Elicea®
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 deterioration
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.
The simultaneous use of escitalopram and MAO A inhibitors is not recommended due to the risk of developing serotonin syndrome.
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.
QT syndrome, 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.
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.
Eliceya®
You should stop using the drug Elitseya if convulsive disorders, epileptic seizures develop, or their frequency increases in case of pharmacologically uncontrolled epilepsy.
If a manic state develops, Elicea® should be discontinued.
Escitalopram may increase blood glucose concentrations in diabetes mellitus, which may require dose adjustments of oral hypoglycemic agents and/or insulin.
Hyponatremia associated with a decrease in ADH secretion occurs rarely with the use of Elitsey® (more often in older people, patients with cirrhosis of the liver, or constantly taking drugs that can cause hyponatremia) and usually disappears when the drug is discontinued.
With the development of serotonin syndrome
the drug should be immediately discontinued and symptomatic treatment prescribed.
Escitalopram should be used with caution in patients with a history of mania/hypomania. If a manic state develops, escitalopram should be discontinued.
Neuroleptic malignant syndrome (NMS) -
a rare, potentially dangerous condition associated with the use of antidepressants, incl. escitalopram. Symptoms of NMS: increased body temperature (hyperpyrexia), muscle rigidity, changes in mental status and instability of the autonomic nervous system (arrhythmia, blood pressure fluctuations, tachycardia, profuse sweating, cardiac arrhythmia). If NMS is detected, you must immediately stop using Elitsey®.
During the first two weeks, akathisia/psychomotor agitation may develop (subjectively unpleasant or irritating restlessness and the need to move, often combined with the inability to sit or stand quietly).
When using the drug Elitsey®, the development of skin hemorrhages (ecchymosis and purpura) is possible. Escitalopram should be used with caution in patients with a tendency to bleeding, as well as those taking indirect anticoagulants and other drugs that affect blood clotting.
The simultaneous use of escitalopram and ethanol is not recommended.
Clinical experience with electroconvulsive therapy and escitalopram is limited and caution is advised.
There is limited experience with the use of escitalopram in patients with coronary artery disease, so Elitseya® is recommended to be used with caution in this group of patients.
When escitalopram therapy is quickly discontinued, withdrawal syndrome often occurs: dizziness, sensory disturbances (including paresthesia), sleep disturbances (insomnia, unusual dreams), psychomotor agitation, anxiety, nausea and/or vomiting, tremor, confusion, sweating, headache, diarrhea, palpitations, emotional lability and visual disturbances. The severity of these reactions is usually mild or moderate and the duration is limited. In this regard, it is recommended to discontinue Elicea® gradually, reducing the dose over several weeks or months.
In children, adolescents and young adults (under 24 years of age) with depression and other mental disorders, antidepressants, compared with placebo, increase the risk of suicidal thoughts and suicidal behavior. Therefore, when using escitalopram or any other antidepressants in children, adolescents and young adults (under 24 years of age), the risk of suicide should be weighed against the benefits of their use. In short-term studies, the risk of suicide did not increase in people over 24 years of age, but it decreased slightly in people over 65 years of age. Any depressive disorder itself increases the risk of suicide. Therefore, during treatment with antidepressants, all patients should be monitored for early detection of disturbances or changes in behavior, as well as suicidality.
Impact on the ability to drive vehicles and operate machinery
During the treatment period, it is necessary to refrain from driving vehicles and engaging in potentially hazardous activities that require increased concentration and speed of psychomotor reactions due to the possibility of dizziness, hallucinations, confusion, depersonalization and other side effects.
Elicea, 56 pcs., 10 mg, film-coated tablets
You should stop using the drug Elitseya if convulsive disorders, epileptic seizures develop, or their frequency increases in case of pharmacologically uncontrolled epilepsy.
If a manic state develops, Elicea® should be discontinued.
Escitalopram may increase blood glucose concentrations in diabetes mellitus, which may require dose adjustments of oral hypoglycemic agents and/or insulin.
Hyponatremia associated with a decrease in ADH secretion occurs rarely with the use of Elitsey® (more often in older people, patients with cirrhosis of the liver, or constantly taking drugs that can cause hyponatremia) and usually disappears when the drug is discontinued.
If serotonin syndrome develops, the drug should be immediately discontinued and symptomatic treatment prescribed.
Escitalopram should be used with caution in patients with a history of mania/hypomania.
If a manic state develops, escitalopram should be discontinued.
Neuroleptic malignant syndrome (NMS) is a rare, potentially dangerous condition associated with the use of antidepressants, incl. escitalopram. Symptoms of NMS: increased body temperature (hyperpyrexia), muscle rigidity, changes in mental status and instability of the autonomic nervous system (arrhythmia, blood pressure fluctuations, tachycardia, profuse sweating, cardiac arrhythmia). If NMS is detected, you must immediately stop using Elitsey®.
During the first two weeks, akathisia/psychomotor agitation may develop (subjectively unpleasant or irritating restlessness and the need to move, often combined with the inability to sit or stand quietly).
When using the drug Elicea®, the development of skin hemorrhages (ecchymosis and purpura) is possible.
Escitalopram should be used with caution in patients with a tendency to bleeding, as well as those taking indirect anticoagulants and other drugs that affect blood clotting.
The simultaneous use of escitalopram and ethanol is not recommended.
Clinical experience with ECT and escitalopram is limited and caution is advised.
There is limited experience with the use of escitalopram in patients with coronary artery disease, so Elitseya® is recommended to be used with caution in this group of patients.
When escitalopram therapy is quickly discontinued, withdrawal syndrome often occurs: dizziness, sensory disturbances (including paresthesia), sleep disturbances (insomnia, unusual dreams), psychomotor agitation, anxiety, nausea and/or vomiting, tremor, confusion, sweating, headache, diarrhea, palpitations, emotional lability and visual disturbances.
The severity of these reactions is usually mild or moderate and the duration is limited.
In this regard, it is recommended to discontinue Elicea® gradually, reducing the dose over several weeks or months.
In children, adolescents and young adults (under 24 years of age) with depression and other mental disorders, antidepressants, compared with placebo, increase the risk of suicidal thoughts and suicidal behavior. Therefore, when using escitalopram or any antidepressants in children, adolescents and young adults (under 24 years of age), the risk of suicide should be weighed against the benefits of their use. In short-term studies, the risk of suicide did not increase in people over 24 years of age, but it decreased slightly in people over 65 years of age.
Any depressive disorder itself increases the risk of suicide. Therefore, during treatment with antidepressants, all patients should be monitored for early detection of disturbances or changes in behavior, as well as suicidality.
Impact on the ability to drive vehicles and other technical devices.
During the treatment period, it is necessary to refrain from driving vehicles and engaging in potentially hazardous activities that require increased concentration of attention and speed of psychomotor reactions, due to the possibility of developing dizziness, hallucinations, confusion, depersonalization and other side effects.
Elycea
Use during pregnancy and breastfeeding
Elicea® is not used during pregnancy (safety has not been established).
Due to the fact that escitalopram is secreted into breast milk, the use of the drug during breastfeeding is not recommended. If it is necessary to use Elicea® during lactation, breastfeeding should be discontinued.
Use for liver dysfunction
For liver dysfunction, the initial dose is 5 mg/day for 2 weeks. Depending on the patient's individual response, the dose may be increased to 10 mg/day. In severe liver dysfunction, slower dose titration is recommended.
Use for renal impairment
For mild or moderate renal failure (creatinine clearance more than 30 ml/min), no dose adjustment is required. In severe renal failure (creatinine clearance less than 30 ml/min), the drug should be prescribed with caution.
Use in children
The use of the drug in children under 18 years of age is contraindicated.
Use in elderly patients
The drug should be used with caution in elderly patients.
special instructions
You should stop using the drug Elitseya if convulsive disorders, epileptic seizures develop, or their frequency increases in case of pharmacologically uncontrolled epilepsy.
If a manic state develops, Elicea® should be discontinued.
Escitalopram may increase blood glucose concentrations in diabetes mellitus, which may require dose adjustments of oral hypoglycemic agents and/or insulin.
Hyponatremia associated with a decrease in ADH secretion occurs rarely with the use of Elitsey® (more often in older people, patients with cirrhosis of the liver, or constantly taking drugs that can cause hyponatremia) and usually disappears when the drug is discontinued.
If serotonin syndrome develops, the drug should be immediately discontinued and symptomatic treatment prescribed.
Escitalopram should be used with caution in patients with a history of mania/hypomania. If a manic state develops, escitalopram should be discontinued.
Neuroleptic malignant syndrome (NMS) is a rare, potentially dangerous condition associated with the use of antidepressants, incl. escitalopram. Symptoms of NMS: increased body temperature (hyperpyrexia), muscle rigidity, changes in mental status and instability of the autonomic nervous system (arrhythmia, blood pressure fluctuations, tachycardia, profuse sweating, cardiac arrhythmia). If NMS is detected, you must immediately stop using Elitsey®.
During the first two weeks, akathisia/psychomotor agitation may develop (subjectively unpleasant or irritating restlessness and the need to move, often combined with the inability to sit or stand quietly).
When using the drug Elitsey®, the development of skin hemorrhages (ecchymosis and purpura) is possible. Escitalopram should be used with caution in patients with a tendency to bleeding, as well as those taking indirect anticoagulants and other drugs that affect blood clotting.
The simultaneous use of escitalopram and ethanol is not recommended.
Clinical experience with electroconvulsive therapy and escitalopram is limited and caution is advised.
There is limited experience with the use of escitalopram in patients with coronary artery disease, so Elitseya® is recommended to be used with caution in this group of patients.
When escitalopram therapy is quickly discontinued, withdrawal syndrome often occurs: dizziness, sensory disturbances (including paresthesia), sleep disturbances (insomnia, unusual dreams), psychomotor agitation, anxiety, nausea and/or vomiting, tremor, confusion, sweating, headache, diarrhea, palpitations, emotional lability and visual disturbances. The severity of these reactions is usually mild or moderate and the duration is limited. In this regard, it is recommended to discontinue Elicea® gradually, reducing the dose over several weeks or months.
In children, adolescents and young adults (under 24 years of age) with depression and other mental disorders, antidepressants, compared with placebo, increase the risk of suicidal thoughts and suicidal behavior. Therefore, when using escitalopram or any other antidepressants in children, adolescents and young adults (under 24 years of age), the risk of suicide should be weighed against the benefits of their use. In short-term studies, the risk of suicide did not increase in people over 24 years of age, but it decreased slightly in people over 65 years of age. Any depressive disorder itself increases the risk of suicide. Therefore, during treatment with antidepressants, all patients should be monitored for early detection of disturbances or changes in behavior, as well as suicidality.
Impact on the ability to drive vehicles and operate machinery
During the treatment period, it is necessary to refrain from driving vehicles and engaging in potentially hazardous activities that require increased concentration and speed of psychomotor reactions due to the possibility of dizziness, hallucinations, confusion, depersonalization and other side effects.
