Elicea Qu-tab tablets, dispersible in the oral cavity 10 mg 28 pcs. in Moscow
When using drugs belonging to the SSRI therapeutic group, including escitalopram, the following should be considered:
Use in children and adolescents under 18 years of age
Antidepressants should not be prescribed to children and adolescents under 18 years of age due to an increased risk of suicidal behavior (suicide attempts and suicidal thoughts), hostility (with a predominance of aggressive behavior, confrontational behavior and irritation). If a decision is made to initiate antidepressant therapy based on clinical assessment, the patient should be closely monitored. In addition, there is insufficient data on long-term safety in children and adolescents regarding growth, maturation, cognitive and behavioral development.
Paradoxical anxiety
Some patients with panic disorder may experience increased anxiety when starting antidepressant treatment. This paradoxical reaction usually disappears within the first two weeks of treatment. To reduce the likelihood of an anxiogenic effect, low initial doses are recommended.
Convulsions
Escitalopram should be discontinued in the event of the primary development of convulsive seizures or in the event of an increase in their frequency (in patients with previously diagnosed epilepsy). SSRIs should not be used in patients with unstable epilepsy; controlled seizures require careful monitoring.
Mania
Escitalopram should be used with caution in patients with a history of mania/hypomania. If a manic state develops, escitalopram should be discontinued.
Diabetes
In patients with diabetes mellitus, treatment with escitalopram may alter plasma glucose concentrations. Therefore, dose adjustments of insulin and/or oral hypoglycemic drugs may be required.
Suicide/suicidal ideation or clinical worsening
Depression is associated with an increased risk of suicidal ideation, self-harm, and suicide (suicidal events). This risk persists until significant remission occurs. Since improvement may not be observed during the first few weeks of therapy or even longer, patients should be closely monitored until their condition improves.
General clinical practice shows that in the early stages of recovery the risk of suicide may increase.
Other psychiatric conditions for which escitalopram is prescribed may also be associated with an increased risk of suicidal events and events. In addition, these conditions may be a comorbidity in relation to a depressive episode. When treating patients with other mental disorders, the same precautions should be taken as when treating patients with a depressive episode.
Patients with a history of suicidal behavior or patients with a significant level of suicidal thoughts before treatment are at greater risk for suicidal ideation or suicide attempts and should be closely monitored during treatment.
A meta-analysis of placebo-controlled clinical trials of antidepressants in adult patients with mental disorders found that there is an increased risk of suicidal behavior in patients under 25 years of age when taking antidepressants compared with placebo. Drug treatment of these patients, and in particular those at high risk for suicide, should be accompanied by careful monitoring, especially early in treatment and during dose changes.
Patients (and caregivers) should be warned to monitor for any signs of clinical worsening, suicidal behavior or ideation, or unusual changes in behavior, and to seek immediate medical advice if these symptoms occur.
Akathisia/psychomotor agitation
The use of SSRIs/SNRIs is associated with the development of akathisia, characterized by the development of subjectively unpleasant or depressing restlessness and the need for constant movement, often combined with an inability to sit or stand quietly. This most often occurs during the first few weeks of treatment. In patients with such symptoms, increasing the dose may lead to worsening.
Hyponatremia
Hyponatremia, possibly associated with impaired ADH secretion, occurs rarely with SSRIs and usually disappears when therapy is discontinued. Caution should be exercised when using escitalopram and other SSRIs in persons at risk of developing hyponatremia: elderly patients, patients with cirrhosis of the liver, and those taking drugs that can cause hyponatremia.
Bleeding
Cases of skin hemorrhages (ecchymosis and purpura) have been reported when taking SSRIs. Escitalopram should be used with caution in patients taking oral anticoagulants and drugs that affect blood clotting, as well as in patients with a tendency to bleed.
Electroconvulsive therapy
Because clinical experience with the concomitant use of SSRIs and ECT is limited, caution should be used when escitalopram and ECT are used concomitantly.
Serotonin syndrome
The simultaneous use of escitalopram and MAO A inhibitors is not recommended due to the risk of developing serotonin syndrome. Escitalopram should be used with caution concomitantly with drugs that have serotonergic effects, such as sumatriptan or other triptans, tramadol and tryptophan. Patients taking escitalopram and other SSRIs concomitantly with serotonergic drugs have rarely developed serotonin syndrome. Its development may be indicated by a combination of symptoms such as agitation, tremor, myoclonus and hyperthermia. If this occurs, concomitant treatment with SSRIs and serotonergic drugs should be discontinued immediately and symptomatic treatment initiated.
Withdrawal syndrome after cessation of therapy
When stopping treatment, withdrawal syndrome is common, especially if treatment is stopped abruptly. In clinical studies, adverse events at treatment discontinuation occurred in approximately 25% of patients treated with escitalopram and in 15% of patients treated with placebo.
The risk of withdrawal syndrome may depend on several factors, including the duration of therapy and the dose of the drug, as well as the rate of dose reduction. The most commonly reported reactions were dizziness, sensory disturbances (including paresthesia and electric shock), sleep disturbances (including insomnia and intense dreams), agitation or anxiety, nausea and/or vomiting, tremor, confusion, increased sweating, headache, diarrhea, palpitations, emotional instability, irritability and visual disturbances. These symptoms are usually mild to moderate, but may be severe in some patients.
Symptoms usually occur within the first few days after stopping treatment, but such symptoms have been extremely rarely reported in patients who accidentally missed taking the drug.
As a rule, these symptoms resolve on their own, usually within 2 weeks, although in some patients they can be prolonged (2-3 months or more). Therefore, when stopping treatment, it is recommended to gradually reduce the dose over several weeks or months in accordance with the patient's condition.
Coronary heart disease (CHD)
Due to limited experience with use in patients with coronary artery disease, caution is recommended when using the drug.
QT prolongation
Escitalopram has been found to cause a dose-dependent prolongation of the QT interval. Cases of QT prolongation and ventricular arrhythmias, including torsade de pointes (TdP), have been reported post-marketing, predominantly in female patients with hypokalemia or pre-existing QT prolongation, or other cardiac disease.
Caution is required when using the drug in patients with severe bradycardia or in patients with recent acute myocardial infarction or decompensated heart failure.
Electrolyte imbalances, such as hypokalemia and hypomagnesemia, increase the risk of developing malignant arrhythmias; these disturbances must be corrected before starting treatment with escitalopram.
In patients with stable coronary artery disease, an ECG should be performed before starting treatment.
If signs of cardiac arrhythmia occur during treatment with escitalopram, it is necessary to stop therapy and perform an ECG.
Angle-closure glaucoma
SSRIs, including escitalopram, may affect pupil size, leading to mydriasis. This pupil dilation effect has the potential to narrow the anterior chamber angle, leading to increased intraocular pressure and the development of angle-closure glaucoma, especially in patients with a predisposition to this disease. Therefore, in patients with angle-closure glaucoma or a history of glaucoma, caution should be exercised when using escitalopram.
Sexual dysfunction
SSRIs/SSRIs may cause symptoms of sexual dysfunction. There have been reports of long-term sexual dysfunction where symptoms continued despite discontinuation of SSRIs/SNRIs.
Special information on excipients
Elitsey® contains lactose, so it should not be used for the following conditions: lactose intolerance, lactase deficiency, glucose-galactose malabsorption syndrome.
Impact on driving vehicles and machinery
Despite the fact that Elitsey® does not affect intellectual functions and psychomotor activity, it is not recommended to drive vehicles or machinery during the treatment period.
Elycea ku-tab Tablets, box, 56 pcs, 10 mg, for oral administration
special instructions
Contraindications for use: simultaneous use of MAO inhibitors, children and adolescents under 15 years of age, pregnancy, lactation, hypersensitivity to escitalopram. Use for liver dysfunction: Use with caution in liver cirrhosis. Use for impaired renal function: should be used with caution in patients with renal failure (creatinine clearance less than 30 ml/min). Use in children: contraindicated in children and adolescents under 15 years of age. Use in elderly patients: Use with caution in elderly patients. Special instructions: Use with caution in patients with renal failure (creatinine clearance less than 30 ml/min), hypomania, mania, with pharmacologically uncontrolled epilepsy, with depression with suicidal attempts, diabetes mellitus, in elderly patients, with cirrhosis of the liver, with addiction to bleeding, simultaneously with taking medications that reduce the threshold of convulsive readiness, causing hyponatremia, with ethanol, with drugs metabolized with the participation of isoenzymes of the CYP2C19 system. Escitalopram should be prescribed only after 2 weeks. after discontinuation of irreversible MAO inhibitors and 24 hours after discontinuation of therapy with a reversible MAO inhibitor. Non-selective MAO inhibitors can be prescribed no earlier than 7 days after discontinuation of escitalopram. Some patients with panic disorder may experience increased anxiety at the beginning of treatment with escitalopram, which usually disappears over the next 2 weeks. treatment. To reduce the likelihood of anxiety, low initial doses are recommended. Escitalopram should be discontinued if epileptic seizures develop or become more frequent in pharmacologically uncontrolled epilepsy. If a manic state develops, escitalopram should be discontinued. Escitalopram can increase the concentration of glucose in the blood in diabetes mellitus, which may require dose adjustment of hypoglycemic drugs. Clinical experience with escitalopram indicates a possible increase in the risk of suicide attempts in the first weeks of therapy, and therefore it is very important to carefully monitor patients during this period. Hyponatremia associated with decreased ADH secretion occurs rarely with escitalopram and usually disappears when it is discontinued. If serotonin syndrome develops, escitalopram should be immediately discontinued and symptomatic treatment prescribed. Impact on the ability to drive vehicles and operate machinery During the treatment period, patients should avoid driving vehicles and other activities that require high concentration and speed of psychomotor reactions.
