Elysea
Elicea: instructions for use and reviews
- 1. Release form and composition
- 2. Pharmacological properties
- 3. Indications for use
- 4. Contraindications
- 5. Method of application and dosage
- 6. Side effects
- 7. Overdose
- 8. Special instructions
- 9. Application during pregnancy and lactation
- 10. Use in childhood
- 11. In case of impaired renal function
- 12. Use in the elderly
- 13. Drug interactions
- 14. Analogs
- 15. Terms and conditions of storage
- 16. Terms of dispensing from pharmacies
- 17. Reviews
- 18. Price in pharmacies
Latin name: Elicea
ATX code: N06AB10
Active ingredient: escitalopram (escitalopram)
Manufacturer: KRKA (Slovenia), KRKA-RUS (Russia)
Description and photo update: 2018-21-11
Prices in pharmacies: from 585 rubles.
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Elycea is a drug with an antidepressant effect.
Release form and composition
Dosage form of release of Elycea - film-coated tablets: white, biconvex; the core in cross section is a rough white mass; 5 mg each - round, chamfered; 10 or 20 mg - oval, on one side with a line (in a carton box 4, 6 or 8 blisters of 7 tablets).
Composition of 1 tablet:
- active substance: escitalopram - 5, 10 or 20 mg (escitalopram oxalate - 6.39; 12.78 or 25.56 mg);
- auxiliary components (5/10/20 mg): lactose monohydrate - 53.61 / 107.22 / 214.44 mg; crospovidone - 3.75 / 7.5 / 15 mg; povidone K30 - 0.375 / 0.75 / 1.5 mg; microcrystalline cellulose - 7.5 / 15/30 mg; pregelatinized starch - 1.875 / 3.75 / 7.5 mg; magnesium stearate - 1.5 / 3/6 mg;
- shell (5/10/20 mg): Opadry white 33G28707 (triacetin - 6%; lactose monohydrate - 22%; a mixture of hypromellose 6cP - 40%; titanium dioxide - 24%; macrogol 3000 - 8%) - 1.875 / 3.75 / 7.5 mg.
Pharmacological properties
Pharmacodynamics
Escitalopram is an antidepressant, selective serotonin reuptake inhibitor.
The main properties of the substance:
- an increase in the concentration of a neurotransmitter in the synaptic cleft (provided by inhibition of neuronal reuptake of serotonin);
- strengthening and prolonging the effect of serotonin on postsynaptic receptors.
Escitalopram has very weak / practically does not have an affinity for a number of receptors, including serotonin (5-HT 1A, 5-HT 2), dopamine (D 1 and D 2), H 1 -histamine, alpha 1 - and alpha 2 - and beta-adrenergic receptors, m-cholinergic receptors, opioid and benzodiazepine receptors. This causes a weak severity / absence of various sedative, anticholinergic, cardiovascular adverse reactions.
Also, escitalopram does not bind / has a very low degree of affinity for various ion channels, including Na +, K +, Cl -, Ca 2+ -channels.
Pharmacokinetics
The absorption of escitalopram does not depend on food intake. T max (time to reach the maximum concentration of the substance) after repeated use is about 4 hours. Bioavailability is 80%.
After oral administration, the apparent V d (volume of distribution) is in the range from 12 to 26 l / kg. Escitalopram and its main metabolites bind to blood plasma proteins at a level of 80%. The substance has linear kinetics. C ss (stationary concentration of the substance) is achieved after 7 days, the average C ss when taking Elycea in a daily dose of 10 mg is 50 nmol / l (in the range of 20–125 nmol / l).
Metabolism occurs in the liver with the formation of pharmacologically active metabolites (didemethylated and demethylated). Escitalopram and metabolites are excreted partially in the form of glucuronides.
After repeated administration, the average concentrations of didemethylated and demethylated metabolites from the concentration of escitalopram are less than 5% and 28–31%, respectively.
The dominant role in the metabolism of escitalopram and the demethylated metabolite is taken by the following isoenzymes of cytochrome P 450: CYP2C19, CYP2D6 and CYP3A4.
T 1/2 (half-life) after repeated use is approximately 30 hours.
When taken orally, clearance is 0.6 l / min, including renal - 7%. T 1/2 for the main metabolites is significantly higher. Most of escitalopram and its main metabolites are excreted by the kidneys, the liver also takes part in the excretion process, and is partially excreted in the form of glucuronides.
In elderly patients, the period of elimination of the substance is lengthened, the AUC (area under the concentration-time curve) is significantly higher in comparison with younger patients.
T 1/2 in patients with hepatic insufficiency (according to the Child-Pugh classification of classes A and B) increases by 2 times.
The concentration of escitalopram at low activity of the isoenzyme CYP2C19 can be twice as high as in patients with high activity of this isoenzyme. With a weak activity of the CYP2D6 isoenzyme, significant changes in the concentration of escitalopram are not observed.
With reduced renal function (creatinine clearance 10–53 ml / min), there is a greater T 1/2.
Indications for use
- depression;
- panic disorder (including those accompanied by agoraphobia).
Contraindications
Absolute:
- lactase deficiency, galactosemia, glucose-galactose malabsorption syndrome;
- combination therapy with MAO (monoamine oxidase) inhibitors and pimozide;
- age up to 18 years;
- pregnancy and lactation;
- individual intolerance to the components of the drug.
Relative (Elicea is prescribed under medical supervision):
- burdened history of mania / hypomania;
- depression with suicidal attempts;
- diabetes;
- cardiac ischemia;
- chronic renal failure (creatinine clearance less than 30 ml / min);
- bleeding tendency;
- cirrhosis of the liver;
- pharmacologically uncontrolled epilepsy;
- simultaneous electroconvulsive therapy;
- combination therapy with drugs that can lead to the development of hyponatremia and lower the seizure threshold, drugs metabolized with the participation of the CYP2C19 isoenzyme system, anticoagulants or drugs that affect platelet aggregation, as well as with alcohol, lithium, St. John's wort, tryptophan;
- age from 18 to 24 years (due to the risk of developing suicidal behavior);
- elderly age.
Instructions for the use of Elicea: method and dosage
Elicea tablets are taken orally, regardless of the meal.
The daily dose should be taken in one dose.
For depressive episodes, Elysea is prescribed 10 mg per day, the maximum dose is 20 mg. The antidepressant effect after the start of treatment develops in 2-4 weeks. After the disappearance of the symptoms of depression, to consolidate the obtained effect, it is necessary to continue therapy for at least 6 months. The drug is canceled gradually over 1–2 weeks.
In case of panic disorder, for 7 days, Elysea is taken at 5 mg per day, then the dose is increased to 10–20 mg. The maximum is 20 mg per day. After starting treatment, the maximum therapeutic effect is achieved in about three months.
The recommended daily dose for patients over 65 is 5 mg, the maximum is 10 mg.
When creatinine clearance is less than 30 ml / min, Elycea should be administered with caution.
For patients with impaired hepatic function and with a reduced activity of the isoenzyme CYP2C19, Elycea is prescribed for two weeks at an initial dose of 5 mg per day. Depending on the individual reaction, the dose can be doubled. For severe hepatic impairment, a slower dose titration is recommended.
Side effects
Possible adverse reactions (> 10% - very common;> 1% and 0.1% and 0.01% and <0.1% - rarely; <0.01%, including isolated messages - very rare):
- nervous system: often - nightmares, anxiety, drowsiness, insomnia, dizziness, tremors, paresthesias, anxiety; infrequently - panic disorders, taste disturbances, confusion, akathisia, psychomotor agitation, sleep disturbances, fainting, teeth grinding, increased irritability; rarely - aggressiveness, serotonin syndrome (tremor, myoclonus, agitation, hyperthermia), depersonalization, hallucinations, suicidal behavior / thoughts; very rarely - dyskinesia, manic / convulsive disorders;
- cardiovascular system: infrequently - tachycardia; rarely - bradycardia; very rarely - orthostatic hypotension;
- hematopoietic system: very rarely - thrombocytopenia;
- genitourinary system: often - decreased libido, ejaculation disorders, impotence, anorgasmia (in women); rarely - menorrhagia, metrorrhagia; very rarely - priapism, urinary retention, galactorrhea;
- digestive system: very often - nausea; often - decreased / increased appetite, diarrhea, vomiting, constipation, xerostomia; infrequently - gastrointestinal bleeding (including rectal); very rarely - hepatitis;
- musculoskeletal system: often - myalgia, arthralgia;
- endocrine system: very rarely - galactorrhea, inadequate secretion of antidiuretic hormone;
- allergic reactions: often - skin rash / itching, urticaria; rarely - anaphylactic reactions; very rarely - Quincke's edema;
- skin: often - alopecia, increased sweating; very rarely - ecchymosis;
- respiratory organs: often - yawning, sinusitis; infrequently - nosebleeds;
- sense organs: infrequently - visual disturbances, mydriasis, tinnitus;
- laboratory indicators: often - an increase in body weight; infrequently - weight loss; very rarely - changes in laboratory parameters of liver function, hyponatremia;
- others: often - fever, weakness; infrequently - edema; with a sharp cancellation of therapy - withdrawal syndrome.
Overdose
The main symptoms: convulsions, tremors, dizziness, agitation, drowsiness, serotonin syndrome, depression of consciousness of varying severity (especially in combination with alcohol and / or other drugs that depress the function of the central nervous system), vomiting, nausea, decreased blood pressure, tachycardia, ECG changes (change in the T wave, ST segment, increase in the QT interval, expansion of the QRS complex), arrhythmias, metabolic acidosis, rhabdomyolysis, hyponatremia, hypokalemia, respiratory depression.
There is no specific antidote. Symptomatic and supportive therapy - gastric lavage, the appointment of activated charcoal, ensuring airway patency, adequate oxygenation, control of the functions of the respiratory and cardiovascular systems.
special instructions
In cases of convulsive disorders, epileptic seizures, or with their increase in pharmacologically uncontrolled epilepsy, Elysea is canceled. Also, therapy is stopped with the development of a manic state.
In diabetes mellitus, taking Elycea may lead to an increase in the concentration of glucose in the blood (adjustment of doses of insulin and / or oral hypoglycemic drugs may be required).
The development of hyponatremia associated with a decrease in the secretion of antidiuretic hormone is observed in rare cases (more often in elderly patients, as well as with cirrhosis of the liver or against the background of constant use of drugs that can cause hyponatremia). When Elicea is canceled, this violation usually goes away.
Immediate withdrawal of therapy is required in the event of the development of serotonin syndrome. Conducting symptomatic treatment is shown.
During the period of taking Elycea, the development of ZNS (neuroleptic malignant syndrome) is possible. This disorder is potentially dangerous in nature and is manifested by the following symptoms: hyperpyrexia (increased body temperature), changes in mental status, muscle rigidity and instability of the autonomic nervous system, including arrhythmia, fluctuations in blood pressure, tachycardia, profuse sweating, heart rhythm disturbances. If ZNS is detected, the immediate cancellation of Elicea is shown.
During the first two weeks of taking the drug, akathisia / psychomotor agitation (subjectively irritating or unpleasant anxiety and the need for movement, often combined with the inability to stand or sit still) may develop.
During the use of Elycea, skin hemorrhages (purpura and ecchymosis) may appear. Therapy should be carried out with caution in cases of a tendency to bleeding, as well as against the background of the use of indirect anticoagulants and other drugs that affect blood clotting.
With abrupt withdrawal of the drug, withdrawal symptoms often occur, manifested by dizziness, sensory disturbances (including paresthesias), sleep disturbances (insomnia, unusual dreams), psychomotor agitation, anxiety, nausea / vomiting, tremors, confusion, sweating, headache, diarrhea, sensation palpitations, emotional lability and visual impairment. The severity of these disorders is usually moderate or mild, their duration is limited. In this regard, Elicea should be canceled gradually, reducing the dose over several weeks / months.
In patients under 24 years of age with depression, other mental disorders, therapy may be accompanied by an increase in the likelihood of developing suicidal thoughts / behavior. In this regard, before prescribing Elicea, this group of patients must be correlated with the expected benefit with the possible risk. The condition of all patients during the period of therapy requires medical monitoring for early detection of behavioral changes / disorders, as well as suicidal tendencies.
Influence on the ability to drive vehicles and complex mechanisms
Due to the possibility of confusion, dizziness, depersonalization, hallucinations and other adverse reactions, patients should refrain from driving vehicles and engaging in potentially hazardous activities during therapy.
Application during pregnancy and lactation
According to the instructions, Elicea is not prescribed during pregnancy / lactation.
Pediatric use
Elicea tablets are not prescribed for patients under 18 years of age.
With impaired renal function
Conduct therapy for chronic renal failure (creatinine clearance less than 30 ml / min) should be under medical supervision.
Use in the elderly
Elderly patients should be treated under medical supervision.
Drug interactions
Due to the risk of developing serotonin syndrome, combined use with MAO-A inhibitors is contraindicated. Also, Elicea cannot be used in combination with pimozide.
Pharmacokinetic interaction:
- inhibitors of the CYP2C19 isoenzyme (in particular, lansoprazole, omeprazole, fluvoxamine, esomeprazole, ticlopidine) or cimetidine: the concentration of escitalopram in the blood plasma increases, and therefore may require a decrease in its dose; the combination requires caution;
- metoprolol, desipramine: the concentration of these drugs doubles;
- drugs metabolized by the CYP2C19 isoenzyme and having a low therapeutic index (in particular, propafenone, flecainide, metoprolol), or drugs mainly metabolized by the CYP2C19 isoenzyme and acting on the central nervous system (in particular, antidepressants - clomipramine, desipramine; nortriptyline - thioridazine, risperidone, haloperidol): the combination requires caution, the dosage regimen of these drugs may need to be adjusted.
Other possible interactions:
- serotonergic drugs (tramadol, sumatriptan and other triptans): the likelihood of developing serotonin syndrome increases; the combination requires caution;
- drugs that lower the seizure threshold (mefloquine, tramadol, bupropion, tricyclic antidepressants, antipsychotics - derivatives of thioxanthene, phenothiazine, butyrophenone): the likelihood of seizures increases;
- lithium preparations, tryptophan: their effect is enhanced;
- St. John's wort: its toxicity increases;
- indirect anticoagulants and drugs that affect platelet aggregation (atypical antipsychotics and typical antipsychotics - most tricyclic antidepressants, phenothiazine derivatives, non-steroidal anti-inflammatory drugs, acetylsalicylic acid, dipyridamole, ticlopidinum increase in the beginning of the blood intake and control of bleeding rates, the risk of bleeding is required); and at its end;
- ethanol: combination not recommended.
Analogs
The analogues of Elysea are: Eisipe, Selektra, Escitalopram, Miracitol, Tsipralex, Sancipam, Lenuxin.
Terms and conditions of storage
Store at temperatures up to 30 ° C. Keep out of the reach of children.
Shelf life is 2 years.
Terms of dispensing from pharmacies
Dispensed by prescription.
Reviews about Elice
According to reviews, Elicea is an effective drug. It is noted that as a result of its use, well-being, memory and sleep are improved.
Of the shortcomings, they point to the high cost, long-term development of the therapeutic effect, in some cases - to pronounced side effects.
Price for Elicea in pharmacies
The approximate price for Elicea is 570-740 rubles (28 tablets of 10 mg) or 1131-1280 rubles (56 tablets of 10 mg).
Elicea: prices in online pharmacies
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Drug name Price Pharmacy |
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Elicea Ku-tab 10 mg orodispersible tablets 28 pcs. 585 RUB Buy |
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Elicea KU-Tab tablets dispersion 10mg 28 pcs. 588 r Buy |
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Elycea 10 mg film-coated tablets 28 pcs. 669 r Buy |
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Elicea Ku-tab 10 mg orodispersible tablets 56 pcs. 709 r Buy |
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Elycea tablets p.p. 10mg 28 pcs. 721 RUB Buy |
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Elicea KU-Tab tablets dispersion 10mg 56 pcs. RUB 1009 Buy |
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Elycea 10 mg film-coated tablets 56 pcs. 1139 RUB Buy |
Maria Kulkes Medical journalist About the author
Education: First Moscow State Medical University named after I. M. Sechenov, specialty "General Medicine".
Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!
