Instruction for use: Escitalopram 5mg

International Nonproprietary Name (INN): Escitalopram

Pharmaceutic group: Antidepressant

Presentation:

Film-coated tablets of 5 mg, 10 mg and 20 mg.

Available with prescription

Indications for Escitalopram

Escitalopram - a drug prescribed by a doctor-specialist (usually a psychiatrist) in depressive episodes, moderate and severe, and panic disorders.

Action escitalopram typically through intermediary reuptake slowing of nerve impulse transmission in the central nervous system (CNS) such as serotonin. As a result, the concentration of released serotonin in nerve synapses increased, which in most cases is associated with improved mood, normalization of behavior, relieved state of physical, mental and emotional sphere, which are violated in depressive and panic disorders. Escitalopram very selectively acts exactly on the reuptake of serotonin, not other possible CNS neurotransmitters, so it belongs to the group of selective serotonin reuptake inhibitors (SSRIs), which confirms the high clinical efficacy of the drug (at therapeutic concentrations of escitalopram) with a minimum of side effects, if compare it with the older generation of antidepressants: monoamine oxidase inhibitors (MAOIs) and tricyclic antidepressants. It should be noted that escitalopram has a different from other SSRIs chemical structure (bicyclic isobenzofuran derivative), which has no analogues among the other antidepressants, and, accordingly, has some differences in the mechanism of antidepressant action, demonstrating effectiveness where other drugs may be ineffective.

Escitalopram has no effect on the serum levels of prolactin and growth hormone. Escitalopram does not impair cognitive / intellectual function and psychomotor function, and practically no sedative effect. Escitalopram has no severe toxicity to the heart, however, care is needed if high doses are assigned escitalopram (20 mg daily), or if both are assigned escitalopram with other drugs, particularly those that affect the increase in QT interval on the electrocardiogram. Before the appointment of the drug, please refer to the instruction for use.

Escitalopram is taken once a day, a long course of treatment, the antidepressant effect usually develops after 2-4 weeks of treatment.

Escitalopram belongs to a new generation of antidepressants with good tolerability, low toxicity and high safety in case of overdose.

Trade name of the drug – Escitalopram

Dosage Form: tablets

Active substance:

A film-coated tablet 5 mg comprises:

escitalopram oxalate - 6.39 mg (equivalent to 5.00 mg escitalopram);

Excipients: Microcrystalline cellulose - 48.01 mg pregelatinized starch - 24,00 mg colloidal silicon dioxide (Aerosil) - 0.80 mg magnesium stearate - 0.80 mg;

coated tablets: Opadry White 3.20 mg (lactose monohydrate - 1.15 mg, Valium - 0.90 mg of titanium dioxide - 0.83 mg macrogol - 0.32 mg).

A film-coated tablet 10 mg contains:

Active ingredient: escitalopram oxalate - 12.78 mg (calculated as escitalopram 10.00 mg);

excipients: microcrystalline cellulose - 96.02 mg pregelatinized starch - 48.00 mg colloidal silicon dioxide (Aerosil) - 1.60 mg of magnesium stearate - 1,60 mg;

coated tablets: Opadry White 6.40 mg (lactose monohydrate - 2.30 mg, Valium - 1.80 mg of titanium dioxide - 1.66 mg macrogol - 0.64 mg).

A film-coated tablet 20 mg contains:

Active ingredient: escitalopram oxalate - 25.56 mg (calculated as escitalopram 20.00 mg);

excipients: microcrystalline cellulose - 192.04 mg, pregelatinised starch - 96.00 mg colloidal silicon dioxide (Aerosil) - 3.20 mg of magnesium stearate - 3,20 mg;

coated tablets: Opadry white 12.80 mg (lactose monohydrate - 4.60 mg, Valium - 3.60 mg of titanium dioxide - 3.32 mg macrogol - 1.28 mg).

Description:

Round biconvex tablets, film-coated white. On cross-section - the inner layer of white or nearly white.

Pharmacotherapeutic group: Antidepressant

ATX code: N06AB10

Pharmacological Properties of Escitalopram

Pharmacodynamics

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

Escitalopram has no or has a very weak ability to bind to a number of receptors including: serotonin 5-HT1A and 5-HT2 receptors, D1 and D2 dopamine receptors, α1-, α2-, β-adrenergic receptors, the histamine H1, muscarinic cholinergic, benzodiazepine and opiate receptors.

Inhibition of reuptake of 5-HT is the only action possible mechanism that explains the pharmacological and clinical effects of escitalopram.

Escitalopram is the S-enantiomer of racemic citalopram with a private therapeutic activity. It is proved that the R-enantiomer is not inert, and counteracts the serotonergic properties and pharmacological effects corresponding S-enantiomer.

Pharmacokinetics

Suction

The absolute bioavailability of escitalopram is 80% and is independent of food intake. The maximum concentration (Cmax) in plasma is achieved at a mean of 4 hours after repeated use.

Distribution

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

Metabolism

Escitalopram is metabolized by demethylation, deamination and oxidation with cytochrome P450. Biotransformation of escitalopram to the demethylated metabolite occurs primarily via isoenzyme CYP2C19. Perhaps some part of isozymes CYP3A4 and CYP2D6. Inhibition of one of these enzymes may be offset by other enzymes.

In human blood plasma is dominated escitalopram unchanged. At equilibrium, the concentration of S-DCT (es demetiltsitalopram) in plasma is approximately 33% of the concentration of escitalopram. Level S-DDTST (es didemetiltsitalopram) was not detected in the majority of subjects. Studies in vitro have shown that the metabolites do not contribute significantly to the antidepressant action of escitalopram.

breeding

The half-life (T1 / 2) of escitalopram after repeated use is 27-32 hours. Total clearance after oral administration is about 0.6 l / min. In the main metabolites of escitalopram half-life is longer.

Escitalopram and its metabolites are excreted through a liver (pathway) and through the kidney, with most of the administered dose excreted in urine as metabolites.

linearity pharmacokinetics

Pharmacokinetics of escitalopram is linear dose-dependent. Equilibrium plasma concentration (Css) is set approximately at 1 week of therapy. The average equilibrium concentration of 50 nmol / L (ranging from 20 to 125 nmol / L) is achieved at a daily dose of 10 mg.

Patients over the age of 65 years

In the elderly (over 65 years) there is a longer half-life and lower clearance values compared with younger patients. The amount of substance escitalopram present in the systemic circulation, calculated using the pharmacokinetic parameter "area under the curve» (AUC) in the elderly by 50% more than in young healthy volunteers.

Patients with hepatic impairment

In patients with reduced liver function escitalopram appears more slowly, escitalopram clearance is reduced by approximately 37%. The half-life of escitalopram almost twice escitalopram increased and equilibrium plasma concentration almost twice as compared with patients with normal liver function after receiving the same dose.

Patients with impaired renal function

In patients with mild to moderate reduction of renal function excretion of escitalopram is slower (ground clearance is reduced by approximately 17%) with no significant effect on the pharmacokinetics. In patients with severe renal insufficiency (creatinine clearance below 30 ml / min) requires caution.

Patients with low activity of isoenzyme CYP2C19

In persons with a weak activity of CYP2C19 escitalopram concentration twice higher than in the case of high activity of the isozyme. Significant changes in the concentration of the drug in cases with weak CYP2D6 isoenzyme activity was found.

Indications for Escitalopram

Depressive episodes of any severity.

Panic disorder with / without agoraphobia.

Social anxiety disorder (social phobia).

Generalized anxiety disorder.

Obsessive-compulsive disorder.

Contraindications for Escitalopram

Hypersensitivity to escitalopram or to any of the excipients included in the composition of the drug.

Escitalopram should not be used in combination with monoamine oxidase inhibitors (MAOIs), monoamine oxidase-A (MAO-A) or the reversible non-selective MAO inhibitors.

Escitalopram is contraindicated in concomitant use with drugs that prolong the QT interval on an electrocardiogram (in particular, with pimozide, antiarrhythmics IA and III classes, tricyclic antidepressants, macrolides), as well as congenital prolongation of the QT interval.

Children under 18 years of age a contraindication to the use of escitalopram, as its efficacy and safety have not been established in this age group.

Pregnancy, lactation.

Lactose intolerance, lactase deficiency, glucose-galactose malabsorption.

Precautions: Renal insufficiency (creatinine clearance less than 30 ml / min), manic disorders (including history), pharmacologically uncontrolled epilepsy, depression with suicidal attempts, diabetes, electroconvulsive therapy; advanced age (over 65 years), cirrhosis of the liver, bleeding tendency; concomitant use with drugs that reduce the seizure threshold, tryptophan, pharmaceutical preparations 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 of CYP2C19, ethanol.

Escitalopram Dosage and Administration

Escitalopram is taken orally once a day (not liquid, squeezed small amount of liquid), regardless of the meal. The preparation can be applied at any time, it is desirable to take the drug at the same time. It is recommended to regularly assess the treatment.

Depressive episodes:

Usually begins with receiving escitalopram 10 mg 1 time per day. Depending on the individual response of the patient the dose may be increased to a maximum of 20 mg per day. Antidepressant effect usually develops within 2-4 weeks after starting treatment. After the disappearance of symptoms of depression is still necessary to continue treatment for at least 6 months to secure the effect obtained.

Panic disorder with / without agoraphobia:

In panic disorder during the first week of treatment, the recommended dose of - 5 mg per day and then to increase the dose of 10 mg per day. The daily dose, depending on the individual patient's response, can be further increased to 20 mg per day. The maximum therapeutic effect is reached after about 3 months after initiation of treatment. The therapy lasts several months.

Social anxiety disorder (social phobia)

Typically prescribed 10 mg once a day. The weakening of symptoms usually occurs within 2-4 weeks after starting treatment. Depending on the individual response of the patient the dose may subsequently be reduced to 5 mg per day or increased to a maximum of 20 mg per day. Since social anxiety disorder is a disease with a chronic course, the minimum recommended duration of the therapeutic course is 12 weeks. In order to prevent recurrence of the disease the drug is administered for 6 months or longer, depending on the individual patient response.

Generalized anxiety disorder:

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

Allowed long term administration of the drug (6 months and longer) at a dose of 20 mg per day.

Obsessive-compulsive disorder:

Typically prescribed 10 mg 1 time per day. Depending on the individual response of the patient the dose may subsequently be increased to a maximum of 20 mg per day. As obsessive-compulsive disorder is a disease with a chronic course of treatment should be long enough to provide complete relief of symptoms, and last at least six months. recommended course of treatment is not less than 1 year to prevent recurrence.

Elderly patients (over 65 years):

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

Patients with renal failure:

In chronic renal insufficiency of mild to moderate severity correct dosing regimen is required. In patients with severe renal insufficiency (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 scale of Child-Pugh), the recommended starting dose for the first two weeks of treatment is 5 mg per day. Depending on the individual response of the patient the dose may be increased to 10 mg per day. In severe hepatic insufficiency (class C Child-Pugh), care must be taken during the titration, treatment is carried out under close medical supervision.

Reduced activity of isoenzyme CYP2C19:

For patients with low activity of CYP2C19 isozyme recommended starting dose for the first two weeks of treatment is 5 mg per day. Depending on the individual response of the patient the dose may be increased to 10 mg per day.

Cancel the drug:

Avoid abrupt withdrawal of the drug. When stopping treatment with escitalopram the dose should be reduced gradually at intervals of 1-2 weeks in order to avoid the syndrome of "cancellation". When intolerance dose reduction is possible resumption of the drug in the same dose or a dose reduction with a large interval. The doctor decides this question individually: some patients may need a period of 2-3 months or more.

pregnancy and breastfeeding

Pregnancy

You should not assign the drug escitalopram to pregnant and lactating women, if the potential clinical benefit prevails over theoretical risk, since safety of the drug during pregnancy and lactation in women has not been established.

During reproductive toxicity studies in rats escitalopram observed embriofetotoksichnost, however, it has not been established increase in the number of birth defects. If receiving escitalopram lasted late in pregnancy, especially during the third trimester, the newborn should be under surveillance.

If receiving escitalopram continued until delivery, or has been discontinued shortly before delivery, the newborn may develop "cancellation" syndrome. In the case of selective inhibitors of the mother of serotonin reuptake, or selective serotonin reuptake inhibitors and noradrenaline (SSRIs / SNRIs) in late pregnancy in the newborn may develop the following side effects: persistent pulmonary hypertension, respiratory distress, cyanosis, apnea, seizure disorders, temperature jumps , difficulties with feeding, vomiting, hypoglycemia, hypertension, hypotonia, hyperreflexia, tremor, increased neuro-reflex excitability, irritability, lethargy, constant crying, sleepiness or insomnia. These symptoms may be due to the development of the syndrome of "cancellation" or serotonergic action. In most cases, such complications occur within 24 hours after birth.

Epidemiological evidence suggests that the use of SSRIs / SNRIs during pregnancy, particularly in late pregnancy, may increase the risk of development of resistant pulmonary hypertension in neonates with a frequency of up to 5 per 1000 at a frequency in the general population 1-2 1000.

Use during breastfeeding

The drug is released in small quantities in breast milk, so while taking the drug during lactation is recommended to resolve the issue of termination of breastfeeding.

fertility

Ongoing studies in animals have shown that escitalopram may affect sperm quality. Cases of medical practice, including the use of SSRIs have shown that the effect on sperm quality is reversible. Until now, the impact was detected on human fertility.

Side effect ofEscitalopram

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

Laboratory tests: often - changes in laboratory parameters of liver function; rarely - increased activity of "liver" enzymes, changes in the electrocardiogram (QT prolongation), hyponatremia.

Other: often - weakness; Infrequent - edema; rarely - hyperthermia.

1 have been reported cases of suicidal feelings and suicidal behavior while taking escitalopram, or immediately after the cessation of treatment.

2 posts of the data received in relation to the phenomena of the therapeutic class of SSRIs.

The Post-registration period, cases of QT interval prolongation and ventricular arrhythmias have been observed, including ventricular tachycardia type "pirouette", mainly in female patients with hypokalemia, or pre-existing QT prolongation or other cardiovascular diseases. In double-blind, placebo-controlled ECG study in healthy volunteers, the change from baseline QTc (using the formula Friederici correction) was 4.3 msec at a dose of 10 mg / day. and 10.7 ms - at 30 mg / day.

Class-effects

In epidemiological studies involving patients aged 50 years and over reported an increased risk of bone fractures in patients receiving SSRIs and TCAs. The mechanism leading to this risk is unknown.

Withdrawal symptoms after treatment

Discontinuation of SSRIs / SNRIs (selective noradrenaline reuptake inhibitors and serotonin) (especially sharp), as a rule, leads to symptoms of "cancellation". The most frequently observed dizziness, sensory disturbances (including paresthesia and sensations of current passage), sleep disturbances (including insomnia and intense dreams), agitation or anxiety, nausea and / or vomiting, tremor, confusion, sweating, headache, diarrhea, palpitations palpitations, emotional instability, irritability and visual disturbances. Generally these events are mild or moderate severity and are on their own, but in some patients it can cause severe illness and be more prolonged. It is recommended that the gradual abolition of the drug by reducing the dose.

overdose

Overdose symptoms: dizziness, tremor, agitation, somnolence, dizziness, in rare cases may develop serotonin syndrome, seizures, and coma, tachycardia, ECG changes (change of segment ST, wave T, the expansion of the complex the QRS, prolongation of the interval QT), arrhythmia, depression respiratory function, vomiting, rhabdomyolysis, metabolic acidosis, hypokalemia.

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

Overdose Treatment: there is no specific antidote. Treatment is symptomatic and supportive: gastric lavage (as soon as possible after ingestion of the drug), to provide an open airway, adequate oxygenation and ventilation. Recommended ECG monitoring function of the cardiovascular system (possible arrhythmias including fatal) and monitoring of the respiratory system.

Interaction

Pharmacodynamic interactions:

Concomitant use is contraindicated:

With non-selective irreversible MAO inhibitors

Reported cases of serious adverse reactions in patients receiving combination therapy with SSRIs and non-selective irreversible MAO inhibitors, as well as in patients who have recently discontinued SSRI treatment and initiating such therapy MAO inhibitors. In some cases, patients developed serotonin syndrome. Escitalopram may be appointed 14 days after discontinuation of treatment non-selective irreversible MAO inhibitors. At least 7 days should elapse after stopping escitalopram before treatment can be prescribed non-selective irreversible MAO inhibitors.

With reversible selective MAO inhibitors type A (moclobemide)

Due to the risk of serotonin syndrome of joint use of escitalopram with reversible selective MAO inhibitors, such as moclobemide, are contraindicated. If there is a legitimate need to apply such a combination, the treatment should start with the lowest recommended dose under close clinical supervision.

With the reversible non-selective MAO inhibitors (linezolid)

The antibiotic linezolid is a reversible non-selective MAO inhibitor and should not be used in patients receiving therapy with escitalopram. If there is a legitimate need to apply such a combination, the treatment should start with the minimum dose under careful clinical observation.

With selective irreversible MAO inhibitors type B (selegiline)

Care should be taken in the case of joint use of escitalopram and selective irreversible MAO-B inhibitor selegiline because of the risk of serotonin syndrome. Selegiline at doses up to 10 mg per day has been used successfully in conjunction with ratsemirovannym citalopram.

With the means prolong the QT interval

Unacceptable use with drugs prolong the interval of the QT, such as antiarrhythmics (procainamide, amiodarone, etc.), Antipsychotics / neuroleptics (eg, pimozide, phenothiazines (chlorpromazine, trifluoperazine, thioridazine, and others.), Derivatives of butyrophenone (haloperidol, droperidol et al.), tricyclic and tetracyclic antidepressants (amitriptyline, imipramine, maprotiline, etc.), SSRIs, and the like antidepressants (e.g., fluoxetine, venlafaxine, etc.), antimicrobials (macrolide antibiotics and their analogs, such as erythromycin, clarithromycin ; quinolone derivatives and fluoroquinolones: sparfloxacin, moxifloxacin, pentamidine), antifungals azole (ketoconazole, fluconazole), domperidone, ondansetron, as escitalopram at doses exceeding 20 mg per day, can cause abnormal changes in cardiac electrical activity (lengthening QT interval on ECG) and disrupt the heart rhythm (including the development of arrhythmias by "pirouette" type), which can be fatal.

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

Drugs that reduce the seizure threshold

Escitalopram may lower the seizure threshold. It requires caution while taking other means of lowering the seizure threshold (tricyclic antidepressants, SSRIs, neuroleptics - phenothiazine derivatives, thioxanthene and butyrophenone, mefloquine and tramadol).

Serotonergic drugs

Preferably not combine with the drug receiving Escitalopram serotonergic drugs such as sumatriptan or other triptans and tramadol, as this may lead to the development of serotonin syndrome.

Lithium, tryptophan

In an application with lithium or tryptophan drugs reported cases enhance the action of escitalopram.

St. John's wort

Concomitant use of escitalopram and products containing St. John's wort (Hypericum perforatum) may lead to increased side effects.

Anticoagulants and drugs affecting blood clotting

With simultaneous use of escitalopram with indirect anticoagulants and other agents that affect blood clotting (eg, atypical antipsychotics and phenothiazines derivatives, the majority of tricyclic antidepressants, acetylsalicylic acid and non-steroidal anti-inflammatory drugs, ticlopidine and dipyridamole) may have problems with blood clotting. In such cases, the beginning or the end of treatment with escitalopram requires regular monitoring of blood clotting.

When concomitant administration with warfarin the prothrombin time increases by 5%.

There was no interaction of escitalopram with alcohol. However, as with other antidepressants, should refrain from drinking during the entire period of drug treatment.

Pharmacokinetic interactions:

Effect of other drugs on the pharmacokinetics of escitalopram

Metabolism escitalopram is mainly by means of the enzyme CYP2C19. CYP2D6 and CYP3A4 may also be involved in the metabolism, although to a lesser degree. Metabolism main metabolite, S-DCT (demethylated escitalopram) partially catalyzed CYP2D6.

Simultaneous administration of escitalopram and omeprazole 30 mg once daily (CYP2C19 inhibitor) resulted in moderate (about 50%) increase escitalopram concentration in blood plasma.

Simultaneous administration of cimetidine escitalopram and 400 mg 2 times a day (total of medium strength inhibitor enzyme) resulted in moderate (about 70%) increase escitalopram concentration in blood plasma. Escitalopram, caution should be combined with cimetidine. Recommended dose adjustments.

Thus, the drug needs to be combined with caution CYP2C19 inhibitors (such as omeprazole, esomeprazole, fluvoxamine, lansoprazole, ticlopidine) or cimetidine. After tracking the side effects caused by simultaneous use of other medications may require dose reduction escitalopram.

Effect of escitalopram on the pharmacokinetics of other drugs

Escitalopram is an inhibitor of the enzyme CYP2D6. Care should be taken while the use of escitalopram and drugs with a narrow therapeutic index, which is mainly metabolized by this enzyme, such as flecainide, propafenone and metoprolol (for use in heart failure), or of some drugs acting on the central nervous system, which are mainly metabolized by 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 administration of the drug with desipramine or metoprolol resulted in a twofold increase in data CYP2D6 substrates concentration in blood plasma.

Invitro Studies have shown that escitalopram may also be a weak inhibitor of CYP2C19. It is recommended to use the drug with caution in conjunction with drugs metabolized by CYP2C19.

special instructions for Escitalopram

Children under 18 years of age a contraindication to the use of escitalopram, as its efficacy and safety have not been established in this age group.

Due to the possibility of suicide attempts in patients with depression requires careful monitoring of patients in the early treatment and appointment of the minimum effective dose to reduce the risk of overdose. This precaution should be observed in the treatment of other psychiatric disorders because of the simultaneous disease depressive episode.

Major depression is peculiar risk of suicidal actions, which may persist until significant remission. In this regard, at the beginning of treatment requires constant medical supervision, supervision over the behavior of patients and the organization of storage and dispensing of medicinal products authorized persons only. In the treatment of panic disorder with the appointment of antidepressants and / or benzodiazepines, some patients in response to the initiation of treatment is greatly enhanced anxiety or anxiety. This condition is called by experts "pathological disinhibition" or simply "paradoxical anxiety", regarded as rare, although the pathological reaction has been repeatedly documented in the scientific literature. This "paradoxical anxiety" usually decreases during the first two weeks after starting treatment. It is recommended to start with a low dose to reduce the risk of paradoxical anxiety. Cancel the drug is recommended in this case, if such a paradoxical reaction for a long time does not disappear, and if such complications of therapy exceed the benefits of the treatment.

In children, adolescents and young adults (under 24 years) with depression and others. Mental disorders antidepressants compared to placebo, increased the risk of suicidal thoughts or suicidal behavior. Therefore, the appointment of the drug escitalopram or any other antidepressant in these patients should be related to the risk of suicide and the benefits from their use. In short-term studies in people older than 24 years, the risk of suicide did not increase, and in people over 65 years is somewhat reduced. During antidepressant treatment all patients should be monitored for early detection of behavioral disorders, and suicidal tendencies.

Escitalopram may cause a dose-dependent prolongation of the QT interval on the ECG, which can lead to irregular heartbeat.

Hyponatremia develops due to disorders of secretion of antidiuretic hormone, especially a high level of risk in older women.

While taking escitalopram may develop skin bleeding (ecchymosis and purpura). Caution should use the drug in patients at risk of bleeding, as well as taking oral anticoagulants and drugs that affect blood clotting.

Treatment with Escitalopram may alter glycemic control in patients with diabetes mellitus. Dose of insulin and / or oral hypoglycemic agents to be adjusted.

Rarely possible development of akathisia, characterized by continuous or periodic emerging sense of inner motor restlessness, and manifests itself in the inability to sit still for a long time in one position for a long time, or remain motionless. Taking place during the first weeks of treatment.

In patients with bipolar disorder or mania / hypomania may occur in the history of mania. Then treatment with Escitalopram should be discontinued.

It should be used with caution in the presence of Escitalopram drug dependence (including history) and epileptic seizures in history. In the case of seizures, and in patients with seizure disorders with increasing frequency of seizures drug escitalopram, as well as other SSRIs, should be abolished. Not recommended in patients with unstable epilepsy.

Escitalopram should not be used in combination with monoamine oxidase inhibitors (MAOIs) (see. "Contraindications" and "Interaction with other medicinal products").

When mild to moderate severity renal impairment dose adjustment is required in severe renal impairment require caution. If abnormal liver function taking the drug restrict the minimum recommended dose. In elderly patients require a dose reduction of escitalopram.

With the development of mania drug should be discontinued.

Clinical experience with the simultaneous use of the drug escitalopram, and electroconvulsive therapy is not sufficient, so caution is required.

Early treatment can occur insomnia and feelings of anxiety that may be solved by correcting the initial dose.

There was no interaction of escitalopram with alcohol. However, as with other antidepressants, should refrain from drinking during the entire period of drug treatment.

Abrupt discontinuation of therapy with Escitalopram may lead to a syndrome of "cancellation". You may experience adverse reactions such as dizziness, headaches, nausea. To avoid the syndrome of "cancellation" necessary phasing out of the drug for 1-2 weeks. The doctor decides this question individually: some patients may need a period of 2-3 months or more.

Information on the effect of the drug on the ability to drive vehicles, machinery

During treatment with escitalopram in patients is not recommended to drive or mechanisms. The patient should be informed of the potential hazard effect of escitalopram on ability to drive and use machines.

Release form of Escitalopram

Film-coated tablets of 5 mg, 10 mg and 20 mg.

10 tablets in blisters of PVC film and aluminum foil printed patent.

At 3 or 6 contour cell package, along with instructions for use are placed in a pile of cardboard.

Storage conditions of Escitalopram

In a dry, dark place at a temperature no higher than 25 ° C.

Keep out of the reach of children.

Shelf life of Escitalopram

3 years.

Do not use beyond the expiration date printed on the package.

Conditions of supply of Escitalopram from pharmacies

With prescription.