ELICEA PILLS 10MG

Indications for use

Depression, panic disorders (including with agoraphobia).

Dosage and Administration

The drug should be taken orally, 1 time per day, regardless of the meal.

Depressive episodes

The recommended dose is 10 mg per day.

Depending on the patient's individual response, the dose may be increased to a maximum of 20 mg per day.

The antidepressant effect develops 2-4 weeks after the start of treatment. After the disappearance of the symptoms of depression, it is necessary to continue therapy for at least 6 months. to consolidate the effect.

To stop therapy with escitalopram, it is necessary to gradually reduce the dose within 1-2 weeks in order to reduce the risk of developing the syndrome of "cancellation".

Panic disorders (including with agoraphobia)

5 mg / day for the first week, then 10-20 mg / day.

The maximum daily dose is 20 mg.

The maximum therapeutic effect is achieved approximately 3 months after the start of treatment.

Elderly patients (over 65)

The recommended dose is 5 mg per day, the maximum daily dose is 10 mg per day.

Renal dysfunction

With a mild or moderate degree of renal failure (creatinine clearance (QC) of more than 30 ml / min), dose adjustment is not required;

In severe renal failure (CC less than 30 ml / min) - the drug should be prescribed with caution.

Liver dysfunction

In case of abnormal liver function, the initial dose is 5 mg per day for 2 weeks.Depending on the individual response of the patient, the dose may be increased to 10 mg per day;

For severely impaired liver function, a slower dose titration is recommended.

Reduced activity of the isoenzyme CYP2C19

The recommended initial dose for the first 2 weeks is 5 mg per day, depending on the patient's individual response, the dose may be increased to 10 mg per day.

Contraindications

• hypersensitivity to escitalopram and other components of the drug;
• simultaneous use with monoamine oxidase inhibitors (MAO);
• age up to 18 years (efficacy and safety have not been studied);
• pregnancy and breastfeeding;
• simultaneous use with pimozide;
• galactosemia, lactase deficiency, glucose-galactose malabsorption syndrome.

Carefully

Pharmacologically uncontrolled epilepsy, history of mania / hypomania, diabetes mellitus, depression with suicidal attempts, old age, liver cirrhosis, chronic renal failure (creatinine clearance (CK) less than 30 ml / min), coronary heart disease (CHD), bleeding tendency; simultaneous use of drugs capable of causing hyponatremia, reducing the threshold of convulsive readiness, with anticoagulants or drugs that affect platelet aggregation, with alcohol, with lithium, St. John's wort, with tryptophan, drugs that are metabolized with the participation of the CYP2C19 isoenzyme system; with simultaneous use of electroconvulsive therapy (ECT), age 18-24 years (due to the risk of suicidal behavior).

Precautions and special instructions for use

You should stop using the drug Elycea® in the case of the development of convulsive disorders, epileptic seizures, or their increase in pharmacologically uncontrolled epilepsy.

With the development of the manic state of the drug Elycea® must be canceled.

Estsitalopram may increase the concentration of glucose in the blood in diabetes mellitus, which may require correction of oral hypoglycemic doses and / or insulin.

Hyponatremia associated with a decrease in the secretion of adrenocorticotropic hormone (ADH), against the background of the use of the drug Elycea® rarely occurs (often in older people, patients with cirrhosis of the liver, or constantly taking drugs that can cause hyponatremia) and usually disappears when the drug is canceled.

With the development of serotonin syndrome, the drug should be immediately canceled and symptomatic treatment prescribed.

Caution should be used with escitalopram in patients with a history of mania / hypomania. With the development of a manic state, escitalopram must be canceled.

Malignant neuroleptic syndrome (NNS) is a rare, potentially dangerous condition associated with the use of antidepressants, including escitalopram. Symptoms of ZNS: fever (hyperpyrexia), muscle rigidity, change in mental status and instability of the autonomic nervous system (arrhythmia, fluctuations in blood pressure, tachycardia, profuse sweating, heart rhythm disturbance). At detection of ZNS it is necessary to stop use of the drug Elyceya® immediately.

During the first two weeks, the development of akathisia / psychomotor agitation (subjectively unpleasant or annoying anxiety and the need for movement, often in combination with the inability to sit or stand still) is possible.

At use of the drug Elitseya® development of skin hemorrhages (an ecchymosis and purpura) is possible. It is necessary with caution to apply escitalopram in patients with a tendency to bleeding, as well as taking indirect anticoagulants and other drugs that affect blood clotting.

Simultaneous use of esciopalopram and ethanol is not recommended.

Clinical experience with electroconvulsive therapy (ECT) and escitalopram is limited, so caution is advised.

Limited experience with the use of escitalopram in patients with coronary artery disease, so the drug Elyceya® is recommended to be used with caution in this group of patients.

With rapid withdrawal of therapy with escitalopram, a syndrome of "withdrawal" often occurs: dizziness, sensory disturbances (including paresthesias), sleep disorders (insomnia, unusual dreams), psychomotor agitation, anxiety, nausea and / or vomiting, tremor, confusion, sweating, headache, diarrhea, palpitations, emotional lability and visual disturbances. The severity of these reactions is usually mild or moderate and the duration is limited. In this regard, the drug Elycea® It is recommended to cancel gradually, reducing the dose over several weeks or months.

In children, adolescents and young people (under 24 years) with depression, other mental disorders, antidepressants, compared with placebo, increase the risk of suicidal thoughts and suicidal behavior. Therefore, when using escitalopram or any other antidepressants in children, adolescents and young people (under 24), the risk of suicide should be correlated with the benefits of their use. In short-term studies, the risk of suicide was not increased in people over 24 years of age, and in people over 65 years of age it was somewhat reduced. Any depressive disorder itself increases the risk of suicide. Therefore, during treatment with antidepressants, all patients should be monitored for the purpose of early detection of abnormalities or behavioral changes, as well as suicidal tendencies.

Interactions with other drugs and other forms of interactions

Simultaneous use with MAO-A inhibitors is contraindicated (risk of developing serotonin syndrome).

With simultaneous use with serotonergic drugs (tramadol, Sumatriptan and other triptans) caution must be exercised (risk of developing serotonin syndrome). Doses of selegiline up to 10 mg per day were safely administered with racemic citalopram.

Concurrent use of escitalopram and pimozide is contraindicated.

The simultaneous use of drugs that reduce the threshold of convulsive readiness (tricyclic antidepressants, antipsychotics - phenothiazine, thioxanthene, butyrophenone, mefloquine, bupropion and tramadol derivatives) increases the risk of seizures.

Estsitalopram enhances the effect of drugs lithium, tryptophan.

Increases the toxicity of Hypericum perforatum preparations.

With the simultaneous use of escitalopram with indirect anticoagulants and pills, which affect the culture of the cross-functional societies, they are at the level of anti-depressants and pills; therapy and its termination (the risk of bleeding).

The simultaneous use of escitalopram and ethanol is not recommended.

Pharmacokinetic interaction

Caution should be taken with escitalopram simultaneously with inhibitors of the CYP2C19 isoenzyme (for example, Omeprazole , esomeprazole, fluvoxamine, lansoprazole, ticlopidine) or cimetidine, since the concentration of escitalopram in plasma increases, and therefore, you may need to reduce the dose of escitalopram.

Care must be taken with simultaneous use of escitalopram and drugs metabolized by the CYP2C19 isoenzyme and having a low therapeutic index, for example, flecainide, propafenone, Metoprolol (for heart failure) or drugs mainly metabolized by the CYP2C19 isoenzyme and acting on the central nervous system (CNS) and acting on the central nervous system (CNS), for example antidepressants (desipramine, clomiprama,nortriptiline) or neuroleptics (risperidone, thioridazine, haloperidol). In these cases, you may need a dose adjustment of these drugs.

Simultaneous use with metoprolol or desipramine can lead to a twofold increase in the concentrations of the last two drugs.

Use during pregnancy and lactation

Drug Elyceya® not used during pregnancy (safety is not established).

Due to the fact that escitalopram is secreted into breast milk, the use of the drug during breastfeeding is not recommended. In case of need of use of the drug Elitseya® in the period of a lactation, breastfeeding should be stopped.

Influence on ability to drive a car and other cars

during the period of treatment, it is necessary to refrain from driving vehicles and practicing potentially hazardous activities that require increased concentration and psychomotor speed due to the possibility of dizziness, hallucinations, confusion, depersonalization, and other side effects.

Unwanted effects

Classification of the incidence of side effects (WHO):

very often> 1/10

often from> 1/100 to <1/10

infrequently from> 1/1000 to <1/100

rarely from> 1/10000 to <1/1000

very rarely from <1/10000, including individual messages.

Since the cardiovascular system:

infrequently - tachycardia;

rarely bradycardia;

very rarely, orthostatic hypotension;

From the hemopoietic system:

very rarely - thrombocytopenia;

From the nervous system:

often - insomnia, drowsiness, dizziness, paresthesias, tremor, anxiety, anxiety, nightmares;

infrequently - taste disorders, sleep disorders, fainting, gnashing of teeth, psychomotor agitation, akathisia, irritability, panic disorders, confusion;

rarely, serotonin syndrome (agitation, tremor, myoclonus, hyperthermia), aggressiveness, depersonalization, hallucinations, suicidal thoughts and behavior;

very rarely - dyskinesia, convulsive and manic disorders;

On the part of the respiratory system:

often - sinusitis, yawning;

infrequently - nosebleeds;

From the digestive system:

very often nausea;

often - increased or decreased appetite, diarrhea, constipation, vomiting, dryness of the oral mucosa;

infrequently - Gastrointestinal bleeding (including rectal bleeding);

very rarely - hepatitis;

From the genitourinary system:

often - ejaculatory disorders, impotence, decreased libido, anorgasmia (in women);

rarely - metrorrhagia, menorrhagia;

very rarely - urinary retention, priapism, galactorrhea;