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
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.
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
