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ESSOBEL (ESSOBEL)

ESCITALOPRAM N06A B10

Nobel

COMPOSITION AND FORM OF ISSUE:

tab. p / o 10 mg, No. 28

Escitalopram10 mg

No. UA / 10328/01/01 from 12/10/2009 to 12/10/2014

tab. p / o 20 mg, No. 28

Escitalopram20 mg

No. UA / 10328/01/02 from 12/10/2009 to 12/10/2014

PHARMACOLOGICAL PROPERTIES:

Pharmacodynamics Essobel is an antidepressant, a selective serotonin reuptake inhibitor (SSRI), which causes the clinical and pharmacological effects of the drug. It has a high affinity for the main binding element and the adjacent allosteric element of the serotonin transporter and does not show or is very weakly able to bind to a number of receptors, including serotonin 5-HT1A-, 5-HT2receptors, dopamine D1- and D2receptors, α1-, α2-, β-adrenergic receptors, histamine H1-, M-cholinergic receptors, benzodiazepine and opiate receptors.
Pharmacokinetics Absorption is almost complete and does not depend on food intake. Cmax in blood plasma is achieved 4 hours after application. The bioavailability of escitalopram is about 80%. The binding of escitalopram and its main metabolites to blood proteins <80%. It is metabolized in the liver to the formation of metabolites that are demethylated and didemethylated. Both are pharmacologically active. The biotransformation of escitalopram to a demethylated metabolite occurs using cytochrome P450 2C19. Perhaps insignificant participation in this process of isoenzymes CYP 3A4 and CYP 2D6. T½ the drug - about 30 hours. Ground clearance (Cloral) when taken orally, is approximately 0.6 l / min. The main metabolites of T½ longer lasting. Escitalopram and its main metabolites are excreted by the liver (metabolic pathway) and kidneys. Most of the dose is excreted as metabolites in the urine. The kinetics of escitalopram is linear. Equilibrium concentration is reached after approximately 1 week. In elderly patients (over 65), escitalopram is excreted more slowly than in young patients.

INDICATIONS:

treatment for major depressive episodes, panic disorders with / without agoraphobia, social anxiety disorders (social phobia), generalized anxiety disorders.

APPLICATION:

Essobel is used in adults once a day, regardless of food intake.
Great depressive episode. Usually prescribed 10 mg 1 time per day. Depending on the individual sensitivity of the patient, the daily dose may be increased to 20 mg. The antidepressant effect usually develops after 2–4 weeks. After the symptoms of depression disappear for at least another 6 months, therapy should be continued to consolidate the effect.
Panic disorders with agoraphobia or without it. During the 1st week, an initial dose of 5 mg / day is recommended, followed by its increase to 10 mg / day. Depending on individual sensitivity, the dose can be further increased to 20 mg / day. The maximum effect in the treatment of panic disorders is achieved after 3 months. The treatment period is several months and depends on the severity of the disease.
Social anxiety disorders (social phobia). Usually prescribed 10 mg 1 time per day. Depending on individual sensitivity, the daily dose can be increased to 20 mg. Symptom relief usually occurs after 2–4 weeks of treatment. It is recommended to continue treatment for 3 months. Long-term treatment (6 months) is prescribed to prevent relapse, given the individual manifestations of the disease; regularly evaluate the effectiveness of treatment.
Generalized anxiety disorders. Usually prescribed 10 mg 1 time per day. Depending on individual sensitivity, the dose may be increased to a maximum of 20 mg / day. It is recommended to continue treatment for 3 months. Long-term treatment (6 months) is prescribed to prevent relapse, given the individual manifestations of the disease; treatment effectiveness is regularly evaluated.
Elderly patients (over the age of 65). The initial dose is half the usual recommended dose. The recommended daily dose for the elderly is 5 mg.Depending on the individual sensitivity and severity of depression, the daily dose may be increased to a maximum of 10 mg / day.
Renal failure. In case of renal failure, mild to moderate dose adjustment is not required. With caution, it is necessary to use the drug in patients with severe renal failure (creatinine clearance <30 ml / min).
Impaired liver function. The recommended initial dose for the first 2 weeks of treatment is 5 mg / day. Depending on individual sensitivity, the dose may be increased to 10 mg / day.
Reduced activity of cytochrome P450 2C19. For patients with reduced activity of the cytochrome P450 2C19 isoenzyme, the recommended initial dose for the first 2 weeks of treatment is 5 mg / day. Depending on individual sensitivity, the dose may be increased to 10 mg / day.
Discontinuation of treatment. Upon termination of treatment with Essobel, the dose should be gradually reduced over 1-2 weeks in order to avoid the withdrawal syndrome.

CONTRAINDICATIONS:

hypersensitivity to escitalopram or other components of the drug, simultaneous use with MAO inhibitors or pimozide, pregnancy and lactation, childrens age.

SIDE EFFECTS:

as a rule, they are transient and insignificant, are noted during the 1-2 weeks of treatment and gradually disappear:
from the hematopoietic system: thrombocytopenia;
from the immune system: anaphylactic reactions;
from the endocrine system: violation of the secretion of antidiuretic hormone;
from the side of metabolism: decreased or increased appetite, hyponatremia;
mental disorders: often - anxiety, anxiety, abnormal dreams, decreased libido, in women - anorgasmia; infrequently - bruxism, agitation, nervousness, panic attacks, confusion; rarely - aggression, depersonalization, hallucinations, suicide; in isolated cases - mania;
from the central nervous system: often - insomnia, drowsiness, dizziness, paresthesia, tremor; sometimes - taste disturbance, sleep disturbance, loss of consciousness; rarely - serotonin syndrome; very rarely - dyskinesia, motor disorders, convulsions;
on the part of the organ of vision: dilated pupil, blurred vision;
on the part of the hearing organ: tinnitus;
from the cardiovascular system: tachycardia, bradycardia, postural hypotension;
from the respiratory system: sinusitis, yawning, nosebleeds;
from the gastrointestinal tract: often nausea; sometimes - diarrhea, constipation, vomiting, dry mouth; rarely - gastrointestinal bleeding (including rectal);
hepatobiliary disorders: hepatitis;
on the part of the skin and subcutaneous tissue: increased sweating, skin rash, baldness, itching; in isolated cases - hematomas, edema;
from the musculoskeletal system: arthralgia, myalgia.
from the urinary tract: urinary retention;
from the reproductive system and mammary glands: often - men - ejaculation disorders, impotence; women - metrorrhagia, menorrhagia; in isolated cases - men - priapism, galactorrhea;
general violations: fatigue, pyrexia, edema;
laboratory indicators: increase / decrease in body weight, abnormal indicators of liver function.
There are reports of side effects with the use of SSRI class drugs such as anorexia and akathisia. About cases of lengthening the interval Q – T It was reported in the clinical use of the drug in patients with diseases of the cardiovascular system, while a clear causal relationship has not been established.
Symptoms of withdrawal: usually occur within a few days after the sudden cessation of the drug and pass in most cases within 2 weeks.In clinical studies, withdrawal symptoms were observed in approximately 25% of patients taking escitalopram and in 15% of patients taking placebo. Dizziness, headache, sensory disturbances, sleep disturbances, anxiety, nausea and / or vomiting, tremors, confusion, increased sweating, headache, diarrhea, tachycardia, emotional lability, irritability and visual impairment were noted most often. Most of these symptoms are minor and transient, but may have a severe and / or prolonged course in some patients. In order to avoid withdrawal symptoms, it is recommended that the drug is gradually discontinued for 1–2 weeks.

SPECIAL INSTRUCTIONS:

paradoxical anxiety: in some patients with panic disorders, an increase in anxiety may occur at the beginning of treatment with SSRIs. Such a paradoxical reaction usually disappears within 2 weeks of treatment. To reduce the likelihood of an anxiogenic effect, it is recommended to use the drug in low initial doses;
convulsive attacks: it is necessary to cancel the drug in case of convulsive attacks;
mania: SSRIs are used with caution in patients with a history of mania / hypomania. When a manic state appears, the drug must be canceled;
diabetes: in patients with diabetes, treatment with SSRIs can change glycemic parameters (hypoglycemia or hyperglycemia). Dosing of insulin and / or oral hypoglycemic drug requires correction;
suicide: suicidal attempts are characteristic of people in a state of depression, their threat may exist until a stable remission is achieved both spontaneously and as a result of therapy. It is necessary to carefully monitor the condition of patients taking antidepressants, especially at the beginning of therapy, regarding the clinical deterioration and / or occurrence of suicidal thoughts and behavior; such caution is necessary in the treatment of patients with other mental disorders due to the possible presence of concomitant major depressive disorder;
akathisia: the use of SSRIs, as well as SSRIs and norepinephrine, is associated with the development of akathisia, a condition characterized by an unpleasant debilitating feeling of anxiety and hyperactivity, usually accompanied by an inability to sit or stand in one place. This condition most often occurs during the first few weeks of therapy. Increasing the dose can lead to a deterioration in the condition of patients who have such symptoms;
hyponatremia: hyponatremia, probably associated with impaired secretion of antidiuretic hormone, rarely occurs with SSRIs and usually disappears when therapy is canceled. SSRIs should be prescribed with caution to patients at risk (old age, the presence of cirrhosis or simultaneous treatment with drugs that cause hyponatremia);
hemorrhage: when taking SSRIs, hemorrhages (ecchymosis and purpura) may develop. It is necessary to use SSRIs with caution in patients at risk of bleeding, as well as in patients who take anticoagulants and drugs that affect blood coagulation;
electroconvulsive therapy: caution must be exercised when using SSRIs and electroconvulsive therapy due to limited clinical experience;
reverse selective MAO type A inhibitors: combining escitalopram and type A MAO inhibitors is not recommended because of the risk of serotonin syndrome;
serotonin syndrome: in patients taking SSRIs combined with serotonergic drugs, in isolated cases, the development of serotonin syndrome is possible.It is necessary to use escitalopram with caution in parallel with drugs that have a serotonergic effect. A combination of symptoms such as agitation, tremor, myoclonus, hyperthermia may indicate the development of serotonin syndrome. In case of serotonin syndrome, SSRIs and serotonergic drugs must be urgently canceled and symptomatic therapy prescribed;
St. Johns wort: the simultaneous use of SSRIs and herbal preparations containing St. Johns wort can lead to an increase in the frequency of adverse reactions.
During pregnancy and breastfeeding. Do not use.
Children. Do not use. Antidepressants should not be used in children. Suicidal behavior (suicidal attempts / thoughts) and hostility (mainly aggression, oppositional behavior, anger) during clinical trials were more often observed in children and adolescents who took antidepressants, compared with those who took placebo.
The ability to influence the reaction rate when driving vehicles or working with other mechanisms. Escitalopram does not affect intellectual functions and psychomotor reactions, but the possible development of adverse reactions from the central nervous system, such as dizziness, drowsiness, should be considered.

INTERACTIONS:

combinations, the use of which is prohibited:
Non-selective MAO inhibitors. Essobel is not prescribed to patients taking non-selective irreversible MAO inhibitors, and for 2 weeks after stopping their use. Treatment with MAO inhibitors should be started no earlier than 7 days after stopping the use of Essobel.
Pimozide. The simultaneous use of escitalopram with pimozide in low doses enhances the side effect of the latter, and therefore this combination is contraindicated.
Unwanted combinations. Due to the risk of developing serotonin syndrome, a combination of escitalopram with a type A MAO inhibitor (moclobemide) is not recommended. If the purpose of this combination is necessary, then at first apply the minimum recommended dose under close medical supervision.
Precautions
Selegiline. The combination with selegiline (an irreversible MAO inhibitor of type B) should be used with caution. There is experience of a safe combination of selegiline in a dose of up to 10 mg / day with racemic citalopram.
Serotonergic drugs. The combined use with serotonergic drugs (e.g. tramadol, sumatriptan, etc.) can cause the development of serotonin syndrome.
Drugs that lower the seizure threshold. SSRIs can lower the seizure threshold. Caution is advised when the combined use of drugs that reduce the seizure threshold, for example: antidepressants (tricyclic, SSRIs), antipsychotics (phenothiazines, thioxanthenes, butyrophenones), mefloquine, bupropion and tramadol.
Lithium, tryptophan. It is recommended to use SSRIs with caution simultaneously with lithium or tryptophan preparations in connection with the mutual enhancement of the action of these drugs.
Anticoagulants. Possible changes in the effects of anticoagulants due to simultaneous use with escitalopram. In patients taking oral anticoagulants, it is necessary to monitor the blood coagulation system before and after the use of escitalopram.
Alcohol. Escitalopram does not interact with alcohol.
The simultaneous use of escitalopram and omeprazole (a CYP 2C19 inhibitor) increases the concentration of the first (approximately 50%) in blood plasma.
The simultaneous use of escitalopram and cimetidine (a moderately strong enzyme inhibitor) increases the concentration of the former in the blood plasma by approximately 70%.
Thus, with the combined use of escitalopram with CYP 2C19 inhibitors (e.g. omeprazole, fluoxetine, fluvoxamine, lansoprazole, ticlopidine) and cimetidine, caution must be exercised when prescribing escitalopram in minimal doses. A dose reduction of escitalopram may be necessary depending on the clinical situation.

OVERDOSE:

toxicity. Clinical evidence of an overdose of escitalopram is limited. Most cases are the results of a simultaneous overdose with other drugs. At the same time, minor overdose symptoms were noted or none occurred. There are very few reports of deaths due to an overdose of escitalopram, most of them include simultaneous overdose with other drugs. A dose in the range of 400-800 mg of escitalopram did not cause severe symptoms.
Symptoms dizziness, tremor, agitation, serotonin syndrome, convulsions and coma, nausea, vomiting, arterial hypotension, tachycardia, prolonged interval Q – T, arrhythmia, electrolyte imbalance (hypokalemia, hyponatremia).
Treatment: no specific antidote exists. The proper functioning of the respiratory system should be maintained, adequate oxygenation should be provided, and gastric lavage should be carried out. Perhaps the use of activated carbon. The patient must constantly monitor the vital functions of the body and symptomatic therapy.

STORAGE CONDITIONS:

at a temperature below 25 ° C.