Elicea Ku-tab, 10 mg 56 pcs

Special Instructions

Severe renal insufficiency (creatinine clearance (CK) less than 30 ml/min), mania/hypomania, pharmacologically uncontrolled epilepsy, severe suicidal behavior, diabetes, cirrhosis of liver, tendency to bleeding, concurrent use with MAO B inhibitor (selegiline), serotonergic drugs, drugs that reduce seizure threshold, lithium, tryptophan, Drugs containing St. John’s Wort, oral anticoagulants and drugs that affect blood clotting, drugs that may cause hyponatremia, drugs metabolized with CYP2C19, ethanol, electroconvulsive therapy (ECT), elderly patients, pregnancy, breast-feeding.

The drug Elicea^® Ku-tab^® should not be used in children and adolescents under 18 years of age.

Kidney function impairment

Dose adjustment is not necessary in mild to moderate renal failure.

In severe renal insufficiency (CKI less than 30 ml/min), Elicea^® Ku-tab^® should be prescribed with caution.

Hepatic dysfunction

The recommended starting dose for the first two weeks of treatment is 5 mg/day. Depending on the individual patient’s reaction, the dose may be increased to 10 mg/day.

Antidepressants should not be prescribed to children and adolescents under 18 years of age because of the increased risk of suicidal behavior (suicide attempts and suicidal ideation), hostility (with a predominance of aggressive behavior, tendency to confrontation and irritation). If a decision is made based on a clinical assessment to initiate antidepressant therapy, the patient should be closely monitored.

The following should be considered when using drugs belonging to the therapeutic group of SSRIs, including escitalopram

Some patients with panic disorder may have increased anxiety at the start of antidepressant treatment. This paradoxical reaction usually disappears within the first two weeks of treatment. Low initial doses are recommended to reduce the likelihood of anxiogenic effects.

Escitalopram should be discontinued if there is a primary development of seizures or if their frequency increases (in patients with previously diagnosed epilepsy). SSRIs should not be used in patients with unstable epilepsy, and close monitoring is required in controlled seizures.

Escitalopram should be used with caution in patients with a history of mania/hypomania. If a manic state develops, escitalopram should be withdrawn.

In patients with diabetes mellitus, treatment with escitalopram may alter plasma glucose concentrations. Therefore, it may be necessary to adjust the doses of insulin and/or hypoglycemic drugs for oral administration.

Depression is associated with an increased risk of suicidal ideation, self-inflicted injuries, and suicide (suicidal ideation). This risk persists until the onset of significant remission. Because improvement may not be seen for the first few weeks of therapy or even longer, patients should be monitored closely until improvement occurs.

Common clinical practice shows that in the early stages of recovery, there may be an increased risk of suicide.

Other psychiatric conditions for which escitalopram is prescribed may also be associated with an increased risk of suicidal events and phenomena. In addition, these conditions may be co-occurring pathology in relation to the depressive episode. When treating patients with other psychiatric disorders, the same precautions should be followed as when treating patients with a depressive episode.

Patients with a history of suicidal behavior or patients with significant levels of suicidal ideation prior to treatment are at greater risk for suicidal thoughts or suicide attempts, so they should be monitored closely during treatment.

A meta-analysis of placebo-controlled clinical trials of antidepressants involving adult patients with psychiatric disorders found that antidepressant medication administration in patients younger than 25 years old had an increased risk of suicidal behavior compared to placebo administration. Medication treatment of these patients, and in particular those at high risk for suicide, should be accompanied by close monitoring, especially in the early phase of treatment and with dose changes.

Patients (and caregivers) should be warned to monitor for any signs of clinical deterioration, suicidal behavior or thoughts, and unusual behavioral changes, and to seek medical advice immediately if these symptoms occur.

The use of SSRIs/ SSRIs is associated with the development of akathisia, characterized by the development of subjectively unpleasant or depressing restlessness and a need for constant movement, often combined with an inability to sit or stand still. This most often manifests itself during the first few weeks of treatment. In patients with these symptoms, increasing the dose may lead to worsening.

Hyponatremia, possibly associated with impaired ADH secretion, is rare with SSRIs and usually resolves with treatment withdrawal. Caution should be exercised when using escitalopram and other SSRIs in individuals at risk for hyponatremia: elderly patients, patients with cirrhosis of the liver, and patients taking medications that may cause hyponatremia.

When taking SSRIs, there have been cases of skin hemorrhages (ecchymosis and purpura). Caution should be exercised when using escitalopram in patients taking oral anticoagulants and medications that affect blood clotting, as well as in patients who are prone to bleeding.

As clinical experience with concomitant use of SSRIs and ECT is limited, caution should be exercised when concomitantly using escitalopram and ECT.

The concomitant use of escitalopram and MAO A inhibitors is not recommended because of the risk of serotonin syndrome.

Escitalopram should be used with caution concomitantly with drugs with serotonergic effects, such as sumatriptan or other triptans, tramadol and tryptophan. Patients taking escitalopram and other SSRIs concomitantly with serotonergic drugs have rarely developed serotonin syndrome. Its development may be indicated by a combination of symptoms such as agitation, tremor, myoclonus and hyperthermia. If this occurs, concomitant treatment with SSRIs and serotoninergic drugs should be stopped immediately and symptomatic treatment should be initiated.

When treatment is discontinued, “withdrawal” symptoms are common, especially when treatment is stopped abruptly. In clinical studies, discontinuation-related adverse events occurred in approximately 25% of patients treated with escitalopram and 15% of those treated with placebo.

The risk of “withdrawal” symptoms may depend on several factors, including the duration of therapy and the dose of the drug, as well as the rate of dose reduction. The most commonly reported reactions include dizziness, sensory disturbances (including paresthesia and a sensation of electric shock), sleep disturbances (including insomnia and intense dreaming), agitation or anxiety, nausea and/or vomiting, tremor, confusion, increased sweating, headache, diarrhea, palpitations, emotional instability, irritability and visual disturbances. Usually these symptoms are mild to moderate, but they can be severe in some patients.

Symptoms usually occur within the first few days of stopping treatment, but very rarely have these symptoms been reported in patients who have accidentally missed taking the drug.

These symptoms usually go away on their own usually within two weeks, although in some patients they can be prolonged (2-3 months or more). Therefore, gradual dose reduction over several weeks or months is recommended when treatment is discontinued, according to the patient’s condition.

Because of the limited experience of use in patients with coronary heart disease, caution is recommended when using the drug.

Escitalopram has been found to cause dose-dependent prolongation of the QT interval. In the post-registration period, cases of QT interval prolongation and ventricular arrhythmias, including bidirectional ventricular tachycardia, have been reported primarily in female patients, with hypokalemia, or pre-existing QT interval prolongation, or other heart disease.

Cautions are required when using in patients with significant bradycardia or in patients with recent acute myocardial infarction or decompensated heart failure.

Electrolyte disturbances, such as hypokalemia and hypomagnesemia, increase the risk of malignant arrhythmias; these disturbances should be corrected before starting treatment with escitalopram.

In patients with stable coronary heart disease, an ECG should be performed before starting treatment.

If signs of cardiac arrhythmia occur during treatment with escitalopram, therapy should be stopped and an ECG should be performed.

The SSRIs, including escitalopram, may affect pupil size, resulting in mydriasis. This effect of pupil dilation has the potential to narrow the angle of the anterior chamber of the eye, leading to increased intraocular pressure and the development of closed angle glaucoma, especially in patients with a predisposition to this disease. Therefore, caution should be exercised when using escitalopram in patients with closed angle glaucoma or with a history of glaucoma.

Sexual dysfunction

Selective serotonin reuptake inhibitors/serotonin and norepinephrine reuptake inhibitors (SSRIs) can cause symptoms of sexual dysfunction. Long-term sexual dysfunction has been reported, with symptoms persisting after discontinuation of SSRIs/SRIs.

While the drug Elicea^® Ku-tab^® does not affect intellectual function or psychomotor activity, it is not recommended to drive vehicles or operate machinery during treatment.

Synopsis

5 mg tablets:

Round, flat-cylindrical tablets, white or nearly white, beveled and engraved “5” on one side.

Tablets 10 mg:

Round, flat-cylindrical tablets white or nearly white, beveled and engraved “10” on one side.

Tablets 20 mg:

Round, flat-cylindrical tablets white or nearly white, beveled and engraved “20” on one side.

Contraindications

• High sensitivity to escitalopram and other drug components.

• Simultaneous use of non-selective irreversible monoamine oxidase inhibitors (MAOIs).
• Simultaneous use of reversible MAO A inhibitors (moclobemide), reversible non-selective MAO inhibitors (linezolid).
• Anamnesis of QT interval prolongation, including congenital prolonged QT interval syndrome.
• Simultaneous use of QT interval prolonging drugs (see section “Interaction with other medicinal products”).
• Simultaneous use of pimozide.

• children and adolescents under 18 years of age (effectiveness and safety have not been studied).

• Lactose intolerance, lactase deficiency, or glucose-galactose malabsorption syndrome (Elicea^® Ku-tab^® contains lactose).

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Side effects

Side effects most often develop during the first or second week of therapy, then usually become less intense and occur less frequently if therapy is continued.

The side effects occurring with drugs belonging to the SSRI class and noted when taking escitalopram are as follows The information is based on data from placebo-controlled clinical trials and spontaneous reports.

Frequency is indicated as: very frequently (≥ 1/10), frequently (≥ 1/100 to < 1/10), infrequently

(≥ 1/1000 to < 1/100), rare (≥ 1/10000 to < 1/1000), very rare (< 1/10000), frequency unknown (incidence cannot be estimated from existing data).

Blood and lymphatic system disorders:

frequency unknown: thrombocytopenia.

Disorders of the immune system:

rarely: anaphylactic reactions.

Disorders of the endocrine system:

frequency unknown: insufficient secretion of antidiuretic hormone (ADH).

Disorders in the side of metabolism and nutrition:

often: decreased appetite, increased appetite, increased body weight;

infrequent: decreased body weight;

frequency unknown: hyponatremia, anorexia.

Mental disorders:

often: anxiety, restlessness, unusual dreams, decreased libido, anorgasmia (in women);

infrequent: bruxism, agitation, nervousness, panic attacks, confusion;

rarely: aggression, depersonalization, hallucinations;

frequency unknown: mania, suicidal thoughts, suicidal behavior.

Incidents of suicidal thoughts and behavior have been noted while taking escitalopram and immediately after discontinuation of therapy.

Nervous system disorders:

very often: headache

often: insomnia, drowsiness, dizziness, paresthesia, tremor;

infrequently: taste disturbance, sleep disturbance, syncope;

recommon: serotonin syndrome;

frequent unknown: dyskinesia, movement disorders, seizure disorders, psychomotor agitation/acathisia.

Visual disorders:

frequent: mydriasis (dilation of the pupil), visual disturbances.

Hearing organ and labyrinth disorders:

infrequent: tinnitus (tinnitus).

Cardiovascular disorders:

infrequent: tachycardia;

rarely: bradycardia;

frequent unknown: prolongation of the QT interval on the electrocardiogram (ECG), orthostatic hypotension.

Disorders of the respiratory system, thoracic and mediastinal organs:

often: sinusitis, yawning;

infrequently: nasal bleeding.

Gastrointestinal tract disorders:

very often: nausea;

often: Diarrhea, constipation, vomiting, dry oral mucosa;

infrequently: gastrointestinal bleeding (including bleeding from the rectum).

Disorders of theliver and biliary tract:

frequency unknown: hepatitis, increased activity of “liver” enzymes.

Skin and subcutaneous tissue disorders:

often: increased sweating;

infrequent: urticaria, alopecia, skin rash, skin itching;

frequency unknown: ecchymosis, angioedema.

Musculoskeletal and connective tissue disorders:

often: arthralgia, myalgia.

Repnal and urinary tract disorders:

frequent unknown: urinary retention.

Disorders of the genitals and mammary gland:

often: Impotence, impaired ejaculation;

infrequent: menorrhagia, metrorrhagia;

frequency unknown: galactorrhea, priapism.

General disorders and disorders at the site of administration:

often: weakness, hyperthermia;

infrequently: edema.

There have been cases of QT interval prolongation in the post-registration period, mostly in patients with pre-existing heart disease. In double-blind, placebo-controlled ECG studies in healthy volunteers, the change from baseline QTc value (Friedericia formula correction) was 4.3 msec at 10 mg/day dose and 10.7 msec at 30 mg/day.

Epidemiological studies involving patients aged 50 years and older have shown the existence of an increased risk of bone fracture in patients taking SSRIs and tricyclic antidepressants. The mechanism for this risk has not been established.

Withdrawal of SSRIs/ SSRIs (especially abrupt) often results in “withdrawal” syndrome. The most common effects are dizziness, sensory disturbances (including paresthesia and current sensations), sleep disturbances (including insomnia and intense dreaming), agitation or anxiety, nausea and/or vomiting, tremor, confusion, increased sweating, headache, diarrhea, palpitations, emotional instability, irritability, visual disturbances. These effects are usually mild to moderate and disappear quickly, but in some patients they may be more acute and/or of longer duration. A gradual withdrawal of the drug by reducing the dose is recommended.

Overdose

The data on overdose with escitalopram are limited, in many such cases there was also an overdose with other drugs. In most cases, the symptoms of overdose are mild or absent.

The cases of fatal overdose with escitalopram (without taking other drugs) are rare, in most cases there is also overdose with other drugs. When taking escitalopram in the dosage range of 400-800 mg in monotherapy no clinically significant overdose symptoms have occurred.

Symptoms

In case of overdose with escitalopram mostly symptoms of the central nervous system occur (from dizziness, tremor, and agitation to rare cases of serotonin syndrome, seizure disorders and coma), gastrointestinal tract (nausea/vomiting), cardiovascular system (arterial hypotension, tachycardia, prolongation of QT interval and arrhythmia), and electrolyte disorders (hypokalemia, hyponatremia).

Treatment

There is no specific antidote. The normal airway patency, oxygenation and ventilation of the lungs should be ensured. Gastric lavage should be performed and activated charcoal prescribed. Gastric lavage should be performed as soon as possible after ingestion. It is recommended to monitor the performance of the heart and other vital organs and to carry out symptomatic and supportive therapy.

Pregnancy use

There are limited data on the use of escitalopram during pregnancy.

Escitalopram studies in animals have demonstrated reproductive toxicity.

Escitalopram during pregnancy should only be taken when absolutely necessary and after careful assessment of the benefit/risk ratio.

If administration of escitalopram has continued into late pregnancy, especially in the third trimester, the newborn should be monitored. If administration of escitalopram continued until delivery or was discontinued shortly before delivery, the newborn may develop withdrawal symptoms.

If the mother takes SSRIs/ SSRIs (selective serotonin reuptake inhibitors/selective serotonin and noradrenaline reuptake inhibitors) in late pregnancy, the following side effects may develop in the newborn Respiratory depression, cyanosis, apnea, seizure disorders, temperature spikes, feeding difficulties, vomiting, hypoglycemia, muscle hypertension, muscle hypotonia, hyperreflexia, tremor, increased neuroreflex excitability, irritability, lethargy, constant crying, drowsiness and poor sleep. These symptoms may occur due to the development of withdrawal or serotoninergic syndrome. In most cases, these complications occur within 24 hours of birth.

The data from epidemiological studies suggest that the use of SSRIs during pregnancy, especially in the late term, may increase the risk of sustained pulmonary hypertension (PPHN) in newborns. The observed risk was 5 cases per 1,000 pregnancies. In the general population, there are 1-2 cases of PPHN per 1,000 pregnancies.

Escitalopram is expected to be excreted with breast milk, so breastfeeding is not recommended during treatment with escitalopram.

The data from animal studies have shown that some SSRIs can affect sperm quality. There is no animal research data on this aspect for escitalopram. Reports on the use of some SSRIs in humans have shown that the effects of these medications on semen quality are reversible. So far, the effects of escitalopram on fertility in humans have not been observed.

Similarities

Cipralex, Lenuxin, Excitalopram