Excitalopram-ALSI, 20 mg 30 pcs

Pharmacotherapeutic group:antidepressant

ATX code: N06AB10

Pharmacological Properties.

Pharmacodynamics:

Escitalopram is an antidepressant, a selective serotonin reuptake inhibitor (SSRI) with high affinity for the primary active center. Escitalopram also binds to the allosteric center of the serotonin transporter protein with an affinity 1000 times lower. Allosteric modulation of the transporter protein enhances the binding of escitalopram at the primary binding site, resulting in a more complete inhibition of serotonin reuptake.

Escitalopram has no or very weak ability to bind to a number of receptors, including: Serotonin 5-HT_1A, 5-HT₂ receptors, dopamine D₁ and D₂ receptors, α₁-, α₂-, β-adrenergic receptors, histamine H₁, muscarinic cholinergic, benzodiazepine and opiate receptors.

The inhibition of 5-NT reuptake is the only possible mechanism of action that explains the pharmacological and clinical effects of escitalopram.

Escitalopram is the S-enantiomer of racemic citalopram with intrinsic therapeutic activity. The R-enantiomer has been shown not to be inert but to counteract the serotonergic properties and corresponding pharmacological effects of the S-enantiomer‑.

Pharmacokinetics:

Eabsorption

The absolute bioavailability of escitalopram is 80% and is independent of food intake. The maximum concentration (Cmax) in plasma is reached on average 4 hours after multiple administration.

Distribution

The estimated volume of distribution after oral administration is 12 to 26 L/kg. The binding of escitalopram to human plasma proteins is not more than 80% (on average about 56%). It penetrates into the breast milk.

Metabolism

Escitalopram is metabolized in the liver to demethylated and didemethylated metabolites. They are both pharmacologically active. Nitrogen can be oxidized to the metabolite N-oxide. The main substance and its metabolites are partially excreted as glucuronides. After multiple uses, the average concentration of demethyl and didemethyl metabolites is usually 28-31% and less than 5%, respectively, of the concentration of escitalopram. The biotransformation of escitalopram to a demethylated metabolite occurs primarily via the CYP2C19 isoenzyme. Some involvement of CYP3A4 and CYP2D6 isoenzymes is possible.

Elimation

The half-life (T_1/2) of escitalopram after multiple uses is about 30 hours. Total clearance with oral administration is about 0.6 l/min. The main metabolites of escitalopram have a longer elimination half-life.

Escitalopram and its metabolites are excreted both via the liver (metabolic route) and the kidneys, with most of the administered dose excreted as metabolites in the urine.

Linearity of pharmacokinetics

The pharmacokinetics of escitalopram are linear dose-dependent. The equilibrium plasma concentration (C_ss) is established after approximately 1 week of therapy. An average equilibrium concentration of 50 nmol/L (range 20 to 125 nmol/L) is reached at a daily dose of 10 mg.

Patients over 65 years of age

The elderly (over 65 years) have a longer half-life and lower clearance values compared to younger patients. The amount of escitalopram in the systemic bloodstream, calculated using the area under the curve (AUC) pharmacokinetic index, is 50% greater in the elderly than in young healthy volunteers.

Patients with impaired liver function

In patients with mild to moderate hepatic impairment (Child-Pugh class A and B), T_1/2 escitalopram is approximately twice as long and the AUC is 60% longer than in patients with normal liver function.

Patients with impaired renal function

. When racemic citalopram is used in patients with renal impairment (creatinine clearance 10-53 ml/min), there is a prolongation of T_1/2 and a slight increase in AUC. Plasma concentrations of metabolites have not been studied, but they may be elevated.

Patients with low isoenzyme activity CYP2C19

Persons with poor CYP2C19 activity have twice the concentration of escitalopram as those with high activity of this isoenzyme. No significant changes in drug concentrations were found in cases with weak CYP2D6 isoenzyme activity.

Indications

• Depressive episodes of any severity.
• Panic disorder with/without agoraphobia.
• Obsessive-compulsive disorder.

Active ingredient

Escitalopram

Composition

Effective ingredient: escitalopram oxalate – 25.56 mg (in terms of escitalopram 20.00 mg);

Auxiliary substances: microcrystalline cellulose – 192.04 mg, pregelatinized starch – 96.00 mg, colloidal silica (aerosil) – 3.20 mg, magnesium stearate – 3.20 mg;

film coating: Opadray II white (31F28678) (lactose monohydrate – 4.60 mg, hypromellose – 3.60 mg, titanium dioxide – 3.32 mg, macrogol 3000 – 1.28 mg) – 12.80 mg.

How to take, the dosage

Escitalopram is taken orally once a day (without chewing, with a small amount of liquid), regardless of meals. The drug may be taken at any time of the day, preferably at the same time of the day. It is recommended that the treatment be evaluated regularly.

Depressive episodes:

It is usually started with 10 mg of escitalopram once daily. Depending on the patient’s individual response, the dose may be increased to a maximum of 20 mg per day. Antidepressant effect usually develops in 2-4 weeks after the start of treatment. After disappearance of depression symptoms it is necessary to continue therapy for at least 6 more months to consolidate the effect obtained.

Panic disorder with/without agoraphobia:

In panic disorder, the recommended dose for the first week of treatment is 5 mg daily, then the dose is increased to 10 mg daily. The daily dose, depending on the individual reaction of the patient, may be further increased to 20 mg per day. Maximum therapeutic effect is achieved about 3 months after the start of treatment. Therapy lasts for several months.

Obsessive-compulsive disorder:

Perhaps 10 mg once daily is usually prescribed. Depending on the patient’s individual response, the dose may subsequently be increased to a maximum of 20 mg per day. Because obsessive-compulsive disorder is a disease with a chronic course, the course of treatment should be long enough to ensure complete relief from symptoms and last for at least 6 months. A course of treatment of at least 1 year is recommended to prevent recurrence.

Elderly patients (>65 years):

Half the usual recommended dose is recommended i.e. 5 mg per day. The maximum dose for elderly patients is 10 mg per day.

Patients with renal insufficiency:

In mild to moderate renal failure (creatinine clearance greater than 30 mL/min), dosing adjustments are not required. In patients with severe renal failure (creatinine clearance below 30 ml/min) the drug should be used with caution under medical supervision.

Patients with hepatic impairment:

In mild to moderate hepatic impairment (Child-Pugh class A or B), the recommended starting dose for the first two weeks of treatment is 5 mg daily. Depending on the patient’s individual response, the dose may be increased to 10 mg per day. In severe hepatic insufficiency (class C on the Child-Pugh scale) caution should be exercised when titrating, treatment should be carried out under close supervision of a physician.

Decreased isoenzyme activity CYP2C19:

For patients with low CYP2C19 isoenzyme activity, the recommended starting dose for the first two weeks of treatment is 5 mg daily. Depending on the individual response of the patient, the dose may be increased to 10 mg per day.

Cancellation of the drug:

Abrupt withdrawal of the drug should be avoided. When discontinuing treatment with escitalopram, the dose of the drug should be reduced gradually at 1-2 week intervals to avoid the occurrence of “withdrawal” syndrome. If the dose reduction is intolerable, it is possible to resume taking the drug in the same dose or reduce the dose at longer intervals. The physician decides this question individually: for some patients, a period of 2-3 months or more may be necessary.

Interaction

Pharmacodynamic interactions:

Controlled for co-administration:

With non-reversible nonselective MAO inhibitors

The occurrence of serious adverse reactions has been reported when concomitantly taking SSRIs and non-selective non-selective MAO inhibitors, as well as when starting MAO inhibitors in patients who have recently stopped therapy with SSRIs and started therapy with such MAO inhibitors. In some cases, patients have developed serotonin syndrome.

The use of escitalopram concomitantly with non-selective non-reversible MAOI inhibitors is contraindicated.

Escitalopram may be prescribed 14 days after discontinuation of treatment with unreversible non-selective MAO inhibitors.A minimum of 7 days must pass after stopping escitalopram before treatment with unreversible non-selective MAO inhibitors may be prescribed.

With reversible type A selective MAO inhibitors (moclobemide)

Because of the risk of serotonin syndrome, co-administration of escitalopram with convertible selective MAO inhibitors, such as moclobemide, is contraindicated. If there is a reasonable need for such a combination, treatment should be started at the lowest recommended dose with increased clinical monitoring.

Escitalopram can be started at least one day after withdrawal of the reversible MAOA inhibitor moclobemide.

With reversible non-selective MAO inhibitors (linezolid)

The antibiotic linezolid is a reversible non-selective MAO inhibitor and should not be used in patients receiving escitalopram therapy. If there is a reasonable need for such a combination, treatment should be started with minimal doses under close clinical supervision.

With irreversible selective MAO type B inhibitors (selegiline)

Caution is required when using escitalopram and unreversible selective MAO type B inhibitor selegiline because of the risk of serotonin syndrome. Selegyline at doses up to 10 mg per day has been used successfully in conjunction with racemic citalopram.

With agents that prolong the interval QT

. Pharmacokinetic and pharmacodynamic studies of the use of escitalopram in combination with other QT interval prolonging drugs have not been performed. Additive effect of escitalopram and these drugs cannot be excluded. Therefore, concomitant use of escitalopram and drugs that prolong the QT interval, such as antiarrhythmic drugs (procainamide, amiodarone, etc.), antipsychotics/neuroleptics (eg, pimozide, phenothiazine derivatives (chlorpromazine, trifluoperazine, thioridazine, etc.), butyrofluoride derivatives, etc.) is contraindicated.), butyrophenone derivatives (haloperidol, droperidol, etc), tricyclic and tetracyclic antidepressants (amitriptyline, imipramine, maprotiline, etc), SSRIs and similar antidepressants (e.g. fluoxetine, venlafaxine, etc), antimicrobials (e.g. narcotics and psychotropic agents) and other drugs.), antimicrobials (macrolide antibiotics and analogues such as erythromycin, clarithromycin; quinolone and fluoroquinolone derivatives: sparfloxacin, moxifloxacin; pentamidine), azole antifungals (ketoconazole, fluconazole), domperidone, ondansetron, drugs to treat malaria, especially halofantrine, some antihistamines (astemizole, misolastine), because escitalopram in doses higher than 20 mg per day may cause abnormal changes in electrical activity of heart (prolongation of QT interval on ECG) and result in heart rhythm disorders (includingPirouette arrhythmias), which can be fatal.

Combined use of Excitalopram should be performed with caution when used:

Drugs that lower seizure threshold

Escitalopram may lower seizure threshold. Caution is required with other drugs that lower seizure threshold (tricyclic antidepressants, SSRIs, phenothiazine derivatives, tioxanthene and butyrophenone neuroleptics; mefloquine and tramadol, bupropion).

Serotonergic drugs

It is preferable not to combine administration of Eszitalopram-ALSI with serotonergic drugs such as sumatriptan or other triptans or tramadol, as this may lead to serotonin syndrome.

Lithium, tryptophan

In concomitant use with tryptophan or with lithium preparations, there have been cases of increased effect of escitalopram.

Hence, caution should be exercised when prescribing escitalopram and these drugs concomitantly.

Herb’s wort

The simultaneous use of escitalopram and preparations containing Hypericum perforatum may lead to increased side effects.

Anticoagulants and agents affecting blood clotting

. When using escitalopram concomitantly with indirect anticoagulants and other drugs that affect blood clotting (e.g., atypical neuroleptics and phenothiazine derivatives, most tricyclic antidepressants, acetylsalicylic acid and nonsteroidal anti-inflammatory drugs, ticlopidine and dipyridamole) there may be clotting disorders. In such cases, regular monitoring of blood clotting is necessary at the beginning or end of therapy with escitalopram.

The interaction of escitalopram with alcohol has not been revealed. However, as with other antidepressants, you should refrain from drinking alcohol during the entire period of treatment with the drug.

Simultaneous use with nonsteroidal anti-inflammatory drugs may lead to increased bleeding.

Drugs that cause hypokalemia/hypomagnesemia

Cautious concomitant use of drugs that cause hypokalemia/hypomagnesemia is required because of the increased risk of malignant arrhythmias with these conditions.

Pharmacokinetic interactions:

Influence of other drugs on the pharmacokinetics of escitalopram

The metabolism of escitalopram is primarily through the enzyme CYP2C19. CYP3A4 and CYP2D6 may also participate in metabolism, although to a lesser extent. The metabolism of the main metabolite, S-DCT (demethylated escitalopram), is partially catalyzed by CYP2D6.

Concomitant administration of escitalopram and Omeprazole 30 mg once daily (CYP2C19 inhibitor) resulted in a moderate (approximately 50%) increase in plasma concentration of escitalopram.

Concomitant administration of escitalopram and cimetidine 400 mg 2 times daily (a common medium strength enzyme inhibitor) resulted in a moderate (approximately 70%) increase in plasma concentration of escitalopram. Excitalopram should be combined with caution with cimetidine.The dose may need to be adjusted.

Thus, the drug should be combined with caution with CYP2C19 inhibitors (such as omeprazole, esomeprazole, fluvoxamine, lansoprazole, ticlopidine) or cimetidine. If escitalopram and the above drugs are taken concomitantly, a reduction in the dose of escitalopram may be required based on clinical evaluation.

Effects of escitalopram on the pharmacokinetics of other drugs

Escitalopram is an inhibitor of the CYP2D6 enzyme. Caution should be exercised when concomitant use of escitalopram and drugs with a narrow therapeutic range that are primarily metabolized by this enzyme, such as flecainide, propafenone andmetoprolol (for use in heart failure), or some drugs affecting the CNS that are primarily metabolized by CYP2D6, such as antidepressants such as desipramine, clomipramine and nortriptyline or neuroleptics such as risperidone, thioridazine and haloperidol. Dose adjustments may be necessary in these cases.

The concomitant administration of the drug with desipramine or metoprolol resulted in a twofold increase in plasma concentrations of these CYP2D6 substrates.

The in vitro studies have shown that escitalopram may also be a weak inhibitor of CYP2C19. Caution is advised in using the drug concomitantly with drugs metabolized by CYP2C19.

Special Instructions

The following should be considered when using drugs belonging to the therapeutic group of SSRIs, including escitalopram:

Application in children and adolescents younger than 18 years

Antidepressants should not be prescribed to children and adolescents under 18 years of age because of the increased risk of suicidal behavior (suicide attempts and suicidal ideation), hostility (with a predominance of aggressive behavior, confrontational tendencies and irritability). If a decision is made to initiate antidepressant therapy on the basis of a clinical evaluation, the patient should be closely monitored. In addition, there are insufficient data on long-term safety in children and adolescents with respect to growth, maturation, cognitive and behavioral development.

Paradoxical Anxiety

Some patients with panic disorder may experience increased anxiety at the start of antidepressant treatment. This paradoxical reaction usually disappears within the first two weeks of treatment. Low initial doses are recommended to reduce the likelihood of anxiogenic effects.

Convulsions

Escitalopram should be discontinued if seizures develop initially or if their frequency increases (in patients with previously diagnosed epilepsy). SSRIs should not be used in patients with unstable epilepsy; in controlled seizures, close monitoring is necessary.

Mania

Escitalopram should be used with caution in patients with a history of mania/hypomania. If a manic state develops, escitalopram should be withdrawn.

Diabetes mellitus

In patients with diabetes mellitus, treatment with escitalopram may alter blood glucose concentrations. Therefore, it may be necessary to adjust the doses of insulin and/or oral hypoglycemic drugs.

Suicidal ideation/suicidal thoughts or clinical deterioration

Depression is associated with an increased risk of suicidal ideation, self-injury, and suicide (suicidal ideation). This risk persists until the onset of significant remission. Because improvement may not be seen for the first few weeks of therapy or even longer, patients should be monitored closely until improvement occurs.

Common clinical practice shows that in the early stages of recovery, there may be an increased risk of suicide.

Other psychiatric conditions for which escitalopram is prescribed may also be associated with an increased risk of suicidal events and phenomena. In addition, these conditions may be co-occurring pathology in relation to the depressive episode. When treating patients with other psychiatric disorders, the same precautions should be followed as when treating patients with a depressive episode.

Patients with a history of suicidal behavior or patients with significant levels of suicidal ideation prior to treatment are at greater risk for suicidal thoughts or suicide attempts, so they should be monitored closely during treatment.

A meta-analysis of placebo-controlled clinical trials of antidepressants involving adult patients with psychiatric disorders found that antidepressant medication administration in patients younger than 25 years old had an increased risk of suicidal behavior compared to placebo administration. Medication treatment of these patients, and in particular patients at high risk for suicide, should be accompanied by close monitoring, especially in the early phase of treatment and during dose changes.

Patients (and caregivers) should be warned to monitor for any signs of clinical deterioration, suicidal behavior or thoughts, and unusual behavioral changes, and to seek medical advice immediately if these symptoms occur.

Akathisia/psychomotor agitation

Participation of SSRIs/SIOSSNs is associated with the development of akathisia, characterized by the development of a subjectively unpleasant or depressing anxiety of a need to constantly move, often combined with an inability to sit or stand still. This most often manifests itself during the first few weeks of treatment. In patients with these symptoms, increasing the dose may lead to worsening.

Hyponatremia

Hyponatremia, possibly associated with impaired antidiuretic hormone (ADH) secretion, is rare with SSRIs and usually disappears with treatment withdrawal. Caution should be exercised when using escitalopram and other SSRIs in individuals at risk of hyponatremia: the elderly, patients with cirrhosis, and those taking medications that may cause hyponatremia.

bleeding

When taking SSRIs, there have been cases of skin bleeding (ecchymosis and purpura). Caution is necessary when using escitalopram in patients taking oral anticoagulants and medications affecting blood clotting, as well as in patients prone to bleeding.

Electroconvulsive therapy

Because clinical experience with concomitant use of SSRIs and electroconvulsive therapy (ECT) is limited, caution should be exercised when concomitant use of escitalopram and ECT.

Serotonin syndrome

The concomitant use of escitalopram and MAOA inhibitors is contraindicated because of the risk of serotonin syndrome.

The use of escitalopram concomitantly with drugs with serotonergic effects, such as sumatriptan or other triptans, tramadol and tryptophan, should be used with caution. Patients taking escitalopram and other SSRIs concomitantly with serotonergic drugs have rarely developed serotonin syndrome. Its development may be indicated by a combination of symptoms such as agitation, tremor, myoclonus and hyperthermia. If this occurs, concomitant treatment with SSRIs and serotoninergic drugs should be stopped immediately and symptomatic treatment should be initiated.

Withdrawal syndrome after discontinuation of therapy

Withdrawal syndrome is common, especially when treatment is stopped abruptly. In clinical studies, adverse events upon discontinuation of treatment were seen in approximately 25% of patients who received escitalopram and 15% of patients who received placebo.

The risk of withdrawal may depend on several factors, including the duration of therapy and the dose of the drug, as well as the rate of dose reduction. The most commonly reported reactions include dizziness, sensory disturbances (including paresthesia and a sensation of electric shock), sleep disturbances (including insomnia and intense dreaming), agitation or anxiety, nausea and/or vomiting, tremor, confusion, increased sweating, headache, diarrhea, palpitations, emotional instability, irritability and visual disturbances. Usually these symptoms are mild to moderate in severity, but in some patients they may be severe. Symptoms usually occur within the first few days of stopping treatment, but very rarely have these symptoms been reported in patients who have accidentally missed taking the drug.

In general, these symptoms usually resolve on their own within 2 weeks, although in some patients they may be prolonged (2-3 months or more). Therefore, gradual dose reduction over several weeks or months is recommended when treatment is discontinued, according to the patient’s condition.

Ischemic heart disease (IHD)

Because of limited experience with use in patients with IHD, caution is recommended when using the drug.

QT interval prolongationQT

Escitalopram has been found to cause dose-dependent prolongation of the QT interval. In the post-registration period, cases of QT interval prolongation and ventricular arrhythmias, including bidirectional ventricular tachycardia (pirouette type), were reported primarily in female patients, with hypokalemia or pre-existing QT interval prolongation, or other heart disease.

Cautions are required when using in patients with significant bradycardia or in patients with recent acute myocardial infarction or decompensated heart failure.

Electrolyte disturbances, such as hypokalemia and hypomagnesemia, increase the risk of malignant arrhythmias; these disturbances should be corrected before starting treatment with escitalopram.

In patients with chronic heart disease, an ECG should be performed before starting treatment.

If signs of cardiac arrhythmias occur during treatment with escitalopram, therapy should be stopped and an ECG should be performed.

Closed angle glaucoma

SRIOPPS, including escitalopram, may affect pupil size, leading to mydriasis. This effect of pupil dilation has the potential to narrow the angle of the anterior chamber of the eye, leading to increased intraocular pressure and the development of closed angle glaucoma, especially in patients with a predisposition to this disease. Therefore, caution should be exercised when using escitalopram in patients with closed angle glaucoma or a history of glaucoma.

Sexual dysfunction

SSRIs/ SSRIs may cause symptoms of sexual dysfunction. There have been reports of long-term sexual dysfunction where symptoms continued despite discontinuing SSRIs/ SSRIs.

Alcohol

Escitalopram has no pharmacodynamic or pharmacokinetic interaction with alcohol. However, as with other psychotropic medications, concomitant use of escitalopram and alcohol is not recommended.

Influence on the ability to drive vehicles, mechanisms

Patients are not recommended to drive or operate machinery during treatment with the drug escitalopram. The patient should be informed about the potential danger of the effect of escitalopram on the ability to drive vehicles and machines.

Synopsis

Round biconvex white film-coated tablets. In the cross section there is an inner layer of white or almost white color.

Contraindications

• High sensitivity to escitalopram or to any of the excipients contained in this drug.
• Simultaneous use of non-selective irreversible monoamine oxidase inhibitors (MAOIs), simultaneous use of reversible MAOI A inhibitors (moclobemide), reversible non-selective MAOI inhibitors (linezolid).
• A history of QT interval prolongation, including congenital prolonged QT interval syndrome.
• Simultaneous use of drugs that prolong the QT interval (e.g., antiarrhythmic drugs of classes IA and III, tricyclic antidepressants, macrolides).
• Simultaneous use of pimozide.
• Children and adolescents under 18 years of age (efficacy and safety of use not studied).
• Pregnancy, period of breastfeeding.
• Lactose intolerance, lactase deficiency, glucose-galactose malabsorption.

WARNING

Severe renal failure (creatinine clearance less than 30 ml/min), manic disorders (including a history of history), pharmacologically uncontrolled epilepsy, suicidal behavior, coronary heart disease, diabetes, anticonvulsant therapy; elderly age (>65 years), cirrhosis of liver, bleeding tendency; concurrent use with drugs that lower seizure threshold, tryptophan, drugs containing St. John’s wort, lithium; with drugs that cause hyponatremia, oral anticoagulants and other drugs that affect blood clotting; with drugs metabolized with participation of CYP2C19 isoenzyme, ethanol, simultaneous use with MAO inhibitor B (selegiline), serotonergic drugs.

Side effects

Adverse reactions with escitalopram occur during the first one to two weeks of treatment and usually subside significantly as therapy continues and patients improve.

The incidence of adverse reactions (according to WHO classification): Very common, ≥10%; common, ≥1%, but < 10%; infrequent, ≥0.1%, but < 1%; rare, ≥0.01%, but < 0.1%; very rare, < 0.01%, unknown – no data on the incidence of adverse reactions are currently available.

The following adverse reactions may occur:

Blood and lymphatic system disorders

Frequency unknown: thrombocytopenia.

Disorders of the immune system

Rarely: anaphylactic reactions.

Endocrine system disorders

Frequency unknown: insufficient secretion of antidiuretic hormone (ADH).

Metabolic and nutritional disorders

Frequently: decreased appetite, increased appetite, increased body weight;

Infrequent: decreased body weight;

Frequency unknown: hyponatremia, anorexia¹.

Psychiatric disorders

Frequently: anxiety, restlessness, unusual dreams, decreased libido,

anorgasmia (in women);

Infrequent: bruxism, agitation, nervousness, panic attacks, confusion;

Rarely: aggression, depersonalization, hallucinations;

Frequency unknown: mania, suicidal thoughts, suicidal behavior².

Nervous system disorders

very often: headache;

Often: insomnia, drowsiness, dizziness, paresthesias, tremor;

Infrequent: taste disturbances, sleep disturbances, syncopal states (fainting);

Rarely: serotonin syndrome;

Frequency unknown: dyskinesia, motor disturbances, seizure disorders, psychomotor agitation/acathisia¹.

Visual disorders

Infrequent: mydriasis (dilated pupil), visual disturbances.

Hearing organ and labyrinth disorders

Infrequent: tinnitus (tinnitus).

Cardiac disorders

Infrequent: tachycardia;

Rarely: bradycardia;

Frequency unknown: longening of the QT interval on the electrocardiogram, ventricular arrhythmias, including pirouette-type ventricular tachycardia.

vascular disorders

Frequency unknown: orthostatic hypotension.

Disorders of the respiratory system, thoracic and mediastinal organs

Frequently: sinusitis, yawning;

Infrequent: nasal bleeding.

Gastrointestinal tract disorders

very often: nausea;

Frequently: diarrhea, constipation, vomiting, dry mouth;

Infrequent: gastrointestinal bleeding (including rectal bleeding).

Liver and biliary tract disorders

Frequency unknown: hepatitis, impaired liver function.

Skin and subcutaneous tissue disorders

Frequently: high sweating;

Infrequent: hives, alopecia, rash, itching;

Frequency unknown: ecchymosis, angioedema.

Musculoskeletal and connective tissue disorders

Frequently: arthralgia, myalgia.

Kidney and urinary tract disorders

Frequency unknown: painful urine retention.

Renital and breast disorders

Frequently: impotence, impaired ejaculation;

Infrequent: metrorrhagia (uterine bleeding), menorrhagia;

Frequency unknown: galactorrhea, priapism.

General disorders and disorders at the site of administration

Frequently: weakness, hyperthermia;

Infrequent: edema.

¹ Adverse events reported with SSRI class drugs.

²Incidents of suicidal thoughts and behavior have been reported while taking escitalopram and immediately after withdrawal of therapy.

In the post-registration period, cases of QT interval prolongation and ventricular arrhythmias, including pirouette-type ventricular tachycardia, have been reported primarily in female patients with hypokalemia or pre-existing QT interval prolongation or other cardiovascular disease. In double-blind, placebo-controlled ECG studies in healthy volunteers, the change from baseline QTc (corrected by the Friedericia formula) was 4.3 msec at the 10 mg/day dose and 10.7 msec at 30 mg/day.

Class effect

Epidemiological studies involving patients aged 50 years or older have reported an increased risk of bone fractures in patients receiving SSRIs and tricyclic antidepressants. The mechanism leading to this risk is unknown.

Cancellation symptoms after treatment discontinuation

Discontinuation of SSRIs/SRIs (selective norepinephrine and serotonin reuptake inhibitors) (especially abrupt) usually results in “withdrawal” symptoms. The most common symptoms are dizziness, sensory disturbances (including paresthesias and current sensations), sleep disturbances (including insomnia and vivid dreams), agitation or anxiety, nausea and/or vomiting, tremor, confusion, increased sweating, headache, diarrhea, palpitations, emotional instability, irritability and visual disturbances. These are usually mild to moderate in severity and pass on their own, but in some patients they may be severe and prolonged. Gradual withdrawal with lower doses is recommended.

Overdose

The data on overdose with escitalopram are limited, in many such cases there was also an overdose with other drugs. In most cases, the symptoms of overdose are mild or absent. Cases of fatal overdose with escitalopram (without taking other drugs) are rare, in most cases there is also overdose with other drugs. No clinically significant overdose symptoms have occurred when taking escitalopram in a dose range of 400 mg to 800 mg in monotherapy.

Symptoms

. When overdosed with escitalopram, symptoms mainly occur in the central nervous system (from dizziness, tremor, and agitation to rare cases of serotonin syndrome, seizure disorders, and coma), gastrointestinal tract (nausea/vomiting), cardiovascular system (hypotension, tachycardia, prolonged QT interval and arrhythmia) and electrolyte disturbances (hypokalemia, hyponatremia).

Treatment

There is no specific antidote. Normal airway patency, oxygenation and ventilation of the lungs should be ensured. Gastric lavage should be performed and activated charcoal prescribed. Gastric lavage should be performed as soon as possible after ingestion. It is recommended to monitor the performance of the heart and other vital organs and to carry out symptomatic and supportive therapy.

Pregnancy use

Pregnancy

There are limited data on the administration of escitalopram during pregnancy.

Escitalopram studies in animals have demonstrated reproductive toxicity.

Escitalopram during pregnancy should only be taken when absolutely necessary and after careful assessment of the benefit/risk ratio.

If administration of escitalopram has continued into late pregnancy, especially in the third trimester, the newborn should be monitored. If administration of escitalopram continued until delivery or was discontinued shortly before delivery, the newborn may develop withdrawal symptoms.

If the mother takes SSRIs/ SSRIs (selective serotonin and norepinephrine reuptake inhibitors) in late pregnancy, the following side effects may develop in the newborn: Respiratory depression, cyanosis, apnea, seizure disorders, temperature spikes, feeding difficulties, vomiting, hypoglycemia, hypertension, muscle hypotonia, hyperreflexia, tremor, increased neuroreflex excitability, irritability, lethargic sleep, constant crying, sleepiness, poor sleep. These symptoms may occur due to the development of withdrawal or serotoninergic syndrome. In most cases, complications occur within 24 hours after birth.

The data from epidemiological studies suggest that the use of SSRIs during pregnancy, especially in the late term, may increase the risk of sustained pulmonary hypertension in newborns (PPHN). The observed risk was about 5 cases per 1,000 pregnancies. In the general population, there are 1-2 cases of PPHN per 1,000 pregnancies.

Breastfeeding period

Escitalopram is expected to be excreted with breast milk, so breastfeeding is contraindicated during treatment with escitalopram. Breastfeeding should be discontinued if the use of escitalopram is necessary.

Fertility

The data from animal studies showed that some SSRIs may affect sperm quality. There are no data from animal studies on this aspect for escitalopram. Reports on the use of some SSRIs in humans have shown that the effects of these medications on semen quality are reversible. So far, the effects of escitalopram on fertility in humans have not been observed.

Similarities

Cipralex, Elicea, Lenuxin, Elicea Ku-tab