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Escitalopram (Tablets) Instructions for Use

ATC Code

N06AB10 (Escitalopram)

Active Substance

Escitalopram (Rec.INN WHO registered)

Clinical-Pharmacological Group

Antidepressant

Pharmacotherapeutic Group

Psychoanaleptics; antidepressants; selective serotonin reuptake inhibitors

Pharmacological Action

Antidepressant. It selectively inhibits the reuptake of serotonin; increases the concentration of the neurotransmitter in the synaptic cleft, enhances and prolongs the action of serotonin on postsynaptic receptors. Escitalopram has virtually no affinity for serotonin (5-HT), dopamine (D1 and D2) receptors, α-adreno-, m-cholinoceptors, as well as benzodiazepine and opioid receptors.

The antidepressant effect usually develops 2-4 weeks after the start of treatment. The maximum therapeutic effect in the treatment of panic disorders is achieved approximately 3 months after the start of treatment.

Pharmacokinetics

Absorption is independent of food intake. Bioavailability is 80%. Time to reach Cmax in plasma is 4 hours. The kinetics of escitalopram are linear. Css is achieved after 1 week. The mean Css is 50 nmol/L (range 20 to 125 nmol/L) and is achieved at a dose of 10 mg/day. Apparent Vd ranges from 12 to 26 L/kg. Plasma protein binding is 80%.

It is metabolized in the liver to active demethylated and didemethylated metabolites. After multiple administration, the mean concentration of demethyl and didemethyl metabolites is 28-31% and less than 5%, respectively, of the escitalopram concentration. The metabolism of escitalopram to form the demethylated metabolite occurs mainly with the participation of the CYP2C19, CYP3A4 and CYP2D6 isoenzymes. In individuals with weak CYP2C19 isoenzyme activity, the concentration of escitalopram may be 2 times higher than in individuals with high activity of this isoenzyme. No significant changes in drug concentration are noted with weak CYP2D6 isoenzyme activity.

T1/2 after multiple administration is 30 hours. The main metabolites of escitalopram have a longer T1/2. Clearance is 0.6 L/min. Escitalopram and its main metabolites are excreted by the liver and mostly by the kidneys; partially excreted in the form of glucuronides. T1/2 and AUC increase in elderly patients.

Indications

Depression, panic disorders (including with agoraphobia).

ICD codes

ICD-10 code Indication
F31 Bipolar affective disorder
F32 Depressive episode
F33 Recurrent depressive disorder
F40 Phobic anxiety disorders (including agoraphobia, social phobias)
F41.0 Panic disorder [episodic paroxysmal anxiety]
F41.2 Mixed anxiety and depressive disorder
ICD-11 code Indication
6A60.Z Bipolar type I disorder, unspecified
6A61.Z Bipolar type II disorder, unspecified
6A6Z Bipolar or similar disorder, unspecified
6A70.Z Single episode depressive disorder, unspecified
6A71.Z Recurrent depressive disorder, unspecified
6A73 Mixed depressive and anxiety disorder
6B01 Panic disorder
6B0Z Anxiety or fear-related disorders, unspecified
6C9Z Disruptive behavior or dissocial disorders, unspecified

Dosage Regimen

The method of application and dosage regimen for a specific drug depend on its form of release and other factors. The optimal dosage regimen is determined by the doctor. It is necessary to strictly adhere to the compliance of the dosage form of a specific drug with the indications for use and dosage regimen.

Tablets

Take orally, regardless of meals. Depending on the indications, a single dose is 10-20 mg/day. Maximum daily dose is 20 mg. Duration of treatment is several months. When discontinuing treatment, the dose should be gradually reduced over 1-2 weeks to avoid the occurrence of withdrawal syndrome.

For elderly patients (over 65 years), the recommended dose is 5 mg/day, maximum daily dose is 10 mg.

For impaired liver function, the recommended initial dose during the first 2 weeks of treatment is 5 mg/day. Depending on individual response, the dose may be increased to 10 mg/day.

For patients with weak CYP2C19 isoenzyme activity, the recommended initial dose during the first 2 weeks of treatment is 5 mg/day. Depending on individual response, the dose may be increased to 10 mg/day.

Adverse Reactions

Nervous system disorders: dizziness, weakness, insomnia or drowsiness, seizures, tremor, movement disorders, serotonin syndrome (agitation, tremor, myoclonus, hyperthermia), hallucinations, mania, confusion, agitation, anxiety, depersonalization, panic attacks, increased irritability, visual disturbances.

Digestive system disorders: nausea, vomiting, dry oral mucosa, taste disturbances, decreased appetite, diarrhea, constipation, changes in liver function tests.

Cardiovascular system disorders: orthostatic hypotension.

Endocrine system disorders: decreased ADH secretion, galactorrhea.

Reproductive system disorders: decreased libido, impotence, ejaculation disorder, anorgasmia (in women).

Urinary system disorders: urinary retention.

Dermatological reactions: skin rash, itching, ecchymoses, purpura, increased sweating.

Allergic reactions: angioedema, anaphylactic reactions.

Metabolism and nutrition disorders: hyponatremia, hyperthermia.

Musculoskeletal and connective tissue disorders: arthralgia, myalgia.

Other: sinusitis, withdrawal syndrome (dizziness, headache and nausea).

Contraindications

Concomitant use of MAO inhibitors, children and adolescents under 15 years of age, pregnancy, lactation period, hypersensitivity to escitalopram.

Use in Pregnancy and Lactation

Contraindicated during pregnancy and during lactation (breastfeeding).

Use in Hepatic Impairment

Should be used with caution in liver cirrhosis.

Use in Renal Impairment

Should be used with caution in patients with renal failure (creatinine clearance less than 30 ml/min).

Pediatric Use

Contraindicated in children and adolescents under 15 years of age.

Geriatric Use

Should be used with caution in elderly patients.

Special Precautions

Should be used with caution in patients with renal failure (creatinine clearance less than 30 ml/min), hyponatremia, mania, in pharmacologically uncontrolled epilepsy, in depression with suicidal attempts, diabetes mellitus, in elderly patients, in liver cirrhosis, in patients with a tendency to bleeding, concomitantly with drugs that lower the seizure threshold, cause hyponatremia, with ethanol, with drugs metabolized with the participation of CYP2C19 isoenzymes.

Escitalopram should be prescribed only 2 weeks after discontinuation of irreversible MAO inhibitors and 24 hours after stopping therapy with a reversible MAO inhibitor. Non-selective MAO inhibitors can be prescribed no earlier than 7 days after discontinuation of escitalopram.

In some patients with panic disorder, increased anxiety may be observed at the beginning of treatment with escitalopram, which usually disappears during the subsequent 2 weeks of treatment. To reduce the likelihood of anxiety, it is recommended to use low initial doses.

Escitalopram should be discontinued in case of development of epileptic seizures or their increased frequency in pharmacologically uncontrolled epilepsy.

If a manic state develops, Escitalopram should be discontinued.

Escitalopram can increase blood glucose concentration in diabetes mellitus, which may require adjustment of the doses of hypoglycemic drugs.

Clinical experience with escitalopram indicates a possible increased risk of suicide attempts during the first weeks of therapy, which is why it is very important to carry out careful monitoring of patients during this period.

Hyponatremia associated with decreased ADH secretion during escitalopram administration occurs rarely and usually disappears upon its discontinuation.

If serotonin syndrome develops, Escitalopram should be immediately discontinued and symptomatic treatment prescribed.

Effect on ability to drive vehicles and operate machinery

During the treatment period, patients should avoid driving vehicles and other activities requiring high concentration and speed of psychomotor reactions.

Drug Interactions

With simultaneous use with MAO inhibitors, the risk of developing serotonin syndrome and serious adverse reactions increases.

Concomitant use with serotonergic agents (including tramadol, triptans) may lead to the development of serotonin syndrome.

With simultaneous use with drugs that lower the seizure threshold, increases the risk of seizures.

Escitalopram enhances the effects of tryptophan and lithium preparations, increases the toxicity of St. John’s wort preparations, the effects of drugs affecting blood clotting (control of blood clotting parameters is necessary).

Drugs metabolized with the participation of the CYP2C19 isoenzyme (including omeprazole), as well as those that are strong inhibitors of CYP3A4 and CYP2D6 (including flecainide, propafenone, metoprolol, desipramine, clomipramine, nortriptyline, risperidone, thioridazine, haloperidol), increase the plasma concentration of escitalopram.

Escitalopram increases the plasma concentration of desipramine and metoprolol by 2 times.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Rx Only

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.

Medical Disclaimer

Brand (or Active Substance), Marketing Authorisation Holder, Dosage Form

Marketing Authorization Holder

Teva Pharmaceutical Industries, Ltd. (Israel)

Manufactured By

Teva Kutno S.A. (Poland)

Dosage Form

Bottle Rx Icon Escitalopram-Teva Film-coated tablets, 5 mg: 28, 30, or 56 pcs.

Dosage Form, Packaging, and Composition

Film-coated tablets 1 tab.
Escitalopram 5 mg

10 pcs. – blisters made of PVC/PVDF/aluminum foil (3) – cardboard packs.
28 pcs. – blisters made of PVC/PVDF/aluminum foil (1) – cardboard packs.
28 pcs. – blisters made of PVC/PVDF/aluminum foil (2) – cardboard packs.

Marketing Authorization Holder

Teva Pharmaceutical Industries, Ltd. (Israel)

Dosage Form

Bottle Rx Icon Escitalopram-Teva Film-coated tablets, 5 mg: 28, 30, or 56 pcs.

Dosage Form, Packaging, and Composition

Film-coated tablets 1 tab.
Escitalopram 5 mg

10 pcs. – blisters made of PVC/PVDF/aluminum foil (3) – cardboard packs.
28 pcs. – blisters made of PVC/PVDF/aluminum foil (1) – cardboard packs.
28 pcs. – blisters made of PVC/PVDF/aluminum foil (2) – cardboard packs.

Marketing Authorization Holder

Teva Pharmaceutical Industries, Ltd. (Israel)

Manufactured By

Teva Kutno S.A. (Poland)

Dosage Form

Bottle Rx Icon Escitalopram-Teva Film-coated tablets, 10 mg: 28, 30, or 56 pcs.

Dosage Form, Packaging, and Composition

Film-coated tablets 1 tab.
Escitalopram 10 mg

10 pcs. – blisters made of PVC/PVDF/aluminum foil (3) – cardboard packs.
14 pcs. – blisters made of PVC/PVDF/aluminum foil (1) – cardboard packs.
14 pcs. – blisters made of PVC/PVDF/aluminum foil (2) – cardboard packs.
14 pcs. – blisters made of PVC/PVDF/aluminum foil (4) – cardboard packs.

Marketing Authorization Holder

Teva Pharmaceutical Industries, Ltd. (Israel)

Dosage Form

Bottle Rx Icon Escitalopram-Teva Film-coated tablets, 10 mg: 28, 30, or 56 pcs.

Dosage Form, Packaging, and Composition

Film-coated tablets 1 tab.
Escitalopram 10 mg

10 pcs. – blisters made of PVC/PVDF/aluminum foil (3) – cardboard packs.
14 pcs. – blisters made of PVC/PVDF/aluminum foil (1) – cardboard packs.
14 pcs. – blisters made of PVC/PVDF/aluminum foil (2) – cardboard packs.
14 pcs. – blisters made of PVC/PVDF/aluminum foil (4) – cardboard packs.

Marketing Authorization Holder

Teva Pharmaceutical Industries, Ltd. (Israel)

Manufactured By

Teva Kutno S.A. (Poland)

Dosage Form

Bottle Rx Icon Escitalopram-Teva Film-coated tablets, 20 mg: 28, 30, or 56 pcs.

Dosage Form, Packaging, and Composition

Film-coated tablets 1 tab.
Escitalopram 20 mg

10 pcs. – blisters made of PVC/PVDF/aluminum foil (3) – cardboard packs.
14 pcs. – blisters made of PVC/PVDF/aluminum foil (1) – cardboard packs.
14 pcs. – blisters made of PVC/PVDF/aluminum foil (2) – cardboard packs.
14 pcs. – blisters made of PVC/PVDF/aluminum foil (4) – cardboard packs.

Marketing Authorization Holder

Teva Pharmaceutical Industries, Ltd. (Israel)

Dosage Form

Bottle Rx Icon Escitalopram-Teva Film-coated tablets, 20 mg: 28, 30, or 56 pcs.

Dosage Form, Packaging, and Composition

Film-coated tablets 1 tab.
Escitalopram 20 mg

10 pcs. – blisters made of PVC/PVDF/aluminum foil (3) – cardboard packs.
14 pcs. – blisters made of PVC/PVDF/aluminum foil (1) – cardboard packs.
14 pcs. – blisters made of PVC/PVDF/aluminum foil (2) – cardboard packs.
14 pcs. – blisters made of PVC/PVDF/aluminum foil (4) – cardboard packs.

Marketing Authorization Holder

Beryozovsky Pharmaceutical Plant, CJSC (Russia)

Dosage Form

Bottle Rx Icon Escitalopram Film-coated tablets, 10 mg: 10, 14, 28, 30, or 56 pcs.

Dosage Form, Packaging, and Composition

Film-coated tablets white or almost white, round, biconvex, with a score on one side; on the cross-section, the tablet cores are white or almost white.

1 tab.
Escitalopram oxalate 12.77 mg,
   Equivalent to escitalopram content 10 mg

Excipients: silicified microcrystalline cellulose (prosolv SMCC) – 124.33 mg, incl.: [microcrystalline cellulose – 121.843 mg, colloidal silicon dioxide – 2.487 mg], croscarmellose sodium – 6.9 mg, talc – 4.5 mg, magnesium stearate – 1.5 mg.

Film coating composition: hypromellose – 4.5 mg, macrogol (polyethylene glycol) – 0.9 mg, talc – 1.25 mg, titanium dioxide (E171) – 0.85 mg).

7 pcs. – contour cell packs (2) – cardboard packs.
7 pcs. – contour cell packs (4) – cardboard packs.
7 pcs. – contour cell packs (8) – cardboard packs.
10 pcs. – contour cell packs (1) – cardboard packs.
10 pcs. – contour cell packs (3) – cardboard packs.
28 pcs. – polymer jars (1) – cardboard packs.

Marketing Authorization Holder

Pranapharm, LLC (Russia)

Dosage Forms

Bottle Rx Icon Escitalopram Film-coated tablets, 5 mg: 7, 10, 14, 20, 21, 28, 30, 35, 40, 50, 60, 70, 80, 90, or 100 pcs.
Film-coated tablets, 10 mg: 7, 10, 14, 20, 21, 28, 30, 35, 40, 50, 60, 70, 80, 90 or 100 pcs.
Film-coated tablets, 20 mg: 7, 10, 14, 20, 21, 28, 30, 35, 40, 50, 60, 70, 80, 90 or 100 pcs.

Dosage Form, Packaging, and Composition

Film-coated tablets white, round, biconvex, without a score; the cross-section is white or almost white.

1 tab.
Escitalopram oxalate 6.39 mg,
   Equivalent to escitalopram content 5 mg

Excipients: lactose monohydrate – 54.185 mg, microcrystalline cellulose – 20.28 mg, croscarmellose sodium – 3.75 mg, low molecular weight povidone – 2.025 mg, corn starch – 1.875 mg, magnesium stearate – 0.925 mg.

Film coating composition: hypromellose – 3.43 mg, titanium dioxide – 0.728 mg, macrogol 400 – 0.612 mg, dimethicone 100 – 0.23 mg.

7 pcs. – contour cell packs (1) – cardboard packs.
7 pcs. – contour cell packs (2) – cardboard packs.
7 pcs. – contour cell packs (3) – cardboard packs.
7 pcs. – contour cell packs (4) – cardboard packs.
7 pcs. – contour cell packs (5) – cardboard packs.
10 pcs. – contour cell packs (1) – cardboard packs.
10 pcs. – contour cell packs (2) – cardboard packs.
10 pcs. – contour cell packs (3) – cardboard packs.
10 pcs. – contour cell packs (4) – cardboard packs.
10 pcs. – contour cell packs (5) – cardboard packs.
10 pcs. – contour cell packs (6) – cardboard packs.
10 pcs. – contour cell packs (7) – cardboard packs.
10 pcs. – contour cell packs (8) – cardboard packs.
10 pcs. – contour cell packs (9) – cardboard packs.
10 pcs. – contour cell packs (10) – cardboard packs.

Film-coated tablets white, round, biconvex, without a score; the cross-section is white or almost white.

1 tab.
Escitalopram oxalate 12.78 mg,
   Equivalent to escitalopram content 10 mg

Excipients: lactose monohydrate – 108.37 mg, microcrystalline cellulose – 41.7 mg, croscarmellose sodium – 7.5 mg, low molecular weight povidone – 4.05 mg, corn starch – 3.75 mg, magnesium stearate – 1.85 mg.

Film coating composition: hypromellose – 3.43 mg, titanium dioxide – 0.728 mg, macrogol 400 – 0.612 mg, dimethicone 100 – 0.23 mg.

7 pcs. – contour cell packs (1) – cardboard packs.
7 pcs. – contour cell packs (2) – cardboard packs.
7 pcs. – contour cell packs (3) – cardboard packs.
7 pcs. – contour cell packs (4) – cardboard packs.
7 pcs. – contour cell packs (5) – cardboard packs.
10 pcs. – contour cell packs (1) – cardboard packs.
10 pcs. – contour cell packs (2) – cardboard packs.
10 pcs. – contour cell packs (3) – cardboard packs.
10 pcs. – contour cell packs (4) – cardboard packs.
10 pcs. – contour cell packs (5) – cardboard packs.
10 pcs. – contour cell packs (6) – cardboard packs.
10 pcs. – contour cell packs (7) – cardboard packs.
10 pcs. – contour cell packs (8) – cardboard packs.
10 pcs. – contour cell packs (9) – cardboard packs.
10 pcs. – contour cell packs (10) – cardboard packs.

Film-coated tablets white, round, biconvex, with a score; the cross-section is white or almost white.

1 tab.
Escitalopram oxalate 25.56 mg,
   Equivalent to escitalopram content 20 mg

Excipients: lactose monohydrate – 176.39 mg, microcrystalline cellulose – 69.5 mg, croscarmellose sodium – 12.5 mg, low molecular weight povidone – 6.75 mg, corn starch – 6.25 mg, magnesium stearate – 3.05 mg.

Film coating composition: hypromellose – 3.43 mg, titanium dioxide – 0.728 mg, macrogol 400 – 0.612 mg, dimethicone 100 – 0.23 mg.

7 pcs. – contour cell packs (1) – cardboard packs.
7 pcs. – contour cell packs (2) – cardboard packs.
7 pcs. – contour cell packs (3) – cardboard packs.
7 pcs. – contour cell packs (4) – cardboard packs.
7 pcs. – contour cell packs (5) – cardboard packs.
10 pcs. – contour cell packs (1) – cardboard packs.
10 pcs. – contour cell packs (2) – cardboard packs.
10 pcs. – contour cell packs (3) – cardboard packs.
10 pcs. – contour cell packs (4) – cardboard packs.
10 pcs. – contour cell packs (5) – cardboard packs.
10 pcs. – contour cell packs (6) – cardboard packs.
10 pcs. – contour cell packs (7) – cardboard packs.
10 pcs. – contour cell packs (8) – cardboard packs.
10 pcs. – contour cell packs (9) – cardboard packs.
10 pcs. – contour cell packs (10) – cardboard packs.

Marketing Authorization Holder

Pharmasintez-Tyumen, LLC (Russia)

Dosage Forms

Bottle Rx Icon Escitalopram Tablets for dispersion in the oral cavity 10 mg
Orally disintegrating tablets 20 mg

Dosage Form, Packaging, and Composition

Orally disintegrating tablets

1 tab.
Escitalopram 10 mg

10 pcs. – jars – cardboard packs (10 pcs.) – Prescription only
14 pcs. – jars – cardboard packs (14 pcs.) – Prescription only
14 pcs. – contour cell packs (2 pcs.) – cardboard packs (28 pcs.) – Prescription only
14 pcs. – contour cell packs (4 pcs.) – cardboard packs (56 pcs.) – Prescription only
28 pcs. – jars – cardboard packs (28 pcs.) – Prescription only
30 pcs. – jars – cardboard packs (30 pcs.) – Prescription only
56 pcs. – jars – cardboard packs (56 pcs.) – Prescription only
7 pcs. – contour cell packs (12 pcs.) – cardboard packs (84 pcs.) – Prescription only
7 pcs. – contour cell packs (4 pcs.) – cardboard packs (28 pcs.) – Prescription only
7 pcs. – contour cell packs (8 pcs.) – cardboard packs (56 pcs.) – Prescription only

Orally disintegrating tablets

1 tab.
Escitalopram 20 mg

10 pcs. – jars – cardboard packs (10 pcs.) – Prescription only
14 pcs. – jars – cardboard packs (14 pcs.) – Prescription only
14 pcs. – contour cell packs (2 pcs.) – cardboard packs (28 pcs.) – Prescription only
14 pcs. – contour cell packs (4 pcs.) – cardboard packs (56 pcs.) – Prescription only
28 pcs. – jars – cardboard packs (28 pcs.) – Prescription only
30 pcs. – jars – cardboard packs (30 pcs.) – Prescription only
56 pcs. – jars – cardboard packs (56 pcs.) – Prescription only
7 pcs. – contour cell packs (12 pcs.) – cardboard packs (84 pcs.) – Prescription only
7 pcs. – contour cell packs (4 pcs.) – cardboard packs (28 pcs.) – Prescription only
7 pcs. – contour cell packs (8 pcs.) – cardboard packs (56 pcs.) – Prescription only

Marketing Authorization Holder

Canonpharma Production, CJS (Russia)

Dosage Forms

Bottle Rx Icon Escitalopram Canon Film-coated tablets, 5 mg: 14, 20, 28, or 56 pcs.
Film-coated tablets, 10 mg: 14, 20, 28, or 56 pcs.
Film-coated tablets, 20 mg: 14, 20, 28, or 56 pcs.

Dosage Form, Packaging, and Composition

Film-coated tablets white or almost white, round, biconvex, with a score; the cross-section is almost white.

1 tab.
Escitalopram oxalate 6.39 mg
   Equivalent to escitalopram content 5 mg

Excipients: croscarmellose sodium – 3 mg, magnesium stearate – 1 mg, prosolv (microcrystalline cellulose 98%, colloidal silicon dioxide 2%) – 108.61 mg, stearic acid – 1 mg.

Film coating composition: opadry white – 4 mg, including: hypromellose (hydroxypropyl methylcellulose) – 1.35 mg, hyprolose (hydroxypropyl cellulose) – 1.35 mg, talc – 0.8 mg, titanium dioxide – 0.5 mg.

7 pcs. – contour cell packs (2) – cardboard packs.
7 pcs. – contour cell packs (4) – cardboard packs.
7 pcs. – contour cell packs (8) – cardboard packs.
10 pcs. – contour cell packs (2) – cardboard packs.
14 pcs. – contour cell packs (1) – cardboard packs.
14 pcs. – contour cell packs (2) – cardboard packs.
14 pcs. – contour cell packs (4) – cardboard packs.

Film-coated tablets white or almost white, round, biconvex, with a score; the cross-section is almost white.

1 tab.
Escitalopram oxalate 12.78 mg
   Equivalent to escitalopram content 10 mg

Excipients: croscarmellose sodium – 4.5 mg, magnesium stearate – 1.5 mg, prosolv (microcrystalline cellulose 98%, colloidal silicon dioxide 2%) – 159.72 mg, stearic acid – 1.5 mg.

Film coating composition: opadry white – 6 mg, including: hypromellose (hydroxypropyl methylcellulose) – 2.025 mg, hyprolose (hydroxypropyl cellulose) – 2.025 mg, talc – 1.2 mg, titanium dioxide – 0.75 mg.

7 pcs. – contour cell packs (2) – cardboard packs.
7 pcs. – contour cell packs (4) – cardboard packs.
7 pcs. – contour cell packs (8) – cardboard packs.
10 pcs. – contour cell packs (2) – cardboard packs.
14 pcs. – contour cell packs (1) – cardboard packs.
14 pcs. – contour cell packs (2) – cardboard packs.
14 pcs. – contour cell packs (4) – cardboard packs.

Film-coated tablets white or almost white, round, biconvex, with a score; the cross-section is almost white.

1 tab.
Escitalopram oxalate 25.55 mg
   Equivalent to escitalopram content 20 mg

Excipients: croscarmellose sodium – 6.75 mg, magnesium stearate – 2.25 mg, prosolv (microcrystalline cellulose 98%, colloidal silicon dioxide 2%) – 233.2 mg, stearic acid – 2.25 mg.

Film coating composition: opadry white – 9 mg, including: hypromellose (hydroxypropyl methylcellulose) – 3.038 mg, hyprolose (hydroxypropyl cellulose) – 3.037 mg, talc – 1.8 mg, titanium dioxide – 1.125 mg.

7 pcs. – contour cell packs (2) – cardboard packs.
7 pcs. – contour cell packs (4) – cardboard packs.
7 pcs. – contour cell packs (8) – cardboard packs.
10 pcs. – contour cell packs (2) – cardboard packs.
14 pcs. – contour cell packs (1) – cardboard packs.
14 pcs. – contour cell packs (2) – cardboard packs.
14 pcs. – contour cell packs (4) – cardboard packs.

Marketing Authorization Holder

Pharmasintez-Tyumen, LLC (Russia)

Dosage Forms

Bottle Rx Icon Escitalopram Pharmasyntez Film-coated tablets 5 mg
Film-coated tablets 10 mg
Film-coated tablets, 20 mg

Dosage Form, Packaging, and Composition

Film-coated tablets

1 tab.
Escitalopram (as oxalate) 5 mg

10 pcs. – jars – cardboard packs (10 pcs.) – Prescription only
10 pcs. – contour cell packs (2 pcs.) – cardboard packs (20 pcs.) – Prescription only
10 pcs. – contour cell packs (3 pcs.) – cardboard packs (30 pcs.) – Prescription only
10 pcs. – contour cell packs (6 pcs.) – cardboard packs (60 pcs.) – Prescription only
10 pcs. – contour cell packs (9 pcs.) – cardboard packs (90 pcs.) – Prescription only
100 pcs. – jars – cardboard packs (100 pcs.) – Prescription only
14 pcs. – contour cell packs – cardboard packs (14 pcs.) – Prescription only
14 pcs. – contour cell packs (2 pcs.) – cardboard packs (28 pcs.) – Prescription only
14 pcs. – contour cell packs (4 pcs.) – cardboard packs (56 pcs.) – Prescription only
20 pcs. – jars – cardboard packs (20 pcs.) – Prescription only
28 pcs. – jars – cardboard packs (28 pcs.) – Prescription only
30 pcs. – jars – cardboard packs (30 pcs.) – Prescription only
40 pcs. – jars – cardboard packs (40 pcs.) – Prescription only
50 pcs. – jars – cardboard packs (50 pcs.) – Prescription only
60 pcs. – jars – cardboard packs (60 pcs.) – Prescription only
7 pcs. – contour cell packs (2 pcs.) – cardboard packs (14 pcs.) – Prescription only
7 pcs. – contour cell packs (4 pcs.) – cardboard packs (28 pcs.) – Prescription only
7 pcs. – contour cell packs (8 pcs.) – cardboard packs (56 pcs.) – Prescription only
70 pcs. – jars – cardboard packs (70 pcs.) – Prescription only
80 pcs. – jars – cardboard packs (80 pcs.) – Prescription only
90 pcs. – jars – cardboard packs (90 pcs.) – Prescription only

Film-coated tablets

1 tab.
Escitalopram (as oxalate) 10 mg

10 pcs. – jars – cardboard packs (10 pcs.) – Prescription only
10 pcs. – contour cell packs (2 pcs.) – cardboard packs (20 pcs.) – Prescription only
10 pcs. – contour cell packs (3 pcs.) – cardboard packs (30 pcs.) – Prescription only
10 pcs. – contour cell packs (6 pcs.) – cardboard packs (60 pcs.) – Prescription only
10 pcs. – contour cell packs (9 pcs.) – cardboard packs (90 pcs.) – Prescription only
100 pcs. – jars – cardboard packs (100 pcs.) – Prescription only
14 pcs. – contour cell packs – cardboard packs (14 pcs.) – Prescription only
14 pcs. – contour cell packs (2 pcs.) – cardboard packs (28 pcs.) – Prescription only
14 pcs. – contour cell packs (4 pcs.) – cardboard packs (56 pcs.) – Prescription only
20 pcs. – jars – cardboard packs (20 pcs.) – Prescription only
28 pcs. – jars – cardboard packs (28 pcs.) – Prescription only
30 pcs. – jars – cardboard packs (30 pcs.) – Prescription only
40 pcs. – jars – cardboard packs (40 pcs.) – Prescription only
50 pcs. – jars – cardboard packs (50 pcs.) – Prescription only
60 pcs. – jars – cardboard packs (60 pcs.) – Prescription only
7 pcs. – contour cell packs (2 pcs.) – cardboard packs (14 pcs.) – Prescription only
7 pcs. – contour cell packs (4 pcs.) – cardboard packs (28 pcs.) – Prescription only
7 pcs. – contour cell packs (8 pcs.) – cardboard packs (56 pcs.) – Prescription only
70 pcs. – jars – cardboard packs (70 pcs.) – Prescription only
80 pcs. – jars – cardboard packs (80 pcs.) – Prescription only
90 pcs. – jars – cardboard packs (90 pcs.) – Prescription only

Film-coated tablets

1 tab.
Escitalopram (as oxalate) 20 mg

10 pcs. – jars – cardboard packs (10 pcs.) – Prescription only
10 pcs. – contour cell packs (2 pcs.) – cardboard packs (20 pcs.) – Prescription only
10 pcs. – contour cell packs (3 pcs.) – cardboard packs (30 pcs.) – Prescription only
10 pcs. – contour cell packs (6 pcs.) – cardboard packs (60 pcs.) – Prescription only
10 pcs. – contour cell packs (9 pcs.) – cardboard packs (90 pcs.) – Prescription only
100 pcs. – jars – cardboard packs (100 pcs.) – Prescription only
14 pcs. – contour cell packs – cardboard packs (14 pcs.) – Prescription only
14 pcs. – contour cell packs (2 pcs.) – cardboard packs (28 pcs.) – Prescription only
14 pcs. – contour cell packs (4 pcs.) – cardboard packs (56 pcs.) – Prescription only
20 pcs. – jars – cardboard packs (20 pcs.) – Prescription only
28 pcs. – jars – cardboard packs (28 pcs.) – Prescription only
30 pcs. – jars – cardboard packs (30 pcs.) – Prescription only
40 pcs. – jars – cardboard packs (40 pcs.) – Prescription only
50 pcs. – jars – cardboard packs (50 pcs.) – Prescription only
60 pcs. – jars – cardboard packs (60 pcs.) – Prescription only
7 pcs. – contour cell packs (2 pcs.) – cardboard packs (14 pcs.) – Prescription only
7 pcs. – contour cell packs (4 pcs.) – cardboard packs (28 pcs.) – Prescription only
7 pcs. – contour cell packs (8 pcs.) – cardboard packs (56 pcs.) – Prescription only
70 pcs. – jars – cardboard packs (70 pcs.) – Prescription only
80 pcs. – jars – cardboard packs (80 pcs.) – Prescription only
90 pcs. – jars – cardboard packs (90 pcs.) – Prescription only

Marketing Authorization Holder

Obnovlenie Pfc, JSC (Russia)

Dosage Forms

Bottle Rx Icon Escitalopram Renewal Film-coated tablets 5 mg
Film-coated tablets 10 mg
Film-coated tablets, 20 mg

Dosage Form, Packaging, and Composition

Film-coated tablets

1 tab.
Escitalopram (as oxalate) 5 mg

10 pcs. – contour cell packs (2) – cardboard packs (20 pcs.) – By prescription
10 pcs. – contour cell packs (3) – cardboard packs (30 pcs.) – By prescription
10 pcs. – contour cell packs (6) – cardboard packs (60 pcs.) – By prescription
14 pcs. – contour cell packs – cardboard packs (14 pcs.) – By prescription
14 pcs. – contour cell packs (2) – cardboard packs (28 pcs.) – By prescription
14 pcs. – contour cell packs (4) – cardboard packs (56 pcs.) – By prescription
15 pcs. – contour cell packs (2) – cardboard packs (30 pcs.) – By prescription
15 pcs. – contour cell packs (4) – cardboard packs (60 pcs.) – By prescription

Film-coated tablets

1 tab.
Escitalopram (as oxalate) 10 mg

10 pcs. – contour cell packs (2) – cardboard packs (20 pcs.) – By prescription
10 pcs. – contour cell packs (3) – cardboard packs (30 pcs.) – By prescription
10 pcs. – contour cell packs (6) – cardboard packs (60 pcs.) – By prescription
14 pcs. – contour cell packs – cardboard packs (14 pcs.) – By prescription
14 pcs. – contour cell packs (2) – cardboard packs (28 pcs.) – By prescription
14 pcs. – contour cell packs (4) – cardboard packs (56 pcs.) – By prescription
15 pcs. – contour cell packs (2) – cardboard packs (30 pcs.) – By prescription
15 pcs. – contour cell packs (4) – cardboard packs (60 pcs.) – By prescription

Film-coated tablets

1 tab.
Escitalopram (as oxalate) 20 mg

10 pcs. – contour cell packs (2) – cardboard packs (20 pcs.) – By prescription
10 pcs. – contour cell packs (3) – cardboard packs (30 pcs.) – By prescription
10 pcs. – contour cell packs (6) – cardboard packs (60 pcs.) – By prescription
14 pcs. – contour cell packs – cardboard packs (14 pcs.) – By prescription
14 pcs. – contour cell packs (2) – cardboard packs (28 pcs.) – By prescription
14 pcs. – contour cell packs (4) – cardboard packs (56 pcs.) – By prescription
15 pcs. – contour cell packs (2) – cardboard packs (30 pcs.) – By prescription
15 pcs. – contour cell packs (4) – cardboard packs (60 pcs.) – By prescription

Marketing Authorization Holder

Sandoz, d.d. (Slovenia)

Manufactured By

Sanofi-Aventis Private, Co. Ltd. (Hungary)

Dosage Form

Bottle Rx Icon Escitalopram Sandoz® Film-coated tablets, 5 mg: 10, 20, 30, 60, or 90 pcs.

Dosage Form, Packaging, and Composition

Film-coated tablets white or almost white, round, biconvex.

1 tab.
Escitalopram oxalate 6.39 mg,
   Equivalent to escitalopram content 5 mg

Excipients : lactose monohydrate – 68.49 mg, microcrystalline cellulose – 6.93 mg, croscarmellose sodium – 4.5 mg, hypromellose – 1.44 mg, magnesium stearate – 1.35 mg, colloidal silicon dioxide – 0.9 mg.

Shell composition hypromellose – 2.07 mg, macrogol 6000 – 0.51 mg, titanium dioxide (E171) – 0.27 mg, talc – 0.15 mg,

10 pcs. – Al/Al blisters (1) – cardboard packs.
10 pcs. – Al/Al blisters (2) – cardboard packs.
10 pcs. – Al/Al blisters (3) – cardboard packs.
10 pcs. – Al/Al blisters (6) – cardboard packs.
10 pcs. – Al/Al blisters (9) – cardboard packs.

Marketing Authorization Holder

Sandoz, d.d. (Slovenia)

Manufactured By

Sanofi-Aventis Private, Co. Ltd. (Hungary)

Dosage Form

Bottle Rx Icon Escitalopram Sandoz® Film-coated tablets, 10 mg: 10, 20, 30, 60, or 90 pcs.

Dosage Form, Packaging, and Composition

Film-coated tablets white or almost white, oval, biconvex, with a score on one side; the core of the tablet on the cross-section is white or almost white.

1 tab.
Escitalopram oxalate 12.77 mg,
   Equivalent to escitalopram content 10 mg

Excipients : lactose monohydrate – 91.23 mg, microcrystalline cellulose – 9.63 mg, croscarmellose sodium – 6.25 mg, hypromellose – 2 mg, magnesium stearate – 1.88 mg, colloidal silicon dioxide – 1.25 mg.

Shell composition hypromellose – 3.45 mg, macrogol 6000 – 0.85 mg, titanium dioxide (E171) – 0.45 mg, talc – 0.25 mg,

10 pcs. – Al/Al blisters (1) – cardboard packs.
10 pcs. – Al/Al blisters (2) – cardboard packs.
10 pcs. – Al/Al blisters (3) – cardboard packs.
10 pcs. – Al/Al blisters (6) – cardboard packs.
10 pcs. – Al/Al blisters (9) – cardboard packs.

Marketing Authorization Holder

Sandoz, d.d. (Slovenia)

Manufactured By

Sanofi-Aventis Private, Co. Ltd. (Hungary)

Dosage Form

Bottle Rx Icon Escitalopram Sandoz® Film-coated tablets, 15 mg: 10, 20, 30, 60, or 90 pcs.

Dosage Form, Packaging, and Composition

Film-coated tablets white or almost white, oval, biconvex, with two scores on each side; the core of the tablet on the cross-section is white or almost white.

1 tab.
Escitalopram oxalate 19.16 mg,
   Equivalent to escitalopram content 15 mg

Excipients : lactose monohydrate – 136.85 mg, microcrystalline cellulose – 14.44 mg, croscarmellose sodium – 9.38 mg, hypromellose – 3 mg, magnesium stearate – 2.81 mg, colloidal silicon dioxide – 1.88 mg.

Shell composition hypromellose – 4.49 mg, macrogol 6000 – 1.11 mg, titanium dioxide (E171) – 0.59 mg, talc – 0.33 mg,

10 pcs. – Al/Al blisters (1) – cardboard packs.
10 pcs. – Al/Al blisters (2) – cardboard packs.
10 pcs. – Al/Al blisters (3) – cardboard packs.
10 pcs. – Al/Al blisters (6) – cardboard packs.
10 pcs. – Al/Al blisters (9) – cardboard packs.

Marketing Authorization Holder

Sandoz, d.d. (Slovenia)

Manufactured By

Sanofi-Aventis Private, Co. Ltd. (Hungary)

Dosage Form

Bottle Rx Icon Escitalopram Sandoz® Film-coated tablets, 20 mg: 10, 20, 30, 60, or 90 pcs.

Dosage Form, Packaging, and Composition

Film-coated tablets white or almost white, round, biconvex, with a cross-shaped score on each side; the core of the tablet on the cross-section is white or almost white.

1 tab.
Escitalopram oxalate 25.54 mg,
   Equivalent to escitalopram content 20 mg

Excipients : lactose monohydrate – 182.46 mg, microcrystalline cellulose – 19.25 mg, croscarmellose sodium – 12.5 mg, hypromellose – 4 mg, magnesium stearate – 3.75 mg, colloidal silicon dioxide – 2.5 mg.

Shell composition hypromellose – 4.83 mg, macrogol 6000 – 1.19 mg, titanium dioxide (E171) – 0.63 mg, talc – 0.35 mg,

10 pcs. – Al/Al blisters (1) – cardboard packs.
10 pcs. – Al/Al blisters (2) – cardboard packs.
10 pcs. – Al/Al blisters (3) – cardboard packs.
10 pcs. – Al/Al blisters (6) – cardboard packs.
10 pcs. – Al/Al blisters (9) – cardboard packs.

Table of Contents

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