Instructions for use Escitodar 10 orodispersible tablets 10 mg blister No. 30
Composition
active ingredient: escitalopram;
1 orodispersible tablet contains 12.775 mg of escitalopram oxalate, equivalent to 10 mg of escitalopram, or 25.55 mg of escitalopram oxalate, equivalent to 20 mg of escitalopram;
Excipients: polacrilin potassium, concentrated hydrochloric acid, lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, acesulfame potassium, neohesperidin dihydrochalcone, peppermint flavor, magnesium stearate.
Dosage form
Orodispersible tablets.
Main physicochemical properties:
10 mg dosage: white to off-white, round tablets with a flat surface, beveled edges and engraving "10" on one side.
20 mg dosage: white to off-white, round tablets with a flat surface, beveled edges and engraving "20" on one side.
Pharmacotherapeutic group
Antidepressants. Selective serotonin reuptake inhibitors (SSRIs). ATC code N06A B10.
Pharmacological properties
Pharmacodynamics.
Escitalopram is a selective serotonin reuptake inhibitor (SSRI) with high affinity for the primary binding site. It also binds to the allosteric site of the serotonin transporter, with a 1000-fold lower affinity for this site.
Escitalopram has no or very weak binding to a number of receptors, including serotonin 5-HT1A, 5-HT2 receptors, dopamine D1 and D2 receptors, α1, α2, β-adrenergic receptors, histamine H1, muscarinic cholinergic, benzodiazepine and opiate receptors.
Inhibition of 5-HT reuptake is the only possible mechanism of action that could explain the pharmacological and clinical effects of escitalopram.
Pharmacodynamic effects
In one double-blind, placebo-controlled study of ECG parameters in healthy subjects, the prolongation of the QTc interval (corrected according to the Friederichia formula) from baseline was 4.3 ms (90% CI: 2.2, 6.4) at a dose of 10 mg/day and 10.7 ms (90% CI: 8.6, 12.8) at a supratherapeutic dose of 30 mg/day.
Major depressive episodes
The efficacy of escitalopram in the treatment of acute major depressive episodes has been demonstrated in three of four double-blind, placebo-controlled, short-term (8-week) studies. In a long-term relapse prevention study, 274 patients who had responded to escitalopram 10 mg/day or 20 mg/day during the initial 8-week open-label phase of the study were randomized to continue escitalopram at the same dose or placebo for up to 36 weeks. In this study, patients who continued to receive escitalopram had a statistically significantly longer time to relapse over the next 36 weeks compared with patients who received placebo.
Social anxiety disorder
Escitalopram has been shown to be effective in the treatment of social anxiety disorder in three short-term (12-week) studies and in a six-month relapse prevention study. In a 24-week optimal dose study, escitalopram was shown to be effective at doses of 5 mg, 10 mg, and 20 mg.
Generalized anxiety disorder
Escitalopram at doses of 10 mg and 20 mg per day was effective in four out of four placebo-controlled studies.
In a pooled study of three similarly designed studies, in which 421 patients received escitalopram and 419 patients received placebo, the response rates were 47.5% and 28.9%, respectively, and remission rates were 37.1% and 20.8%, respectively. A sustained effect was observed from the first week of treatment.
The maintenance effect of escitalopram 20 mg daily was demonstrated in a 24-76 week randomised maintenance study in 373 patients who had responded to the drug during an initial 12-week open-label treatment.
Obsessive-compulsive disorder
In a randomized, double-blind clinical trial, escitalopram 20 mg/day demonstrated a difference from placebo in the total score on the Y-BOCS (Yale-Brown Obsessive Compulsive Scale) after 12 weeks of treatment. After 24 weeks, benefits were observed for both escitalopram 10 mg/day and 20 mg/day compared to placebo.
The efficacy of the drug in preventing relapse was demonstrated at doses of 10 mg and 20 mg escitalopram per day in patients who had a positive response to escitalopram in a 16-week open-label study and were included in a 24-week randomized, double-blind, placebo-controlled study.
Pharmacokinetics.
Absorption is almost complete and independent of food intake. Maximum plasma concentrations are reached 4 hours after administration. As with racemic citalopram, the absolute bioavailability of escitalopram is approximately 80%.
The apparent volume of distribution (Vd, β/F) after oral administration is 12–26 l/kg. The binding of escitalopram and its major metabolites to blood proteins is below 80%.
Biotransformation
Metabolism occurs in the liver to demethylated and didemethylated metabolites. Both are pharmacologically active. Nitrogen can also be oxidized to form the N-oxide metabolite. Both metabolites and the parent compound are partially excreted as glucuronides. After multiple administration, the average concentration of demethylated and didemethylated metabolites is usually 28-31% and 28-31%, respectively. Biotransformation of escitalopram to the demethylated metabolite is carried out by cytochrome CYP2C19. Minor participation in the process isoenzymes CYP3A4 and CYP2D6 is possible.
Elimination
The elimination half-life (t½) of the drug is approximately 30 hours. Oral clearance is approximately 0.6 l/min. The main metabolites have a longer half-life. Escitalopram and its main metabolites are eliminated via the liver (metabolic pathway) and the kidneys. Most of the dose is excreted as metabolites in the urine.
Linearity
Escitalopram has linear kinetics. Steady-state concentrations are reached after approximately 1 week. The mean steady-state concentration of 50 nmol/l (range 20 to 125 nmol/l) is achieved with a daily dose of 10 mg.
Elderly patients (65 years and older)
Escitalopram is eliminated more slowly in patients aged 65 years and older than in younger patients. The amount of substance in the systemic circulation, calculated using the pharmacokinetic parameter "area under the curve" (AUC), is 50% higher in elderly patients than in young healthy volunteers.
Liver dysfunction
In patients with mild to moderate hepatic impairment (Child-Pugh classes A and B), t½ was twice as long and exposure was 60% higher than in subjects with normal hepatic function.
Kidney dysfunction
In patients with reduced renal function (creatinine clearance 10-53 ml/min), a longer half-life and slightly higher exposure were observed with racemic citalopram. Plasma concentrations of metabolites have not been studied but may be increased.
Polymorphism
Patients with poor CYP2C19 metaboliser function had twice the plasma concentrations of escitalopram as patients with normal CYP2C19 function. No significant changes in exposure were observed with reduced CYP2D6 function.
Indication
For the treatment of major depressive episodes, panic disorders, with or without agoraphobia, social anxiety disorders (social phobia), generalized anxiety disorders, obsessive-compulsive disorders.
Contraindication
Hypersensitivity to escitalopram or to any of the other ingredients of the drug.
Concomitant treatment with non-selective, irreversible monoamine oxidase inhibitors (MAOIs) - due to the risk of developing serotonin syndrome, which is manifested by agitation, tremor, hyperthermia and other symptoms.
Combination treatment with escitalopram and reversible type A MAOIs (e.g. moclobemide) or reversible non-selective MAOIs (e.g. linezolid) - due to the risk of serotonin syndrome.
Concomitant use with drugs that prolong the QT interval; known QT prolongation or congenital long QT syndrome.
Interaction with other medicinal products and other types of interactions
Pharmacodynamic interactions
Non-selective irreversible MAOIs
Serious reactions have been reported in patients taking SSRIs in combination with a non-selective, irreversible MAOI and in patients who have recently stopped SSRIs and started taking an MAOI (see section 4.3). Contraindicated combinations Serotonin syndrome has been reported in some cases (see section 4.8). Concomitant use of escitalopram with non-selective, irreversible MAOIs is contraindicated. Escitalopram should be started 14 days after discontinuation of the irreversible MAOI. Non-selective, irreversible MAOI should be started no earlier than 7 days after discontinuation of escitalopram.
Combinations that require caution.
Reversible selective MAOI type A (moclobemide)
Due to the risk of serotonin syndrome, the combination of escitalopram with the type A MAOI moclobemide is contraindicated (see section 4.3). If the need for this combination is proven, the minimum recommended doses should be used initially with increased clinical monitoring.
Non-selective reversible MAO inhibitor (linezolid)
The antibiotic linezolid is a non-selective, reversible MAOI and should not be given to patients receiving escitalopram. If the combination proves necessary, the lowest doses of both drugs should be used under close clinical supervision (see section 4.3).
Selective irreversible MAO inhibitor type B (selegiline)
The combination with selegiline (an irreversible type B MAOI) requires caution due to the risk of serotonin syndrome.
Selegiline at doses up to and including 10 mg/day has been safely co-administered with racemic citalopram.
Pharmacokinetic and pharmacodynamic studies of the combined use of escitalopram with other drugs that prolong the QT interval have not been conducted. When using escitalopram together with such drugs, an additive effect cannot be excluded. In this regard, the simultaneous use of escitalopram with drugs that prolong the QT interval, such as antiarrhythmic drugs of class IA and III, antipsychotics (e.g. phenothiazine derivatives, pimozide, haloperidol), tricyclic antidepressants, some antimicrobials (e.g. sparfloxacin, moxifloxacin, erythromycin for intravenous administration, pentamidine, antimalarials, including halofantrine), some antihistamines (astemizole, hydroxyzine, mizolastine), is contraindicated.
Serotonergic medications
Concomitant use with serotonergic agents (e.g. tramadol, sumatriptan and other triptans) may lead to serotonin syndrome.
Medications that lower the seizure threshold
SSRIs may lower the seizure threshold. Caution is advised when concomitantly using drugs that may lower the seizure threshold, such as antidepressants (tricyclics, SSRIs), neuroleptics (phenothiazines, thioxanthenes, butyrophenones), mefloquine, bupropion and tramadol.
Lithium, tryptophan
Since cases of enhanced effects have been reported with the combined use of SSRIs and lithium or tryptophan, it is recommended to prescribe these drugs concomitantly with caution.
Hypericum
Concomitant use of SSRIs and herbal remedies containing St. John's wort may lead to an increased incidence of adverse reactions.
Anticoagulants
The effects of anticoagulants may be altered by concomitant use with escitalopram. If patients are taking oral anticoagulants, careful monitoring of the blood coagulation system is necessary before and after the use of escitalopram (see section "Special instructions").
Concomitant use of non-steroidal anti-inflammatory drugs (NSAIDs) may increase the tendency to bleed (see section "Special warnings and precautions for use").
Alcohol
Escitalopram does not interact with alcohol in a pharmacodynamic or pharmacokinetic manner. However, as with psychotropic drugs, the combination with alcohol is undesirable.
Drugs causing hypokalemia/hypomagnesemia
Caution should be exercised when using concomitant medications that can cause hypokalemia/hypomagnesemia, as this increases the risk of developing malignant arrhythmias (see section "Special warnings and precautions for use").
Pharmacokinetic interactions
Effect of other agents on the pharmacokinetics of escitalopram
The metabolism of escitalopram is mainly mediated by CYP2C19. The enzymes CYP3A4 and CYP2D6 may also play some role in its metabolism, although to a lesser extent. The metabolism of the main metabolite S-DCT (demethylated escitalopram) appears to be partly catalyzed by CYP2D6.
Co-administration of escitalopram and omeprazole 30 mg once daily (a CYP2C19 inhibitor) results in a moderate (approximately 50%) increase in escitalopram plasma concentrations.
Concomitant administration of escitalopram and cimetidine 400 mg twice daily (a moderate general enzyme inhibitor) resulted in a moderate (approximately 70%) increase in escitalopram plasma concentrations. Caution should be exercised when escitalopram is administered in combination with cimetidine. Dose adjustment may be required (see section 4.4).
Therefore, caution should be exercised when co-administering escitalopram with CYP2C19 inhibitors (e.g. omeprazole, esomeprazole, fluconazole, fluvoxamine, lansoprazole, ticlopidine) and with cimetidine, if the upper limit doses of escitalopram are prescribed. A reduction in the escitalopram dose may be necessary based on clinical judgment.
Effect of escitalopram on the pharmacokinetics of other drugs
Escitalopram is an inhibitor of the enzyme CYP2D6. Caution is advised when escitalopram is co-administered with medicinal products that are primarily metabolised by this enzyme and have a narrow therapeutic index, such as flecainide, propafenone and metoprolol (in heart failure), or with certain central nervous system agents that are primarily metabolised by CYP2D6, such as antidepressants such as desipramine, clomipramine and nortriptyline, or antipsychotics such as risperidone, thioridazine and haloperidol. Dose adjustment may be required.
Combination with desipramine or metoprolol resulted in a twofold increase in plasma levels of these two CYP2D6 substrates.
In vitro studies have shown that escitalopram may also cause slight inhibition of CYP2C19.
Caution is recommended when used concomitantly with drugs metabolized by CYP2C19.
Application features
The following features of use apply to the SSRI therapeutic class in general.
Paradoxical anxiety
Some patients with panic disorder may experience increased anxiety when starting antidepressant treatment. This paradoxical reaction usually resolves within two weeks of treatment. A low initial dose is recommended to reduce the likelihood of anxiogenic effects.
Escitalopram should be discontinued if the patient develops a seizure for the first time or if the seizures become more frequent (in patients with established epilepsy). SSRIs should be avoided in patients with unstable epilepsy and patients with controlled epilepsy should be closely monitored.
Mania
SSRIs should be used with caution in patients with a history of mania/hypomania. If a manic state occurs, the SSRI should be discontinued.
Diabetes mellitus
In patients with diabetes mellitus, treatment with SSRIs may alter glycemic control. The dose of insulin and/or oral hypoglycemic agents may need to be adjusted.
Suicide, suicidal thoughts, or clinical worsening
Depression is associated with a risk of suicidal thoughts, self-harm and suicide (suicidal acts). This risk remains until sustained remission is achieved. As improvement may not occur within the first few weeks of treatment or longer, patients should be closely monitored until their condition improves. It is known that the risk of suicide may be increased in the early stages of recovery.
Other conditions for which escitalopram is used may also be associated with a risk of suicidal behaviour. In addition, such conditions may be accompanied by major depressive disorder. These warnings also apply to the treatment of patients with other psychiatric disorders.
Patients with a history of suicidal behaviour prior to initiating treatment are at greatest risk of suicidal thoughts or attempts and require close monitoring during treatment. A meta-analysis of placebo-controlled clinical trials of antidepressants in adult patients with psychiatric disorders showed an increased risk of suicidal behaviour in patients aged <25 years compared with placebo. Close monitoring of patients at high risk is particularly important at the start of treatment and in the event of dose changes.
Patients and/or their caregivers should be warned to monitor for any worsening of condition, suicidal behavior or thoughts, and unusual changes in behavior and to seek immediate medical advice if these symptoms develop.
Akathisia
The use of SSRIs/SNRIs has been associated with the development of akathisia, a condition characterized by an unpleasant, debilitating feeling of restlessness and a need to move, often accompanied by an inability to sit or stand still. This condition is most likely to occur during the first few weeks of treatment. Increasing the dose may be harmful in patients who develop these symptoms.
Hyponatremia
Hyponatremia, possibly related to impaired antidiuretic hormone secretion, occurs rarely with SSRIs and usually resolves after discontinuation of therapy. SSRIs should be prescribed with caution in patients at risk (old age, liver cirrhosis, or concomitant treatment with drugs that cause hyponatremia).
Hemorrhages
Skin bleeding, ecchymosis and purpura may occur with SSRIs. SSRIs/SNRIs increase the risk of postpartum haemorrhage. SSRIs should be used with caution in patients receiving concomitant anticoagulants, medicinal products that affect platelet function (e.g. atypical antipsychotics, phenothiazines, tricyclic antidepressants, acetylsalicylic acid and non-steroidal anti-inflammatory drugs, dipyridamole and ticlopidine), and in patients with a bleeding tendency.
ECT (electroconvulsive therapy)
Clinical experience with the concomitant use of SSRIs and ECT is limited, therefore caution is recommended in prescribing and using them.
Reversible, selective type A MAOIs
Combining escitalopram and type A MAOIs is not recommended due to the risk of serotonin syndrome.
Serotonin syndrome
Caution is recommended when escitalopram is used concomitantly with serotonergic agents such as sumatriptan or other triptans, tramadol and tryptophan.
There have been isolated reports of serotonin syndrome in patients taking SSRIs concomitantly with serotonergic drugs. Escitalopram should be used with caution when used concomitantly with drugs that have serotonergic effects. The combination of symptoms such as agitation, tremor, myoclonus, and hyperthermia may indicate the development of this condition. In such cases, the SSRI and the serotonergic drug should be discontinued immediately and symptomatic treatment initiated.
Hypericum
Concomitant use of SSRIs and herbal remedies containing St. John's wort (Hypericum perforatum) may lead to an increased incidence of adverse reactions.
Withdrawal symptoms
The risk of withdrawal symptoms depends on several factors, including duration of treatment and dose, and the rate of dose reduction. Dizziness, sensory disturbances (including paraesthesia, electric shock sensations), sleep disturbances (including insomnia, vivid dreams), agitation or anxiety, nausea and/or vomiting, tremor, confusion, increased sweating, headache, diarrhoea, palpitations, emotional lability, irritability and visual disturbances are the most common reactions. These symptoms are usually mild to moderate, but may be severe in some patients. They usually occur within the first few days after discontinuation of treatment, but there have been rare reports of such symptoms in patients who have accidentally missed a dose. These withdrawal symptoms usually resolve within 2 weeks, but may be more prolonged (2–3 months or longer) in some patients. Therefore, it is recommended to gradually discontinue escitalopram treatment by reducing the dose over a period of several weeks or months, depending on the patient's condition.
Sexual dysfunction
The use of SSRIs/SNRIs may cause symptoms of sexual dysfunction. There have been reports of long-term sexual dysfunction, where symptoms persist even after discontinuation of SSRIs/SNRIs.
Coronary heart disease
Due to limited clinical experience, caution is required when treating patients with coronary heart disease.
QT prolongation
Escitalopram has been shown to cause dose-dependent prolongation of the QT interval. Cases of QT prolongation and ventricular arrhythmias, including torsades de pointes, have been reported in the post-marketing setting, predominantly in female patients with hypokalaemia or pre-existing QT prolongation or other cardiac disease.
It is recommended to use the drug with caution in patients with significant bradycardia or in patients with a recent acute myocardial infarction or uncompensated heart failure.
Electrolyte disorders such as hypokalemia and hypomagnesemia increase the risk of malignant arrhythmias and should be corrected before starting treatment with escitalopram.
In patients with stable cardiac disease, an ECG should be performed before starting treatment.
If signs of cardiac arrhythmia occur during treatment with escitalopram, treatment should be discontinued and an ECG performed.
Angle-closure glaucoma
SSRIs, including escitalopram, may affect pupil size, resulting in mydriasis. In turn, pupil dilation may lead to narrowing of the angle of the eye and, as a result, increase intraocular pressure and provoke angle-closure glaucoma, especially in predisposed patients. Therefore, escitalopram should be used with caution in patients with angle-closure glaucoma or a history of glaucoma.
Use during pregnancy or breastfeeding
Pregnancy
Clinical data on the use of escitalopram in pregnant women are limited.
In animal studies with escitalopram, embryofetotoxic effects were observed. Escitalopram is contraindicated in pregnant women, except in cases where, after careful consideration of all risks and benefits, the need for prescribing the drug has been clearly demonstrated. Careful examination of newborns whose mothers took escitalopram during pregnancy, especially in the third trimester, is recommended. The use of the drug during pregnancy should not be stopped abruptly.
The following symptoms may occur in newborns whose mothers took SSRIs/SNRIs in the late stages of pregnancy: respiratory distress, cyanosis, apnea, seizures, temperature instability, feeding difficulties, vomiting, hypoglycemia, hypertension, hypotension, hyperreflexia, tremor, nervous excitement, irritability, apathy, constant crying, drowsiness and difficulty sleeping. Such symptoms may develop either as a result of excessive serotonergic action or as withdrawal symptoms. . Most of these complications occur immediately or shortly after delivery (up to 24 hours).
Epidemiological data suggest that the use of SSRIs during pregnancy increases the risk of persistent pulmonary hypertension in the newborn: up to 5 cases per 1000 pregnancies, according to epidemiological observations. In the general population, the incidence is 1 to 2 cases per 1000 pregnancies.
Breast-feeding
Since escitalopram passes into breast milk, breast-feeding is not recommended during treatment. Observations indicate an increased risk (in
Fertility
Animal data have shown that some SSRIs may affect sperm quality. Reports from some SSRIs in humans have shown that the effects on sperm quality are reversible. Effects on human fertility have not been observed to date.
Ability to influence reaction speed when driving vehicles or other mechanisms
Although escitalopram does not affect intellectual or psychomotor functioning, any psychoactive drug may impair skills or the ability to think clearly. Patients should be warned of the risk of impairment of the ability to drive or operate machinery.
Method of administration and doses
The safety of escitalopram doses above 20 mg per day has not been established.
Major depressive episode
The usual dose is 10 mg once daily. Depending on the individual sensitivity of the patient, the daily dose may be increased to a maximum of 20 mg.
The antidepressant effect usually occurs after 2–4 weeks. After the symptoms disappear, treatment should be continued for at least 6 months to consolidate the effect.
Panic disorders, with or without agoraphobia
A starting dose of 5 mg escitalopram* per day is recommended for the first week before increasing to 10 mg per day. The dose may then be increased to a maximum of 20 mg per day, depending on the individual patient's response.
The maximum effect in the treatment of panic disorders is achieved after 3 months. The duration of treatment is several months and depends on the severity of the disease.
Social anxiety disorder (social phobia)
The usual dose is 10 mg once daily. Depending on the individual patient's response, it is recommended to increase the daily dose to a maximum of 20 mg per day.
Symptom relief usually occurs after 2–4 weeks of treatment.
Since social anxiety disorder is a chronic disease, the minimum recommended duration of treatment is 12 weeks to maintain the achieved effect. To prevent relapse, the drug can be used for 6 months, depending on the individual response of the patients. The therapeutic benefit of the treatment should be regularly reviewed.
Social anxiety disorder has a well-defined diagnostic terminology for a specific condition, which should not be confused with hypertrophic shyness. Pharmacotherapy is indicated only for the disorder, which significantly affects the professional and social activity of the person. The effectiveness of such treatment compared with cognitive behavioral therapy has not been studied. Pharmacotherapy should be part of an overall therapeutic strategy.
Generalized anxiety disorders
The usual dose is 10 mg once daily. Depending on individual sensitivity, the dose may be increased to a maximum of 20 mg daily.
Long-term treatment for 6 months has been shown to prevent relapse and can be individualized. The therapeutic benefit of treatment and dosage should be reviewed regularly.
Obsessive-compulsive disorder (OCD)
The usual dose is 10 mg once daily. Depending on individual response, the dose may be increased to 20 mg daily. OCD is a chronic condition and treatment should be continued for a sufficient period of time until symptoms resolve, which may be several months or longer. The therapeutic benefit and dose should be reviewed regularly.
Elderly patients (65 years and older)
The initial dose is 5 mg of escitalopram* per day. Depending on individual sensitivity and severity of depression, the daily dose can be increased to a maximum of 10 mg per day. The effectiveness of Escitalopram® in social anxiety disorder in elderly patients has not been studied.
Pediatric population
Escitodar® should not be used to treat children and adolescents (under 18 years of age).
Kidney failure
In the presence of mild and moderate renal insufficiency, no dose adjustment is required. The drug should be used with caution in patients with severe renal insufficiency (creatinine clearance 30 ml/min).
Decreased liver function
For patients with mild to moderate hepatic impairment, the recommended starting dose during the first two weeks of treatment is 5 mg escitalopram* per day. Depending on the individual patient response, the dose may be increased to 10 mg per day. In severe hepatic impairment, caution and careful titration of the dose of the drug are required.
Reduced activity of the CYP2C19 isoenzyme
For patients with poor CYP2C19 activity, the recommended starting dose for the first two weeks of treatment is 5 mg escitalopram* per day. Depending on the individual patient response, the dose may be increased to 10 mg per day.
Withdrawal symptoms after stopping treatment
Avoid stopping this medicine suddenly. The dose of escitalopram should be reduced gradually over 1-2 weeks to avoid possible withdrawal symptoms. If withdrawal symptoms occur during the gradual dose reduction, the dose can be resumed at the previously prescribed dose. Your doctor may then continue to reduce the dose, but more gradually.
* A drug with the appropriate dosage of escitalopram should be used.
Children.
Antidepressants are contraindicated in children under 18 years of age. Suicidal behaviour (suicidal attempts and suicidal thoughts) and hostility (predominantly aggression, oppositional behaviour and anger) were observed more frequently in clinical trials among children and adolescents treated with antidepressants compared to those treated with placebo. If a decision to prescribe a medicinal product is nevertheless made for clinical reasons, the patient should be closely monitored for the appearance of suicidal symptoms.
Overdose
Toxicity. Clinical data on escitalopram overdose are limited. Many cases have been caused by concomitant overdose with other drugs. In most cases, symptoms have been mild or asymptomatic. Reports of fatal outcomes from escitalopram overdose are exceptional, most of them involving concomitant overdose with other drugs. Escitalopram doses of 400–800 mg have not caused any severe symptoms.
Symptoms: Signs of escitalopram overdose include central nervous system symptoms (ranging from dizziness, tremor and agitation to rare cases of serotonin syndrome, convulsions and coma), gastrointestinal symptoms (nausea, vomiting), cardiovascular symptoms (hypotension, tachycardia, QT prolongation, arrhythmia) and electrolyte/fluid imbalance (hypokalaemia, hyponatraemia).
Treatment. There is no specific antidote. Maintain proper respiratory function and ensure adequate oxygenation. Gastric lavage and activated charcoal may be used. Monitoring of cardiac and vital signs is recommended along with symptomatic supportive treatment.
In case of overdose, ECG monitoring is recommended in patients with congestive heart failure/bradyarrhythmia, in patients taking concomitant medications that prolong the QT interval, or in patients with metabolic disorders, e.g., hepatic insufficiency.
Adverse reactions
Adverse reactions are most often observed during the first or second week of treatment, and usually their frequency and intensity gradually decrease during further treatment.
The following are adverse reactions to SSRIs and escitalopram that have been observed in placebo-controlled studies and during clinical use.
All adverse reactions are listed by system organ class. The frequency is defined using the following categories: very common (≥ 1/10), common (≥ 1/100) - uncommon (≥ 1/1000 - cannot be estimated from the available data).
On the part of the organs of vision: infrequent - dilation of the pupils, blurred vision.
From the side of the organs of hearing and vestibular apparatus: infrequently - tinnitus.
From the respiratory system, thoracic and mediastinal organs: frequent - sinusitis, yawning; infrequent - epistaxis.
Gastrointestinal: very common - nausea; common - diarrhea, constipation, vomiting, dry mouth; uncommon - gastrointestinal bleeding (including rectal).
Hepatobiliary disorders: frequency unknown - hepatitis, changes in liver function tests.
Renal and urinary disorders: frequency unknown - urinary retention.
On the part of the endocrine system: frequency unknown - impaired secretion of antidiuretic hormone.
Metabolism and metabolism: frequent - decreased or increased appetite, weight gain; infrequent - decreased body weight; frequency unknown - hyponatremia, anorexia2.
Nervous system disorders: very common - headache; common - insomnia, drowsiness, dizziness, paresthesia, tremor; uncommon - taste disturbance, sleep disturbance, syncope; very rare - serotonin syndrome; frequency unknown - dyskinesia, movement disorders, convulsions, psychomotor restlessness/akathisia2.
Psychiatric: common - anxiety, restlessness, abnormal dreams, decreased libido in men and women, anorgasmia in women; uncommon - teeth grinding, agitation, nervousness, panic attacks, confusion; very rare - aggression, depersonalization, hallucinations; frequency unknown - mania, suicidal thoughts, suicidal behavior1.
Cardiovascular system: infrequent - tachycardia; very rare - bradycardia; frequency unknown - prolongation of the QT interval of the electrocardiogram, ventricular arrhythmias, in particular, fusiform arrhythmia, orthostatic hypotension.
Blood and lymphatic system disorders: frequency unknown - thrombocytopenia.
On the part of the immune system: very rare - anaphylactic reactions.
Skin and subcutaneous tissue disorders: frequent - increased
