Expiration date: 05/2025

Release Form: tablets, film-coated

Composition

1 tablet contains 10 mg escitalopram

Packaging: 28 or 56 pcs.

Pharmachologic effect

Elicea - antidepressant, selective serotonin reuptake inhibitor (SSRI), increases the concentration of the neurotransmitter in the synaptic cleft by inhibiting reverse neuronal uptake of serotonin, increases and prolongs the action of serotonin on the postsynaptic receptors. Escitalopram has virtually no or has a very low affinity for a number of receptors including serotonin 5-HT 1A, 5-HT 2, dopamine: the D1 and D2, ?1- and ?2- and .beta.-adrenoceptors, histamine H1-receptor, m nicotinic acetylcholine receptor, benzodiazepine and opioid receptors, resulting in the absence or weak expression of various anticholinergic, sedative , cardiovascular side effects. Escitalopram also does not bind or has a very low affinity to different ion channels, including the Na +, K +, Cl-, Ca2 + channels.

Testimony

Depression, panic disorder (including with agoraphobia).

Contraindications

Hypersensitivity, simultaneous reception of MAO inhibitors, under the age of 15 years, pregnancy, lactation.

Dosing and Administration

Elicea taken orally, regardless of food intake. Depressive episodes: 10-20 mg 1 time per day. After the disappearance of the symptoms of depression, you should continue treatment for fixing the resulting effect within 6 months. Panic disorder (including with agoraphobia): 5 mg / day for the first week, followed by 10-20 mg / day. The maximum daily dose - 20 mg. Duration of treatment - a few months. Upon termination of the treatment the dose should be gradually reduced over 1-2 weeks to avoid the syndrome of "cancellation". In elderly patients (over 65 years), the recommended dose - 5 mg / day, maximum daily dose - 10 mg. When mild to moderate renal impairment dose adjustment is required. The recommended initial dose with reduced liver function during the first two weeks of treatment is 5 mg / day. Depending on the individual response of the patient the dose may be increased to 10 mg / day. For patients with weak activity CYP2C19 isozyme recommended starting dose for the first two weeks of treatment - 5 mg / day. Depending on the individual response of the patient the dose may be increased to 10 mg / day.

Side effects

Since the cardiovascular system: rarely - tachycardia, rarely - bradycardia, rarely - orthostatic hypotension.

Hematopoietic system: rarely - thrombocytopenia.

From the nervous system: often - insomnia, somnolence, dizziness, paraesthesia, tremor, anxiety, restlessness, nightmares, not often - taste disturbances, sleep disturbances, fainting, gnashing of teeth, agitation, akathisia, irritability, panic disorder, confusion rarely - serotonin syndrome (agitation, tremor, myoclonus, hyperthermia), aggression, depersonalization, hallucinations, suicidal thoughts and behavior, it is very rare - dyskinesia, seizure disorders and manic.

From the respiratory system: often - sinusitis, yawning, rarely - nosebleeds.

From the digestive system: very often - nausea, often - increased or decreased appetite, diarrhea, constipation, vomiting, dryness of the oral mucosa, rarely - gastrointestinal bleeding (including rectal), very rarely - hepatitis.

With the genitourinary system: often - abnormal ejaculation, impotence, decreased libido, and anorgasmia (in females), rarely - metrorrhagia, menorrhagia, very rarely - urinary retention, priapism, galactorrhoea.

From the sensory organs: rarely - mydriasis, visual disturbances, tinnitus.

For the skin: often - increased sweating, alopecia, rarely - ecchymosis.

From the musculoskeletal system: often - arthralgia, myalgia.

From endocrine system: very rarely - an inadequate secretion of antidiuretic hormone, galactorrhea.

Allergic reactions: often - urticaria, skin rash, pruritus, rarely - anaphylactic reactions, rarely - angioedema (angioedema).

Other: often - fatigue, fever, rarely - swelling.

From the laboratory parameters: often - increase in body weight, rarely - weight loss, very rarely - hyponatremia, changes in laboratory parameters of liver function.

With a sharp lifting of the drug may develop withdrawal symptoms.

Special instructions

Escitalopram should be administered only after 2 weeks after the cancellation of irreversible MAO inhibitors, and 24 hours after the cessation of therapy, reversible inhibitor of MAO. Non-selective MAO inhibitors may appoint not earlier than 7 days after discontinuation of escitalopram. Some patients with panic disorder at the beginning of treatment with escitalopram may experience increased anxiety, which disappears typically within the next 2 weeks of treatment. To reduce the risk of anxiety, it is recommended to use a low initial dose. It is necessary to stop the drug in case of seizures or increased rates pharmacologically uncontrolled epilepsy. With the development of mania escitalopram should be abolished. Escitalopram may increase in the blood glucose concentration in diabetes, which may require dose adjustment of hypoglycemic drugs. Clinical experience with escitalopram indicates a possible increase in the risk of suicide attempts in the realization of the first week of therapy, and therefore it is very important to carry out careful monitoring of the patients during this period. Hyponatremia, associated with a decrease in the secretion of ADH, while taking escitalopram is rare and usually disappears when you remove the drug. With the development of serotonin syndrome, the drug should be immediately withdrawn and symptomatic treatment. During the period of treatment should refrain from driving and activities potentially hazardous activities that require high concentration and psychomotor speed reactions.

Drug interactions

When concomitantly with MAO inhibitors increases the risk of serotonin syndrome, and serious adverse reactions. The combined use of serotonergic drugs (including with tramadol, sumatriptan and other. Triptans) may lead to serotonin syndrome. Simultaneous treatment with drugs that reduce the seizure threshold, increases the risk of seizures. It enhances the effect of tryptophan and drugs Li +. Increases toxicity of St. John's wort preparations. It enhances the effect of drugs that affect blood clotting (requires monitoring of indicators of blood coagulation). Drugs metabolized involving CYP2C19 system (including omeprazole), and which are potent inhibitors CYPZA4 and CYP2D6 (including flecainide, propafenone, metoprolol, desipramine, clomipramine, nortriptyline, risperidone, thioridazine, haloperidol), increase concentration of escitalopram. Increases in the plasma concentration of metoprolol and desipramine 2 times.

Overdose

Symptoms: dizziness, tremor, agitation, somnolence, serotonin syndrome, seizures, varying severity depression of consciousness (especially in combination with alcohol and / or other means, oppressive central nervous system function), nausea, vomiting, decreased blood pressure, tachycardia, ECG changes ( changes in segment ST, T wave, the QRS complex expansion, an increase in the QT interval), arrhythmia, respiratory depression, metabolic acidosis, rhabdomyolysis, hypokalemia, hyponatremia.

Treatment: symptomatic and supportive therapy: gastric lavage, activated charcoal, airway management, adequate oxygenation, control of the cardiovascular and respiratory systems. There is no specific antidote.

Storage conditions

The drug should be stored out of reach of children at or above 30 ° C, in their original packaging.

Elicea
(Escitalopram)