Elicea, pills 10mg, 56pcs

Composition

for 1 tablet 5 mg / 10 mg / 20 mg

Core:

Active ingredient:

Escitalopram oxalate 6,390 mg / 12,780 mg/25,560 mg, equivalent to escitalopram 5,00 mg/10.00 mg/20.00 mg

Auxiliary substances:

Lactose monohydrate, crospovidone, povidone-K 30, microcrystalline cellulose, pregelatinized starch, magnesium stearate

Film shell:

Opadray white 33G287071

1 Opadray white 33G28707: Hypromellose 6 cP, titanium dioxide (E 171), lactose monohydrate, macrogol, triacetin

Pharmacological action

antidepressant

Clinical Pharmacology

Pharmacodynamics

Escitalopram is an antidepressant, selective serotonin reuptake inhibitor (SSRI) with high affinity for the primary binding site. Escitalopram also binds to the allosteric binding site of the transporter protein, with an affinity less than a thousand times. Allosteric modulation of the transporter protein enhances the binding of escitalopram at the primary binding site, which leads to a more complete inhibition of serotonin reuptake.

Escitalopram has no or 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, m-holinoreceptors, benzodiazepine and opioid receptors.

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

In double-blind placebo-controlled ECG studies in healthy volunteers, the change from the baseline QTc value (Fridericia correction) was 4.3 msec (90% confidence interval (CI): 2.2-6.4) at a dose of 10 mg per day and 10.7 msec (90% CI: 8.6-12.8) at a dose of 30 mg per day.

Clinical efficacy

Severe depressive episodes

Escitalopram was found to be effective in the emergency treatment of severe depressive episodes in three of four double-blind, placebo-controlled, short-term (8-week) studies. During the long-term breakdown prevention trial,274 patients who completed the initial 8-week open-label phase and received escitalopram at a dose of 10 or 20 mg per day were randomized and subsequently received escitalopram at the same dosage or placebo for a maximum of 36 weeks. During this study, patients who continued to take escitalopram did not experience a breakdown for a longer period of time in the subsequent 36 weeks compared to those who took placebo.

Obsessive-compulsive disorder

In a randomized, double-blind clinical trial, the effect of escitalopram at a dose of 20 mg per day was compared with placebo based on the Yale-Brown obsessive-compulsive score at 12 weeks. After 24 weeks, escitalopram at doses of 10 and 20 mg per day showed better results compared to placebo.

Relapse prevention was demonstrated when escitalopram was administered at doses of 10 and 20 mg per day in patients whose treatment with escitalopram showed successful results during a 16-week open-label study, and who participated in a 24-week randomized double-blind placebo-controlled study.

Pharmacokinetics

Suction

Absorption is almost complete and does not depend on the time of food intake. The average time to reach the maximum concentration in blood plasma (TC_max) is 4 hours after repeated use. The absolute bioavailability of escitalopram is about 80%, as well as racemic citalopram.

Distribution

The apparent volume of distribution (_{vd, β}/F) after oral use is 12 to 26 l/kg. Binding of escitalopram and its major metabolites to plasma proteins is below 80%. The kinetics of escitalopram is linear. Steady-state concentration (Ss) is reached after approximately 1 week, with an average Ss of 50 nmol / L (20 to 125 nmol/L) achieved at a daily dose of 10 mg.

Metabolism

Escitalopram is metabolized in the liver to demethylated and didemethylated metabolites. Both metabolites are pharmacologically active. Nitrogen can be oxidized to the N-oxide metabolite. The main substance and its metabolites are partially excreted as glucuronides. After repeated use, the average concentrations of demethylated and didemethylated metabolites are 28-31% and less than 5% (respectively) of the escitalopram concentration. Biotransformation of escitalopram to the demethylated metabolite occurs mainly with the help of the CYP2C19 isoenzyme, and some involvement of the CYP3A4 and CYP2D6 isoenzymes is possible.

Deduction

The half-life (T_1/2) after repeated use is about 30 hours.

Oral clearance (Cl_oral) is 0.6 l/min. In the main metabolites of escitalopram, T_1/2 is longer. Escitalopram and its main metabolites are excreted by the liver (metabolic pathway) and kidneys, most of them are excreted as metabolites by the kidneys.

Special patient groups

Elderly patients (over 65 years of age)

In elderly patients (over 65 years), escitalopram is excreted more slowly than in younger patients. The amount of escitalopram in the systemic circulation, calculated using the pharmacokinetic indicator area under the concentration-time curve (AUC) in elderly patients is 50% higher than in young healthy volunteers.

Impaired liver function

In patients with mild to moderate hepatic insufficiency (Child-Pugh class A and B), escitalopram’s T 1/2 is approximately 2 times longer and AUC is 60% greater than in patients with normal liver function.

Impaired renal function

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

Polymorphism (in individuals with low activity of CYP2C19 or CYP2D6 isoenzymes)

In patients with low activity of the CYP2C19 isoenzyme, 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 were detected with low activity of the CYP2D6 isoenzyme.

Indications

* Depressive episodes of any severity.

* Panic disorders with / without agoraphobia.

* Obsessive-compulsive disorder.

Use during pregnancy and lactation

Pregnancy

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

Studies of escitalopram in animals have demonstrated reproductive toxicity.

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

If the use of escitalopram continued in the late stages of pregnancy, especially in the third trimester, then the newborn should be monitored. If the use of escitalopram continued until delivery or was stopped 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 newborn may develop the following side effects: respiratory depression, cyanosis, apnea, convulsive disorders, temperature jumps, feeding difficulties, vomiting, hypoglycemia, muscle hypertension, muscle hypotension, hyperreflexia, tremor, increased neuro-reflex excitability, irritability, lethargy, constant weight loss. crying, drowsiness, and poor sleep. These symptoms may occur due to the development of a “withdrawal” syndrome or serotonergic action. In most cases, such complications occur within 24 hours after birth.

Data from epidemiological studies suggest that the use of SSRIs during pregnancy, especially in the late stages, may increase the risk of developing persistent pulmonary hypertension in newborns (PPHN). The observed risk was 5 cases per 1000 pregnancies. In the general population, there are 1-2 cases of PPHN per 1000 pregnancies.

Breast-feeding period

Escitalopram is expected to be excreted in breast milk, so breast-feeding is contraindicated during treatment with escitalopram. If it is necessary to use Elycea®, breast-feeding should be discontinued.

Fertility

Data from animal studies have shown that some SSRIs can affect the quality of sperm. There are no animal studies of this aspect 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, no effect of escitalopram on human fertility has been observed.

Contraindications

• Hypersensitivity to escitalopram and other components of the drug.

• Concomitant use of non-selective irreversible monoamine oxidase (MAO) inhibitors.
• Simultaneous use of reversible MAO A inhibitors (moclobemide), reversible non-selective MAO inhibitors (linezolid).
• A history of QT prolongation, including congenital long QT syndrome.
• Concomitant use of drugs that prolong the QT interval (see the section “Interaction with other drugs”).
• Simultaneous use of pimozide.

• Children and adolescents under 18 years of age (efficacy and safety of use have not been studied).

• Lactose intolerance, lactase deficiency, or glucose-galactose malabsorption syndrome (Elycea ® contains lactose).

Side effects

Side effects most often develop during the 1st or 2nd week of therapy, then usually become less intense and occur less frequently with continued therapy.

The following are the side effects that occur when taking SSRI medications and are noted when taking escitalopram. The information is based on data from placebo-controlled clinical trials and spontaneous reports.

The frequency is listed as: very common (≥ 1/10), common (≥ 1/100 to < 1/10), infrequent (≥1/1000 to < 1/100), rare (≥1/10000 to < 1/1000), very rare (

Disorders of the blood and lymphatic system:

frequency unknown: thrombocytopenia.

Immune system disorders:

rare: anaphylactic reactions.

Endocrine system disorders:

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

Metabolic and nutritional disorders:

often: decreased appetite, increased appetite, weight gain;

infrequently: weight loss;

frequency unknown: hyponatremia, anorexia 1.

Mental disorders:

common: anxiety, restlessness, unusual dreams, decreased libido, anorgasmia (in women);

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

rare: aggression, depersonalization, hallucinations;

frequency unknown: mania, suicidal thoughts, suicidal behavior 2.

Nervous system disorders:

very common: headache;

common: insomnia, drowsiness, dizziness, paresthesia, tremor;

uncommon: taste disorders, sleep disorders, syncope;

rare: serotonin syndrome;

frequency unknown: dyskinesia, motor disorders, convulsive disorders, psychomotor agitation/akathisia1.

Visual disturbances:

infrequently: mydriasis (dilated pupil), visual disturbances.

Hearing disorders and labyrinth disorders:

infrequently: tinnitus (tinnitus).

Disorders of the heart and blood vessels:

infrequently: tachycardia;

rarely: bradycardia;

frequency unknown: prolongation of the QT interval on the electrocardiogram( ECG), ventricular arrhythmia, including ventricular tachycardia of the “pirouette” type, orthostatic hypotension.

Respiratory, thoracic and mediastinal disorders:

common: sinusitis, yawning;

infrequent: a nosebleed.

Disorders of the gastrointestinal tract:

very common: nausea;

common: diarrhea, constipation, vomiting, dry mouth;

uncommon: gastrointestinal bleeding (including rectal bleeding).

Liver and biliary tract disorders:

frequency unknown: hepatitis, increased activity of “liver” enzymes in blood plasma.

Skin and subcutaneous tissue disorders:

often: increased sweating;

infrequently: urticaria, alopecia, skin rash, pruritus;

frequency unknown: ecchymosis, angioedema.

Musculoskeletal and connective tissue disorders:

common: arthralgia, myalgia.

Kidney and urinary tract disorders:

frequency unknown: urinary retention.

Genital and breast disorders:

common: impotence, ejaculation disorder;

uncommon: menorrhagia, metrorrhagia;

frequency unknown: galactorrhea, priapism.

General disorders and disorders at the injection site:

often: weakness, hyperthermia;

infrequently: edema.

1 Adverse events reported with the use of SSRI drugs.

2 Cases of suicidal thoughts and behavior have been reported with escitalopram and immediately after discontinuation of therapy.

Prolongation of the QT interval

In the post-marketing period, cases of QT prolongation and ventricular arrhythmia, including pirouette-type ventricular tachycardia, were reported, mainly in female patients with hypokalemia or in patients with pre-existing QT prolongation or other heart diseases.

Class-effect

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 of occurrence of this risk has not been established.

Symptoms of “withdrawal” when stopping therapy

Withdrawal of SSRI/SSRI medications (especially abrupt ones) often leads to a “withdrawal”syndrome. The most common symptoms are dizziness, sensory disturbances (including paresthesia and current passing sensation), sleep disorders (including insomnia and intense dreams), agitation or anxiety, nausea and/or vomiting, tremor, confusion, increased sweating, headache, diarrhea, palpitations, emotional instability, irritability, and visual disturbances. As a rule, these effects are mild or moderate and pass quickly, but in some patients they may appear in a more acute form and/or for a longer time. It is recommended to gradually cancel the drug by reducing its dose.

Interaction

Pharmacodynamic interaction

Non-selective irreversible MAO inhibitors

Serious adverse reactions have been reported with concomitant use of SSRIs and non-selective irreversible MAO inhibitors, as well as with the initiation of MAO inhibitors in patients who have recently stopped taking SSRIs. In some cases, patients developed serotonin syndrome.

Escitalopram should not be used concomitantly with non-selective irreversible MAO inhibitors. Escitalopram may be started 14 days after discontinuation of non-selective irreversible MAO inhibitors. At least 7 days after the end of escitalopram should elapse before starting non-selective irreversible MAO inhibitors.

Reversible selective MAO A inhibitor (moclobemide)

Due to the risk of serotonin syndrome, escitalopram should not be used concomitantly with the MAO A inhibitor moclobemide. If the use of such a combination of drugs is considered clinically necessary, it is recommended to start with the lowest possible doses, as well as to conduct constant clinical monitoring of the patient’s condition. Escitalopram should be started at least 1 day after discontinuation of the reversible MAO A inhibitor moclobemide.

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 the use of such a combination of drugs is considered clinically necessary, it is recommended to start with the lowest possible doses, as well as to conduct constant clinical monitoring of the patient’s condition.

Irreversible selective MAO B inhibitor (selegiline)

Due to the risk of serotonin syndrome, caution should be exercised when taking escitalopram concomitantly with the irreversible MAO inhibitor B selegiline.

Pharmacokinetic and pharmacodynamic studies of the use of escitalopram in combination with other drugs that prolong the QT interval have not been conducted. The additive effect of escitalopram and these drugs cannot be excluded. Therefore, concomitant use of escitalopram and drugs that prolong the QT interval is contraindicated, such as antiarrhythmic drugs of classes IA and III, neuroleptics (for example, phenothiazine derivatives, pimozide, haloperidol), tricyclic and tetracyclic antidepressants (amitriptyline, imipramine, maprotiline, etc. ), selective serotonin reuptake inhibitors and similar antidepressants (for example, fluoxetine, venlafaxine, etc. ), some antimicrobials (macrolide antibiotics and their analogues, for example, erythromycin, clarithromycin, quinolone and fluoroquinolone derivatives: sparfloxacin, moxifloxacin, pentamidine), azole antifungal agents (ketoconazole, fluconazole), domperidone, ondansetron, drugs for the treatment of malaria, in particular, halofantrine, some antihistamines (astemizole, mizolastine).

Serotonergic medications

Concomitant use with serotonergic medicinal products (e. g. tramadol, sumatriptan and other triptans) it can lead to the development of serotonin syndrome.

Medications that reduce the threshold of convulsive readiness

SSRIs can lower the seizure alert threshold. Caution should be exercised when concomitantly using escitalopram with other drugs that reduce the threshold of convulsive readiness (tricyclic antidepressants, SSRIs, mefloquine, bupropion and tramadol, antipsychotic drugs (neuroleptics) – derivatives of phenothiazine, thioxanthene and butyrophenone).

Lithium, tryptophan

Since there have been reported cases of increased activity with concomitant use of SSRIs and lithium or tryptophan, caution is recommended when escitalopram is co-administered with these drugs.

St. John’s wort holed

Concomitant use of SSRIs and medications containing St. John’s wort can lead to an increase in the number of side effects.

Anticoagulants and agents that affect blood clotting

Blood clotting disorders may occur when escitalopram is co-administered with oral anticoagulants and medications that affect blood clotting (for example, atypical antipsychotics and phenothiazine derivatives, most tricyclic antidepressants, acetylsalicylic acid and nonsteroidal anti-inflammatory drugs (NSAIDs), ticlopidine and dipyridamole). In such cases, careful monitoring of blood clotting parameters is necessary at the beginning or at the end of escitalopram therapy. Concomitant use with NSAIDs can lead to an increase in the number of bleeding events.

Ethanol

Escitalopram does not interact pharmacodynamically or pharmacokinetically with ethanol. However, as with other psychotropic medications, concomitant use of escitalopram and ethanol is not recommended.

Medications that cause hypokalemia/hypomagnesemia

Caution should be exercised when concomitantly using drugs that cause the development of hypokalemia/hypomagnesemia, since these conditions increase the risk of developing malignant arrhythmias.

Pharmacokinetic interaction

Effect of other drugs on the pharmacokinetics of escitalopram

Escitalopram is mainly metabolized by the CYP2C19 isoenzyme. To a lesser extent, the isoenzymes CYP3A4 and CYP2D6 can participate in the metabolism. Metabolism of the main metabolite, demethylated escitalopram, appears to be partially catalyzed by the CYP2D6 isoenzyme.

Concomitant use of escitalopram and omeprazole 30 mg once daily (an inhibitor of the CYP2C19 isoenzyme) leads to a moderate (approximately 50%) increase in the concentration of escitalopram in blood plasma.

Concomitant use of escitalopram and cimetidine 400 mg 2 times a day (an inhibitor of the isoenzymes CYP2D6, CYP3A4 and CYP1A2) leads to an increase (approximately 70%) in the concentration of escitalopram in blood plasma.

Therefore, caution should be exercised when using the maximum possible dose of escitalopram concomitantly with inhibitors of the CYP2C19 isoenzyme (for example, omeprazole, fluconazole, fluoxetine, fluvoxamine, lansoprazole, ticlopidine) and cimetidine. When escitalopram and the above medications are co-administered, a reduction in the dose of escitalopram may be necessary based on clinical evaluation.

Effect of escitalopram on the pharmacokinetics of other drugs

Escitalopram is an inhibitor of the CYP2D6 isoenzyme.

Caution should be exercised when using escitalopram concomitantly with drugs that are metabolized by this isoenzyme and have a low therapeutic index, for example, flecainide, propafenone and metoprolol (in cases of use in heart failure) or medications that are mainly metabolized by the CYP2D6 isoenzyme and act on the central nervous system, for example, antidepressants (desipramine, clomipramine, nortriptyline) or antipsychotic drugs (risperidone, thioridazine, haloperidol). In these cases, a dose adjustment may be necessary.

Concomitant use of escitalopram and desipramine or metoprolol leads to a twofold increase in the concentration of the latter two drugs.

Escitalopram may slightly inhibit the CYP2C19 isoenzyme. Therefore, caution is recommended when using escitalopram concomitantly with drugs that are metabolized by the CYP2C19 isoenzyme.

How to take, course of use and dosage

Inside,1 time a day, regardless of the meal time.

Depressive episodes

Usually prescribed 10 mg 1 time a day. Depending on the individual response of the patient, the dose can be increased to a maximum of 20 mg/day.

The antidepressant effect develops 2-4 weeks after the start of treatment. After the symptoms of depression disappear, at least for another 6 months, it is necessary to continue therapy to consolidate the effect obtained.

Panic disorders with / without agoraphobia

During the first week, the recommended dose is 5 mg / day, which is then increased to 10 mg / day. Depending on the individual response of the patient, the dose can be increased to a maximum of 20 mg/day.

The maximum therapeutic effect is achieved approximately 3 months after the start of treatment. The therapy lasts for several months.

Obsessive-compulsive disorder

Usually prescribed 10 mg 1 time a day. Depending on the individual response of the patient, the dose can be increased to a maximum of 20 mg/day.

Since obsessive-compulsive disorder is a chronic disease, the course of treatment should be long enough to ensure complete relief from symptoms and last at least 6 months. To prevent relapses, treatment is recommended for at least 1 year.

Elderly patients (over 65 years of age)

It is recommended to use half of the usually recommended dose (5 mg / day) and a lower maximum dose (10 mg/day).

Children and teenagers (under 18 years of age)

Elycea® should not be used in children and adolescents under 18 years of age (see section “Special instructions”). In addition, there is insufficient evidence from long-term studies on the safety of escitalopram in children and adolescents regarding growth, maturation, cognitive and behavioral development.

Impaired renal function

No dose adjustment is required for mild to moderate renal failure (creatinine clearance greater than 30 ml / min).

In case of severe renal insufficiency (creatinine clearance less than 30 ml/min), the drug is used Elycea® should be administered with caution.

Impaired liver function

In patients with mild to moderate hepatic insufficiency (Child-Pugh class A or B), the recommended initial dose for the first 2 weeks of treatment is 5 mg / day. Depending on the individual response of the patient, the dose can be increased to 10 mg/day. In patients with severe hepatic insufficiency (Child-Pugh class C), Elycea® is prescribed under close medical supervision.

Reduced activity of the CYP2C19 isoenzyme

For patients with reduced activity of the CYP2C19 isoenzyme, the recommended initial dose for the first 2 weeks of treatment is 5 mg / day. Depending on the individual response of the patient, the dose can be increased to 10 mg/day.

Discontinuation of treatment

When stopping treatment with Elycea®, the dose should be reduced gradually over 1-2 weeks to avoid the occurrence of “withdrawal”syndrome.

Overdose

Toxicity

Data on overdose with escitalopram are limited, and in many such cases, there was also an overdose with other drugs. In most cases, overdose symptoms do not appear or are mild.

Cases of overdose with escitalopram (without taking other drugs) with a fatal outcome are rare, in most cases there is also an overdose with other drugs. No clinically significant symptoms of overdose occurred when escitalopram was administered in the dose range from 400 mg to 800 mg in monotherapy.

Symptoms

Overdose with escitalopram mainly causes symptoms of the central nervous system (from dizziness, tremor and agitation to rare cases of serotonin syndrome, convulsive disorders and coma), gastrointestinal tract (nausea/vomiting), cardiovascular system (hypotension, tachycardia, QT prolongation and arrhythmia) and electrolyte balance disorders (hypokalemia, hyponatremia).

Treatment

There is no specific antidote. It is necessary to ensure normal airway patency, oxygenation and ventilation of the lungs. Gastric lavage should be performed and activated charcoal should be prescribed. Gastric lavage should be performed as soon as possible after taking the drug. It is recommended to monitor the performance of the heart and other vital organs and conduct symptomatic and supportive therapy.

Description

5 mg tablets:

Round, biconvex tablets, white film-coated tablets with a chamfer.

View at the break: a rough mass of white color with a film shell of white color.

10 mg and 20 mg tablets:

Oval, biconvex tablets, white film-coated tablets with a risk on one side.

View at the break: a rough mass of white color with a film shell of white color.

Special instructions

Severe renal insufficiency (creatinine clearance less than 30 ml/min), mania/hypomania, pharmacologically uncontrolled epilepsy, severe suicidal behavior, diabetes mellitus, cirrhosis of the liver, tendency to bleed, concomitant use with an MAO B inhibitor (selegiline), serotonergic drugs, drugs that reduce the threshold of convulsive readiness, lithium, tryptophan, drugs containing St. John’s wort oral anticoagulants and drugs that affect blood clotting, drugs that can cause hyponatremia, drugs that are metabolized with the participation of the CYP2C19 isoenzyme, ethanol, when using electroconvulsive therapy (ECT), in elderly patients, during pregnancy, during breastfeeding.

It is contraindicated in children and adolescents under 18 years of age (the effectiveness and safety of use have not been studied).

Elderly patients (over 65 years of age)

It is recommended to use half of the usually recommended dose (5 mg / day) and a lower maximum dose (10 mg/day).

Impaired renal function

No dose adjustment is required for mild to moderate renal failure (creatinine clearance greater than 30 ml / min).

In case of severe renal insufficiency (creatinine clearance less than 30 ml/min), the drug is used Elycea® should be administered with caution.

Impaired liver function

In patients with mild to moderate hepatic insufficiency (Child-Pugh class A or B), the recommended initial dose for the first 2 weeks of treatment is 5 mg / day. Depending on the individual response of the patient, the dose can be increased to 10 mg/day. In patients with severe hepatic insufficiency (Child-Pugh class C), Elycea® is prescribed under close medical supervision.

Reduced activity of the CYP2C19 isoenzyme

For patients with reduced activity of the CYP2C19 isoenzyme, the recommended initial dose for the first 2 weeks of treatment is 5 mg / day. Depending on the individual response of the patient, the dose can be increased to 10 mg/day.

When using medications that belong to the SSRI therapeutic group, including escitalopram, the following should be considered:

Use in children and adolescents under 18 years of age

Antidepressants should not be prescribed to children and adolescents under 18 years of age due to an 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 based on a clinical assessment to start antidepressant therapy, the patient should be closely monitored. In addition, there is insufficient data on long-term safety in children and adolescents in terms of growth, maturation, cognitive and behavioral development.

Paradoxical anxiety

Some patients with panic disorder may experience increased anxiety at the beginning of treatment with antidepressants. This paradoxical reaction usually disappears within the first two weeks of treatment. To reduce the likelihood of an anxiogenic effect, it is recommended to use low initial doses.

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 and should be carefully monitored for controlled seizures.

Mania

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

Diabetes mellitus

In patients with diabetes mellitus, treatment with escitalopram may change the concentration of glucose in the blood plasma. Therefore, it may be necessary to adjust the doses of insulin and / or hypoglycemic drugs for oral use.

Suicide / suicidal thoughts or clinical deterioration

Depression is associated with an increased risk of suicidal thoughts, self-harm, and suicide (suicidal phenomena). This risk persists until a pronounced remission occurs. Since there may be no improvement during the first few weeks of therapy or even longer, 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 psychiatric conditions that escitalopram is prescribed to treat may also be associated with an increased risk of suicidal events and phenomena. In addition, these conditions may be comorbidities in relation to a depressive episode. When treating patients with other psychiatric disorders, the same precautions should be taken as when treating patients with a depressive episode.

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

A meta-analysis of placebo-controlled clinical trials of antidepressants in adult patients with psychiatric disorders showed that when taking antidepressants, patients younger than 25 years of age have an increased risk of suicidal behavior compared to placebo. Drug treatment of these patients, and in particular those at high risk of suicide, should be accompanied by close monitoring, especially at an early stage of treatment and when dose changes occur.

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

Akathisia/psychomotor agitation

The use of SSRIs / SSRIs is associated with the development of akathisia, 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 still. This is most often seen during the first few weeks of treatment. In patients with such symptoms, increasing the dose may lead to deterioration.

Hyponatremia

Hyponatremia, possibly associated with impaired ADH secretion, occurs rarely with SSRIs and usually disappears when therapy is discontinued. Caution should be exercised when using escitalopram and other SSRIs to people at risk of hyponatremia: elderly patients, patients with cirrhosis of the liver, and taking medications that can cause hyponatremia.

Bleeding

When taking SSRIs, cases of skin hemorrhage (ecchymosis and purpura) have been reported. Escitalopram should be used with caution in patients taking oral anticoagulants and medications that affect blood clotting, as well as in patients with a tendency to bleeding.

Electroconvulsive therapy

Since clinical experience with concomitant use of SSRIs and ECT is limited, caution should be exercised when using escitalopram and ECT at the same time.

Serotonin syndrome

Concomitant use of escitalopram and MAO A inhibitors is not recommended due to the risk of serotonin syndrome. Escitalopram should be used with caution concomitantly with medications that have serotonergic effects, such as sumatriptan or other triptans, tramadol and tryptophan. Patients taking escitalopram and other SSRIs concomitantly with serotonergic medications 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, you should immediately stop concomitant treatment with SSRIs and serotonergic drugs and start symptomatic treatment.

“Withdrawal” syndrome after discontinuation of therapy

When stopping treatment, withdrawal symptoms are common, especially when treatment is abruptly discontinued. In clinical trials, discontinuation adverse events were observed in approximately 25% of patients treated with escitalopram and 15% of patients treated with placebo.

The risk of withdrawal symptoms 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 frequently reported reactions were dizziness, sensory disturbances (including paresthesia and electric shock sensation), sleep disturbances (including insomnia and intense dreams), agitation or anxiety, nausea and/or vomiting, tremor, confusion, increased sweating, headache, diarrhea, palpitation, emotional instability, irritability, and visual disturbances. These symptoms are usually mild to moderate, but may be severe in some patients.

Symptoms usually occur within the first few days after discontinuation of treatment, but such symptoms have rarely been reported in patients who accidentally missed taking the drug.

As a rule, these symptoms resolve on their own usually within 2 weeks, although in some patients they can be prolonged (2-3 months or more). Therefore, when stopping treatment, it is recommended to gradually reduce the dose over several weeks or months, according to the patient’s condition.

Coronary heart disease (CHD)

Due to the limited experience of use in patients with CHD, caution is recommended when using the drug.

Prolongation of the QT interval

Escitalopram was found to cause a dose-dependent prolongation of the QT interval. In the post-marketing period, cases of QT prolongation and ventricular arrhythmia, including bidirectional ventricular tachycardia (pirouette type), have been reported, mainly in female patients with hypokalemia or pre-existing QT prolongation, or other heart diseases.

Caution should be exercised when using the drug in patients with severe bradycardia or in patients with recent acute myocardial infarction or decompensated heart failure.

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

In patients with stable CHD, an ECG should be performed before starting treatment.

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

Angle-closure glaucoma

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

Sexual dysfunction

SSRIs / SSRIs can cause symptoms of sexual dysfunction. There have been reports of prolonged sexual dysfunction where symptoms continued despite discontinuation of SSRIs/SSRIs.

Special information on excipients

Elycea ® contains lactose, so it should not be used in the following conditions: lactose intolerance, lactase deficiency, glucose-galactose malabsorption syndrome.

Despite the fact that the drug Elycea® does not affect intellectual functions and psychomotor activity, it is not recommended to drive vehicles or mechanisms during treatment.

Form of production

Film-coated tablets,5 mg,10 mg,20 mg.

7 tablets each in a blister of combined OPA/Al/PVC material and aluminum foil.

4 or 8 blisters together with the instructions for use are placed in a cardboard pack.

Storage conditions

At a temperature not exceeding 25 ° C, in the original packaging.

Keep out of reach of children.

Shelf

life is 3 years.

Do not use the drug after the expiration date.

Active ingredient

Escitalopram

Conditions of release from pharmacies

By prescription

Dosage form

Tablets

Purpose

Children as prescribed by a doctor, Adults as prescribed by a doctor

Indications

Depression, Obsessive-compulsive disorder, Phobias and panic attacks