Escitalopram Sandoz - instructions for use, dose, side effects, contraindications

Excipients: lactose monohydrate - 68.49 mg / 91.23 mg / 136.85 mg / 182.46 mg; cellulose microcrystalline - 6.93 mg / 9.63 mg / 14.44 mg / 19.25 mg; croscarmellose sodium - 4.50 mg / 6.25 mg / 9.38 mg / 12.50 mg; hypromellose - 1.44 mg / 2.00 mg / 3.00 mg / 4.00 mg; magnesium stearate - 1.35 mg / 1.88 mg / 2.81 mg / 3.75 mg; silicon dioxide colloidal - 0.90 mg / 1.25 mg / 1.88 mg / 2.50 mg;

sheath: hypromellose - 2.07 mg / 3.45 mg / 4.49 mg / 4.83 mg; macrogol 6000 - 0.51 mg / 0.85 mg / 1.11 mg / 1.19 mg; titanium dioxide (E 171) 0.27 mg / 0.45 mg / 0.59 mg / 0.63 mg; talc - 0.15 mg / 0.25 mg / 0.33 mg / 0.35 mg.

¹ - removed during production

Description:

Tablets 5 mg: round biconvex tablets, film-coated, white or almost white.

Tablets 10 mg: oval biconvex tablets covered with a film shell, white or almost white, with a risk on one side. On the cross section, the core of the tablet is white or almost white in color.

Tablets 15 mg: oval biconvex tablets coated with a film coat, white or almost white, with two risks on each side. On the cross section, the core of the tablet is white or almost white in color.

Tablets of 20 mg: round biconvex tablets coated with a film shell, white or almost white, with a cross-shaped risk on each side. On the cross section, the core of the tablet is white or almost white in color.

Pharmacotherapeutic group:antidepressant

ATX: & nbsp

N.06.A.B.10 Escitalopram

Pharmacodynamics:

Escitalopram is a selective serotonin reuptake inhibitor (5-HT) with a high affinity for the primary active site.It is also associated with the allosteric center on the serotonin transporter with an affinity of 1000 times lower.

Escitalopram does not have or has a low affinity for a number of receptors, including 5-HT_1A, 5-HT₂, DA D₁ and D₂, α₁, α₂-, β-adrenergic receptors, histamine H₁, cholinergic muscarin, benzodiazepine and opioid receptors. Inhibition of 5-HT reuptake is the only possible mechanism of action that explains the pharmacological and clinical effects of escitalopram.

Clinical efficacy

Depressive episodes of severe

The efficacy of escitalopram in the treatment of severe depressive episodes in three of four double-blind, placebo-controlled short-term (8-week) studies was found. During a long-term study to prevent disruption of 274 patients who had undergone an initial 8-week phase of open-label study and were taking escitalopram in a dosage of 10 or 20 mg per day, were randomized and subsequently taken escitalopram in the same dosage or placebo for a maximum of 36 weeks. Throughout this study, patients who continued to take escitalopram, did not experience disruption for a longer period of time in the next 36 weeks compared with those who took placebo.

Social phobia

Escitalopram has been shown to be effective both during three short-term (12-week) studies, and during 6-month studies to prevent disruption in patients with social phobia. During the 24-week dose selection study, the efficacy of escitalopram in a dose of 5, 10 and 20 mg was demonstrated.

Generalized anxiety disorder

Escitalopram in a dose of 10 and 20 mg per day showed its effectiveness in four of the four placebo-controlled studies.

A summary analysis of the data of three similar studies, including 421 patients, receiving escitalopram, and 419 patients taking placebo included 47.5% and 28.9% of patients whose treatment achieved the goal, respectively, and 37.1% and 20.8% of patients whose illness had entered the stage of remission. Steady effect was observed from 1 week.

The maintenance of the efficacy of escitalopram at a dosage of 20 mg per day was demonstrated in a 24-76-week, randomized study aimed at maintaining the effectiveness of treatment with 373 patients,who experienced improvement during the initial 12-week open-label study.

Obsessive-compulsive disorder

In a randomized, double-blind clinical trial, the effect of escitalopram at a dose of 20 mg per day was compared with placebo on the basis of counts on the obsessive-compulsive Yale-Braun scale after 12 weeks. In 24 weeks escitalopram at a dosage of 10 and 20 mg per day showed better results compared with placebo.

Relapse prevention was demonstrated when escitalopram was administered at a dose of 10 and 20 mg per day in patients treated with escitalopram who showed successful results during a 16-week open-label study that participated in a 24-week, randomized, double-blind, placebo-controlled study.

During the double-blind, placebo-controlled ECG study conducted in healthy patients, the difference QT from the isoline (correction by formula Fridericia) was 4.3 msec. (90% CI: 2.2, 6.4) at a dosage of 10 mg per day and 10.7 msec. (90% CI: 8.6, 12.8) at a dosage of 30 mg per day.

Pharmacokinetics:

Suction

The drug is absorbed almost completely and does not depend on food intake (the average time to reach the maximum concentration (mean T_mOh) is 4 hours after administration in various dosages). As in the case of racemic citalopram, the absolute bioavailability of escitalopram is assumed to be about 80%.

Distribution

Assumed level of distribution (V_d_,_β/F) after oral administration is from 12 to 26 l / kg. Binding to plasma proteins does not exceed 80% for escitalopram and its major metabolites.

Metabolism

Escitalopram is metabolized in the liver to demethylated and demodetylated metabolites. Both substances are pharmacologically active. Alternatively, nitrogen oxidizes and forms a metabolite Noxide. Both the parent substance and metabolites are partially excreted as glucuronides. After taking different dosages, the average concentration of demethylated and demodetylated metabolites is generally 28-31% and <5%, respectively, of the concentration of escitalopram.

Biotransformation of escitalopram in the demethylated metabolite is carried out mainly with the help of CYP2C19. Enzymes CYP3A4 and CYP2D6 can also have some impact.

Excretion

Half-life (T_1/2) after taking different dosages is approximately 30 hours, plasma clearance (Cl_oral) for oral administration is about 0.6 l / min. T_1/2the main metabolites last much longer. Escitalopram and the main metabolites are derived mainly through the liver (by metabolism) and the kidney, with the bulk of the dose being excreted as metabolites by the kidneys.

Pharmacokinetics is linear. A stable level of the drug in the blood plasma is achieved after about 1 week. An average equilibrium concentration of 50 nmol / L (in the range of 20 to 125 nmol / L) is achieved with a daily dosage of 10 mg.

Patients of advanced age (> 65 years)

In elderly patients escitalopram is slower than in young patients. Systemic impact (AUC) in elderly patients is about 50% higher than in young patients.

Patients with impaired hepatic function

In patients with mild or moderate impairment of liver function (mild disorder or chronic alcoholic liver damage) T_1/2, escitalopram is approximately twice as long and the effect was approximately 60% higher than in subjects with normal liver function.

Patients with impaired renal function

In the case of racemic citalopram, in patients with impaired renal function (creatinine clearance (CK) 10-53 ml / min), a longer T_1/2 and a slight increase in exposure.The concentrations of metabolites in the blood plasma have not been studied, but they can be increased.

Polymorphism

It was found that slow metabolizers CYP2C19 demonstrate a twice higher concentration of escitalopram in plasma compared to fast metabolizers. Slow metabolizers CYP2D6 there were no significant differences in the effect.

Indications:

- Depressive disorders;

- panic disorder with or without agoraphobia;

- social anxiety disorder (social phobia);

- generalized anxiety disorder;

Contraindications:

- Hypersensitivity to escitalopram or other components of the drug;

- simultaneous administration with monoamine oxidase (MAO) inhibitors, monoamine oxidase-A (MAO-A) (for example, moclobemide) or reversible nonselective MAO inhibitors;

- patients with lengthening interval QT (congenital syndrome of an elongated interval QT);

- simultaneous reception of drugs that can lengthen the interval QT (for example, antiarrhythmic drugs IA and III classes, tricyclic antidepressants, macrolides);

- pregnancy;

- the period of breastfeeding;

- children's age till 18 years;

- deficiency of lactase, lactose intolerance, glucose-galactose malabsorption.

Carefully:

Renal failure (QC less than 30 ml / min), manic disorders (including in history), pharmacologically uncontrolled epilepsy, depression with suicidal attempts, diabetes mellitus, electroconvulsive therapy; elderly age (over 65 years), cirrhosis, tendency to bleeding, simultaneous reception with medications that reduce the threshold of convulsive readiness, lithium, tryptophans, drugs containing St. John's Wort; with drugs that cause hyponatremia, anticoagulants for oral administration and drugs that affect blood clotting; with preparations metabolized with the participation of the system СUR2С19, ethanol.

Pregnancy and lactation:

Application in pregnancy

The use of the drug in pregnancy is contraindicated due to the lack of clinical data on efficacy and safety.

There are limited data on the use of escitalopram during pregnancy. During studies of reproductive toxicity of escitalopram in rats, embryophototoxicity was observed, but an increase in the number of congenital malformations was not established.If the use of escitalopram lasted late in pregnancy, especially in the third trimester, then a newborn should be monitored. In the event that escitalopram treatment was continued until delivery or was discontinued shortly before delivery, the development of withdrawal symptoms may develop in a newborn. In the case of a mother using selective serotonin reuptake inhibitors or selective serotonin and noradrenaline reuptake inhibitors (SSRIs / SSRIs) in late pregnancy, the following side effects may develop in the newborn: persistent pulmonary hypertension, respiratory depression, cyanosis, apnea, convulsive disorders, temperature jumps , difficulty with feeding, vomiting, hypoglycemia, hypertension, muscle hypotension, hyperreflexia, tremor, increased neuro-reflex excitability, irritability, le dreaming, constant crying, drowsiness, bad sleep. These symptoms can occur due to the development of the syndrome of "withdrawal" or serotonergic action. In most cases, such complications occur within 24 hours after birth.

The use of SSRIs / SSRIs in late pregnancy also increases the risk of developing persistent pulmonary hypertension in newborns with a frequency of up to 5 cases per 1000 bets in the general population of 1-2 per 1000.

Application in the period of breastfeeding

The drug in small amounts is excreted in breast milk, so when taking the drug during lactation it is recommended to resolve the issue of stopping breastfeeding.

Fertility

Animal studies have shown that citalopram can affect the quality of sperm. Cases from medical practice, including the use of SSRIs, have shown that the impact on sperm quality is reversible. So far no impact on human fertility has been detected.

Dosing and Administration:

Inside, 1 time per day, regardless of food intake.

The maximum daily dose is 20 mg.

Depressive disorders

The usual dose is 10 mg / day. Depending on the clinical condition of the patient, the dose of the drug can be increased to a maximum of 20 mg / day.

The antidepressant effect usually develops in 2-4 weeks after the start of treatment.After the disappearance of the symptoms of depression for at least another 6 months, it is necessary to continue therapy to fix the effect.

Panic disorder with or without agoraphobia

The recommended initial dose during the first week of therapy is 5 mg, followed by an increase to 10 mg / day. Depending on the clinical condition of the patient, the dose of the drug can be increased to a maximum of 20 mg / day. The maximum clinical effect is achieved 3 months after the start of therapy. Treatment lasts for several months.

Social anxiety disorder (social phobia)

Usually prescribe 10 mg once a day. Symptom weakening usually develops 2-4 weeks after the start of treatment. Depending on the clinical condition of the patient, the dose of the drug can subsequently be reduced to 5 mg / day or increased to a maximum of 20 mg / day.

Because social anxiety disorder is a disease with chronic course, the minimum recommended duration of a therapeutic course is 12 weeks. To prevent recurrence of the disease, the drug can be given within 6 months or longer depending on the clinical condition of the patient.It is recommended that the evaluation of ongoing treatment be performed on a regular basis.

Generalized anxiety disorder

The recommended initial dose is 10 mg / day. Depending on the clinical condition of the patient, the dose of the drug can be increased to a maximum of 20 mg / day. Long-term administration of the drug (6 months and longer) at a dose of 20 mg / day is allowed.

Elderly patients (over 65 years of age)

The initial dose is half of the recommended dose (5 mg). Depending on the clinical condition of the patient, the dose of the drug can be increased to 10 mg / day.

Patients with renal insufficiency

Dose adjustments for mild to moderate renal failure are not required. When creatinine clearance is less than 30 ml / min, the drug should be used with caution under the supervision of a doctor.

Patients with hepatic insufficiency

For patients with mild or moderate hepatic impairment (Child-Pugh A or B scale), the initial dose for the first two weeks is 5 mg / day. Depending on the clinical condition of the patient, the dose of the drug can be increased to 10 mg / day. In severe hepatic insufficiency (class C on the Child-Pugh scale), the drug is administered under close medical supervision.

Isoenzyme deficiency CYP2C19

For patients with an enzyme deficiency CYP2C19 The initial dose in the first 2 weeks is 5 mg / day. Depending on the clinical condition of the patient, the dose of the drug can be increased to 10 mg / day.

Abolition of the drug

Avoid abrupt discontinuation of the drug. When discontinuing treatment with escitalopram, the dose of the drug should gradually decrease at an interval of 1-2 weeks in order to reduce the risk of developing the "withdrawal" syndrome.

With intolerance of dose reduction, it is possible to resume taking the drug at the previous dose or to reduce the dose at a large interval.

Side effects:

According to the World Health Organization (WHO), adverse reactions are classified according to their frequency of development as follows: very often (> 1/10), often (> 1/100, <1/10), infrequently (> 1/1000, < 1/100), rarely (> 1/10000, <1/1000) and very rarely (<1/10000); frequency is unknown - according to available data, it was not possible to establish the frequency of occurrence.

Class of organ systems	Frequency	Adverse events
On the part of the hematopoiesis and lymphatic system	Frequency unknown	Thrombocytopenia
From the immune system	Rarely	Anaphylactic reactions
From the endocrine system	Frequency unknown	Insufficient secretion of antidiuretic hormone (ADH)
Metabolic disorders and eating disorders	Often	Decreased appetite, increased appetite, weight gain
	Infrequently	Weight loss
	Frequency unknown	Hyponatremia, anorexia²
From the side of the psyche	Often	Anxiety, anxiety, unusual dreams, decreased libido, anorgasmia (in women)
	Infrequently	Bruxism, agitation, nervousness, panic attacks, confusion
	Rarely	Aggression, depersonalization, hallucinations
	Frequency unknown	Mania, suicidal thoughts, suicidal behavior. Cases of the appearance of suicidal thoughts and behavior were noted when taking escitalopram and immediately after withdrawal of therapy¹
From the nervous system	Often	Insomnia, drowsiness, dizziness, paresthesia, tremor
	Infrequently	Convulsions
	Rarely	Disturbance of taste sensations, syncope, serotonin syndrome
	Frequency unknown	Dyskinesia, convulsions, convulsive disorders, psychomotor arousal / akathisia²
From the sense organs	Infrequently	Mydriasis (dilated pupil), impaired vision, tinnitus
From the cardiovascular system	Infrequently	Tachycardia
	Rarely	Bradycardia
	Frequency unknown	Ventricular arrhythmia, including ventricular pirouette tachycardia, QT interval elongation, orthostatic hypotension
From the respiratory system	Often	Sinusitis, yawning cramp
From the respiratory system	Infrequently	Nose bleed
From the gastrointestinal tract	Often	Nausea
	Often	Diarrhea, constipation, vomiting, dry mouth
	Infrequently	Gastrointestinal bleeding, including rectal bleeding
From the liver and biliary tract	Frequency unknown	Hepatitis, a violation of liver function
From the skin and subcutaneous tissues	Often	Increased sweating
	Infrequently	Itching, redness, hives, rash, including bullous, alopecia
	Frequency unknown	Angioedema, subcutaneous hemorrhage
From the side of the motor and connective tissue	Often	Arthralgia, myalgia
Disorders from the kidneys and urinary tract	Frequency unknown	Retention of urine
From the side reproductive system and breast	Often	Impotence, impairment ejaculation
	Infrequently	Metrorrhagia (uterine bleeding), menorrhagia
	Frequency unknown	Galactorrhea, priapism
Other	Often	Feeling tired, pyrexia
Other	Infrequently	Edema

¹There are reports of cases of suicidal moods and suicidal behavior at the time of taking escitalopram or immediately after discontinuation of treatment.

²Reports of these events were reported in relation to the SSRI treatment class.

Class Effect

Epidemiological studies involving patients aged 50 years or more reported an increased risk of bone fractures in patients receiving SSRIs and tricyclic antidepressants. The mechanism that leads to this risk is unknown.

Symptoms of cancellation after treatment

Discontinuation of SSRI / SSRIs (especially acute), as a rule, leads to the appearance of withdrawal symptoms. The most common reactions are dizziness, sensory disturbances (including paresthesia and sensations of electric shock), sleep disturbances (including insomnia and bright dreams), agitation or anxiety, nausea and / or vomiting, tremors, confusion, sweating, headache, diarrhea , palpitations, emotional instability, irritability and visual disturbances.As a rule, these phenomena are of mild or moderate severity and pass independently, but in some patients they can take a severe form and be prolonged. Thus, when the need for treatment with escitalopram is eliminated, it is recommended to cancel the drug by gradually reducing the dose.

Cases of lengthening the interval QT

Lengthening of the interval has been reported QT and ventricular arrhythmias, including ventricular pirouette tachycardia, predominantly in female patients, with hypokalemia or pre-existing lengthening of the interval QT or other cardiovascular diseases.

Overdose:

Toxicity. Clinical data on escitalopram overdose are limited, and many cases include simultaneous overdose of other drugs. In most cases, the symptoms are mild or absent. About deaths as a result of an overdose, only escitalopram is rarely reported; In general, there is also an overdose of concurrently taken drugs. Doses of 400 and 800 mg of escitalopram without taking other medications are transferred without any serious symptoms.

Symptoms: with an overdose of the drug develops dizziness, tremor, agitation, nausea, vomiting, arterial hypotension, tachycardia, lengthening interval QT, hypokalemia, hyponatremia, in rare cases - serotonin syndrome, cardiac arrhythmias, convulsions and coma.

Treatment: the specific antidote is unknown. Treatment symptomatic: ensuring a constant influx of fresh air, support the function of external respiration, adequate oxygenation, control of cardiac activity, gastric lavage, the appointment of enterosorbents. Forced diuresis, hemodialysis, hemoperfusion are not effective.

Interaction:

Pharmacodynamic interactions

Contraindicated combinations:

Irreversible non-selective MAO inhibitors

Serious adverse reactions have been reported in patients receiving combination therapy with SSRIs and irreversible nonselective MAO inhibitors, as well as patients who recently discontinued SSRI therapy and started therapy with such MAO inhibitors. In some cases, patients developed serotonin syndrome. Escitalopram can be appointed 14 days after cessation of treatment irreversible nonselective MAO inhibitors. At least 7 days must pass after the end of taking escitalopram before you can begin treatment irreversible nonselective MAO inhibitors.

Reversible selective inhibitors of MAO type A (moclobemide)

Because of the risk of developing serotonin syndrome, the joint use of escitalopram with reversible selective MAO inhibitors, such as moclobemide, is contraindicated. If there is a reasonable need for such a combination, treatment should start with the minimum recommended dose under enhanced clinical supervision.

Reversible non-selective MAO inhibitors (linezolid)

Antibiotic linezolid is an reversible non-selective MAO inhibitor and should not be used in patients receiving escitalopram therapy. If there is a reasonable need for such a combination, treatment should begin with minimal doses under close clinical supervision.

Irreversible selective inhibitors of MAO type B (selegiline)

Caution is necessary in the case of joint use of escitalopram and irreversible selective inhibitor of MAO type B selegiline because of the risk of developing a serotonin syndrome. Selegiline in doses up to 10 mg per day was successfully applied together with racemic citalopram.

Interval lengthening QT

Pharmacokinetic and pharmacodynamic studies of escitalopram in combination with other drugs that extend the interval QT, were not conducted. The additive effect of escitalopram and these medications can not be ruled out. Thus, simultaneous administration of escitalopram with drugs that extend the QT interval, such as class IA and III antiarrhythmics, neuroleptics (eg, phenothiazine derivatives, pimozide, haloperidol), tricyclic antidepressants, some antimicrobial agents (for example, sparfloxacin, moxifloxacin, erythromycin IV, pentamidine, antimalarial drugs, especially halofantrine), some antihistamines (astemizole, misolastine), is contraindicated.

Simultaneous reception of drugs that require caution when used:

Drugs that reduce the threshold of convulsive readiness

Escitalopram can reduce the threshold of convulsive alertness.Caution should be exercised when concomitant use of escitalopram and other drugs that reduce the threshold of convulsive readiness (tricyclic antidepressants. SSRIs, neuroleptics - derivatives of phenothiazine, thioxanthene and butyrophenone, mefloquine and tramadol).

With simultaneous application drugs lithium and tryptophan cases of increased activity of escitalopram have been documented.

Simultaneous application from preparations of St. John's wort perfumed (Hypericum perforatum) may lead to an increase in the number of side effects.

With simultaneous application anticoagulants and other drugs that affect blood clotting (eg, atypical neuroleptics and phenothiazine derivatives, tricyclic antidepressants, acetylsalicylic acid and non-steroidal anti-inflammatory drugs, ticlopidine, dipyridamole) there may be a clotting disorder.

Escitalopram does not come with ethanol in pharmacodynamic or pharmacokinetic interaction. However, as with other psychotropic drugs, simultaneous use of escitalopram and alcohol is not recommended.

Pharmacokinetic interactions

The effect of other drugs on the pharmacokinetics of escitalopram

Metabolism of escitalopram is carried out mainly with the help of an enzyme CYP2C19. CYP3A4 and CYP2D6 can also participate in metabolism, although to a lesser extent. Metabolism of the main metabolite, S-DTT (demethylated) escitalopram), is partially catalyzed CYP2D6.

Simultaneous administration of escitalopram and omeprazole 30 mg once a day (inhibitor CYP2C19) led to a moderate (approximately 50%) increase in the concentration of escitalopram in blood plasma.

Simultaneous administration of escitalopram and cimetidine 400 mg twice a day (a common inhibitor of medium strength enzymes) resulted in a moderate (approximately 70%) increase in the concentration of escitalopram in blood plasma.

Escitalopram should be combined with caution with cimetidine. A dose adjustment is recommended.

Thus, the drug should be carefully combined with inhibitors CYP2C19 (such as omeprazole, esomeprazole, fluvoxamine, lansoprazole, ticlopidine) or cimetidine. After tracking the side effects caused by the simultaneous use of other drugs, you may need to reduce the dose of escitalopram.

The effect of escitalopram on the pharmacokinetics of other drugs

Escitalopram is an enzyme inhibitor CYP2D6. Care must be taken when concomitant use of escitalopram and drugs with a narrow therapeutic range, which are mainly metabolized by this enzyme, for example flecainide, propafenone and metoprolol (for use in heart failure), or some drugs that affect the central nervous system, which are mainly metabolized CYP2D6, for example, antidepressants, such as desipramine, clomipramine and nortriptyline or antipsychotics, such as risperidone, thioridazine and haloperidol. A dose adjustment may be recommended.

Simultaneous reception of the drug with desipramine or metoprolol led to a two-fold increase in the concentration of these substrates CYP2D6 in blood plasma.

Research in vitro showed that escitalopram may also be a mild inhibitor CYP2C19. It is recommended that the drug be used with caution at the same time as drugs metabolized CYP2C19.

Special instructions:

Use with MAO inhibitors

Escitalopram should not be administered simultaneously with MAO inhibitors because of the risk of developing serotonin syndrome. Escitalopram can be appointed 14 days after discontinuation of treatment with irreversible MAO inhibitors and at least 1 day after discontinuation of treatment with reversible MAO type A inhibitorsmoclobemide).

At least 7 days must pass after the end of taking escitalopram before treatment with nonselective MAO inhibitors can begin. The use of the drug in children and adolescents under the age of 18 Antidepressants are contraindicated in children and adolescents under the age of 18 because of the increased risk of suicidal behavior (suicide attempts and suicidal ideation), hostility (with a predominance of aggressive behavior, a tendency to confrontation and irritation). In young people under 25 with depression and other mental disorders, antidepressants, compared with placebo, increase the risk of suicidal thoughts and suicidal behavior. Therefore, when prescribing the drug and for any other antidepressant drugs, young people under 25 should compare the risk of suicide and the benefits of their use.If a decision is made to initiate antidepressant therapy, the patient should be carefully monitored for early detection of abnormalities or behavioral changes, as well as suicidal tendencies.

Paradoxical anxiety

When using drugs belonging to the therapeutic group of SSRIs, including escitalopram, it should be borne in mind that in some patients with panic disorders at the beginning of SSRI treatment there may be an increase in anxiety. A similar paradoxical reaction usually disappears during the first two weeks of treatment. To reduce the likelihood of an anxiogenic effect, it is recommended to use low initial doses.

Epileptic seizures

The use of escitalopram should be discontinued if the patient has an epileptic seizure for the first time or his seizures become more frequent (in patients with epilepsy in the anamnesis).

Patients with unstable epilepsy should avoid SSRIs, and patients with controlled epilepsy should be carefully monitored.

Mania

Escitalopram is recommended with caution to prescribe to patients with mania, hypomania in the anamnesis. With the development of the manic state escitalopram should be canceled.

Diabetes

In patients with diabetes, treatment with escitalopram can change the level of glucose in the blood plasma. Therefore, it may be necessary to adjust the dosages of insulin and / or oral hypoglycemic drugs.

Suicide / suicidal thoughts or clinical worsening of depressive conditions

Careful monitoring of patients taking antidepressants is necessary, especially at the beginning of therapy because of the possibility of clinical deterioration and / or the appearance of suicidal thoughts and behavior. Clinical experience shows that an increased risk of suicide, as a rule, is observed in the early stages of recovery.

Other mental disorders, in which appoint escitalopram, may also be associated with an increased risk of suicidal actions and manifestations. In addition, these diseases can accompany severe depressive disorder. Precautions to be observed in the treatment of patients with severe depressive disorder also need to be observed in the treatment of patients with other psychiatric disorders.

It is known that patients with suicidal actions and manifestations in the anamnesis, or those,who have shown a suicidal orientation of thinking before treatment, are at greater risk of suicidal intentions or attempts, so they should be carefully observed during treatment. A meta-analysis of placebo-controlled clinical trials of antidepressants in adult patients with mental disorders showed an increased risk of suicidal behavior when taking antidepressants compared with placebo in patients less than 25 years old. Careful observation of patients, particularly those at high risk, should accompany drug therapy, especially at the beginning of treatment and after a dose change.

Patients and caregivers should be warned about the need to monitor any clinical impairment, suicidal behavior or intentions, and unusual behavioral changes, and seek medical attention immediately if they notice a manifestation of such symptoms.

Akathisia / psychomotor agitation

The use of SSRIs is associated with the development of akathisia - a condition characterized by an unpleasant debilitating sense of anxiety and hyperactivity and is often accompanied by an inability to sit or stand onone place. This condition most likely occurs during the first few weeks of therapy. Increasing the dose may harm patients who have experienced such symptoms.

Hyponatremia

Against the background of taking the drug, hyponatremia occurs, possibly associated with a violation of the secretion of antidiuretic hormone (ADH). Usually disappears when you cancel therapy.

Caution should be exercised in prescribing patients who have a history of or at risk of developing hyponatremia: elderly people, patients with cirrhosis.

Bleeding

Against the background of taking escitalopram, it is possible to develop skin hemorrhages (ecchymosis and purpura). It is necessary to use the drug with caution in patients with a risk of bleeding, as well as taking oral anticoagulants and drugs that affect blood clotting.

Electroconvulsive therapy

Care should be taken when using the drug and electroconvulsive therapy (ECT) concomitantly, due to limited experience.

Serotonin syndrome

In patients receiving escitalopram and other SSRIs simultaneously with serotonergic drugs, in rare cases, a serotonin syndrome may develop.The development of this disease may be indicated by a combination of symptoms such as excitation, tremor, myoclonus, and hyperthermia. In this situation, you should immediately stop taking SSRIs and serotonergic drugs and begin symptomatic treatment.

Symptom of withdrawal after discontinuation of treatment

Symptoms of cancellation when discontinuing treatment are common, especially if the treatment is stopped dramatically. In clinical trials, adverse events in the withdrawal of treatment were observed in approximately 25% of patients who received escitalopram, and in 15% of patients taking placebo.

The risk of cancellation of treatment may depend on several factors, including the duration, dose of treatment, and the rate of dose reduction. The most common reactions are dizziness, sensory disturbances (including paresthesia and electric shock), sleep disturbances (including insomnia and bright dreams), agitation or anxiety, nausea and / or vomiting, tremor, confusion, sweating, headache, diarrhea, palpitations, emotional imbalance, irritability and visual disturbances.Typically, these symptoms are mild or moderate severity, but in some patients they can take a severe form.

They usually occur within the first few days after the withdrawal of treatment, with much less reported similar symptoms in patients who accidentally missed the dose.

As a rule, these symptoms are self-healing and usually last for 2 weeks, although in some people they can be observed for a longer time (2-3 months or more). Therefore, it is recommended to gradually reduce the dose of escitalopram after cancellation of treatment for several weeks or months, depending on the needs of the patient.

Cardiac ischemia

Due to limited experience of use, care should be taken when using the drug in patients with coronary heart disease (CHD).

Cases of lengthening the interval QT

It was found that escitalopram causes a dose-dependent lengthening QT-Interval. Cases of lengthening the interval QT and ventricular arrhythmias, including bidirectional tachycardia, were recorded during the post-registration period, predominantly in female patients, with hypokalemia,or with the already existing lengthening of the QT interval or other cardiovascular diseases. Care should be taken when recommending the drug to patients with severe bradycardia, patients after a recent acute myocardial infarction, or with uncompensated heart failure.

Electrolyte disorders, such as hypokalemia and hypomagnesemia, increase the risk of a dangerous arrhythmia, and these diseases should be corrected before the appointment of escitalopram.

If the drug is prescribed to patients with persistent heart disease, an ECG should be performed prior to treatment.

If, during treatment with escitalopram, signs of cardiac arrhythmia appear, treatment should be discontinued and an ECG should be done.

Escitalopram does not come with alcohol in pharmacodynamic or pharmacokinetic interaction. However, as with other psychotropic drugs, concomitant use of escitalopram and alcohol is not recommended.

This medication contains lactose. Patients with rare hereditary problems of intolerance to galactose, congenital insufficiency of lactase or impaired absorption of glucose-galactose accept escitalopram do not do it.

Effect on the ability to drive transp. cf. and fur:

During the use of escitalopram, one should refrain from engaging in potentially dangerous activities that require an increased concentration of attention and speed of psychomotor reactions.

Form release / dosage:

Tablets, film-coated, 5 mg, 10 mg, 15 mg, 20 mg.

Packaging:

For 10 tablets in Al / Al blister.

By 1, 2, 3, 6 or 9 blisters in a pack of cardboard along with instructions for use.

Storage conditions:

At a temperature of no higher than 25 ° C.

Keep out of the reach of children.

Shelf life:

2 years.

Do not use after the expiry date printed on the package.

Terms of leave from pharmacies:On prescription

Registration number:LP-002797

Date of registration:29.12.2014

Date of cancellation:2019-12-29

The owner of the registration certificate:Sandoz d.Sandoz d. Slovenia

Manufacturer: & nbsp

LEK, S.A. Poland

SANDOZ PRIVATE, Limited India

Representation: & nbspSANDOZ SANDOZ Switzerland

Information update date: & nbsp03.10.2015

Illustrated instructions

Instructions

Escitalopram Sandoz (Escitalopram Sandoz)