Instructions Medopram film-coated tablets 20 mg blister No. 30
Composition
active ingredient: escitalopram;
1 film-coated tablet contains escitalopram (as escitalopram oxalate) 5 mg, 10 mg, 20 mg;
excipients: croscarmellose sodium, silicified microcrystalline cellulose (colloidal silicon dioxide, microcrystalline cellulose), talc, magnesium stearate;
film coating: Opadry II White (lactose monohydrate, hypromellose, titanium dioxide (E 171), macrogol).
Dosage form
Film-coated tablets.
Main physicochemical properties:
5 mg tablets – almost white, round, biconvex, film-coated tablets, marked “E” on the upper side;
10 mg tablets – off-white, oval, biconvex, film-coated tablets with a deep breakline on the upper side and marking “A A” on the lower side;
20 mg tablets are off-white, oval, biconvex, film-coated tablets with a deep breakline on the upper side and “EE” marking on the lower side.
Pharmacotherapeutic group
Antidepressants. Selective serotonin reuptake inhibitors. ATX code N06A B10.
Pharmacological properties
Pharmacodynamics
Mechanism of action. Escitalopram is a selective serotonin reuptake inhibitor (SSRI) (5-HT) 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. Escitalopram has no or very weak binding to a number of receptors, including 5-HT1A, 5-HT2, 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 a double-blind, placebo-controlled ECG study in healthy volunteers, the change from baseline in QTc (Friedrichian correction) was 4.3 msec (90% confidence interval (CI): 2.2, 6.4) at a dose of 10 mg/day and 10.7 msec (90% CI: 8.6, 12.8) at a supratherapeutic dose of 30 mg/day (see sections 4.3, 4.5, 4.8, 4.9, 5.1, 5.2, 5.3, 5.4, 5.5, 5.6, 5.6, 5.7, 5.8, 5.1, 5.1, 5.2, 5.3, 5.4, 5.5, 5.61, 5.2, 5.3, 5.4, 5.5, 5.6, 5.6, 5.6, 5.7, 5.6, 5.7, 5.8, 5.1, 5.1, 5.1, 5.1, 5.2, 5.3, 5.4, 5.5, 5.6, 5.6, 5.6, 5.7, 5.6, 5.7, 5.6, 5.7, 5.7, 5.8, 5.1, 5.1, 5.1, 5.1, 5.1, 5.1, 5.1, 5.1, 5.1, 5.1, 5.1, 5.1, 5.1,
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 of 4 placebo-controlled studies. In a pooled analysis of three similarly designed studies, involving a total of 421 patients treated with escitalopram and 419 patients treated with placebo, 47.5% and 28.9% of patients responded to treatment, respectively, and 37.1% and 20.8% of patients went into remission, respectively. Sustained efficacy was observed from the first week of treatment. The maintenance efficacy of escitalopram at a dose of 20 mg/day was demonstrated in a 24- to 76-week, randomized maintenance study in 373 patients who had responded during an initial 12-week open-label treatment period.
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 Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) after 12 weeks of treatment. After 24 weeks, escitalopram was superior to placebo at both 10 mg/day and 20 mg/day. Efficacy in relapse prevention was demonstrated for escitalopram 10 and 20 mg/day in patients who responded to escitalopram in the 16-week open-label period and entered a 24-week randomized, double-blind, placebo-controlled period.
Pharmacokinetics
Distribution: The apparent volume of distribution (Vd,β/F) after oral administration is approximately 12–26 l/kg. The plasma protein binding of escitalopram and its major metabolites is less than 80%.
Biotransformation. Escitalopram is metabolized in the liver to the demethylated and didemethylated metabolites. Both are pharmacologically active. Alternatively, nitrogen oxidation to the N-oxide metabolite is possible. Both the parent compound and the metabolites are partially excreted as glucuronides. With repeated administration of the drug, the average concentrations of the demethylated and didemethylated metabolites are 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. Some participation of the enzymes CYP3A4 and CYP2D6 is also possible.
Elimination. The elimination half-life (t½β) after multiple administration is approximately 30 hours. Plasma clearance (Cloral) after oral administration is approximately 0.6 l/min. The main metabolites have a longer half-life. Escitalopram and its main metabolites are believed to be eliminated by the liver (metabolic pathway) and the kidneys, with the majority being excreted as metabolites in the urine.
Linearity: Escitalopram has linear kinetics. Steady-state concentrations are reached after approximately 1 week. Mean steady-state concentrations of 50 nmol/l (range: 20–125 nmol/l) are achieved with a daily dose of 10 mg.
Elderly patients (aged 65 years and over): Escitalopram appears to be eliminated more slowly in elderly patients than in young patients. Systemic exposure (AUC) in elderly patients is approximately 50% higher than in young healthy volunteers (see section 4.2).
Reduced liver function: In patients with mild or moderate hepatic impairment (Child-Pugh A and B criteria), the half-life of escitalopram was almost doubled and exposure was 60% higher than in subjects with normal hepatic function (see section 4.2).
Reduced renal function: In patients with reduced renal function (creatinine clearance CLcr 10-53 ml/min), a longer half-life and a slight increase in exposure were observed with racemic citalopram. Plasma concentrations of metabolites have not been studied but may be increased (see section 4.2).
Polymorphism: In patients with insufficient activity of the CYP2C19 isoenzyme, plasma concentrations of escitalopram were twice as high as in patients with normal metabolism of escitalopram. In patients with insufficient CYP2D6 isoenzyme, no significant changes in AUC were observed (see section "Method of administration and dosage").
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 excipients. Concomitant treatment with non-selective irreversible monoamine oxidase inhibitors (MAOIs) due to the risk of serotonin syndrome with agitation, tremor, hyperthermia and other symptoms (see section "Interaction with other medicinal products and other forms of interaction"). The combined use of escitalopram and reversible MAO inhibitors type A (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 forms of interaction"). Escitalopram is contraindicated for use in patients with long QT syndrome (congenital or acquired). Escitalopram is contraindicated for use with medicinal products that can prolong the QT interval (see section "Interaction with other medicinal products and other forms of interaction").
Interaction with other medicinal products and other types of interactions
Pharmacodynamic interactions
Contraindicated combinations
Irreversible non-selective MAO inhibitors. Cases of serious reactions have been reported in patients taking SSRIs in combination with non-selective irreversible MAO inhibitors and in patients who have recently completed treatment with SSRIs and started taking MAO inhibitors (see section "Contraindications"). There have been occasional cases of serotonin syndrome (see section "Adverse reactions"). The combination of escitalopram with non-selective irreversible MAO inhibitors is contraindicated. Treatment with escitalopram should be started 14 days after discontinuation of irreversible MAO inhibitors. Treatment with non-selective irreversible MAO inhibitors can only be started 7 days after discontinuation of escitalopram.
Reversible non-selective MAOI (linezolid). The antibiotic linezolid is a reversible non-selective MAOI and should not be given to patients taking escitalopram. If the combination proves necessary, the lowest doses of both drugs should be used under close clinical supervision (see section 4.3).
Irreversible selective MAOI type B inhibitor (selegiline). Combination with selegiline (an irreversible MAOI type B inhibitor) requires caution due to the risk of serotonin syndrome. Selegiline at doses up to and including 10 mg/day has been safely used with racemic citalopram.
QT prolongation. Pharmacokinetic and pharmacodynamic studies of the combined use of escitalopram with other drugs that prolong the QT interval have not been conducted. When escitalopram is used 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 use, pentamidine, antimalarials, in particular halofantrine), some antihistamines (including astemizole, hydroxyzine, mizolastine), is contraindicated.
Combinations requiring caution when used.
Serotonergic medicinal products: Concomitant use with serotonergic medicinal products (e.g. opioids (including tramadol) and triptans (including sumatriptan)) may lead to serotonin syndrome (see section 4.4).
Drugs that lower the seizure threshold. SSRIs may lower the seizure threshold. Caution is advised with concomitant use of drugs that may lower the seizure threshold (e.g. 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, caution is recommended when these drugs are prescribed simultaneously.
St. John's wort: Concomitant use of SSRIs and herbal remedies containing St. John's wort (Hypericum perforatum) may lead to an increased incidence of adverse reactions (see section 4.4).
Anticoagulants. The effects of anticoagulants may be altered by concomitant use with escitalopram. In patients taking oral anticoagulants, careful monitoring of the blood coagulation system is necessary before and after the use of escitalopram. Concomitant use of nonsteroidal anti-inflammatory drugs may increase the tendency to bleed (see section "Special instructions").
Alcohol: Escitalopram does not interact with alcohol in a pharmacodynamic or pharmacokinetic manner. However, as with psychotropic drugs, the combination with alcohol is undesirable.
Medicinal products causing hypokalemia/hypomagnesemia: Caution is required when concomitantly administering medicinal products that can cause hypokalemia/hypomagnesemia, as this increases the risk of malignant arrhythmias (see section 4.4).
Pharmacokinetic interactions
Effects of other agents on the pharmacokinetics of escitalopram The metabolism of escitalopram is mainly mediated by CYP2C19. CYP3A4 and CYP2D6 enzymes may also play some role in its metabolism, although to a lesser extent. CYP2D6 is thought 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.
Effect of escitalopram on the pharmacokinetics of other medicinal products. 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 (used in heart failure) or with certain CNS-active medicinal products that 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 has been shown to increase plasma levels of these two CYP2D6 substrates by a factor of two. In vitro studies have shown that escitalopram may also cause slight inhibition of CYP2C19. Caution is recommended when co-administered with medicinal products metabolised by CYP2C19.
Application features
The following application features apply to the therapeutic class of SSRIs.
Children. The drug should not be prescribed to children. In clinical studies, a higher incidence of suicidal behavior (suicide attempts and thoughts), hostility (predominantly aggression, confrontational tendencies and irritability) was observed among children treated with antidepressants compared to those who took placebo. If the clinical situation still requires the appointment of such treatment, the patient should be carefully monitored for the timely detection of suicidal symptoms. In addition, there are no data on the subsequent safety in children with regard to growth, puberty and cognitive and behavioral development.
Paradoxical anxiety. Some patients with panic disorder may experience increased anxiety at the beginning of treatment with antidepressants. This paradoxical reaction usually disappears within two weeks of treatment. To reduce the likelihood of an anxiogenic effect, a low initial dose is recommended (see section "Dosage and administration").
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 a previous diagnosis of 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 affect glycaemic control (hypoglycaemia or hyperglycaemia). The dose of insulin and/or oral hypoglycaemic agents may need to be adjusted.
Suicide/suicidal thoughts or worsening of clinical condition. Depression is associated with a risk of suicidal thoughts, self-harm and suicide. This risk persists 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 improvement occurs. It is known that the risk of suicide may be increased in the early stages of recovery. Other psychiatric disorders for which escitalopram is used may also be associated with an increased 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 behavior prior to initiation of treatment are at greatest risk of suicidal thoughts or attempts and require close monitoring during treatment. A meta-analysis of studies has found an increased risk of suicidal behavior among patients under 25 years of age who received antidepressants compared with those who received placebo. Close monitoring of high-risk patients is particularly necessary at the beginning of treatment and during dose changes.
Patients and their caregivers should be warned to monitor for any worsening of condition, suicidal behaviour or thoughts, and unusual changes in behaviour and to seek immediate medical advice if these symptoms develop.
Akathisia/psychomotor agitation. 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 within the first few weeks of treatment. Increasing the dose may be harmful in patients who develop these symptoms.
Haemorrhage. Skin bleeding, ecchymosis and purpura may occur with SSRIs. SSRIs/NSAIDs may increase the risk of postpartum haemorrhage (see sections “Use during pregnancy or lactation”, “Adverse reactions”). SSRIs should be prescribed with caution in patients treated concomitantly with oral anticoagulants, medicinal products that affect platelet function (e.g. atypical antipsychotics, phenothiazines, most tricyclic antidepressants, acetylsalicylic acid and non-steroidal anti-inflammatory drugs, ticlopidine and dipyridamole), and in patients with a known tendency to bleed.
Electroconvulsive therapy (ECT): Clinical experience with the concomitant use of SSRIs and ECT is limited, so caution is recommended.
Serotonin syndrome: Caution is advised when escitalopram is co-administered with serotonergic agents, such as triptans (including sumatriptan), opioids (including tramadol) and tryptophan.
Serotonin syndrome has been reported in isolated cases in patients taking SSRIs concomitantly with serotonergic medicinal products. 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 medicinal product should be discontinued immediately and symptomatic treatment should be initiated.
St. John's wort: Concomitant use of SSRIs and herbal preparations containing St. John's wort (Hypericum perforatum) may lead to an increased incidence of adverse reactions (see section 4.5).
Withdrawal symptoms seen on discontinuation of treatment. Withdrawal symptoms are common when treatment is discontinued, particularly if it is abrupt (see section 4.8). In studies, adverse reactions related to discontinuation of treatment were observed in approximately 25% of patients in the escitalopram group and 15% of patients in the placebo group. The risk of withdrawal symptoms depends on several factors, including duration and dose, and the gradualness of dose reduction. Dizziness, sensory disturbances (including paraesthesia and electric shock sensations), sleep disturbances (including insomnia and vivid dreams), agitation or anxiety, vomiting and/or nausea, 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, although very rarely such symptoms have been reported after accidentally missing only one dose. These symptoms are usually short-lived and resolve within 2 weeks, but in some individuals they may be longer (2-3 months or longer). In this case, it is recommended to discontinue escitalopram by gradually reducing the dose over a period of several weeks to several months, depending on the patient's condition.
Sexual dysfunction: SSRIs/SNRIs may cause symptoms of sexual dysfunction (see section 4.8). There have been reports of persistent sexual dysfunction where symptoms persist despite discontinuation of SSRIs/SNRIs.
Coronary heart disease: Due to limited clinical experience, caution is recommended when using the drug in 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 torsade de pointes, have been reported predominantly in women, in patients with hypokalaemia or pre-existing QT prolongation, or in patients with other cardiac diseases. The drug should be used with caution in patients with marked bradycardia, in patients with recent acute myocardial infarction, or in decompensated heart failure. Electrolyte imbalances such as hypokalaemia and hypomagnesaemia increase the risk of malignant arrhythmias and should be corrected before initiating treatment with escitalopram. In patients with stable cardiac disease, a careful ECG assessment should be performed before initiating treatment with escitalopram. If cardiac arrhythmias occur during treatment with escitalopram, treatment should be discontinued and an ECG should be performed.
Angle-closure glaucoma. SSRIs, including escitalopram, may affect pupil size, resulting in mydriasis. This mydriatic effect has the potential to narrow the angle of the eye, leading to increased intraocular pressure and angle-closure glaucoma, especially in predisposed patients. Escitalopram should therefore be used with caution in patients with angle-closure glaucoma or a history of glaucoma.
Medopram® contains lactose. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Special precautions for use regarding excipients: One tablet of Medopram® contains less than 1 mmol (23 mg) of sodium, i.e. this medicinal product can be considered essentially sodium-free.
Use during pregnancy or breastfeeding
Animal studies have shown reproductive toxicity. Escitalopram is contraindicated in pregnant women unless the need for the drug is clearly demonstrated after careful consideration of the risks and benefits. Careful observation of newborns whose mothers have taken escitalopram during pregnancy is recommended, especially in the third trimester. Abrupt withdrawal of the drug during pregnancy should be avoided. The following symptoms may occur in newborns whose mothers have taken SSRIs/SNRIs in late pregnancy: respiratory distress, cyanosis, apnea, convulsions, body temperature fluctuations, difficulty breastfeeding, vomiting, hypoglycemia, hypertension, hypotonia, hyperreflexia, tremor, agitation, irritability, apathy, constant crying, drowsiness and difficulty sleeping. These symptoms may be due to either serotonergic effects or withdrawal symptoms. In most cases, such complications occur immediately or shortly (up to 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, according to observational data). In the general population, it is 1–2 cases per 1000 pregnancies.
Breastfeeding: Escitalopram is believed to pass into breast milk, so breastfeeding is recommended to be discontinued during treatment.
Fertility: Animal data have shown that escitalopram 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
Escitalopram does not generally affect intellectual status or psychomotor function, but it should be borne in mind that as a psychotropic drug it may affect decision-making and abilities. Patients should be warned of the potential risk of affecting the ability to drive and use machines.
Method of administration and doses
The safety of doses above 20 mg per day has not been established.
Medopram is taken orally once a day, regardless of meals.
Major depressive episode. Usually prescribed 10 mg once a day. 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 achieved effect.
Panic disorder with or without agoraphobia. An initial dose of 5 mg/day is recommended for the first week, before increasing to 10 mg/day. The dose may then be increased to a maximum of 20 mg/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): Usually prescribed 10 mg once a day.
Usually, 2-4 weeks of therapy are required to alleviate symptoms. Subsequently, depending on the individual patient's response, the dose may be reduced to 5 mg or increased to a maximum of 20 mg per day. Social anxiety disorder is a chronic disease, and to consolidate the achieved effect, it is recommended to continue treatment for 12 weeks. Long-term treatment for 6 months has been shown to prevent relapse and can be prescribed individually, depending on the individual response of patients; the therapeutic benefit of treatment should be regularly checked.
Social anxiety disorder is a well-defined diagnostic term for a specific disorder, not to be confused with excessive shyness. Pharmacological treatment is indicated only if the disorder significantly interferes with occupational and social functioning. The effectiveness of such treatment compared with cognitive behavioral therapy has not been evaluated. Pharmacological treatment should be part of an overall therapeutic strategy.
Generalized anxiety disorder. Usually prescribed 10 mg 1 time per day. Depending on individual sensitivity, the dose may be increased to a maximum of 20 mg per day.
Long-term treatment has been studied for at least 6 months in patients receiving a dose of 20 mg per day; the benefit of treatment should be assessed regularly (see section 5.1).
Obsessive-compulsive disorder (OCD). Usually initially prescribed 10 mg 1 time per day. Depending on individual sensitivity, the dose may be increased to 20 mg per day. OCD is a chronic disease, treatment should last a sufficient period to ensure complete disappearance of symptoms, which may be several months or even more. The benefit of treatment and the dose of the drug should be assessed at regular intervals.
Paediatric population: Escitalopram should not be used in the treatment of children and adolescents (under 18 years of age) (see section 4.4).
Patients with renal impairment. No dose adjustment is required in patients with moderate to mild renal impairment. Caution should be exercised in patients with severe renal impairment (Clcr <30 mL/min).
Patients with hepatic impairment. The recommended starting dose during the first two weeks of treatment is 5 mg per day for patients with mild to moderate hepatic impairment. Depending on the individual patient response, the dose may be increased to 10 mg per day. Patients with severe hepatic impairment are advised to use the drug with caution and to titrate the dose very carefully.
Poor CYP2C19 activity: For patients with known poor CYP2C19 activity, the recommended starting dose for the first two weeks of treatment is 5 mg/day. Depending on the individual patient response, the dose may be increased to 10 mg/day.
Withdrawal symptoms observed on discontinuation of treatment. Abrupt discontinuation of the drug should be avoided. When discontinuing treatment with escitalopram, the dose should be reduced gradually over at least 1-2 weeks to reduce the risk of withdrawal symptoms (see sections "Special instructions" and "Adverse reactions"). If unacceptable symptoms occur after dose reduction or discontinuation, a return to the previously prescribed dose of the drug may be considered. In the future, the doctor may continue to reduce the dose, but more gradually.
Children: Antidepressants should not be used in the treatment of children and adolescents (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 in children and adolescents treated with antidepressants than in those treated with placebo. If a decision to prescribe is made for clinical reasons, the patient should be closely monitored for suicidal symptoms.
Children
Medopram® should not be used to treat children (under 18 years of age).
Overdose
Toxicity. Clinical data on overdose with escitalopram are limited, in many cases overdose with concomitant medications. In most cases, symptoms were mild or asymptomatic. Reports of fatal outcomes from overdose with escitalopram are exceptional, most of them involving concomitant overdose with other drugs. Escitalopram doses of 400–800 mg did not cause any severe symptoms.
Symptoms: Signs of escitalopram overdose are mainly manifested by symptoms from the central nervous system (ranging from dizziness, tremor and agitation to rare cases of serotonin syndrome, convulsions and coma), the digestive tract (nausea, vomiting), the cardiovascular system (hypotension, tachycardia, QT prolongation, arrhythmia) and electrolyte/fluid imbalance (hypokalemia, hyponatremia).
Treatment. There is no specific antidote. Maintain adequate 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/bradyarrhythmias, in patients taking concomitant medications that prolong the QT interval, and in patients with impaired drug metabolism, such as patients with hepatic impairment.
Side effects
Adverse reactions are most often observed during the first or second week of treatment and usually their frequency and intensity gradually decrease with further treatment. Adverse reactions known for SSRIs and escitalopram, which were observed during placebo-controlled studies and during clinical use, are presented by system organ class and frequency below. The frequency is defined as: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1000 to <1/100), rare (≥1/10000 to <1/1000), very rare (<1/10000), frequency unknown (cannot be estimated from the available data).
From the blood and lymphatic system: frequency unknown - thrombocytopenia.
On the part of the immune system: rarely - anaphylactic reactions.
From the endocrine system
