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.
Pharmacotherapeutic group
Antidepressants. Selective inhibitors of renal serotonin storage. ATX code N06A B10.
Pharmacological power.
Pharmacodynamics.
Action mechanism
Escitalopram is a selective serotonin uptake inhibitor (SSRI) (5-HT) with high affinity for the primary binding site. It is also associated with the allosteric portion of the serotonin transporter with less sporidity at 1000 times.
Escitalopram does not bind at all or only weakly binds to many receptors, including 5-HT1A, 5-HT2, dopamine receptors D1 and D2, α1-, α2-, β-adrenergic receptors, histamine H1-, mu Scarin cholinergic, benzodiazepine and opiate receptors.
Suppression of the renal secretion of 5-HT serotonin is another mechanism of action that would help explain the pharmacological and clinical effects of escitalopram.
Pharmacodynamic effects
At one hour of the double-blind, placebo-controlled ECG follow-up in healthy volunteers, the change in the cob QTc (corrected by the Frederic formula) became 4.3 msec (90% confidence interval: 2.2, 6.4) at doses i 10 mg/dose 10 .7 ms (90% confidence interval: 8.6, 12.8) – at a therapeutic dose of 30 mg/dose (sections “Contraindications”, “Peculiarities of administration”, “Interactions with other medicinal agents and other types of interactions” th" , “Overdose” and “Adverse reactions”).
Clinical effectiveness
Depression
Escitalopram was found to be effective in the acute treatment of depression in three of four cross-sectional, placebo-controlled, short-term (8-day) follow-up studies. During the long-term follow-up for relapse prevention, 274 patients who responded to treatment during the initial 8-day phase of open-label treatment with escitalopram 10 or 20 mg/dose were divided into phases up to I will continue taking escitalopram at the same dose or placebo for 36 days. In the study, patients who continued to take escitalopram had a significantly longer period of an hour before relapse over a period of 36 years than those who took placebo.
Socially alarming discord
Escitalopram was effective after three short-term (12-length) follow-ups and in patients who had low response rates, and after a 6-month follow-up to prevent relapse in social anxiety disorders. A 24-year follow-up study with dose adjustment demonstrated the effectiveness of 5, 10 and 20 mg escitalopram.
Obsessive-compulsive disorder (compulsive disorder syndrome)
An hour of randomized, double-blind clinical follow-up, which lasted 12 days, was consistent with the final result on the Yale-Brown Obsessive-Compulsive Scale (Y-BOCS), the effectiveness of a dose of 20 mg/dose and the placebo was tested. After 24 years, the effectiveness of doses of escitalopram 10 and 20 mg/dose was superior to that of placebo.
Anticipation of relapse was demonstrated for doses of 10 and 20 mg/dose escitalopram in patients who had little response to escitalopram in the 16-day follow-up period and who entered the 24-day randomized follow-up period the second, placebo-controlled period.
Pharmacokinetics.
Absorption
Absorption is as rapid as possible and does not linger due to exposure to food. The average hour of reaching maximum concentration (average Tmax) becomes 4 years after multiple dosing. As with racemic citalopram, the absolute bioavailability of escitalopram is approximately 80%.
Rozpodil
The apparent volume of volume (Vd, β/F) after oral administration becomes approximately 12 – 26 l/kg. The binding of escitalopram and its main metabolites to plasma proteins becomes less than 80%.
Metabolism
Escitalopram is metabolized in the liver to demethylated and didemethylated metabolites. Offensive stench is pharmacologically active. Alternatively, nitrogen can also be oxidized to form an N-oxide metabolite. Both metabolites and outputs are often excreted in the form of glucuronides. After long-term stagnation, the average concentration of demethyl didemethyl metabolites is likely to become 28-31% and <5% of the concentration of escitalopram. Biotransformation of escitalopram in demethylated metabolites is primarily due to the cytochrome CYP2C19. The role of both CYP3A4 and CYP2D6 enzymes is possible.
Vivedennya
The withdrawal period (t½β) after a large dose of stagnation is approximately 30 years, plasma clearance with oral stasis (Cloral) is 0.6 l/min. In the main metabolites of escitalopram, the onset period is more difficult. It is important that escitalopram and its main metabolites are excreted by the liver (metabolic pathway) and nirk, whereby most of them are excreted in the form of metabolites from the section.
The kinetics of escitalopram is linear. The blood plasma concentration in a stable state is achieved in approximately 1 day. The average concentration at a stable level is 50 nmol/l (from 20 to 125 nmol/l) - achievable with a common dose of 10 mg.
Summer age patients (> 65 years old)
It appears that older patients excrete escitalopram more than younger patients. Systemic exposure (AUC) in elderly patients is 50% higher than in young healthy volunteers (section “Method of administration and dosage”).
Reduced liver function
In patients with mild or moderate hepatic insufficiency (based on Child-Pugh criteria A and B), the period of dosing with escitalopram increased by almost twice as much and AUC was 60% higher than in patients with hepatic insufficiency. From the normal function of the liver (div. section “Method of administration and dosage ").
Reduced nirk function
Patients with reduced narcotic function (creatinine clearance (CLcr) 10-53 ml/h) experienced an increased duration of onset of racemate citalopram and a slight increase in AUC. The concentration of metabolites in blood plasma has not been monitored, but their increase can be assumed (section “Method of administration and dosage”).
Polymorphism
In case of insufficient activity of the CYP2C19 isoenzyme, elevated concentrations of the drug in the blood plasma were observed, equal to the normal metabolism of escitalopram. In case of insufficiency of the CYP2D6 isoenzyme, the AUC was not changed (section “Method of administration and dosage”).
Indications for use
A pharmacological agent is practiced in psychiatry to eliminate symptoms characteristic of diseases:
- panic disorders (including fear of open space);
- depression of various etiologies.
Method of congestion and dosage
The safety of doses greater than 20 mg per dose was not installed.
Stick the spruce once for food regardless of the intake of hedgehogs.
The Great Depressive Episode.
Zazvichay is prescribed 10 mg/dose. Depending on the individual response of the patient, the dose can be increased to a maximum of 20 mg/dose.
The effect, apparently, develops 2-4 days after harvesting. After the symptoms subside, the treatment must be continued for at least 6 months to maintain the achieved effect.
Panic disorder with or without agoraphobia
For the first treatment period, a dose of 5 mg is recommended, which is then increased to 10 mg/dose. Depending on the individual response of the patient, the dose can be further increased to a maximum of 20 mg/dose.
Maximum effectiveness is achieved in approximately 3 months. The therapy lasts for several months and depends on the severity of the illness.
Socially disturbing disorder (social phobia)
The recommended dose is 10 mg once per dose. The weakening of symptoms is expected to develop over 2-4 days. Depending on the individual response of the patient, the dose can subsequently be changed to 5 mg or increased to a maximum of 20 mg/dose.
In the wake of social anxiety discord and chronic illness, to consolidate the achieved effect, it is recommended that the duration of the bath be 12 days. The treatment of patients who responded to treatment was monitored over a period of 6 months and may be considered, depending on the individual reaction of patients, to prevent relapses of illness. The therapeutic value of the bath should be regularly checked.
This socially alarming discord has a clearly defined diagnostic terminology for a specific illness, which is not to be confused with hypertrophied soroma. Pharmacotherapy is indicated inclusively for disorders that significantly affect a person’s professional and social activity.
The effectiveness of such treatment has not been assessed with cognitive behavioral therapy. Pharmacotherapy is partly responsible for the therapeutic strategy.
Generalized alarming discord
Zazvichay is prescribed 10 mg 1 time per dose. Depending on individual sensitivity, the dose can be increased to a maximum of 20 mg/dose.
It is recommended to continue the treatment for 3 months to enhance the effect. It has been proven that treatment for 6 months precedes relapse and can be prescribed individually; Next, regularly evaluate the benefits of bathing.
Obsessive-compulsive disorder
The initial dose should be 10 mg 1 time per dose. Depending on the individual response of the patient, the dose can subsequently be increased to a maximum of 20 mg/dose.
In cases of obsessive-compulsive disorder and chronic illnesses, patients should be treated for a sufficient period to relieve symptoms. It is necessary to regularly check the therapeutic value of treatment and dosing.
Summer age patients (over 65 years)
The initial dose should be 5 mg 1 time per dose. Depending on the individual response of the patient, the dose can subsequently be increased to 10 mg/dose.
The effectiveness of escitalopram for social anxiety disorder has not been assessed in summer patients.
Patients with impaired nirofunctions
Patients with severe or mild impairment of nitric function do not require dose adjustment. For patients with severely impaired nitric function (CLcr less than 30 ml/xv), the drug should be prescribed with caution.
Patients with impaired liver function
For patients with mild or mild hepatic insufficiency, the initial dose in the first two days is recommended to be 5 mg/dose. Depending on the individual response of the patient, the dose can subsequently be increased to 10 mg/dose. In case of severe liver failure, care must be taken in the prescribed and carefully titrated dose.
Weak activity of CYP2C19
For patients with known weak activity of the CYP2C19 enzyme, the recommended dose for the first two days is 5 mg/dose.
Depending on the individual response of the patient, the dose can subsequently be increased to 10 mg/dose.
Symptoms of symptoms to watch out for when you are under treatment
A trace of the uniqueness of the rapt drug. When a treatment is administered, the dose of escitalopram should be gradually changed at intervals of at least 1-2 times to reduce the reaction (section “Peculiarities of treatment” and “Adverse reactions”). If unbearable symptoms occur before the dose is changed or after treatment, the previously prescribed dose can be renewed. In the future, the doctor can continue to change the dose, or more incrementally.
Children.
The drug Elitsea should not be used for the treatment of children (up to 18 years of age).
