Selectra, 28 pcs., 10 mg, film-coated tablets
Some patients with panic disorder may experience increased anxiety when starting SSRI treatment. This paradoxical reaction usually disappears within two weeks of treatment. To reduce the likelihood of an anxiogenic effect, it is recommended to use the drug in a low initial dose.
The drug should be discontinued if seizures develop. Use in patients with uncontrolled epilepsy is not recommended; Controlled seizures require careful monitoring. If the frequency of seizures increases, SSRIs, including escitalopram, should be discontinued.
Escitalopram should be used with caution in patients with a history of mania/hypomania. If a manic state develops, escitalopram should be discontinued.
In patients with diabetes mellitus, treatment with escitalopram may change blood glucose levels (both hypoglycemia and hyperglycemia are possible). Therefore, dose adjustments of insulin and/or oral hypoglycemic agents may be necessary.
The risk of committing suicide is inherent in depression and may persist until the condition significantly improves, either spontaneously or as a result of therapy. Careful monitoring of patients being treated with antidepressants is necessary, especially at the beginning of treatment, due to the possibility of clinical deterioration and/or the emergence of suicidal manifestations (thoughts and behavior). This precaution should also be observed when treating other mental disorders due to the possibility of simultaneous development of depression.
In some cases, when treated with SSRI antidepressants, there was an increased risk of developing suicidal thoughts and behavior in children, adolescents and young adults under 24 years of age, compared to placebo.
Hyponatremia, possibly associated with impaired ADH secretion, occurs rarely with escitalopram and usually disappears when therapy is discontinued. Caution should be exercised when prescribing escitalopram and other SSRIs to persons at risk of developing hyponatremia: the elderly, those with liver cirrhosis, and those taking medications that can cause hyponatremia.
When taking escitalopram, subcutaneous hemorrhages (ecchymosis and purpura) may develop. Escitalopram should be used with caution in patients with a tendency to bleed, as well as those taking oral anticoagulants and other drugs that affect blood clotting.
Since clinical experience with the simultaneous use of escitalopram and electroconvulsive therapy is limited, caution should be exercised in such cases.
The combination of escitalopram and MAO type A inhibitors is not recommended due to the risk of developing serotonin syndrome.
In rare cases, patients taking escitalopram and other SSRIs concomitantly with serotonergic drugs may develop serotonin syndrome. Escitalopram should be used with caution concomitantly with drugs that have serotonergic effects. A combination of symptoms such as agitation, tremor, myoclonus, and hyperthermia may indicate the development of serotonin syndrome. If this occurs, SSRIs and serotonergic drugs should be immediately discontinued and symptomatic treatment prescribed.
Impact on the ability to drive vehicles and operate machinery
During treatment with the drug, patients should avoid performing potentially hazardous activities that require high speed psychomotor reactions, such as driving a car or operating machinery.
Selectra
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.
When using drugs belonging to the SSRI therapeutic group, including escitalopram,
the following should be considered
: some patients with panic disorder may experience increased anxiety when starting treatment with antidepressants. This paradoxical reaction usually disappears within two weeks of treatment. To reduce the likelihood of an anxiogenic effect, it is recommended to use low initial doses.
The drug 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.
Escitalopram should be used with caution in patients with a history of mania/hypomania. If a manic state develops, escitalopram should be discontinued.
In patients with diabetes mellitus, treatment with escitalopram may change blood glucose concentrations. Therefore, dose adjustments of insulin and/or oral hypoglycemic drugs may be required.
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 cautioned 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.
SSRI/SNRI use is associated with the development of akathisia, characterized by the development of subjectively unpleasant or distressing restlessness and a 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, possibly associated with impaired antidiuretic hormone (ADH) secretion, occurs rarely with SSRIs and usually disappears when therapy is discontinued. Caution should be exercised when prescribing escitalopram and other SSRIs to persons at risk of developing hyponatremia: the elderly, patients with cirrhosis, and those taking drugs that can cause hyponatremia.
Cases of skin hemorrhages (ecchymosis and purpura) have been reported when taking SSRIs. Escitalopram should be used with caution in patients with a tendency to bleed, as well as those taking oral anticoagulants and medications that affect blood clotting.
Because clinical experience with the concomitant use of SSRIs and electroconvulsive therapy (ECT) is limited, caution should be used when escitalopram and ECT are used concomitantly.
Combining 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.
Alcohol
Escitalopram does not interact pharmacodynamically or pharmacokinetically with alcohol. However, as with other psychotropic drugs, the simultaneous use of escitalopram and alcohol is not recommended.
SELECTRA
Interaction
Monoamine oxidase inhibitors (MAOIs)
Serious adverse reactions may occur when taking SELECTRA and MAO inhibitors concomitantly, as well as when taking MAO inhibitors in patients who have recently stopped taking the drug. In such cases, serotonin syndrome may develop.
Escitalopram should not be administered concomitantly with MAO inhibitors. Escitalopram can be prescribed 14 days after stopping treatment with irreversible MAO inhibitors and at least 1 day after stopping treatment with the reversible MAO type A inhibitor, moclobemide. At least 7 days must pass after stopping escitalopram before treatment with non-selective MAO inhibitors can be started.
Serotonergic drugs
Concomitant use with serotonergic drugs (eg, tramadol, sumatriptan and other triptans) may lead to the development of serotonin syndrome.
Medicines that lower the seizure threshold
SELECTRA may lower the seizure threshold. Caution is required when co-administered with other drugs that lower the seizure threshold (tricyclic antidepressants, other SSRIs, antipsychotics (phenothiazines, thioxanthene and butyrophenone derivatives), mefloquine and tramadol).
Lithium, tryptophan
Escitalopram enhances the pharmacological effects of tryptophan (increased serotonergic effect) and the toxic effects of lithium preparations.
St. John's wort (Hypericum perforatum)
The simultaneous administration of escitalopram and drugs containing St. John's wort (Hypericum perforatum) may lead to an increase in the number of side effects.
Anticoagulants and other drugs that affect blood clotting
Bleeding disorders may occur when escitalopram is co-administered with oral anticoagulants and other drugs that affect blood clotting (for example, atypical antipsychotics and phenothiazines, most tricyclic antidepressants, acetylsalicylic acid and non-steroidal anti-inflammatory drugs, ticlopidine and dipyridamole). In such cases, monitoring of blood coagulation parameters is necessary.
Ethanol
Escitalopram does not interact pharmacodynamically or pharmacokinetically with ethanol. However, as with other psychotropic drugs, the simultaneous use of escitalopram and alcohol is not recommended.
Effect of other drugs on the pharmacokinetics of escitalopram
Co-administration with drugs that inhibit cytochrome CYP2C19 may increase plasma concentrations of escitalopram. Caution should be exercised when escitalopram is used concomitantly with similar drugs, such as omeprazole. A dose reduction of escitalopram may be required.
Caution should be exercised when high doses of escitalopram are administered concomitantly with high doses of cimetidine, which is a strong inhibitor of the cytochromes CYP2D6, CYP3A4 and CYP1A2.
Effect of escitalopram on the pharmacokinetics of other drugs
Escitalopram is an inhibitor of the CYP2D6 isoenzyme. Caution should be exercised when co-prescribing escitalopram and drugs metabolized by this isoenzyme and having a low therapeutic index, for example, flecainide, propafenone and metoprolol (in cases of use in heart failure) or drugs mainly metabolized through CYP2D6 and acting on the central nervous system , for example, antidepressants - desipramine, clomipramine, nortriptyline, or antipsychotics - risperidone, thioridazine, haloperidol. In these cases, dose adjustment may be required as the concentration of escitalopram in the blood plasma increases.
The simultaneous administration of escitalopram and desipramine or metoprolol leads to a twofold increase in the concentration of the latter two drugs, which should be taken into account when choosing doses.
Escitalopram may slightly inhibit the CYP2C19 isoenzyme. Therefore, caution is recommended when using escitalopram concomitantly with medicinal products metabolized by CYP2C19.
