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

Excipients: microcrystalline cellulose 48.01 mg, pregelatinized starch 24.00 mg, silicon dioxide colloid (aerosil) 0.80 mg, magnesium stearate 0.80 mg;

tablet shell: opadray white 3.20 mg (lactose monohydrate 1.15 mg, hypromellose 0.90 mg, titanium dioxide 0.83 mg, macrogol 0.32 mg).

1 tablet, film-coated, 10 mg contains:

active substance: escitalopram oxalate 12.78 mg, (in terms of escitalopram 10.00 mg);

Excipients: cellulose microcrystalline 96.02 mg, pregelatinized starch 48.00 mg, silicon dioxide colloid (aerosil) 1.60 mg, magnesium stearate 1.60 mg;

tablet shell: opadray white 6.40 mg (lactose monohydrate 2,30 mg, hypromellose 1.80 mg, titanium dioxide 1.66 mg, macrogol 0.64 mg).

1 tablet, film-coated, 20 mg contains:

active substance: escitalopram oxalate 25.56 mg (in terms of escitalopram 20.00 mg);

Excipients: cellulose microcrystalline 192.04 mg, pregelatinized starch 96.00 mg, silicon dioxide colloid (aerosil) 3.20 mg, magnesium stearate 3.20 mg;

tablet shell: opadrai white 12.80 mg (lactose monohydrate 4.60 mg, hypromellose 3.60 mg titanium dioxide 3.32 mg, macrogol 1.28 mg).

Description:

Round biconvex tablets, covered with a film coating of white color. On the cross-section - an inner layer of white or almost white color.

Pharmacotherapeutic group:antidepressant

ATX: & nbsp

N.06.A.B.10 Escitalopram

Pharmacodynamics:

Escitalopram is an antidepressant, a selective serotonin reuptake inhibitor (SSRI) with high affinity to primary active center. Escitalopram also binds to the allosteric center of the protein-transporter of serotonin with an affinity lower 1000 times. Allosteric modulation of the transporter protein enhances the binding of escitalopram to the primary binding site, which results in a more complete inhibition of serotonin capture.

Escitalopram has no or very little ability to bind to a number of receptors, including: serotonin 5-HT₁_A, 5-HT₂-receptors, dopamine D₁ and D₂-receptors, α₁, α₂, β-adrenergic receptors, histamine H₁, muscarinic, cholinergic, benzodiazepine and opiate receptors.

Inhibition of 5-HT reuptake is the only possible mechanism of action that explains the pharmacological and clinical effects of escitalopram. Escitalopram is an Senantiomer of racemic citalopram with its own therapeutic activity. It is proved that Rthe enantiomer is not inert but counteracts the serotonergic properties and the corresponding pharmacological affects S-enantiomera.

Pharmacokinetics:

Suction

Absolute o inaccessibility of escitalopram is 80% and does not depend on food intake.Maximum concentration (FROM_m_Oh) in plasma is achieved on average 4 hours after repeated use.

Distribution

The apparent volume of distribution after oral administration is from 12 to 26 l / kg. The binding of escitalopram to human blood plasma proteins is no more than 80% (an average of about 56%). Penetrates into breast milk.

Metabolism

Escitalopram is metabolized by demethylation, deamination and oxidation involving cytochrome P450. Biotransformation of escitalopram to the demethylated metabolite occurs mainly through the use of an isoenzyme CYP2C19. Some participation of isoenzymes is possible CYP3A4 and CYP2D6. Inhibition of one of these enzymes can be compensated by other enzymes.

In human blood plasma prevails escitalopram in unmodified form. In the equilibrium state, the concentration S-DTT (es-demethyl citalopram) in plasma is approximately 33% of the concentration of escitalopram. Level S-DDTST (es-didemetilcitalopram) was not determined in most subjects. Research in vitro showed that metabolites do not make a significant contribution to the antidepressant effect of escitalopram.

Excretion

The half-life (T₁_/₂) escitalopram after repeated use is 27-32 hours. The total clearance for oral administration is about 0.6 l / min. The main metabolites of escitalopram have a longer half-life. Escitalopram and its metabolites are derived both through the liver (the metabolic pathway) and through the kidneys, with most of the administered dose being excreted in the form of metabolites with urine.

Linearity of pharmacokinetics

The pharmacokinetics of escitalopram have a linear dose-dependent character. The equilibrium concentration in plasma (C_ss) is established after about 1 week of therapy. An average equilibrium concentration of 50 nmol / L (in the range of 20 to 125 nmol / L) is achieved with a daily dose of 10 mg.

Patients over the age of 65 years

In the elderly (over 65 years), a longer half-life and lower clearance rates are observed compared to younger patients. The amount of escitalopram substance in the systemic blood flow calculated using the pharmacokinetic indicator "area under the curve" (AUC) in the elderly is 50% greater than in young healthy volunteers.

Patients with impaired hepatic function

In patients with reduced liver function escitalopram is withdrawn more slowly, the clearance of escitalopram is reduced by approximately 37%. The half-life of escitalopram is almost doubled and the equilibrium concentrations of escitalopram in plasma are almost two times higher than in patients with normal liver function after taking a similar dose.

Patients with impaired renal function

In patients with mild to moderate renal dysfunction, excretion of escitalopram proceeds more slowly (clearance decreases by approximately 17%) without a significant effect on pharmacokinetics. Care should be taken in patients with severe renal insufficiency (creatinine clearance below 30 ml / min).

Patients with low isoenzyme activity CYP2C19

In individuals with mild activity CYP2C19 the concentration of escitalopram is twice as high as in cases with high activity of this isoenzyme. Significant changes in drug concentration in cases with a weak isoenzyme activity CYP2D6 was not found.

Indications:

- Depressive episodes of any severity;

- panic disorder with / without agoraphobia;

- social anxiety disorder (social phobia);

- generalized anxiety disorder;

- obsessive-compulsive disorder.

Contraindications:

- Hypersensitivity to escitalopram or any of the excipients that make up this drug;

- escitalopram should not be used in combination with monoamine oxidase (MAO) inhibitors, monoamine oxidase-A (MAO-A) or reversible nonselective MAO inhibitors;

- escitalopram is contraindicated with simultaneous use with drugs that extend the interval QT on the ECG (in particular, with pimozide, antiarrhythmic drugs IA and III classes, tricyclic antidepressants, macrolides), and also with congenital lengthening of the interval QT;

- Children under 18 years of age are a contraindication for the use of escitalopram. hack as the effectiveness and safety of its use at this age is not established;

- pregnancy, the period of breastfeeding;

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

Carefully:

Renal failure (creatinine clearance less than 30 ml / min), manic disorders (incl.in the anamnesis), pharmacologically uncontrolled epilepsy, depression with suicidal attempts, diabetes mellitus, electroconvulsive therapy; elderly age (over 65 years), cirrhosis, tendency to bleeding; simultaneous reception with drugs that reduce the threshold of convulsive readiness, tryptophan, drugs containing St. John's wort, lithium; with drugs that cause hyponatremia, oral anticoagulants and other drugs that affect blood clotting; with drugs metabolized with the participation of isoenzyme CYP2C19, with ethanol.

Pregnancy and lactation:

Application in pregnancy

Do not prescribe a drug Escitalopram pregnant and breastfeeding women, the potential clinical benefit has not prevailed over the theoretical risk, t. The safety of the drug during pregnancy and lactation in women is not established.

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 case the reception of escitalopram lasted until childbirth or was discontinued shortly before the birth, a "cancellation" syndrome may develop in the 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 failure, cyanosis, apnea, convulsive disorders, temperature jumps , difficulty with feeding, vomiting, hypoglycemia, hypertension, muscle hypotension, hyperreflexia, tremor, increased nervous reflex excitability, irritate lethargic dream, permanent crying, drowsiness or insomnia. 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.

Epidemiological evidence suggests that the use of SSRIs / SSRIs during pregnancy, especially late in life, may increase the risk of developing pulmonary hypertension in newborns with a frequency of up to 5 cases per 1000 at a frequency 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 escitalopram 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:

Escitalopram is taken orally once a day (not liquid, squeezed with a small amount of liquid), regardless of the intake of food. The drug can be used at any time of the day, it is desirable to take the drug at the same time of day. It is recommended that the evaluation of ongoing treatment be performed on a regular basis.

Depressive episodes

Usually begin with the administration of 10 mg escitalopram 1 time per day. Depending on the individual reaction of the patient, the dose may be increased to a maximum of 20 mg per day. The antidepressant effect usually develops in 2-4 weeks after the start of treatment. After the disappearance of the symptoms of depression should continue therapy for at least 6 months to fix the effect.

Panic disorder with or without agoraphobia

For panic disorders during the first week of treatment, the recommended dose is 5 mg per day, then the dose is increased to 10 mg per day. The daily dose, depending on the individual reaction of the patient, may be further increased to 20 mg per day. The maximum therapeutic effect is achieved approximately 3 months after the start of treatment. The therapy lasts for several months.

Social anxiety disorder (social phobia)

Usually prescribe 10 mg once a day. Relaxation of symptoms usually develops in 2-4 weeks after the beginning of treatment. 15 Depending on the individual reaction of the patient, the dose can subsequently be reduced to 5 mg per day or increased to a maximum of 20 mg per 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 individual reaction of the patient.

Generalized anxiety disorder

The recommended initial dose is 10 mg once a day. Depending on the individual reaction of the patient, the dose may be increased to a maximum of 20 mg per day.

Long-term administration of the drug (6 months and longer) is allowed at a dose of 20 mg per day.

Obsessive-compulsive disorder

Usually prescribe 10 mg once a day. Depending on the individual reaction of the patient, the dose can subsequently be increased to a maximum of 20 mg per day. Because obsessive-compulsive disorder is a disease with chronic course, treatment should be long enough to ensure complete relief from symptoms and last at least 6 months. To prevent recurrence, a course of treatment of at least 1 year is recommended.

Elderly patients (over 65 years of age)

It is recommended to use half the usual recommended dose ie. 5 mg per day. The maximum dose for elderly patients is 10 mg per day.

Patients with renal insufficiency

In chronic renal failure of mild to moderate severity, correction of the dosing regimen is not required. In patients with severe renal failure (creatinine clearance below 30 ml / min), the drug should be used with caution under the supervision of a physician.

Patients with hepatic insufficiency

In mild to moderate hepatic insufficiency (class A or B on the Child-Pugh scale), the recommended initial dose for the first two weeks of treatment is 5 mg per day. Depending on the individual reaction of the patient, the dose may be increased to 10 mg per day. In severe hepatic insufficiency (class C on the Child-Pugh scale), care must be taken when titrating, treatment should be performed under close medical supervision.

Reduced isoenzyme activity CYP2C19

For patients with low isoenzyme activity CYP2C19 The recommended initial dose for the first two weeks of treatment is 5 mg per day.Depending on the individual reaction of the patient, the dose may be increased to 10 mg per day.

Abolition of the drug

Avoid abrupt discontinuation of the drug. When discontinuing treatment with escitalopram, the dose of the drug should decrease gradually with an interval of 1-2 weeks in order to avoid the occurrence of 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. The doctor solves this issue individually: for some patients it may take 2-3 months or more.

Side effects:

Adverse reactions with the use of escitalopram are observed during the first one to two weeks of treatment and usually significantly weaken as therapy continues and the patients improve.

Frequency of adverse reactions (WHO classification): very often - ≥10%; often - ≥ 1%, but <10%; infrequently - ≥0,1%, but <1%; rarely - ≥ 0.01%, but <0.1%; very rarely - <0.01%, it is not known - there are currently no data on the prevalence of adverse reactions.

The following adverse reactions may occur:

On the part of the blood and lymphatic system: unknown - thrombocytopenia.

Allergic reactions: infrequently - hypersensitivity; very rarely - anaphylactic reactions.

From the central nervous system: very often - drowsiness, headache, tremor, dizziness; often - migraine, paresthesia, sleep disorder; infrequently - extrapyramidal disorders, syncopal conditions, taste disorders; rarely - serotonin syndrome (combination of excitation, tremor, myoclonus and hyperthermia); unknown - dyskinesia, motor disorders, convulsive disorders.

From the psychic sphere: very often - agitation, nervousness; often - decreased libido, violation of orgasm (in women), anxiety, confusion, drowsiness, impaired concentration, strange dreams, amnesia; infrequently - aggression, depersonalization, hallucinations, euphoria, increased libido, bruxism, panic attacks; unknown - mania, suicidal thoughts¹, psychomotor agitation, akathisia².

From the digestive system: very often - nausea, vomiting; often - diarrhea, dry mouth, decreased appetite or vice versa increase, constipation.

From the liver and biliary tract: unknown - hepatitis.

From the skin: very often - excessive sweating, often - skin rash, itching; infrequently - photosensitization, hives, alopecia, purpura; unknown - angioedema, bruising (ecchymosis).

From the cardiovascular system: very often - palpitation: often - tachycardia, arterial hypertension, orthostatic hypotension: rarely - bradycardia, lowering blood pressure, arrhythmia; unknown - interval lengthening QT on the ECG.

On the part of the organs of hematopoiesis: rarely - hemorrhage (eg, gynecological bleeding, gastrointestinal bleeding).

From the sense organs: very often - a violation of accommodation; often - a violation of taste sensations, visual impairment, infrequently - mydriasis, tinnitus (ringing in the ears).

From the respiratory system: often - rhinitis, sinusitis, yawning; infrequently - cough, nosebleed: rarely - dyspnea, tracheitis.

On the part of the reproductive system: often - the violation of sexual function, namely the violation of ejaculation, decreased libido, impotence, menstrual irregularities; infrequently - metrorrhagia, menorrhagia; unknown - galactorrhea, priapism.

From the urinary system: often - painful urination, urinary retention.

Metabolic disorders: often - decreased or increased appetite, weight gain; infrequently - weight loss; rarely - insufficient secretion of antidiuretic hormone (ADH), hyponatremia, hypokalemia; unknown - anorexia².

From the side of the musculoskeletal system: infrequently - myalgia, arthralgia, increased risk of injuries and fractures.

Laboratory indicators: often - changes in laboratory parameters of liver function; infrequently - increased activity of "hepatic" enzymes, alteration of the electrocardiogram (lengthening of the interval QT), hyponatremia.

Other: often - weakness; infrequently - swelling; rarely - hyperthermia.

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

²- reports on these phenomena were received in relation to the SSRI treatment class.

During the post-registration period cases of lengthening of the interval 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.In double-blind, placebo-controlled studies of ECG in healthy volunteers, the change from baseline QTc (correction according to the Friderichia formula) was 4.3 msec at a dose of 10 mg / day and 10.7 msec at 30 mg / day.

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

Stopping the use of SSRIs / SSRIs (selective norepinephrine and serotonin reuptake inhibitors) (especially severe) usually leads to symptoms of "withdrawal". Dizziness, sensitivity disorders (including paresthesia and current sensation), sleep disturbances (including insomnia and bright dreams), agitation or anxiety, nausea and / or vomiting, tremors, confusion, increased sweating, headache, diarrhea, fasting palpitations, emotional instability, irritability and visual impairment.As a rule, these phenomena are of mild or moderate severity and pass independently, but in some patients they can take a more severe form and be more prolonged. It is recommended to gradually phase out the drug by reducing its dose.

Overdose:

Symptoms of overdose: dizziness, tremor, agitation, drowsiness, dullness of consciousness, in rare cases, the development of serotonin syndrome, seizures and coma, tachycardia, changes in the ECG (segment change ST, T wave, expansion of the complex QRS, lengthening the interval QT), arrhythmias, suppression of the function of external respiration, vomiting, rhabdomyolysis, metabolic acidosis, hypokalemia.

Coma and legal cases of escitalopram overdose are extremely rare, most of them include a simultaneous overdose with other drugs.

Treatment of overdose: there is no specific antidote. Treatment symptomatic and supportive: gastric lavage (as soon as possible after ingestion), ensure airway patency, adequate oxygenation and ventilation of the lungs.ECG monitoring of cardiovascular function is recommended (arrhythmias, including fatal ones) and monitoring of the respiratory system are possible.

Interaction:

Pharmacodynamic interactions:

Contraindicated joint application:

With irreversible nonselective MAO inhibitors

Serious adverse reactions have been reported in patients receiving combination therapy with SSRIs and irreversible nonselective MAO inhibitors, as well as in patients who recently discontinued SSRI therapy and who started therapy with such MAO inhibitors. In some cases, patients developed serotonin syndrome.

Escitalopram can be prescribed 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 prescribe treatment irreversible nonselective MAO inhibitors.

With reversible selective MAO inhibitors of type A (moclobemide)

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

FROM reversible non-selective MAO inhibitors (linezolid)

Antibiotic linezolid are 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.

FROM 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.

With means extending the interval QT

Do not use with medications that extend the interval QT, such as antiarrhythmics (procainamide, amiodarone and others), antipsychotics / antipsychotics (eg, pimozide, phenothiazine derivatives (chlorpromazine, trifluoperazine, thioridazine and others), butyrophenone derivatives (haloperidol, droperidol and others), tricyclic and tetracyclic antidepressants (amitriptyline, imipramine, maprotiline , etc.), SSRIs and similar antidepressants (for example, fluoxetine, venlafaxine and others), antimicrobials (macrolide antibiotics and their analogues, for example, erythromycin, clarithromycin; derivatives of quinoline and fluoroquinolone: sparfloxacin, moxifloxacin; pentamidine), antifungal agents of the azole series (ketoconazole, fluconazole), domperidone, ondansetron, because the escitalopram in doses exceeding 20 mg per day, can cause abnormal changes in the electrical activity of the heart (lengthening of the interval QT on the ECG) and lead to a violation of the heart rhythm (including the development of arrhythmia by the type of "pirouette"), which can be fatal.

The combined use of escitalopram should be performed with caution when used:

Medicinal products, reducing the threshold of convulsive readiness

Escitalopram can reduce the threshold of convulsive readiness. It is necessary to be cautious while taking other drugs that reduce the threshold of convulsive readiness (tricyclic antidepressants, SSRIs, neuroleptics - phenothiazine derivatives, thioxanthenna and butyrophenone; mefloquine and tramadol).

Serotonergic drugs

It is advisable not to combine the intake of the drug Escitalopram with serotonergic drugs, such as sumatriptan or other triptans, and tramadol, as this can lead to the development of serotonin syndrome.

Lithium, tryptophan

With simultaneous use with tryptophan or with lithium preparations, cases of increased escitalopram have been reported.

The Beastoth holed

Simultaneous use of escitalopram and preparations containing St. John's Wort (perforated)Hypericum perforatum), can lead to an increase in side effects.

Anticoagulants and agents that affect blood coagulability

When concomitant use of escitalopram with indirect anticoagulants and other means that affect blood clotting (for example, atypical antipsychotics and phenothiazine derivatives, most tricyclic antidepressants, acetylsalicylic acid and non-steroidal anti-inflammatory drugs, ticlopidine and dipyridamole), blood clotting may occur.In such cases, when initiating or completing therapy with escitalopram, regular monitoring of blood clotting is necessary.

With the simultaneous appointment of warfarin prothrombin time increases by 5%.

The interaction of escitalopram with alcohol. However, as with other antidepressants, you should refrain from drinking alcohol during the entire period of treatment with the drug.

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 with caution combined with cimetidine. A dose adjustment is recommended.

Thus, the drug should be combined with caution 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.

Impact 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 neuroleptics, such as risperidone, thioridazine and haloperidol. A dose adjustment may be recommended.

Simultaneous reception of the drug with desipramine or metoprolol led to a twofold increase in the concentration of these substrates CYP2D6 in the 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:

Children under 18 years old is a contraindication for the use of escitalopram, since the efficacy and safety of its use at this age is not established.

In connection with the possibility of suicide attempts, patients with depression need careful monitoring of patients at the beginning of treatment and the appointment of minimum effective doses to reduce the risk of overdose. This precaution should be followed in the treatment of other mental disorders due to the possibility of concurrent depressive episode.

Depression is characterized by the risk of suicidal actions, which can persist until a significant remission is achieved. In this regard, at the beginning of the treatment, constant medical supervision, supervision of patients' behavior and organization of storage and dispensing of medicines by only authorized persons are necessary.

In the treatment of panic disorders with the appointment of antidepressants and / or benzodiazepines, anxiety or anxiety is significantly increased in some patients in response to the treatment initiated. This condition, called specialists "pathological disinhibition" or simply "paradoxical anxiety"is considered a rare phenomenon, although this pathological reaction has been documented repeatedly in the scientific literature.This" paradoxical anxiety "usually decreases during the first two pedules after treatment, it is recommended to start with a low dose in order to reduce the risk of paradoxical anxiety. This case is recommended if such a paradoxical reaction does not disappear for a long time, and if such complications of therapy exceed the benefits of the treatment.

In children, adolescents and young people (under 24 years) with depression and other mental disorders, antidepressants, compared with placebo, increase the risk of suicidal thoughts and suicidal behavior. Polomu with the appointment of the drug Escitalopram or any other antidepressants in this category of patients should be related to the risk of suicide and the benefits of their use.In short-term studies in people over 24 years of age, the risk of suicide did not increase, but in people older than 65 years, it declined slightly. During treatment with antidepressants, all patients should be monitored for early detection of behavioral disorders, as well as suicidal tendencies.

Escitalopram can cause a dose-dependent interval lengthening QT on an electrocardiogram, which can lead to a disturbance of the heart rhythm.

Hyponatremia is developed due to disturbances in the secretion of the antidiuretic hormone, especially the high level of risk in older women.

Against the background of taking escitalopram, development cutaneous hemorrhage (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.

Treatment with drug Escitalopram can change glycemic control in patients with diabetes mellitus. The dose of insulin and / or oral hypoglycemic agents should be adjusted.

Rarely possible development akathisia, characterized by a constant or recurring feeling of the internal motoranxiety and manifested in the inability to sit quietly for a long time in one pose or for a long time to remain without movement. It takes place during the first weeks of treatment.

In patients with bipolar disorder or with mania / hypomania, a history may occur mania. Then the drug treatment Escitalopram it is necessary to stop.

It is necessary to use caution Escitalopram in the presence of drug dependence (including in the anamnesis) and epileptic seizures in the anamnesis. In the case of convulsive seizures, as well as in patients with epilepsy with an increase in the frequency of convulsive seizures, the drug Escitalopram As well as other preparations of the SSRI group, it should be canceled. It is not recommended to use in patients with unstable epilepsy.

Escitalopram should not be used in combination with monoamine oxidase inhibitors (MAO) (see the section "Contraindications" and "Interaction with other drugs").

With mild to moderate renal impairment correction of the dose is not required, with severe violations of kidney function, care must be taken.

When a violation of liver function The intake of the drug is limited to the minimum recommended doses.

In elderly patients a decrease in the dose of escitalopram is required.

With the development of the manic state the drug should be discarded.

Clinical experience of simultaneous use of the drug Escitalopram and electroconvulsive therapy is insufficient, therefore caution is required.

At the beginning of treatment may occur Insomnia and anxiety, which can be solved by adjusting the initial dose.

The interaction of escitalopram with alcohol. However, as with other antidepressants, you should refrain from drinking alcohol during the entire period of treatment with the drug.

Sharply discontinuation of drug therapy Escitalopram can lead to withdrawal syndrome. There may be unwanted reactions like dizziness, headaches, nausea. To avoid the occurrence of the "withdrawal" syndrome, a gradual withdrawal of the drug within 1-2 weeks is necessary. The doctor solves this issue individually: for some patients it may take 2-3 months or more.

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

During the period of drug treatment Escitalopram patients are not advised to drive or operate machinery. The patient should be informed of the potential danger of the effect of escitalopram on the ability to drive vehicles and mechanisms.

Form release / dosage:

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

Packaging:

For 10 tablets in a contour mesh box made of polyvinylchloride film and aluminum foil printed lacquered.

For 3 or 6 contour packagings together with the instruction for use, place in a pack of cardboard.

Storage conditions:

In the dark place at a temperature of no higher than 25 ° C.

Keep out of the reach of children.

Shelf life:

3 years.

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

Terms of leave from pharmacies:On prescription

Registration number:LP-003048

Date of registration:18.06.2015

Date of cancellation:2020-06-18

The owner of the registration certificate:ALSI Pharma, ZAO ALSI Pharma, ZAO Russia

Manufacturer: & nbsp

ALSI Pharma, ZAO Russia

Representation: & nbspALSI Pharma CJSC ALSI Pharma CJSC Russia

Information update date: & nbsp03.10.2015

Illustrated instructions

Instructions

Escitalopram (Escitalopram)