Egilok tab 50mg 60 pc

$2.90

Egilok tab 50mg 60 pc

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Description

Composition
Active substance:
50 mg metoprolol tartrate.
Excipients:
microcrystalline cellulose 41.5 / 83/166 mg, sodium carboxymethylstarch (type A) 7.5 / 15/30 mg colloidal anhydrous silica 2/4/8 mg, povidone (K-90) 2/4/8 mg magnesium stearate mg 2/4/8.
Description:
White or almost white, round, biconvex tablets with the mark on one side and with an engraving E 434 – on the other side, odorless.
Product form:
60 tablets in brown glass vial with cap with PE-cushion bellows, with the first control opening. 1 vial together with instructions for use is packed in a cardboard box. Or 15 tablets in a blister of PVC / PVDC // Al. foil. 4 blisters together with instructions for use packed in a cardboard box.
Contraindications
Hypersensitivity to metoprolol or any other component of the preparation, and other beta-blockers; atrioventricular (AV) II or III degree; sinoatrial block; sinus bradycardia (heart rate less than 50 / min), sick sinus syndrome; cardiogenic shock; severe peripheral circulatory disorders; heart failure decompensation, age 18 years (in the absence of sufficient clinical data), the simultaneous on / in administering verapamil, severe asthma and pheochromocytoma without simultaneous use of alpha blockers.
Due to lack of clinical data Egilok® contraindicated during acute myocardial infarction accompanied by heart rate less than 45 beats / min, PQ interval of 240 ms, and systolic blood pressure below 100 mm Hg
CAREFULLY
Diabetes mellitus, metabolic acidosis, bronchial asthma, chronic obstructive pulmonary disease (COPD), renal / hepatic failure, myasthenia gravis, pheochromocytoma (while the use of alpha blockers), thyrotoxicosis, AV block I degree, depression (including disease), psoriasis, obliterating peripheral vascular disease ( “intermittent” claudication, Raynaud syndrome), pregnancy, lactation, older age, patients with allergic history (possibly reduction response at the application and renalina).
Dosage
50 mg
Indications
Arterial hypertension (in monotherapy or (if required) in combination with other antihypertensive drugs); functional disorders of cardiac activity, accompanied by palpitations.
Coronary heart disease: myocardial infarction (secondary prevention – complex therapy), prevention of angina attacks.
Cardiac arrhythmias (supraventricular tachycardia, ventricular premature beats).
Hyperthyroidism (complex therapy).
Prevention of migraine attacks.
Interaction with other drugs
Antihypertensive effects of the drug Egilok® and other antihypertensives typically amplified. To avoid hypotension requires careful monitoring of the patients receiving the combination of such means. However, summation of the effects of antihypertensive agents can be used to achieve an effective control of blood pressure, if necessary.
Simultaneous blockers metoprolol and “slow” calcium channel blockers diltiazem and verapamil types can lead to increased negative inotropic and chronotropic effects. Avoid intravenous calcium channel blockers verapamil-type patients receiving beta-blockers.
Use caution while taking the following means:
Oral antiarrhythmic drugs (such as quinidine and amiodarone) – the risk of bradycardia, atrioventricular block.
Cardiac glycosides (risk of bradycardia, disturbances of, metoprolol does not affect the positive inotropic effect of cardiac glycosides).
Other antihypertensive agents (especially group guanethidine, reserpine, alpha-methyldopa, clonidine and guanfacine) because of the risk of hypotension and / or bradycardia.
Termination and simultaneous metoprolol clonidine must necessarily start, canceling metoprolol, and then (after a few days) clonidine; if the first cancel clonidine may develop a hypertensive crisis.
Some drugs acting on the central nervous system, such as sleeping pills, tranquilizers, tri- and tetracyclic antidepressants, antipsychotics and ethanol increases the risk of hypotension.
Means for anesthesia (risk of cardiac depression).
Alpha and beta sympathomimetics (risk of hypertension, significant bradycardia; the possibility of cardiac arrest).
Ergotamine (increased vasoconstrictor effect).
Beta2-sympathomimetics (functional antagonism).
Nonsteroidal anti-inflammatory drugs (e.g., indomethacin) – may reduce the antihypertensive effect.
Estrogens (may reduce the antihypertensive effect of metoprolol).
Hypoglycemic agents for oral and insulin (metoprolol may enhance hypoglycemic effects and masked symptoms of hypoglycemia).
Curariform relaxants (gain neuromuscular blockade).
Enzyme inhibitors (e.g., cimetidine, ethanol, hydralazine; selective serotonin reuptake inhibitors, e.g., paroxetine, fluoxetine and sertraline) – metoprolol amplification effects due to the increase of its concentration in plasma.
Enzyme inducers (rifampicin and barbiturates): Effects of metoprolol may be reduced due to increased “hepatic” metabolism.
Simultaneous application means blocking the sympathetic ganglia, or other beta-blockers (eg eye drops) or monoamine oxidase inhibitors requires close medical supervision.
Overdose
Symptoms: marked decrease in blood pressure, sinus bradycardia, atrioventricular block, congestive heart failure, cardiogenic shock, asystole, nausea, vomiting, bronchospasm, cyanosis, hypoglycemia, loss of consciousness, coma.
The above symptoms may worsen while taking ethanol, antihypertensive drugs, quinidine and barbiturates.
The first symptoms appear overdose 20 min – 2 h after dosing.
Treatment: the need for careful monitoring of the patient (control of blood pressure, heart rate, respiratory rate, kidney function, blood glucose, serum electrolytes) under intensive care.
If the drug was passed recently, gastric lavage with activated charcoal may reduce further absorption of the drug (if washing is not possible, can cause vomiting, if the patient is conscious).
In case of excessive reduction in blood pressure, bradycardia and heart failure threat – in / at intervals of 2-5 min, beta-adrenergic agonist – to achieve the desired effect or / 0.5-2 mg atropine. If no positive effect – dopamine, dobutamine or norepinephrine (noradrenaline). When hypoglycemia – glucagon administration 1-10 mg, temporary pacemaker. When bronchospasm enter beta2-agonists. In convulsions – slow / w diazepam. Hemodialysis is ineffective.
pharmachologic effect
Pharmacological group:
beta1-selective blocker
Pharmacodynamics:
Mechanism of action:
Metoprolol inhibits hyperactivity of the sympathetic system influence on the heart, and also causes a rapid decrease in heart rate, contractility, cardiac output and blood pressure.
When hypertension metoprolol reduces blood pressure in patients in the “standing” and “lying down.” Prolonged antihypertensive effect of the drug is associated with a gradual decrease in total peripheral vascular resistance.
When hypertension long-term use of the drug leads to a statistically significant reduction in left ventricular mass and improvement of diastolic function.
In men with mild to moderate hypertension metoprolol reduces mortality from cardiovascular causes (especially sudden death, fatal and non-fatal heart attack and stroke).
As with other beta-blockers metoprolol reduces myocardial oxygen demand by reducing the systemic blood pressure, heart rate and myocardial contractility. Decrease of heart rate and corresponding elongation at diastole metoprolol provide improved blood flow and myocardial oxygen uptake with impaired blood flow. Therefore angina drug reduces the number, duration and severity of attacks, but also displays asymptomatic ischemia and improves patient’s physical performance.
Myocardial infarction, metoprolol lowers mortality, reducing the risk of sudden death. This effect is primarily related to the prevention of ventricular fibrillation episodes. Decrease in mortality can also be observed in the application of metoprolol in the early and in the late phase of myocardial infarction, as well as in high-risk patients and patients with diabetes mellitus. Use of the drug after myocardial infarction reduces the likelihood of nonfatal reinfarction.
In chronic heart failure with idiopathic hypertrophic obstructive cardiomyopathy metoprolol tartrate, a received starting with a low dose (2 `5 mg / day) dose with gradual increase significantly improves heart function, quality of life and physical stamina of the patient.
If supraventricular tachycardia, atrial fibrillation and ventricular arrhythmia metoprolol reduces the incidence of ventricular contractions and PVCs number.
At therapeutic doses peripheral vasoconstrictor and bronchoconstrictor effects of metoprolol less pronounced than the same effects of nonselective beta-blockers.
Compared with non-selective beta-blockers metoprolol has less effect on insulin production and carbohydrate metabolism. He does not increase the duration of hypoglycemic episodes.
Metoprolol causes a slight increase in triglyceride concentration and a slight decrease in the serum concentration of free fatty acids. There is a significant reduction in total serum cholesterol concentration of the blood after several years of metoprolol.
Pharmacokinetics:
Metoprolol is rapidly and completely absorbed in the gastrointestinal tract. For typical linear pharmacokinetics of the drug in the therapeutic dose range.
The maximum plasma concentration is reached after 1.5-2 hours after ingestion.
After absorption metoprolol largely metabolized first pass through the liver. The bioavailability of metoprolol is approximately 50% with a single and 70% when taken regularly.
The reception at the same time with food may increase the bioavailability of metoprolol by 30-40%.
Metoprolol slightly (~ 5-10%) bound to plasma proteins.
The volume of distribution of 5.6 l / kg.
Metoprolol is metabolized by the liver cytochrome P-450. Metabolites not possess pharmacological activity.
The half-life (t1 / 2) in average, 3.5 hours (from 1 to 9 hours). The total clearance is approximately 1 l / min.
Approximately 95% of the administered dose excreted by the kidneys, 5% as unchanged metoprolol. In some cases, this value can reach 30%.
There were no significant changes in the pharmacokinetics of metoprolol have been identified in older patients.
Renal dysfunction does not affect the systemic bioavailability and elimination of metoprolol. However, in these cases, a decrease in the excretion of metabolites. In severe renal insufficiency (glomerular filtration rate of less than 5 ml / min), there is a significant accumulation of metabolites. However, this accumulation of metabolites does not increase the level of beta-adrenergic blockade.
Impaired function of the liver has little effect on the pharmacokinetics of metoprolol. However, in severe hepatic cirrhosis and after application portocaval shunt bioavailability can be increased and total body clearance from the body down. After portocaval bypass total clearance of the drug from the body is approximately 0.3 liters / minute, and under the concentration-time curve area is increased about 6 times compared with that in healthy volunteers.
Pregnancy and breast-feeding
Use of the drug is not recommended during pregnancy. Use of the drug is only possible if the benefit to the mother outweighs the potential risk to the fetus. If the drug is required, should be monitored closely for the fruit, and then the newborn for a few days (48 – 72 hours) after delivery as possible bradycardia, respiratory depression, lowering blood pressure and hypoglycemia.
Despite the fact that at the therapeutic doses of metoprolol only small amounts of drugs are excreted into breast milk, the newborn should be kept under surveillance (available bradycardia). Use of the drug during lactation is not recommended. If necessary, use during lactation should stop breastfeeding.
Conditions of supply of pharmacies
On prescription
side effects
Egilok® generally well tolerated by patients. Side effects are usually mild and reversible. The following side effects reported in clinical trials, and the therapeutic use of metoprolol. In some cases, the connection to an adverse event using the drug not been reliably established. The following parameters defined by the frequency of side effects as follows: very often 3 to 10%, often: 1-9,9% infrequently: 0.1-0.9%, rare: 0,01-0,09%, very seldom (including individual messages): 0.01% pound.
From the nervous system: very often – fatigue; often – dizziness, headache; rarely – increased irritability, anxiety, impotence / sexual dysfunction; rarely – paresthesia, convulsions, depression, poor concentration, drowsiness, insomnia, “nightmarish” dream; very rarely – Amnesia / memory impairment, depression, hallucinations.
With the cardiovascular system: often – bradycardia, orthostatic hypotension (in some cases, possible syncope), cooling of the lower extremities, palpitations; infrequently – a temporary increase of symptoms of heart failure, cardiogenic shock in patients with myocardial infarction, atrioventricular block of I degree; rarely – conduction abnormalities, arrhythmias; very rarely – gangrene (in patients with impaired peripheral circulation).
From the digestive system: often – nausea, abdominal pain, constipation or diarrhea; rarely – vomiting; rarely – dryness of the oral mucosa, the liver.
For the skin: rarely – urticaria, increased sweating; rare – alopecia; very rarely – photosensitivity, exacerbation of psoriasis flow.
The respiratory system: often – shortness of breath on exertion; rarely – bronchospasm in patients with bronchial asthma; rarely – rhinitis.
From the sensory organs: rarely – blurred vision, dry and / or irritated eyes, conjunctivitis; very rarely – ringing in the ears, impaired sense of taste.
Other: rarely – weight gain; very rarely – arthralgia, thrombocytopenia.
Admission Egilok® drug should be discontinued if any of the above-mentioned effect is achieved clinically significant intensity, and its cause can not be reliably set.
special instructions
Monitoring of patients receiving beta-blockers, includes regular measurement of heart rate (HR) and blood pressure, blood glucose concentration in diabetic patients. If necessary, for diabetic patients, insulin or hypoglycemic agents should be selected for receiving individually inside. It should teach the patient’s heart rate counting procedure and to instruct the need of medical advice in heart rate less than 50 beats / min. When receiving doses greater than 200 mg per day decreases cardioselective.
In heart failure, treatment with Egilok® begin only after reaching the stage of compensation of cardiac function.
Perhaps increased severity of hypersensitivity reactions and lack of effect of administration of conventional doses of epinephrine (adrenaline) in patients with allergic history.
Anaphylaxis may be more severe in patients taking Egilok®.
May exacerbate symptoms of peripheral arterial circulation.
Avoid Egilok® abrupt discontinuation of drug. The drug should be lifted gradually by reducing the dose within about 14 days. Abrupt withdrawal may intensify symptoms of angina and increase the risk of coronary events. Particular attention should be given to the abolition of the drug in patients with coronary artery disease.
When angina Egilok® chosen dose of the drug should provide a resting heart rate in the range of 55-60 beats / min, with a load – not more than 110 beats / min.
Patients who use contact lenses should bear in mind that during treatment with beta-blockers may reduce the production of tear fluid.
Egilok® may mask some of the clinical manifestations of hyperthyroidism (e.g., tachycardia). Abrupt withdrawal in patients with hyperthyroidism contraindicated because the symptoms can increase.
In diabetes may mask tachycardia caused by hypoglycemia. In contrast, nonselective beta-blockers practically no increase insulin-induced hypoglycemia and delay recovery of blood glucose to normal levels. В случае назначения препарата Эгилок® больным сахарным диабетом следует контролировать концентрацию глюкозы крови и при необходимости корригировать дозу инсулина или гипогликемических средств для приема внутрь (см. раздел “Взаимодействие с другими лекарственными препаратами”).
При необходимости назначения пациентам с бронхиальной астмой, в качестве сопутствующей терапии назначают бета2-адреностимуляторы; при феохромоцитоме -альфа-адреноблокаторами.
При необходимости проведения хирургического вмешательства необходимо предупредить хирурга/анестезиолога о проводимой терапии (выбор средства для общей анестезии с минимальным отрицательным инотропным действием), отмены препарата не рекомендуется.
Препараты, снижающие запасы катехоламинов (например, резерпин), могут усилить действие бета-адреноблокаторов, поэтому больные, принимающие такие сочетания препаратов, должны находиться под постоянным наблюдением врача на предмет выявления чрезмерного снижения артериального давления или брадикардии.
У пожилых пациентов рекомендуется регулярно осуществлять контроль функции печени. Коррекция режима дозирования требуется только в случае появления у пациента пожилого возраста нарастающей брадикардии (менее 50 уд/мин), выраженного снижения АД (систолическое артериальное давление ниже 100 мм рт.ст.), атриовентрикулярной блокады, бронхоспазма, желудочковых аритмий, тяжелых нарушений функции печени, иногда необходимо прекратить лечение. Пациентам с тяжелой почечной недостаточностью рекомендуется осуществлять контроль функции почек.
Следует проводить особый контроль за состоянием пациентов с депрессивными расстройствами, принимающими метопролол; в случае развитии депрессии, вызванной приемом бета-адреноблокаторов, рекомендуется прекратить терапию.
При возникновении прогрессирующей брадикардии следует снизить дозу или прекратить прием препарата.
Из-за отсутствия достаточного количества клинических данных препарат не рекомендуется применять у детей.
Влияние на способность управлять транспортными средствами и сложной техникой. Необходимо соблюдать осторожность при управлении транспортными средствами и при занятиях потенциально опасными видами деятельности, требующими повышенной концентрации внимания (риск развития головокружения и повышенной утомляемости).
Storage conditions
ХРАНИТЬ ПРИ ТЕМПЕРАТУРЕ ОТ 15 ДО 25 °C, В НЕДОСТУПНОМ ДЛЯ ДЕТЕЙ МЕСТЕ
Dosing and Administration
Эгилок® таблетки принимают внутрь. Таблетки можно принимать с пищей или вне зависимости от приема пищи. При необходимости таблетку можно разломить пополам.
Дозу следует подобрать постепенно и индивидуально во избежание чрезмерной брадикардии. Максимальная суточная доза составляет 200 мг.
Рекомендуемые дозы:
Arterial hypertension
При мягкой или умеренной степени артериальной гипертензии начальная доза 25-50 мг два раза в день (утром и вечером). При необходимости суточную дозу можно постепенно повысить до 100-200 мг/сут или добавить другое гипотензивное средство.
angina
Начальная доза 25-50 мг от двух до трех раз в сутки. В зависимости от эффекта, эту дозу можно постепенно повысить до 200 мг в сутки или добавить другой антиангинальный препарат.
Поддерживающая терапия после инфаркта миокарда
Обычная суточная доза – 100 – 200 мг/сут, разделенная на два приема (утром и вечером).
Нарушения ритма сердца
Начальная доза от 25 до 50 мг два или три раза в день. При необходимости суточную дозу можно постепенно повысить до 200 мг/сут или добавить другое противоаритмическое средство.
Гипертиреоз
Обычная суточная доза составляет 150-200 мг в сутки за 3 – 4 приема.
Функциональные расстройства сердца, сопровождающиеся ощущением сердцебиения
Обычная суточная доза составляет 50 мг 2 раза в день (утром и вечером); при необходимости ее можно повысить до 200 мг в два приема.
Профилактика приступов мигрени
Обычная суточная доза составляет 100 мг/сут в два приема (утром и вечером); при необходимости ее можно повысить до 200 мг/сут в 2 приема.
Special patient groups
При нарушении функции почек изменение режима дозирования не требуется.
При циррозе печени обычно не требуется изменение дозы в связи с низким связыванием метопролола с белками плазмы крови (5-10%). При тяжелой печеночной недостаточности (например, после операции портокавального шунтирования) может возникнуть необходимость в снижении дозы Эгилок®.
У пожилых больных коррекции дозы не требуется.
Information
Appearance may differ from that depicted in the picture. There are contraindications. You need to read the manual or consult with a specialist

Additional information

Weight0.100 kg
Manufacturer

EGIS

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