Instructions Escitalopram Asino film-coated tablets 10 mg blister No. 30
Composition
active ingredient: escitalopram;
1 tablet contains escitalopram oxalate (12.775 mg or 25.55 mg) equivalent to escitalopram 10 mg or 20 mg;
excipients: microcrystalline cellulose, croscarmellose sodium, hydroxypropylmethylcellulose (hypromellose), colloidal anhydrous silicon dioxide, talc, magnesium stearate;
Opadry II White shell: polyvinyl alcohol, titanium dioxide (E 171), polyethylene glycol (macrogol), talc.
Dosage form
Film-coated tablets.
Main physicochemical properties:
10 mg tablets: round tablets with a biconvex surface, film-coated in white, with a score;
20 mg tablets: round tablets with a biconvex surface, film-coated in white, with a score.
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-, M-cholinoreceptors, 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 Friederike 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 (see sections “Contraindications”, “Special instructions for use”, “Interaction with other medicinal products and other types of interactions”, “Adverse reactions”, “Overdose”).
Clinical efficacy
Major depressive episodes
The efficacy of escitalopram in the treatment of acute major depressive episodes has been demonstrated in 3 of 4 double-blind, placebo-controlled, short-term (8-week) studies. In a long-term relapse prevention study, 274 patients who responded to escitalopram 10 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 within the next 36 weeks compared with those 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 6-month relapse prevention study. In a 24-week optimal dose study, escitalopram was shown to be effective at doses of 5, 10 and 20 mg.
Generalized anxiety disorder
Escitalopram at doses of 10 and 20 mg/day was effective in 4 out of 4 placebo-controlled studies.
In a pooled analysis of three studies with a similar design, involving a total of 421 patients treated with escitalopram and 419 patients treated with placebo, 47.5% and 28.9% of patients respectively responded to treatment, and 37.1% and 20.8% of patients respectively achieved remission. A sustained effect was observed from the first week of treatment.
The maintenance effect of escitalopram 20 mg/day was demonstrated in a 24-76 week randomized maintenance study in 373 patients who responded to the drug during the initial 12 weeks of 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 of 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 for escitalopram at doses of 10 and 20 mg/day in patients who responded to escitalopram in a 16-week open-label period and were included in a 24-week randomized double-blind placebo-controlled period.
Pharmacokinetics.
Absorption is almost complete and independent of food intake. Peak plasma concentrations are reached 4 hours after administration. As with racemic citalopram, the absolute bioavailability of escitalopram is expected to be approximately 80%.
The apparent volume of distribution (Vd, β/F) after oral administration is 12 to 26 l/kg. The bioavailability of escitalopram is approximately 80%. The binding of escitalopram and its major metabolites to blood proteins is less than 80%.
Biotransformation
In the liver, demethylated and didemethylated metabolites are formed, which are pharmacologically active. Alternatively, nitrogen oxidation with the formation of the N-oxide metabolite is possible. Both metabolites and the parent compound are partially excreted in the form of glucuronides. After multiple administration, the average concentration of demethylated and didemethyl metabolites is usually 28-31% and < 5% of the concentration of escitalopram, respectively. The biotransformation of escitalopram to the demethylated metabolite occurs mainly with the help of cytochrome CYP2C19. The isoenzymes CYP3A4 and CYP2D6 may also participate in the process to a minor extent.
Elimination
The elimination half-life (T1/2β) of the drug is approximately 30 hours. The oral clearance (Cloral) is approximately 0.6 l/min. The main metabolites have a longer half-life. Escitalopram and its main metabolites are eliminated by 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
In elderly patients (65 years and older), escitalopram is eliminated more slowly than in young patients. The systemic exposure (AUC) in elderly subjects is 50% higher than in young healthy volunteers (see section 4.2).
Liver failure
In patients with mild to moderate hepatic impairment (Child-Pugh classes A and B), the half-life was twice as long and exposure was 60% higher than in subjects with normal hepatic function (see section 4.2).
Kidney failure
In patients with reduced renal function (CLcr 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 (see section 4.2).
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 (see section 4.2).
Indication
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 (MAO inhibitors) is contraindicated due to the risk of serotonin syndrome with agitation, tremor, hyperthermia, etc. (see section "Interaction with other medicinal products and other types of interactions"); the combination of escitalopram with reversible MAO-A inhibitors (e.g. moclobemide) or the reversible non-selective MAO inhibitor linezolid is contraindicated due to the risk of serotonin syndrome (see section "Interaction with other medicinal products and other types of interactions").
Escitalopram is contraindicated in patients with known QT prolongation or congenital long QT syndrome; escitalopram is contraindicated in combination with medicinal products known to prolong the QT interval (see section 4.5).
Interaction with other medicinal products and other types of interactions
Pharmacodynamic interactions.
Contraindicated combinations.
Non-selective, irreversible MAO inhibitors.
Serious reactions have been reported in patients receiving SSRIs in combination with non-selective irreversible MAOIs and in patients who have recently stopped SSRIs and started taking an MAOI (see section 4.3). Serotonin syndrome has occurred in some cases. The combination of escitalopram with non-selective irreversible MAOIs is contraindicated. Escitalopram treatment should be initiated 14 days after discontinuation of the irreversible MAOI. Treatment with non-selective irreversible MAOIs should be initiated no earlier than 7 days after discontinuation of escitalopram.
Combinations that require caution.
Reversible selective MAO inhibitor type A (moclobemide).
Due to the risk of serotonin syndrome, the combination of escitalopram with an MAOI type A such as moclobemide is contraindicated. If the need for this combination is proven, the minimum recommended doses should be used initially with close clinical monitoring.
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. If the combination proves necessary, it should be started at the lowest dose and under close clinical monitoring (see section 4.3).
Combination with selegiline (an irreversible MAO inhibitor of type B) 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.
QT prolongation.
Pharmacokinetic and pharmacodynamic studies of escitalopram in combination with other drugs that prolong the QT interval have not been performed. An effect of the combined use of escitalopram and these drugs cannot be excluded. Therefore, 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, certain antimicrobial drugs (e.g. sparfloxacin, moxifloxacin, erythromycin for intravenous administration, pentamidine, antimalarials, including halofantrine), certain antihistamines (astemizole, hydroxyzine, mizolastine), is contraindicated.
Serotonergic drugs.
Concomitant use with serotonergic drugs (e.g. tramadol, sumatriptan and other triptans) may lead to the development of serotonin syndrome.
Drugs that lower the seizure threshold.
SSRIs may lower the seizure threshold. Caution is advised when concomitantly using drugs that 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 oral anticoagulants may be altered by concomitant use with escitalopram. Patients taking oral anticoagulants should have their blood coagulation status carefully monitored before and after use of escitalopram (see section 4.4).
Concomitant use of non-steroidal anti-inflammatory drugs 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 other psychotropic drugs, the combination with alcohol is undesirable.
Drugs causing hypokalemia/hypomagnesemia.
Caution is required with concomitant use of drugs that cause hypokalemia/hypomagnesemia, as this increases the risk of malignant arrhythmia.
Pharmacokinetic interactions.
Effects of other agents on the pharmacokinetics of escitalopram. The metabolism of escitalopram is mainly mediated by CYP2C19, but CYP3A4 and CYP2D6 are also involved in the metabolism, although to a lesser extent. The CYP2D6 isoenzyme is considered to be a partial catalyst for the metabolism of the main metabolite S-DCT (demethylated escitalopram).
Concomitant use of escitalopram and omeprazole 30 mg once daily (CYP2C19 inhibitor) leads to a moderate (approximately 50%) increase in escitalopram plasma concentrations.
Concomitant use 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 is recommended when escitalopram is co-administered with cimetidine. Dose adjustment may be necessary (see section 4.4).
Therefore, caution should be exercised when prescribing the upper limit doses of escitalopram when co-administering escitalopram with CYP2C19 inhibitors (e.g. omeprazole, esomeprazole, fluconazole, fluvoxamine, lansoprazole, ticlopidine) or with cimetidine. A dose reduction of escitalopram may be necessary based on clinical judgment.
Effect of escitalopram on the pharmacokinetics of other drugs. Escitalopram is an inhibitor of the CYP2D6 enzyme.
Caution is advised when escitalopram is co-administered with drugs that are primarily metabolised by this enzyme and have a narrow therapeutic index, such as flecainide, propafenone and metoprolol (in heart failure), or with some drugs that affect the central nervous system and are primarily metabolised by CYP2D6, such as antidepressants such as desipramine, clomipramine and nortriptyline, and antipsychotics such as risperidone, thioridazine and haloperidol. Dose adjustment may be necessary.
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 causes weak inhibition of CYP2C19. Caution is recommended when co-administered with medicinal products metabolised by CYP2C19.
Application features
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. To reduce the likelihood of anxiogenic effects, low initial doses are recommended.
Seizures: The drug should be discontinued if the patient develops a seizure for the first time or if 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, SSRIs should be discontinued.
Diabetes mellitus: In patients with diabetes mellitus, treatment with SSRIs may alter glycemic control. Dosage adjustments of insulin and/or oral hypoglycemic agents may be required.
Suicide, suicidal ideation or clinical worsening. Depression is associated with a risk of suicidal ideation, self-harm and suicide. This risk persists until sustained remission is achieved. As improvement may not be achieved 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 comorbid with 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 initiation of treatment are at greatest risk of suicidal thoughts or suicide attempts and require close monitoring during treatment. A meta-analysis of studies with escitalopram found an increased risk of suicidal behaviour in patients aged <25 years who received antidepressants compared with those who received placebo. Close monitoring of patients at high risk is particularly necessary at the start of treatment and when changing the dose.
Patients and caregivers should be warned about the need to monitor for any worsening of condition, suicidal behavior or thoughts, and unusual changes in behavior, and to seek medical advice immediately if these symptoms develop.
Akathisia/psychomotor agitation. The use of SSRIs/SNRIs has been associated with the development of akathisia, a condition characterised 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 worsen the condition of patients who develop these symptoms.
Hyponatremia. Hyponatremia, possibly related to impaired antidiuretic hormone (ADH) secretion, occurs rarely with SSRIs and usually resolves after discontinuation of therapy. SSRIs should be used with caution in patients at risk (elderly, with cirrhosis of the liver, or concomitant treatment with drugs known to cause hyponatremia).
Bleeding. When taking SSRIs, skin bleeding (ecchymosis and purpura) may develop. SSRIs/NSAIDs may increase the risk of postpartum bleeding (see sections “Use during pregnancy or lactation” and “Adverse reactions”). SSRIs should be used with caution in patients taking anticoagulants and drugs that affect platelet function (e.g. atypical antipsychotics, phenothiazines, tricyclic antidepressants, acetylsalicylic acid and nonsteroidal anti-inflammatory drugs, dipyridamole and ticlopidine), as well as in patients with a tendency to bleeding.
ECT (electroconvulsive therapy): Clinical experience with the concomitant use of SSRIs and ECT is limited, so caution is recommended.
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 drugs that have serotonergic effects, such as sumatriptan or other triptans, tramadol and tryptophan.
In patients taking SSRIs concomitantly with serotonergic drugs, serotonin syndrome may develop in isolated cases. Escitalopram should be used with caution in conjunction with drugs that have serotonergic effects. Its development may be indicated by a combination of symptoms such as agitation, tremor, myoclonus, hyperthermia. If such a situation occurs, SSRIs and serotonergic drugs should be urgently discontinued and symptomatic treatment should be prescribed.
Withdrawal symptoms. Withdrawal symptoms are common when treatment is discontinued, especially if it is abrupt. In studies, it is known that adverse reactions occurred in approximately 25% of patients taking escitalopram and in 15% of patients taking placebo. The risk of withdrawal symptoms may depend on several factors, including duration 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 in severity, but may be more severe in some patients. They usually occur within the first few days after stopping treatment, but there have been very rare reports of similar symptoms in patients who accidentally missed a dose. Withdrawal symptoms usually resolve within 2 weeks, but may persist for longer in some patients (2-3 months or more). 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 (see section 4.2).
Sexual dysfunction: SSRIs/SNRIs may cause symptoms of sexual dysfunction (see section 4.8). In some cases, these symptoms have persisted after discontinuation of SSRIs/SNRIs.
Coronary heart disease: Caution is recommended when prescribing the drug to patients with coronary heart disease due to limited clinical experience.
QT prolongation: Escitalopram has been shown to cause dose-dependent prolongation of the QT interval. Cases of QT prolongation and ventricular arrhythmias, including torsade 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 (see sections 4.3, 4.5, 4.8, 4.1, and 4.2).
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 heart disease, an ECG should be reviewed 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.
Excipients: This medicinal product contains less than 1 mmol sodium (23 mg), i.e. essentially ‘sodium-free’.
Use during pregnancy or breastfeeding
Pregnancy: Clinical data on the use of escitalopram in pregnant women are limited.
Animal studies are known to have shown reproductive toxicity.
Escitalopram® Asino is contraindicated in pregnant women, except in cases where, after careful consideration of all the disadvantages and advantages, the need for prescribing the drug has been clearly proven.
Careful observation of newborns whose mothers have taken Escitalopram® during pregnancy, especially in the third trimester, is recommended. Abrupt discontinuation of the drug during pregnancy should be avoided.
Neonates whose mothers took SSRIs/SNRIs late in pregnancy may experience the following symptoms: respiratory distress, cyanosis, apnea, seizures, temperature fluctuations, feeding difficulties, vomiting, hypoglycemia, hypertension or hypotension, hyperreflexia, tremor, agitation, irritability, apathy, constant crying, drowsiness, and difficulty sleeping. These symptoms may be due to serotonergic effects or may be signs of withdrawal. In most cases, the symptoms occur immediately or shortly (< 24 hours) after delivery.
Epidemiological data have shown that the use of SSRIs during pregnancy may increase the risk of persistent pulmonary hypertension in the newborn (up to 5 cases per 1000 pregnancies). In the general population, the incidence is 1 to 2 cases per 1000 pregnancies.
Breastfeeding: Since escitalopram passes into breast milk, breastfeeding is not recommended during treatment.
Fertility. Some SSRIs may affect sperm quality. Reports of some SSRIs have shown that the effects on sperm quality in humans are reversible. Effects on human fertility have not been observed to date.
Ability to influence reaction speed when driving vehicles or other mechanisms
Escitalopram does not generally affect intellectual function or psychomotor reactions, but it should be borne in mind that any psychoactive drug may impair the skills or ability to think rationally. Patients should be warned of the potential risk of impairment in driving or operating machinery.
Method of administration and doses
The safety of doses above 20 mg per day has not been established.
Escitalopram should be administered orally to adults once daily, regardless of meals.
Major depressive episode.
Usually, 10 mg should be prescribed once a day. Depending on the individual sensitivity of the patient, the daily dose can 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 6 months to consolidate the effect.
Panic disorders with or without agoraphobia.
An initial dose of 5 mg per day is recommended during the first week, after which the dose can be increased to 10 mg per day. The dose can be further increased to a maximum of 20 mg per day, depending on the individual sensitivity of the patient.
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 disorders (social phobia).
The usual dose is 10 mg once daily. Relief of symptoms usually occurs after 2-4 weeks of treatment. Depending on the individual patient's response, the dose may be further reduced to 5 mg/day or increased to a maximum of 20 mg/day.
Since social anxiety disorder is a chronic disease, it is recommended to continue treatment for 12 weeks to consolidate the achieved effect.
Long-term treatment for 6 months should be prescribed to prevent relapse, taking into account individual manifestations of the disease; the effectiveness of treatment is regularly assessed.
Social anxiety disorder is a well-defined diagnostic term for a specific disorder, not to be confused with excessive shyness. Drug therapy is indicated only if the disorder significantly interferes with occupational and social functioning.
The value of this treatment compared to cognitive behavioral therapy has not been evaluated. Drug therapy is one component of the patient's overall treatment 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 should be prescribed to prevent relapse, taking into account individual manifestations of the disease; the effectiveness of treatment is regularly assessed.
Obsessive-compulsive disorder (OCD).
Usually, 10 mg once daily should be prescribed. Depending on individual sensitivity, the dose can be increased to 20 mg daily. OCD is a chronic disease, treatment should last for a sufficient period to ensure complete resolution of symptoms, which may be several months or even longer. The benefit of treatment and the dose of the drug should be assessed at regular intervals.
Elderly patients (aged 65 and over).
The initial dose is 5 mg per day. Depending on the individual patient's response, the daily dose may be increased to 10 mg per day.
The efficacy of escitalopram in social anxiety disorder in elderly patients has not been evaluated.
Pediatric population.
Escitalopram should not be used to treat children and adolescents under 18 years of age.
Kidney failure.
In the presence of mild to moderate renal insufficiency, there is no need for dose adjustment. The drug should be used with caution in patients with severe renal insufficiency (creatinine clearance < 30 ml/min).
Decreased liver function.
In patients with moderate and mild hepatic impairment, the recommended starting dose during the first two weeks of treatment is 5 mg 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 dose titration are required.
Reduced activity of the CYP2C19 isoenzyme.
For patients with poor CYP2C19 activity, the recommended starting dose is 5 mg/day for the first two weeks of treatment. Depending on the individual patient response, the dose may be increased to 10 mg/day.
Withdrawal symptoms that appear when treatment is stopped.
Abrupt discontinuation of treatment should be avoided. When discontinuing treatment with Escitalopram® Asino, the dose should be reduced gradually over 1–2 weeks to avoid possible withdrawal symptoms (see sections “Special instructions for use” and “Adverse reactions”). If withdrawal symptoms occur during gradual dose reduction, the dose can be resumed at the previously prescribed dose. In the future, the doctor may continue to reduce the dose, but more gradually.
Antidepressants should not be used in children and adolescents (under 18 years of age). Suicidal behavior (suicide attempt and suicidal thoughts) and hostility (predominantly aggression, oppositional behavior, and anger) were more frequently observed in clinical trials in children and adolescents treated with antidepressants than in those treated with placebo. If a decision to prescribe antidepressants is made for clinical reasons, the patient should be closely monitored for suicidal thoughts.
Overdose
Toxicity. Data on overdose with escitalopram are limited. Most cases have been caused by concomitant overdose with other drugs. In most cases, mild or asymptomatic symptoms of overdose have been observed. Reports of fatal outcomes of escitalopram overdose are exceptional, most of them involving concomitant overdose with other drugs. Doses in the range of 400-800 mg of escitalopram have not caused any severe symptoms.
Symptoms: Escitalopram overdose is manifested mainly by symptoms from the central nervous system (ranging from dizziness, tremor and agitation to rare cases of serotonin syndrome, convulsions and coma), the gastrointestinal system (nausea/vomiting), the cardiovascular system (arterial hypotension, tachycardia, QT prolongation, arrhythmia) and electrolyte imbalance (hypokalemia, hyponatremia).
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 with continued treatment.
Adverse reactions common to all SSRIs and escitalopram, observed in placebo-controlled studies and in clinical practice, are listed by system organ class and frequency: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000) or frequency unknown (cannot be estimated from the available data).
From the side of the blood and lymphatic system: frequency unknown - thrombocytopenia.
On the part of the immune system: rare - anaphylactic reactions.
On the part of the endocrine system: unknown - impaired secretion of antidiuretic hormone.
Metabolism and metabolism: frequent - decreased or increased appetite, weight gain; infrequent - decreased body weight; frequency unknown - hyponatremia, anorexia2.
Psychiatric: common - anxiety, restlessness, abnormal dreams, decreased libido in men and women, anorgasmia in women; uncommon - teeth grinding, agitation, nervousness, panic attacks, confusion; rare - aggression, depersonalization, hallucinations; frequency unknown - mania, suicidal thoughts, suicidal behavior1.
Nervous system disorders: very common - headache; common - insomnia, drowsiness, dizziness, paresthesia, tremor; uncommon - taste disturbance, sleep disturbance, syncope; rare - serotonin syndrome; frequency unknown - dyskinesia, movement disorders, convulsions, psychomotor restlessness/akathisia2.
On the part of the organs of vision: infrequent - pupil dilation, blurred vision.
On the part of the organs of hearing: infrequent - ringing in the ears.
