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, 10 mg, film-coated tablets, 28 pcs.
inside. The drug is prescribed to adults once a day, regardless of food intake. Depressive disorders: usually prescribed 10 mg once daily. Depending on the patient’s individual response, the dose can be increased to a maximum of 20 mg/day. The antidepressant effect usually develops 2-4 weeks after the start of treatment. After the symptoms of depression disappear, therapy must be continued for at least another 6 months to consolidate the effect. Panic disorder with/without agoraphobia: during the first week of treatment, a dose of 5 mg/day is recommended, which is then increased to 10 mg/day. Depending on the patient’s individual response, the dose can be increased to a maximum of 20 mg/day. The maximum therapeutic effect is achieved approximately 3 months after the start of treatment. Therapy lasts several months. Social anxiety disorder (social phobia): usually prescribed 10 mg once daily. Depending on the patient’s individual response, the dose can be increased to a maximum of 20 mg/day. Relief of symptoms usually develops 2-4 weeks after the start of treatment. Since social anxiety disorder is a chronic disease, the minimum recommended duration of the therapeutic course is 3 months. To prevent relapse of the disease, the drug may be prescribed for 6 months or longer, depending on the individual patient's response. It is recommended to regularly evaluate the treatment being carried out. Generalized anxiety disorder: usually prescribed 10 mg once daily. Depending on the patient’s individual response, the dose can be increased to a maximum of 20 mg/day. The minimum recommended duration of the therapeutic course is 3 months. To prevent relapses of the disease, long-term use of the drug (6 months or longer) is allowed. It is recommended to regularly evaluate the treatment being carried out. Obsessive-compulsive disorder: usually prescribed 10 mg once daily. Depending on the patient’s individual response, the dose can be increased to a maximum of 20 mg/day. Because obsessive-compulsive disorder is a chronic disorder, treatment should be long enough to provide complete relief of symptoms, lasting at least 6 months. To prevent relapses, treatment for at least 1 year is recommended. Elderly patients (over 65 years of age): It is recommended to use half the usually recommended dose (i.e., only 5 mg/day) and a lower maximum dose (10 mg/day). Reduced renal function: For mild to moderate renal failure, no dosage adjustment is required. Patients with severe renal failure (creatinine clearance below 30 ml/min) should be prescribed the drug with minimal therapeutic doses, gradually increasing them taking into account the tolerability and effectiveness of the drug. Reduced liver function: the recommended initial dose during the first two weeks of treatment is 5 mg/day. Depending on the patient's individual response, the dose may be increased to 10 mg/day. Reduced activity of the CYP2C19 isoenzyme: for patients with weak activity of the CYP2C19 isoenzyme, the recommended initial dose during the first two weeks of treatment is 5 mg/day. Depending on the patient's individual response, the dose may be increased to 10 mg/day. Discontinuation of treatment: When discontinuing treatment with the drug, the dose should be gradually reduced over 1-2 weeks in order to avoid withdrawal symptoms. If the dose reduction is intolerable, it is possible to resume taking the drug at the previous dose or reduce the dose at a larger interval.
Contraindications
Before the appointment, the specialist examines the characteristics of the patient’s physical condition, clarifies information about the presence of other diseases in order to exclude contraindications.
The antidepressant is not recommended for use in the following cases:
- with hypersensitivity to the active component (escitalopram);
- during pregnancy and breastfeeding;
- in combination with MAO inhibitors, serotonergic drugs.
The use of Selectra in pediatrics is not practiced. The age limit for contraindications is up to 18 years.
Selectra tablet film 10 mg pack contact cell/pack card x28
Trade name: Selectra
International name: Escitalopram&, (Escitalopram)
Pharmacological group: antidepressant
Pharmacological group for ATC: N06AB10. Escitalopram
Pharmacodynamics:
An antidepressant that selectively inhibits the reuptake of serotonin, increases the concentration of the neurotransmitter in the synaptic cleft, enhances and prolongs the effect of serotonin on postsynaptic receptors. Escitalopram practically does not bind to serotonin (5-HT), dopamine (D1 and D2), alpha-adrenergic, histamine, m-cholinergic receptors, as well as benzodiazepine and opiate receptors. The antidepressant effect usually develops 2-4 weeks after the start of treatment. The maximum therapeutic effect of treatment for panic disorders is achieved approximately 3 months after the start of treatment.
Pharmacokinetics:
Absorption is independent of food intake. Bioavailability - 80%. TCmax - 4 hours. The kinetics of escitalopram is linear. Css is achieved after 1 week. An average Css of 50 nmol/l (range 20 to 125 nmol/l) is achieved with a daily dose of 10 mg. The apparent volume of distribution is from 12 to 26 l/kg. Protein binding - 80%. Metabolized in the liver to active demethylated and didemethylated metabolites. After repeated use, the average concentration of demethyl and didemethyl metabolites is 28-31% and less than 5%, respectively, of the concentration of escitalopram. Metabolism of escitalopram into a demethylated metabolite occurs mainly through the isoenzymes of cytochrome P450: CYP2C19, CYP3A4 and CYP2D6. In individuals with weak activity of the CYP2C19 isoenzyme, the concentration of escitalopram may be 2 times higher than in individuals with high activity of this isoenzyme. There are no significant changes in the concentration of the drug with weak activity of the CYP2D6 isoenzyme. T1/2 after repeated use is 30 hours. For the main metabolites of escitalopram, T1/2 is longer. Clearance - 0.6 l/min. Escitalopram and its main metabolites are excreted by the liver and most of them by the kidneys, partially excreted in the form of glucuronides. T1/2 and AUC increase in elderly patients.
Indications for use:
Depression, panic disorders (including agoraphobia).
Contraindications:
Hypersensitivity, simultaneous use of MAO inhibitors, age under 15 years, pregnancy, lactation.
Carefully:
Renal failure (creatinine clearance below 30 ml/min), hypomania, mania, pharmacologically uncontrolled epilepsy, depression with suicidal attempts, diabetes mellitus, old age, liver cirrhosis, bleeding tendency, concomitant use with drugs that reduce the threshold of convulsive readiness, causing hyponatremia, ethanol, drugs metabolized with the participation of the CYP2C19 system.
Dosage regimen:
Inside, regardless of food intake. Depressive episodes: 10-20 mg 1 time per day. After the symptoms of depression disappear, it is necessary to continue therapy to consolidate the effect obtained for 6 months. Panic disorders (including agoraphobia): 5 mg/day during the first week, then 10-20 mg/day. The maximum daily dose is 20 mg. The duration of treatment is several months. When stopping treatment, the dose should be gradually reduced over 1-2 weeks in order to avoid the occurrence of withdrawal syndrome (dizziness, headaches and nausea).
Overdose:
Symptoms: dizziness, tremor, agitation, drowsiness, confusion, convulsions, tachycardia, ECG changes (changes in the ST segment, T wave, widening of the QRS complex, prolongation of the QT interval), arrhythmias, respiratory depression, vomiting, rhabdomyolysis, metabolic acidosis, hypokalemia. Treatment: symptomatic and supportive, including gastric lavage, adequate oxygenation, monitoring the function of the cardiovascular and respiratory systems. There is no specific antidote.
Interaction:
When taken concomitantly with MAO inhibitors, the risk of developing serotonin syndrome and serious adverse reactions increases. Combined use with serotonergic drugs (including tramadol, sumatriptan and other triptans) can lead to the development of serotonin syndrome. Concomitant use with drugs that lower the seizure threshold increases the risk of developing seizures. Enhances the effect of tryptophan and Li+ preparations. Increases the toxicity of St. John's wort preparations. Enhances the effect of drugs that affect blood coagulation (monitoring of blood coagulation parameters is necessary). Drugs that are metabolized with the participation of the CYP2C19 system (including omeprazole), and also are strong inhibitors of CYP3A4 and CYP2D6 (including flecainide, propafenone, metoprolol, desipramine, clomipramine, nortriptyline, risperidone, thioridazine, haloperidol), increase concentration of escitalopram. Increases plasma concentrations of desipramine and metoprolol by 2 times.
Special instructions:
Escitalopram should be prescribed only 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 of treatment. To reduce the likelihood of anxiety, low initial doses are recommended. The drug 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 may increase the concentration of glucose in the blood in diabetes mellitus, which may require dose adjustment of hypoglycemic drugs. Clinical experience with the use of 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 when taking escitalopram and usually disappears when the drug is discontinued. If serotonin syndrome develops, the drug should be immediately discontinued and symptomatic treatment prescribed. 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.
Description connected via INN
Instruction update date 10/27/2015
Manufacturer: Actavis Ltd, Malta
Marketing authorization holder: Actavis Group hf., Iceland
Release forms: film-coated tablets 10 mg, blisters, film-coated tablets 5 mg, blisters, film-coated tablets 15 mg, contour blister packaging
Dispensing conditions: by prescription
State data registration: LSR-008205/09 dated 10/16/2009
Date of re-registration of RU: 01.12.2016
Registration certificate status: valid
Pharmaceutical article number: LSR-008205/09-161009
