EGILOK PILLS 100MG

Indications

- arterial hypertension (in monotherapy or in combination with other antihypertensive drugs);

- functional disorders of cardiac activity, accompanied by tachycardia;

- IHD (secondary prevention of myocardial infarction, prevention of angina attacks);

- cardiac arrhythmias (supraventricular arrhythmias, ventricular premature beats);

- hyperthyroidism (as part of complex therapy);

- prevention of migraine attacks.

Dosage and administration

The drug should be taken orally during or regardless of the meal. If necessary, the pill can be broken in half.

The dose should be chosen gradually and individually in order to avoid the development of excessive bradycardia. The maximum daily dose is 200 mg.

At mild or moderate hypertension The initial dose is 25-50 mg 2 times / day (morning and evening). If necessary, the dose can be gradually increased to 100-200 mg / day or add another antihypertensive agent.

At angina pectoris The initial dose is 25-50 mg 2-3 times / day. Depending on the effect, the dose can be gradually increased to 200 mg / day, or another antianginal drug can be added.

The recommended dose of the drug for maintenance therapy after myocardial infarction - 100-200 mg / day, divided into 2 doses (in the morning and in the evening).

At cardiac arrhythmias The initial dose is 25-50 mg 2-3 times / day. If necessary, the daily dose can be gradually increased to 200 mg / day or add another anti-arrhythmic agent.

At hyperthyroidism The usual daily dose is 150-200 mg in 3-4 doses.

At functional disorders of the heart, accompanied by a sensation of heartbeat the usual dose is 50 mg 2 times / day (morning and evening); if necessary, the dose can be increased to 200 mg in 2 doses.

For prevention of migraine attacks The recommended dose is 100 mg / day in 2 doses (morning and evening); if necessary, the dose can be increased to 200 mg / day in 2 doses.

Have patients with renal impairment no change in dosage regimen is required.

In cirrhosis of the liver, a dose change is usually not required due to the low binding of Metoprolol to plasma proteins. At severe liver failure (for example, after carrying out portocaval shunting) it may be necessary to reduce the dose of Egilok ®.

Have elderly patients dose adjustment is not required.

Adverse effects

Egilok® usually well tolerated by patients. Side effects are usually mild and reversible. The following side effects are documented in clinical trials and in the therapeutic use of metoprolol. In some cases, the relationship of adverse events with the use of the drug has not been reliably established.The side effect frequency parameters listed below are defined as follows: very often (> 10%), often (1-9.9%), infrequently (0.1-0.9%), rarely (0.01-0.09%), very rare, including individual messages (< 0.01%).

Nervous system: very often - increased fatigue; often - dizziness, headache; rarely, anxiety, anxiety; infrequently - paresthesias, convulsions, depression, loss of concentration, drowsiness, insomnia, nightmares; very rarely - amnesia / memory impairment, depression, hallucinations.

Cardiovascular: often - bradycardia, orthostatic hypotension (in some cases syncopal states are possible), cooling of the lower limbs, palpitations; infrequently - a temporary increase in the symptoms of heart failure, cardiogenic shock in patients with myocardial infarction, AV-blockade of the first degree; rarely - conduction disorders, arrhythmia; very rarely - gangrene (in patients with impaired peripheral circulation).

Respiratory: often - shortness of breath during physical exertion; infrequently - bronchospasm in patients with bronchial asthma; rarely - rhinitis.

Gastrointestinal: often - nausea, abdominal pain, constipation or diarrhea; infrequently - vomiting; rarely - dryness of the oral mucosa, abnormal liver function.

From the skin: infrequently - urticaria, increased sweating; rarely - alopecia; very rarely - photosensitization, exacerbation of the course of psoriasis.

Special senses: rarely - blurred vision, dryness and / or eye irritation, conjunctivitis; very rarely - ringing in the ears, a violation of taste.

From the reproductive system: rarely, impotence / sexual dysfunction.

Other: infrequently - weight gain; very rarely - arthralgia, thrombocytopenia.

Use of the drug Egilok® should be discontinued if any of the above effects reaches a clinically significant intensity, and its cause cannot be reliably ascertained.

Contraindications

- cardiogenic shock;

- AV blockade II and III degree;

- sinoatrial block;

- SSSU;

- sinus bradycardia (heart rate <50 beats / min);

- heart failure in the stage of decompensation;

- Violations of the peripheral blood circulation severe;

- age up to 18 years (due to the lack of sufficient clinical data);

- simultaneous i / v Verapamil;

- severe bronchial asthma;

- pheochromocytoma without simultaneous use of alpha-blockers;

- hypersensitivity to metoprolol or any other component of the drug;

- hypersensitivity to other beta-blockers.

Due to the lack of clinical data Egiokol® contraindicated in acute myocardial infarction, accompanied by heart rate <45 beats / min, with an interval of PQ> 240 ms, and systolic blood pressure <100 mm Hg.

Carefully should be prescribed the drug for diabetes; metabolic acidosis; bronchial asthma; COPD; renal / hepatic failure; myasthenia; pheochromocytoma (with simultaneous use with alpha-blockers); thyrotoxicosis; AV-blockade I degree, depression (includingin history); psoriasis; peripheral vascular disease obliterans (intermittent claudication, Raynaud's syndrome); pregnancy; during lactation; elderly patients; patients with a history of allergic history (a decrease in response is possible when using adrenaline).

Use during pregnancy and lactation

The use of the drug is not recommended during pregnancy. The use of the drug is possible only in the case when the intended benefit to the mother outweighs the potential risk to the fetus. If necessary, the appointment of the drug during pregnancy requires careful monitoring of the condition of the fetus and newborn for 48-72 hours after delivery, since the development of bradycardia, hypotension, hypoglycemia and respiratory depression is possible.

Despite the fact that when using the drug in therapeutic doses, only a small amount of metoprolol is excreted in breast milk, it is necessary to monitor the condition of the newborn (bradycardia is possible). The use of the drug during lactation is not recommended. If necessary, the use of the drug Egilok® during lactation should stop breastfeeding.

Application for violations of the liver

In cirrhosis of the liver, a dose change is usually not required due to the low binding of metoprolol to plasma proteins. At severe liver failure (for example, after carrying out portocaval shunting) it may be necessary to reduce the dose of Egilok®.

Precautions should be prescribed the drug for liver failure.

Application for violations of kidney function

Have patients with renal impairment no change in dosage regimen is required.

Precautions should be prescribed the drug for renal failure.

Use in children

Due to the lack of sufficient clinical data, the drug is not recommended for use. in children and adolescents under the age of 18.

Use in elderly patients

WITH caution the drug should be prescribed to elderly patients.

Special notes

When prescribing the drug Egilok® should regularly monitor heart rate and blood pressure. The patient should be trained in the method of calculating heart rate and instructed on the need for medical consultation with heart rate <50 beats / min.

Patients with diabetes should regularly monitor blood glucose levels and, if necessary, adjust the dose of insulin or oral hypoglycemic drugs.

When using the drug in a dose exceeding 200 mg / day, cardioselectivity decreases.

Appointment of Egilok in patients with chronic heart failure is possible only after reaching the stage of compensation.

In patients taking Egilok®, it is possible to increase the severity of hypersensitivity reactions (against the background of burdened allergological anamnesis) and the lack of effect of administering ordinary doses of epinephrine (adrenaline).

Anaphylactic shock may be more severe in patients taking Egilok.®.

With the use of Egilok, the symptoms of peripheral circulatory disorders may worsen.

Egilok® should be abolished gradually, consistently reducing its dose within 14 days. With a sharp cessation of treatment may increase angina attacks and the risk of developing coronary disorders. In the period of drug withdrawal, patients with coronary artery disease must be under close medical supervision.

With angina pectoris, the selected dose of Egilok® should provide a heart rate at rest within 55-60 beats / min, with a load - no more than 110 beats / min.

Patients using contact lenses should take into account that, during treatment with beta-blockers, a reduction in the production of tear fluid is possible.

Egilok® may mask some clinical manifestations of hyperthyroidism (for example, tachycardia). Abrupt withdrawal of the drug in patients with thyrotoxicosis is contraindicated because it can enhance symptoms.

In case of diabetes mellitus, Egilok’s administration may mask the tachycardia caused by hypoglycemia. Unlike non-selective beta-adrenergic blockers, insulin-induced hypoglycemia practically does not increase and does not delay the restoration of blood glucose concentration to normal levels.

When prescribing metoprolol to patients with asthma, simultaneous use of beta is necessary.2- adrenomimetics.

In patients with pheochromocytoma Egilok® should be used in combination with alpha-blockers.

Before performing any surgical intervention, it is necessary to inform the surgeon / anesthesiologist about the therapy with Egiloc (the choice of the drug for general anesthesia with minimal negative inotropic effect); drug withdrawal is not required.

Drugs that reduce the supply of catecholamines (for example, reserpine) can enhance the effect of beta-blockers, so patients taking such combinations of drugs should be under constant medical supervision to detect excessive blood pressure or bradycardia.

In appointing the drug to elderly patients should regularly monitor the function of the liver. Correction of the dosing regimen is required only in case of an increase in bradycardia (<50 beats / min) in elderly patients, a pronounced decrease in blood pressure (systolic blood pressure <100 mmHg), AV blockade, bronchospasm, ventricular arrhythmias, and severe liver function impairment.. Sometimes it is necessary to stop treatment.

Patients with severe renal failure are advised to monitor renal function.

Special monitoring should be carried out for patients with depressive disorders. In the case of the development of depression caused by the use of beta-blockers, therapy should be discontinued.

If progressive bradycardia occurs, reduce the dose or discontinue the drug.

Use in pediatrics

Due to the lack of sufficient clinical data, the drug is not recommended for use. in children and adolescents under the age of 18.

Influence on ability to drive motor transport and control mechanisms

Care must be taken when driving and when engaging in potentially hazardous activities that require high concentration of attention (risk of dizziness and fatigue).

Overdose

Symptoms: pronounced decrease in blood pressure, sinus bradycardia, AV-blockade, heart failure, cardiogenic shock, asystole, nausea, vomiting, bronchospasm, cyanosis, hypoglycemia, loss of consciousness, coma. The symptoms listed above may worsen with simultaneous use with ethanol, antihypertensive drugs, quinidine and barbiturates.

The first symptoms of overdose appear within 20 min-2 h after taking the drug.

Treatment: careful monitoring of the patient is necessary (control of blood pressure, heart rate, respiratory rate, kidney function, blood glucose concentration, blood serum electrolytes) under conditions of an intensive care unit. If the drug has been taken recently, gastric lavage with Activated carbon may reduce further absorption of the drug (if washing is not possible, vomiting can be caused if the patient is conscious). In case of excessive reduction of blood pressure, bradycardia and the threat of heart failure - in / in, with an interval of 2-5 minutes, the introduction of beta-adrenomimetics (to achieve the desired effect) or in / in the introduction of 0.5-2 mg of atropine.In the absence of a positive effect - dopamine, dobutamine or norepinephrine (norepinephrine). In hypoglycemia - the introduction of 1-10 mg of glucagon, the installation of a temporary pacemaker. With bronchospasm - beta injection2- adrenomimetics. For convulsions, slow i.v. administration of diazepam. Hemodialysis is ineffective.

Drug interaction

Antihypertensive effects of Egilok® with simultaneous use with other antihypertensive agents usually increase. In order to avoid arterial hypotension, careful monitoring of patients receiving combinations of such agents is necessary. However, summing up the effects of antihypertensive drugs can, if necessary, be used to achieve effective control of blood pressure.

The simultaneous use of metoprolol and slow Calcium channel blockers such as diltiazem and verapamil can lead to increased negative inotropic and chronotropic effects. It should be avoided in / in the introduction of calcium channel blockers such as verapamil patients receiving beta-blockers.

Combinations that require caution

Oral antiarrhythmic drugs (such as quinidine and amiodarone): the risk of developing bradycardia, AV blockade.

Cardiac glycosides: the risk of bradycardia, disorders of; Metoprolol does not affect the positive inotropic effect of cardiac glycosides.

Other antihypertensive drugs (especially the guanethidine, reserpine, alpha-methyldopa, clonidine and guanfacine groups): the risk of arterial hypotension and / or bradycardia.

Termination of simultaneous use of metoprolol and clonidine should always be started, canceling metoprolol, and then (after a few days) clonidine; if you cancel clonidine first, a hypertensive crisis may develop.

Some drugs acting on the central nervous system (eg, hypnotics, tranquilizers, tri- and tetracyclic antidepressants, antipsychotics, and ethanol): the risk of arterial hypotension.

Means for anesthesia: the risk of inhibition of cardiac activity.

Alpha and beta sympathomimetics: the risk of developing hypertension, significant bradycardia, the possibility of heart failure.

Ergotamine: increased vasoconstrictor effect.

Beta2- sympathomimetics: functional antagonism.

NSAIDs (for example, indomethacin): a possible weakening of the antihypertensive effect.

Estrogens: may decrease the antihypertensive effect of metoprolol.

Hypoglycemic agents for oral administration and insulin: metoprolol can enhance their hypoglycemic effects and mask the symptoms of hypoglycemia.

Curariform muscle relaxants: increased neuromuscular blockade.

Enzyme inhibitors (for example, cimetidine, ethanol, hydralazine; selective serotonin reuptake inhibitors, for example, paroxetine, Fluoxetine and sertraline): the effects of metoprolol may be enhanced due to an increase in its plasma concentration.

Enzyme inducers (rifampicin and barbiturates): the effects of metoprolol may decrease due to an increase in hepatic metabolism.

The simultaneous use of agents that block sympathetic ganglia or other beta-blockers (for example, eye drops) or MAO inhibitors requires careful medical observation.

Terms and conditions of storage

The drug should be stored out of the reach of children at a temperature of 15 ° to 25 ° C.