Excitalopram-SZ pills 10mg, 30pcs

Composition

1 tablet contains:

Active ingredient:

escitalopram oxalate 12.77 mg in terms of escitalopram-10 mg;

excipients:

microcrystalline cellulose 102-23.73 mg,

croscarmellose sodium (primellose) – 4.5 mg,

lactose monohydrate (lactopress) (milk sugar) – 100.0 mg,

hyprolose low-substituted (hydroxypropylcellulose low-substituted) – 6.0 mg,

colloidal silicon dioxide (aerosil) – 1.5 mg,

magnesium stearate-1.5 mg

. shell composition:  hypromellose-2.55 mg, polysorbate-80 (twin-80) – 1.06 mg, talc-0.85 mg, titanium dioxide E 171-0.54 mg

Pharmacological action

Pharmacotherapy group: Antidepressant Code ATX: N06AB10 Pharmacodynamics :

Escitalopram is an antidepressant selective serotonin reuptake inhibitor (SSRI) with minimal effect on the reuptake of norepinephrine and dopamine by neurons. The mechanism of antidepressant action of escitalopram (S-enantiomer of racemic citalopram) is based on its ability to selectively block the reuptake of serotonin (5-hydroxytryptamine (5-HT)) by the presynaptic membranes of brain neurons, which determines the strengthening of its serotonergic action in the central nervous system responsible for the development of an antidepressant effect and effectiveness in the treatment of panic and social anxiety disorder.

Escitalopram, in comparison with the R-enantiomer (right-handed), has a 100-fold more pronounced effect on serotonin reuptake inhibition. Escitalopram has no or very low affinity for serotonin (5-HT1-7) or other receptors including α1 – α2 – β-adrenergic receptors dopamine (D1-5) m-cholinergic receptors histamine (H 1-3) muscarinic (M 1-5) benzodiazepine and opioid receptors. Escitalopram also does not bind or has a low affinity for various ion channels including Na+ K+ Ca 1+ and Ca 2+ channels.

Pharmacokinetics:

The pharmacokinetics of escitalopram are linear and dose-dependent in the dose range from 10 to 30 mg / day, both with a single and multiple use.

Suction

The absorption of escitalopram is independent of food intake. Bioavailability is about 80%. The average time to reach the maximum concentration in blood plasma (TMAX) is 4 hours after repeated use.

Distribution

The apparent volume of distribution after oral use is between 12 and 26 l / kg. When using the drug once a day, a stable equilibrium concentration in blood plasma (Css) is reached after one week. The average steady-state concentration is 50 nmol / l (20 to 125 nmol/L) at a daily dose of 10 mg. Binding to plasma proteins is about 56%.

Metabolism

Escitalopram biotransformation occurs in the liver to S-demethylcitalopram (S-DCT) and S-didemethylcitalopram (S-DDCT) both metabolites are pharmacologically active. After repeated use, the concentration of demethyl and didemethyl metabolites is usually 28-31% and less than 5%, respectively, of the concentration of escitalopram.

Escitalopram is at least 7 and 27 times more potent than S-DCT and S-DCT, respectively, in inhibiting serotonin reuptake, indicating that escitalopram metabolites do not significantly contribute to the antidepressant effect of the drug. S-DCT and S-DDCT also have no or very low affinity for serotonergic (5-HT 1-7) or other receptors, including alpha – and beta-adrenergic receptors dopamine (D1-5) histamine (H 1-3) muscarinic (M 1-5) and benzodiazepine receptors. S-DCT and S-DDT also do not bind to various ion channels, including Nay K+ Cl-and Ca2+ channels.

Escitalopram is metabolized to a demethylated metabolite mainly by cytochrome P 450 isoenzymes: CYP2C19, CYP3A4, and CYP2D6.

Deduction

The half-life (T 1/2) after repeated use is about 30 hours. Oral clearance (Cloral) is approximately 06 l/min. The main metabolites of escitalopram have a longer half-life. Escitalopram and its major metabolites are excreted by the liver and most of them by the kidneys, partly in the form of glucuronides.

In case of liver failure

In patients with reduced liver function, the clearance of escitalopram is reduced by 37% and the half-life is doubled.

In patients with low activity of the CYP2C19 isoenzyme, the concentration of escitalopram may be twice as high as in cases with high activity of this isoenzyme. There were no significant changes in the drug concentration in cases with weak activity of the CYP2D6 isoenzyme.

In patients with moderate renal insufficiency, the clearance of escitalopram decreases by 17%. Data on the pharmacokinetics of escitalopram in patients with severe renal insufficiency (creatinine clearance below 20 ml / min) missing items.

Escitalopram is excreted more slowly in the elderly (over 65 years of age) than in younger patients. The amount of escitalopram in the systemic circulation (the area under the concentration – time curve) and the elimination half-life in elderly patients increase by approximately 50%.

Indications

Depressive episodes of any severity.

Panic disorder with / without agoraphobia.

Obsessive-compulsive disorder.

Use during pregnancy and lactation

Use during pregnancy

Escitalopram should not be prescribed to pregnant women if the potential clinical benefit does not outweigh the theoretical risk due to insufficient data on the effectiveness and safety of its use in pregnant women.

During the study of the reproductive toxicity of escitalopram in rats, embryophetotoxicity was observed, but no increase in the number of congenital malformations was found. 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 syndrome.

If the mother takes selective serotonin reuptake inhibitors or selective serotonin and norepinephrine reuptake inhibitors in late pregnancy, the newborn may develop the following side effects: persistent pulmonary hypertension respiratory depression cyanosis apnea convulsive disorders temperature jumps feeding difficulties vomiting hypoglycemia muscle hypotension hyperreflexia tremor increased neuro-reflex excitability irritability lethargic sleep constant crying drowsiness poor sleep. These symptoms may occur due to the development of withdrawal syndrome or serotonergic action. In most cases, such complications occur within 24 hours after birth.

Epidemiological data suggest that the use of selective serotonin reuptake inhibitors or selective serotonin and norepinephrine reuptake inhibitors during pregnancy especially in the late stages may increase the risk of developing persistent pulmonary hypertension in newborns with a frequency of up to 5 cases per 1000 with a frequency in the general population of 1-2 per 1000.

Use during breastfeeding

Escitalopram and its metabolites pass into breast milk, so the drug is contraindicated during breastfeeding. If it is necessary to use the drug, breastfeeding should be discontinued.

Fertility

Animal studies have shown that escitalopram can affect sperm quality. Medical cases involving the use of selective serotonin reuptake inhibitors have shown that the effects on sperm quality are reversible. So far, no effects on human fertility have been detected.

Contraindications

– Hypersensitivity to ESCITALOPRAM and other components of the drug;

– concomitant use with monoamine oxidase inhibitors (MAOIS) monoamine oxidase-A (MAO-A) (e. g. moclobemide) or the reversible non-selective MAO inhibitors;

patients with long QT interval (congenital syndrome of extension of the QT interval);

– simultaneous use of drugs can prolong the QT interval (e. g. antiarrhythmics of classes IA and III, tricyclic antidepressants, macrolides);

– concomitant use of pimozide;

– lactose intolerance lactase deficiency, glucose-galactose malabsorption;

– pregnancy and the period of breastfeeding;

– children’s age up to 18 years (efficacy and safety not confirmed).

With caution:

Severe renal insufficiency (creatinine clearance less than 30 ml/min) manic disorders (including a history) pharmacologically uncontrolled epilepsy depression with suicidal ideation and attempts (taking the drug increases the risk of suicidal thoughts and suicidal behavior, especially during the first few months of drug therapy or during dose changes); diabetes mellitus age up to 25 years (due to the risk of suicidal behavior); age over 65 years coronary heart disease heart disease cirrhosis of the liver tendency to hemorrhage and bleeding hyponatremia deficiency of the CYP2C19 isoenzyme; simultaneous use with serotonergic drugs: sumatriptan tramadol tryptophan fentanyl; drugs that reduce the threshold of convulsive readiness lithium preparations preparations containing St. John’s wort; neuroleptics bupronion oral anticoagulants and drugs that affect blood clotting nonsteroidal anti-inflammatory drugs anti-inflammatory drugs drugs that can cause hyponatremia drugs that are metabolized with the participation of the CYP2C19 isoenzyme omeprazole cimetidine fluvoxamine desipramine metoprolol clomipramine nortriptyline haloperidol risperidone; electroconvulsive therapy.

Side effects

Side effects most often develop in the first or second week of treatment and then usually become less intense and occur less frequently with continued therapy.

The frequency of side effects listed below was determined according to the following (World Health Organization classification): very common (≥1/10) common (≥ 1/100 to < 1/10) uncommon (≥ 1/1000 to < 1/100) rare (≥1/10000 to < 1/1000) very rare (

From the blood and lymphatic system: frequency unknown-thrombocytopenia.

From the immune system: rarely – anaphylactic reactions.

From the endocrine system: frequency unknown-insufficient secretion of antidiuretic hormone (ADH).

Metabolic disorders and eating disorders: often-decreased appetite increased appetite weight gain; infrequently – weight loss; frequency unknown-hyponatremia anorexia.

From the side of the psyche: 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 behaviors have been reported with escitalopram and immediately after discontinuation of therapy.

From the nervous system: often-insomnia drowsiness dizziness paresthesia tremor; infrequently-taste disorders sleep disorders syncopal states; rarely-serotonin syndrome; frequency unknown-dyskinesia motor disorders convulsive disorders psychomotor agitation/ akathisia.

From the side of the organ of vision: infrequently-mydriasis (dilated pupil) visual disturbances; frequency unknown – angle-closure glaucoma.

From the side of the organ of hearing and labyrinth disorders: infrequently-tinnitus (tinnitus).

From the cardiovascular system: infrequently-tachycardia; rarely-bradycardia; frequency unknown – prolongation of the QT interval on the electrocardiogram.

Cases of QT prolongation and ventricular arrhythmia, including pirouette-type ventricular tachycardia, have been reported mainly in female patients with hypokalemia or pre-existing QT prolongation or other cardiovascular diseases. In double-blind placebo-controlled ECG studies in healthy volunteers, the change from the baseline QTc value (correction by the Friederichia formula) was 43 msec at a dose of 10 mg/day and 107 msec at 30 mg/day.

Vascular disorders: frequency unknown-orthostatic hypotension.

Respiratory system, thoracic and mediastinal disorders: often – sinusitis, yawning; infrequently-nosebleeds.

From the gastrointestinal tract: very often-nausea; common – diarrhea constipation vomiting dry mouth; infrequently – gastrointestinal bleeding (including rectal bleeding).

Liver and biliary tract disorders: unknown-hepatitis disorders of liver function.

From the skin and subcutaneous tissues: often-increased sweating; infrequently-urticaria alopecia rash pruritus; frequency unknown-ecchymosis angioedema.

Musculoskeletal and connective tissue disorders: often-arthralgia myalgia.

Renal and urinary tract disorders: frequency unknown-urinary retention.

From the reproductive system and breast: often-impotence violation of ejaculation; infrequently-metrorrhagia (uterine bleeding) menorrhagia; frequency unknown-galactorrhea priapism.

General disorders and disorders at the injection site: often-weakness hyperthermia; infrequently-edema.

Influence on the results of laboratory and instrumental studies: often-changes in laboratory parameters of liver function hyponatremia and changes in the electrocardiogram (prolongation of the QT interval expansion of the QRS complex change in the S-T segment and T wave).

Abrupt withdrawal of drugs from the group of selective norepinephrine and serotonin reuptake inhibitors often leads to withdrawal syndrome. The most common symptoms are dizziness sensory disturbances (including paresthesia and current flow sensations) sleep disorders (including insomnia and intense dreams) agitation or anxiety nausea and/or vomiting tremor confusion increased sweating headache diarrhea palpitations emotional instability irritability 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.

Class-effect

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

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 by 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 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 and also conduct constant clinical monitoring of the patient’s condition. Escitalopram should be started at least one day after discontinuation of the reversible MAO A inhibitor moclobemide.

Irreversible 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.

Tools that extend the QT interval

It is unacceptable to use with drugs that prolong the QT interval such as antiarrhythmics (procainamide amiodarone, etc. ) antipsychotics/antipsychotics (for example pimozide phenothiazine derivatives (chlorpromazine trifluoperazine thioridazine, etc. ) butyrophenone derivatives (haloperidol droperidol, etc. ) tricyclic and tetracyclic antidepressants (amitriptyline imipramine maprotiline, etc. ) selective serotonin reuptake inhibitors and similar antidepressants (e. g. fluoxetine venlafaxine, etc. ) antimicrobials (macrolide antibiotics and their analogues e. g. erythromycin clarithromycin; quinolone and fluoroquinolone derivatives: sparfloxacin moxifloxacin; pentamidine) azole-type antifungal agents (ketoconazole fluconazole) domperidone ondansetron or escitalopram in doses exceeding 20 mg per day can cause abnormal changes in the electrical activity of the heart (prolongation of the QT interval on the ECG) and lead to a violation of the heart rhythm (including the development of arrhythmias of the “pirouette” type), which can be fatal.

Serotonergic medications

Concomitant use with serotonergic medications (such as tramadol sumatriptan and other triptans) may 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 using other drugs that reduce the threshold of convulsive readiness simultaneously with escitalopram (tricyclic antidepressants SSRIs antipsychotic drugs (neuroleptics) – derivatives of phenothiazine thioxanthene and butyrophenone-mefloquine bupropion and tramadol).

Lithium tryptophan

Since there have been reported cases of increased action with the simultaneous use of SSRIs and lithium or tryptophan, it is recommended to exercise caution when using escitalopram simultaneously with these drugs.

St. John’s wort holed

Concomitant use of SSRIs and preparations containing St. John’s wort (Hypericumperforatum) This may lead to an increased 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, tricyclic antidepressants with acetylsalicylic acid and nonsteroidal anti-inflammatory drugs ticlopidine and dipyridamole). In such cases, when starting or ending escitalopram therapy, careful monitoring of blood clotting is necessary. Concomitant use with nonsteroidal anti-inflammatory drugs may lead to an increase in the number of bleeding events.

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 (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 (an inhibitor of the isoenzymes CYP2D6, CYP3A4 and CYP1A2) at a dose of 400 mg 2 times a day 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 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 drugs that are mainly metabolized by CYP2D6 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.

Interaction with ethanol

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

How to take, course of use and dosage

The drug Escitalopram-SZ is prescribed orally once a day, regardless of food intake.

Depressive episodes

Usually prescribed 10 mg once 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 usually develops 2-4 weeks after the start of treatment. After the symptoms of depression disappear for at least another 6 months, it is necessary to continue therapy to consolidate the effect obtained.

Panic disorder with / without agoraphobia

During the first week of treatment, a dose of 5 mg/day is recommended, 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 once a day. Depending on the individual response of the patient, the dose can then 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.

Use in special patient groups

Elderly patients (over 65 years of age)

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

Decreased kidney function

No dose adjustment is required for mild to moderate renal failure. Patients with severe renal insufficiency (creatinine clearance below 30 ml/min) should be prescribed Escitalopram-SZ with caution.

Reduced liver function

In patients with mild or moderate hepatic insufficiency (Child-Pugh class A or B), the recommended initial dose for the first two 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 severe hepatic insufficiency (Child-Pugh class C), the drug is prescribed under the close supervision of a doctor.

Reduced activity of the CYP2C19 isoenzyme

For patients with low activity of the CYP2C19 isoenzyme, the recommended initial dose for the first two 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 Escitalopram-SZ, the dose should be reduced gradually over 1-2 weeks in order to avoid the occurrence of “withdrawal”syndrome.

Overdose

Symptoms

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

Coma or fatal cases of escitalopram overdose are extremely rare, most of them involve simultaneous overdose with other medications. Taking a dose of escitalopram in the range of 400 – 800 mg did not cause severe symptoms.

Treatment

There is no specific antidote. Symptomatic and supportive treatment is performed: gastric lavage use of enterosorbents (in particular activated carbon) provision of a constant supply of fresh air support of external respiration function adequate oxygenation of the lungs. Cardiovascular and respiratory system function is monitored along with general symptomatic and supportive care. Forced diuresis hemodialysis and hemosorption are not effective. The outcome is favorable.

Special instructions

Use of the drug in children and adolescents under 18 years of age

Antidepressants should not be prescribed to children and adolescents under the age of 18 because of 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 based on a clinical assessment to start antidepressant therapy, the patient should be closely monitored.

When using medications belonging to the SSRI therapeutic group, including escitalopram, the following should be considered. 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.

Epileptic seizures

Escitalopram should be discontinued in case of initial seizures. It is not recommended for use in patients with unstable epilepsy; for controlled seizures, close monitoring is necessary. If the frequency of seizures increases, SSRIs including escitalopram should be discontinued.

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

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

Suicide / suicidal thoughts and other clinical worsening of depressive states

Depression is associated with an increased risk of suicidal thoughts of 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 a concomitant pathology 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 in patients younger than 25 years, there is an increased risk of suicidal behavior compared to placebo. Drug treatment of these patients, and in particular patients at high risk of suicide, should be accompanied by careful 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 in suicidal behavior or thoughts, as well as unusual behavioral changes, and seek immediate medical advice if these symptoms occur.

Akathisia/psychomotor agitation

Taking 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 antidiuretic hormone (ADH) secretion during SSRIS is rare and usually disappears when therapy is discontinued. Caution should be exercised when prescribing escitalopram and other SSRIs to people at risk of hyponatremia: the elderly, patients with cirrhosis of the liver and taking drugs 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 bleed.

Electroconvulsive therapy

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

Serotonin syndrome

The combination 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, myoclonus tremor and hyperthermia. If this occurs, you should immediately stop concomitant treatment with SSRIs and serotonergic drugs and start symptomatic treatment.

Coronary heart disease

Due to limited clinical experience, caution is recommended when using the drug in patients with coronary heart disease.

Cases of prolongation of the QT interval

Escitalopram has been found to cause dose-dependent QT prolongation and ventricular arrhythmias including bidirectional tachycardia have been reported primarily in female patients with hypokalemia or pre – existing QT prolongation or other cardiovascular conditions.

Caution is recommended when prescribing the drug to patients with severe bradycardia, patients after a recent acute myocardial infarction or with uncompensated heart failure.

Electrolyte disturbances such as hypokalemia and hypomagnesemia increase the risk of arrhythmia.

If escitalopram is prescribed to patients with chronic heart disease, an ECG should be performed before starting treatment.

If there are signs of cardiac arrhythmia during treatment with escitalopram, the treatment should be discontinued and an ECG performed.

Withdrawal symptoms upon discontinuation of SSRI therapy

Withdrawal symptoms when treatment is stopped are common, especially if treatment is stopped abruptly.

In clinical trials, adverse events on discontinuation of treatment were observed in approximately 25% of patients receiving escitalopram and in 15% of patients taking placebo.

The risk of discontinuation of treatment may depend on several factors including the duration of treatment and the rate of dose reduction. The most common reactions are dizziness sensory disturbances (including paresthesia and electric shock sensations) sleep disturbances (including insomnia and vivid dreams) agitation or anxiety nausea and / or vomiting tremor confusion sweating headache diarrhea rapid heartbeat emotional instability irritability and visual disturbances. As a rule, these symptoms are mild or moderate in severity, but in some patients they can take a severe form.

They usually occur within the first few days after discontinuation of treatment, and similar symptoms are much less frequently reported in patients who accidentally missed a dose.

Typically, these symptoms are self-healing and usually resolve within 2 weeks, although some people may experience them for a longer time (2-3 months or more). Therefore, it is recommended to gradually reduce the dose of escitalopram after discontinuation of treatment for several weeks or months, depending on the patient’s needs.

Influence on the ability to drive vehicles and mechanisms:

During the use of escitalopram, you should refrain from engaging in potentially dangerous activities that require increased concentration of attention and speed of psychomotor reactions.

Storage conditions

Store in a dark place at a temperature not exceeding 25 °C.

Keep out of the reach of children.

Shelf

life is 3 years.

Do not use after the expiration date indicated on the package.

Active ingredient

Escitalopram

Conditions of release from pharmacies

By prescription

Dosage form

Tablets