and purple). Escitalopram should be used with caution in patients taking anticoagulants for oral administration and drugs that affect blood clotting, as well as in patients with a tendency to bleeding.
Since the clinical experience of simultaneous use of SSRIs and ECT is limited, caution should be taken when using escitalopram and ECT simultaneously.
Simultaneous use of escitalopram and MAO A inhibitors is not recommended due to the risk of serotonin syndrome.
Escitalopram should be used with caution simultaneously with drugs with serotonergic effects, such as sumatriptan or other tryptanes, tramadol and tryptophan. Patients taking escitalopram and other SSRIs simultaneously with serotonergic drugs rarely developed serotonin syndrome. Its development may be indicated by a combination of symptoms such as agitation, tremors, myoclonus and hyperthermia. If this happens, simultaneous treatment of SSRIs and serotonergic drugs should be stopped immediately and symptomatic treatment should be started.
When treatment is discontinued, symptoms of "cancellation" are often found, especially when treatment is severely discontinued. In clinical trials, undesirable events when discontinued treatment were observed in about 25% of patients treated with escitalopram and 15% of patients receiving placebo.
The risk of "cancellation" symptoms may depend on several factors, including the duration of therapy and dose of the drug, as well as the rate of dose reduction. The most frequently reported reactions were dizziness, sensory disorders (including paresthesia and electric shock), sleep disorders (including insomnia and intense dreams), agitation or anxiety, nausea and/or vomiting, tremors, confusion, increased sweating, headache, diarrhea, heartbeat, emotional instability, irritability and visual impairment. Usually these symptoms are mild or moderate, but in some patients they may be severe.
Usually symptoms occur within the first few days after discontinuation of treatment, but it is extremely rare that such symptoms occur in patients who accidentally missed taking the drug.
As a rule, these symptoms usually disappear on their own for two weeks, although in some patients they may be long (2-3 months or more). Therefore, when discontinuing treatment, it is recommended to gradually reduce the dose for several weeks or months in accordance with the patient's condition.
Due to the limited experience of use in patients with coronary heart disease, it is recommended to be careful when using the drug.
It was found that escitalopram causes dose-dependent elongation of the QT interval. In the post-registration period, cases of elongation of the QT interval and ventricular arrhythmia were reported, including bidirectional ventricular tachycardia,
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