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

Excipients: cellulose microcrystalline 52.43 mg, silicon dioxide colloid 0.65 mg, croscarmellose sodium 2.60 mg, stearic acid 1.95 mg, magnesium stearate 0.98 mg;

film sheath: opada white Y-l 7000H 1.95 mg (hypromelposis 2910 5sP (E464) 1.2188 mg, titanium dioxide (E171) 0.6094 mg, macrogol-400 0.11219 mg).

Dosage of 10 mg:

active substance: escitalopram oxalate (in terms of escitalopram) 12.78 mg (10.0 mg);

Excipients: cellulose microcrystalline 104.86 mg, silicon colloidal dioxide 1.30 mg, croscarmellose sodium 5.20 mg, stearic acid 3.90 mg, magnesium stearate 1.96 mg;

film sheath: Opapray is white. Y-l 7000H 3.90 mg (hypromellose 2910 5sP (E464) 2.4375 mg, titanium dioxide (E171) 1.2188 mg, macrogol-400 0.2438 mg).

Dosage of 20 mg:

active substance: escitalopram oxalate (in terms of escitalopram) 25.56 mg (20.0 mg);

Excipients: microcrystalline cellulose. 209.72 mg, silicon colloidal dioxide 2.60 mg, croscarmellose. sodium. 10.40 mg, stearic acid 7.80 mg, magnesium stearate 3.92 mg;

film sheath: opadray white Y-l 7000H 7.80 mg (hypromellose 2910 5sP (E464) 4.8750 mg, titanium dioxide (E171) 2.4375 mg, macrogol-400 0.4875 mg).

Description:

Round biconvex tablets, covered with a film coating of white color. On the cross section, the core is white or almost white.

Dosage 5 mg: with engraving on one side "93" and "7414" on the other side.

Dosage of 10 mg: on one side with the risk and engraving "9" to the left of the risks, engraving "3" to the right of the risks; on the other side of the engraving "7462".

Dosage of 20 mg: on one side with the risk and engraving "9" to the left of the risks, engraving "3" to the right of the risks; on the other side engraving "7463".

Pharmacotherapeutic group:antidepressant

ATX: & nbsp

N.06.A.B.10 Escitalopram

Pharmacodynamics:

Escitalopram belongs to the group of selective serotonin reuptake inhibitors (SSRIs). The mechanism of action of escitalopram is based on its ability to selectively block the reuptake of serotonin (5-hydroxytryptamine (5-HT)) by the presynaptic membrane of brain neurons, which determines the enhancement of its serotonergic action in the central nervous system responsible for the development of antidepressant effect and efficacy in the treatment of panic and social anxiety disorder.

Escitalopram does not possess or has a low affinity for 5-HT_1A, 5-HT₂, DA D₁ and D2 receptors, α₁-, α₂-, β-adrenoreceptors, histamine H₁, m-cholinergic receptors, benzodiazepine and opioid receptors.

Pharmacokinetics:

Suction. Absorbed from the gastrointestinal tract (GIT) almost completely and regardless of food intake. Absolute bioavailability is about 80%. The mean time to reach the maximum concentration (T_mOh) is 4 hours.

Distribution. Apparent volume distribution of the drug is from 12 to 26 liters / kg. The association of escitalopram and its metabolites with plasma proteins is less than 80%.Stable concentration of the drug in plasma is achieved on average for 1 week and is 50 nmol / l (25-150 nmol / l) achieved at a daily dose of 10 mg / day.

Metabolism. Escitalopram metabolized in the liver to demethylated and didemethylated metabolites, which undergo glucuronidation. The concentration of metabolites in the blood plasma after repeated administration of the drug is 28-31% and 5%, respectively, of the concentration of escitalopram. Both metabolites have pharmacological activity. Biotransformation is happening soonerthe isozymes CYP2C19, CYP3A4 and CYP2D6. With a weak isoenzyme activity CYP2C19 the concentration of escitalopram in the blood plasma is increased 2 times.

Allocation. The half-life (T_1/2) after repeated admission is 30 hours. Clearance after oral administration - 0.6 l / min. T_1/2the main metabolites are more prolonged. Escitalopram and its main metabolites are mostly excreted by the kidneys, partly in the form of glucuronides.

In patients over 65 years of age, patients with mild and moderate hepatic impairment (Child-Pugh A or B classification), severe renal insufficiency (creatinine clearance (CK) less than 30 ml / min) T_1/2 increased.

Indications:

- Episodes of deep depression;

- panic disorder with or without agoraphobia;

- social anxiety disorder;

- generalized anxiety disorder.

Contraindications:

- Hypersensitivity to escitalopram or other components of the drug;

- simultaneous use with monoamine oxidase (MAO) inhibitors, alcohol, St. John's Wort preparations (Hypericum perforatum);

- Pregnancy;

- the period of breastfeeding;

- age up to 18 years;

uncontrolled epilepsy.

Carefully:

Renal failure (creatinine clearance less than 30 ml / min), hypomania, mania, depression with suicidal ideation and attempts, diabetes, age under 25; age over 65 years, ischemic heart disease (IHD) cirrhosis, tendency to hemorrhage, hyponatremia, isoenzyme deficiency CYP2C19; simultaneous application with sumatriptan, tramadol, tryptophan, lithium preparations, tricyclic antidepressants, neuroleptics, bupropion, indirect anticoagulants, nonsteroidal anti-inflammatory drugs, omeprazole, cimetidine, fluvoxamine, desipramine, metoprolol, clomipramine, nortryptiline, haloperidol, risperidone; electroconvulsive therapy.

Pregnancy and lactation:

The drug Escitalopram-Teva is contraindicated during pregnancy (insufficient data on safety and efficacy) and during breastfeeding.

Dosing and Administration:

Inside, once a day, regardless of food intake.

The maximum daily dose is 20 mg.

Episodes of Deep Depression

The usual dose is 10 mg / day. Depending on the clinical condition of the patient, the dose of the drug can be increased to 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 20 mg / day. The maximum clinical effect is achieved after 3 months after the initiation of therapy. The treatment continues 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 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.

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

Elderly patients

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.

Renal insufficiency

Correction of a dose of mild or moderate renal failure is not required.When creatinine clearance is less than 30 ml / min the drug should be administered under the supervision of a doctor.

Liver failure

For patients with mild or moderate hepatic insufficiency (Child-Pugh A or B class), 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 according to Child-Pugh) the drug is administered under careful control inracha.

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 therapy with Escitalopram-Teva, the dose should gradually decrease at an interval of 1-2 weeks in order to reduce the risk of 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:

The incidence of side effects is classified according to the recommendations of the World Health Organization: very often - not less than 10%; often - not less than 1%,but less than 10%; infrequently - not less than 0,1%, but less than 1%; rarely - not less than 0.01%, but less than 0.1%; very rarely (including isolated cases and cases with unknown frequency) - less than 0.01%.

From the hemopoietic and lymphatic systems: rarely - thrombocytopenia.

From the immune system: rarely - anaphylactic reaction, angioedema.

From the endocrine system: decrease in secretion of antidiuretic hormone (ADH).

From the side of metabolism and nutrition: often - changes in appetite, weight gain; infrequently - weight loss; rarely - hyponatremia, anorexia.

From the nervous system: often - insomnia, drowsiness, dizziness, paresthesia, tremor, anxiety, a feeling of "anxiety," unpleasant dreams, decreased libido, anorgasmia in women; infrequently - sleep disturbance, fainting, bruxism, agitation, nervousness, panic attacks, confusion; violation of taste perception; rarely - serotonin syndrome, aggressiveness, depersonalization, hallucinations, suicidal behavior, dyskinesia, convulsions, mania.

From the side of the organ of vision: infrequently - mydriasis, impaired vision.

From the side of the organ of hearing and labyrinth: infrequently, noise in the ears.

From the side of the cardiovascular system: infrequently - tachycardia; rarely - bradycardia; very rarely - orthostatic hypotension, lengthening of the interval QT.

On the part of the respiratory system, the organs of the thorax and the mediastinum: often - sinusitis, yawning; infrequently - epistaxis.

From the gastrointestinal tract: very often - nausea; often - diarrhea, constipation, vomiting, dryness of the oral mucosa; infrequently - bleeding, including bleeding from the rectum.

From the liver and biliary tract: very rare - hepatitis, povyshactivity indexes of "hepatic" enzymes.

From the skin and subcutaneous tissues: often - increased sweating; infrequently - hives, alopecia, rash, itching; rarely - ecchymosis.

From the osteomuscular system and connective tissue: often - arthralgia, myalgia.

From the side of the kidneys and urinary tract: very rarely - retention of urine.

On the part of the reproductive system: often - violation of ejaculation, impotence; infrequently - menorrhagia, uterine bleeding; rarely priapism and galactorrhea in men.

General disorders and disorders at the site of administration: often - weakness, fever; rarely - swelling.

From the laboratory indicators: rarely - increased activity of "liver" transaminases and alkaline phosphatase in the blood serum, an increase in the concentration of bilirubin in the blood plasma.

Overdose:

Symptoms: dizziness, tremor, anxiety, 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. Therapy is aimed at supporting the function of external respiration, adequate oxygenation, monitoring of cardiac activity, removal of the drug from the gastrointestinal tract (gastric lavage, administration of enterosorbents). Forced diuresis, hemodialysis, hemoperfusion are ineffective.

Interaction:

The appointment of escitalopram is contraindicated against the background of the use of irreversible nonselective MAO inhibitors because of the development of serotonin syndrome. Assign escitalopram probably not earlier than 14 days after the withdrawal of irreversible non-selective MAO inhibitors.The administration of irreversible non-selective MAO inhibitors is possible no earlier than 7 days after the withdrawal of escitalopram.

The appointment of escitalopram against the background of taking other MAO inhibitors is possible provided that these drugs will be prescribed in minimal doses under the close supervision of the physician.

The appointment of escitalopram on the background of taking other serotonergic drugs mayriwesdevelopment of serotonin syndrome.

Simultaneous use of escitalopram with lithium salts or tryptophan enhances their serotonergic effects.

Simultaneous reception of escitalopram with drugs that lower the convulsive threshold (tricyclic antidepressants, phenothiazines, thioxanthins, butyrophenones, mefloquine, bupropion, tramadol), reduces the convulsive threshold.

Simultaneous reception of escitalopram and herbal collections containing St. John's wort (Hypericum perforatum), increases the incidence of side effects.

Escitalopram should be administered with caution when taking medications that depress the function of platelets (non-steroidal anti-inflammatory drugs, acetylsalicylic acid, dipyridamone, ticlopidine) because of increased risk of bleeding.

Simultaneous administration of escitalopram and omeprazole at a dose of 30 mg once a day leads to an increase in the concentration of escitalopram in blood plasma by 50%. Simultaneous appointment of escitalopram and cimetidine at a dose of 400 mg 2 times a day leads to an increase in the concentration of escitalopram in blood plasma by 70%.

Esomeprazole, fluvoxamine, lansoprazole, ticlopidine increase the concentration of escitalopram in blood plasma.

Escitalopram increases the concentration in the blood plasma of medicines such as flecainide, propafenone, metoprolol, desipramine, clomipramine, nortriptyline, risperidone, thioridazine and haloperidol.

Special instructions:

Antidepressants should not be given to children and adolescents under the age of 18 because of the increased risk of suicidal behavior (suicidal attempts and thoughts), hostility (with a predominance of aggressive behavior, a tendency to confrontation and irritation), data on efficacy and safety about the use of the drug Escitalopram There are no children in this age group.

In patients with panic disorders at the beginning of therapy with Escitalopram-Tevasymptoms of anxiety increase. This paradoxical reaction usually disappears within 2 weeks of ongoing therapy. A low initial dose reduces the possibility of an anxiogenic effect of the drug.

The risk of suicidal thoughts, self-harm, suicidal attempts is inherent in depression and can persist until a significant remission is achieved. Since the wedgethe improvement may not occur at the beginning of treatment, constant monitoring of the patient is necessary before the onset of clinically significant remission. The likelihood of suicidal behavior increases in the initial stages of treatment of depression. Patients with a history of suicidal behavior or who demonstrate this behavior before starting treatment should be under constant observation during therapy with Escitalopram-Teva. This precaution should be followed in the treatment of other mental disorders due to the possibility of simultaneous development of a depressive syndrome. The risk of suicidal behavior is higher in patients under 25 years of age.

The use of serotonin uptake inhibitors can lead to the development of akathisia, especially during the first weeks of therapy.The increase in the dose of the drug Escitalopram-Teva in this case is contraindicated.

With the development of epileptic seizures, the drug Escitalopram-Teva should be discontinued. This group of drugs is contraindicated in patients with unstable epilepsy. Patients receiving adequate treatment for epilepsy and Escitalopram-Teva should be under constant medical supervision. When the frequency of epileptic seizures increases, Escitalopram-Teva should be withdrawn.

The drug Escitalopram-Teva should be used with caution in patients with a history of mania or hypomania. At the onset of the manic phase, treatment should be discontinued.

In patients with diabetes, treatment with Escitalopram-Teva can change the concentration of glucose in the blood. Therefore, the dosage of insulin and / or oral hypoglycemic agents may need to be adjusted.

Hyponatremia, possibly associated with a decrease in the secretion of ADH, occurs rarely with the use of the drug Escitalopram-Teva and usually disappears when therapy is withdrawn. Caution should be manifested in the appointment of the drug Escitalopram-Teva and individuals at risk of developing hyponatremia: elderly patients,patients with cirrhosis of the liver and taking drugs that can cause hyponatraemia.

When taking Escitalopram-Teva, prolongation of bleeding time or development of cutaneous hemorrhages is possible. It is necessary to use the drug with caution in patients with a tendency to bleeding, and also taking oral anticoagulants and drugs that affect the function of platelets.

Since the clinical experience of simultaneous use of the drug Escitalopram-Teva and electroconvulsive therapy is limited, in such cases, Ostor should be observedIt isfromgt;

In patients taking the drug Escitalopram-Teva concomitantly with serotonergic drugs, in rare cases, a serotonin syndrome may develop. The drug Escitalopram-Teva should be used with caution at the same time with drugs that have a serotonergic effect. The combination of such symptoms as anxiety, tremor, myoclonus, hyperthermia, may indicate the development of serotonin syndrome. If this happens, immediately stop the simultaneous treatment with Escitalopram-Teva and serotonergic drugs and begin symptomatic treatment.

The drug Escitalopram-Teva does not enter with pharmacodynamic or pharmacokinetic interaction with alcohol. However, as with other psychotropic drugs, simultaneous use of Escitalopram-Teva and alcohol is not recommended.

Prescribe the drug Escitalopram-Teva in patients with coronary heart disease with caution.

When discontinuation of Escitalopram-Teva, especially sudden, develops withdrawal syndrome. Its clinical manifestations are dizziness, sensitivity disorders, including paresthesia, sleep disorders, agitation or anxiety, nausea and / or vomiting, tremor, blurred vision, skin hyperhidrosis, headache, diarrhea, palpitations, emotional lability, increased irritability, and visual disturbances . Usually these symptoms are mild or moderate, but it is possible to develop a severe condition. In rare cases, withdrawal syndrome is possible if you miss a regular dose of the drug. The withdrawal syndrome is self-cured within 2 weeks, but a duration of up to 2-3 months is possible.To reduce the risk of withdrawal syndrome, treatment should be discontinued within a few weeks or months, gradually reducing the dose of the drug in accordance with the clinical condition of the patient.

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

During the treatment with the drug Escitalopram-Teva, one should refrain from managing motor transport and practicing 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, 20 mg.

Packaging:

Dosage of 5 mg. For 10 or 28 tablets in a blister of PVC / PVDC / aluminum foil. 3 blisters for 10 tablets or 1 or 2 blisters for 28 tablets, together with instructions for use in kaptoneku.

Dosages of 10 mg and 20 mg. For 10 or 14 tablets in a blister of PVC / PVDC / aluminum foil. 3 blisters for 10 tablets or 1, 2 or 4 blisters for 14 tablets together with instructions for use in a cardboard box.

Storage conditions:

Store at a temperature not exceeding 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-001703

Date of registration:04.05.2012

Date of cancellation:2017-05-04

The owner of the registration certificate:Teva Pharmaceutical Enterprises Co., Ltd.Teva Pharmaceutical Enterprises Co., Ltd. Israel

Manufacturer: & nbsp

TEVA Operations Poland, Sp. z o.o. Poland

Representation: & nbspTeva Teva Israel

Information update date: & nbsp03.10.2015

Illustrated instructions

Instructions

Escitalopram-Teva (Escitalopram-Teva)