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Egilok 30s 100 mg retard tablets coated

$16.50

c12be5c9a1b7

Description

The instruction for medical use

of EGILOK® medicine
the Trade name
of Egilok®

the International unlicensed

name Metoprolol Lekarstvennaya a form
of the Tablet of 25 mg, 50 mg, 100 mg

Structure
One tablet contains
active agent – a metoprolol tartrate of 25 mg, 50 mg, 100 mg,
excipients: microcrystalline cellulose, sodium of starch glikolit (type A), silicon dioxide colloidal anhydrous, povidone (K-90), magnesium stearate.

The description
of the Tablet of white or almost white color, round shape, with a biconvex surface, with the crosswise dividing line and a double bevel (double snep) on one party and an engraving of the stylized letter E and number 435 on other party, without or almost flavourless (for a dosage of 25 mg)
Tablets of white or almost white color, round shape, with a biconvex surface, with risky on one party and an engraving of the stylized letter E and number 434 on other party, without or almost flavourless (for a dosage of 50 mg)
Tablets of white or almost white color, round shape, with a biconvex surface, with a facet, with risky on one party and with an engraving of the stylized letter E and number 432 on other party, without or almost flavourless (for a dosage of 100 mg)

Pharmacotherapeutic group
Drugs for treatment of diseases of a cardiovascular system. Selection beta blockers. Metoprolol.
The ATX C07A B02 code

the Pharmacological

Metoprolol Pharmacokinetics properties is quickly and completely soaked up from digestive tract. In the therapeutic range of doses the linear pharmacokinetics is characteristic of drug. The maximum concentration in blood plasma is reached in 1.5-2 hours after reception. Despite considerable individual fluctuations of indicators of level of drug in blood plasma, at each certain patient these distinctions are insignificant. After absorption metoprolol substantially is exposed to metabolism of the first passing through a liver. The bioavailability of a metoprolol is about 50% at single and about 70% at multiple dose. At the same time meal can increase bioavailability of a metoprolol by 30 – 40%. Contacts proteins of blood plasma approximately for 5-10%. Metoprolol is widely distributed in fabrics and has the high volume of distribution (5.6 l/kg). Metoprolol is metabolized in a liver by enzymes of R-450 CYP2D6 cytochrome. Metabolites have no clinical value. Elimination half-life averages 3.5 hours (from 1 to 9 hours). The general clearance of drug is about 1 l/min. About 95% of the dose accepted inside are brought with urine, out of them 5% – in not changed look (in some cases can reach 30%).
Special groups of patients
of Significant changes of pharmacokinetics of a metoprolol at elderly patients it is not revealed.
The renal failure does not affect system bioavailability or removal of a metoprolol. However in these cases the decrease in excretion of metabolites is observed.
In a heavy renal failure (SKF of 5 ml/min.) the considerable accumulation of metabolites is observed. However such accumulation of metabolites does not strengthen extent of β-adrenergic blockade. The abnormal liver function slightly influences pharmacokinetics of a metoprolol. However in heavy cirrhosis and after imposing of the porto-caval shunt the bioavailability can increase, and the general clearance – to decrease. After porto-caval shunting the general clearance of drug is about 0.3 l/min, and the area under a curve of concentration time increases approximately by 6 times in comparison with healthy faces.
A pharmacodynamics
Metoprolol – cardioselective β1-адреноблокатор, not having internal sympathomimetic or membrane stabilizing activity. Has antihypertensive, anti-anginal and antiarrhytmic effect.
Metoprolol interferes with the stimulating influence of sympathetic nervous system on heart and causes fast decrease in frequency of a warm rhythm, contractility, minute volume and arterial blood pressure at physical and intellectual activities and a stress.
At the increased level of endogenous adrenaline metoprolol to a lesser extent affects arterial blood pressure, than non-selective β-adrenoblockers. If necessary metoprolol in a combination with b2-agonist patients can appoint with obstructive pulmonary diseases. In therapeutic doses metoprolol to a lesser extent affects bronchodilatory effect of b2-agonists, than non-selective b-adrenoblockers.
In comparison with non-selective β-adrenoblockers metoprolol influences products of insulin and carbohydrate metabolism less. Drug significantly does not change cardiovascular reactions to a hypoglycemia and does not increase duration of attacks of a hypoglycemia.
In clinical trials it is established what metoprolol slightly increases the level of triglycerides and slightly lowers the level of free fatty acids in blood plasma. Insignificant lowering of the level of LPVP was in certain cases observed. This lowering was less significant, than at use of non-selective b-adrenoblockers. Nevertheless, in a long-term research the significant lowering of the level of cholesterol after several years of treatment metoprololy was observed. Against the background of treatment metoprololy the quality of life did not change or improved. Treatment the metoprololy ambassador of a myocardial infarction improved quality of life.
In arterial hypertension it reduces arterial blood pressure at patients in a standing position and lying. In an initiation of treatment metoprololy clinically insignificant increase in peripheric vascular resistance was observed short-term (proceeding within several hours). The long-term antihypertensive effect of drug is connected with gradual decrease in the general peripheric vascular resistance.
In arterial hypertension the prolonged use of drug leads to statistically reliable decrease in mass of a left ventricle and improvement of its filling and diastolic function.
At men with average or moderate arterial hypertension metoprolol reduces mortality from cardiovascular disturbances (first of all, sudden death, fatal and not fatal myocardial infarctions and strokes).
As well as other β-adrenoblockers, metoprolol the need of a myocardium for oxygen by means of decrease in system arterial blood pressure, heart rate and contractility of a myocardium reduces. By decrease in heart rate and the corresponding lengthening of a diastole metoprolol improves blood supply and oxygenation of areas of a myocardium with the broken blood-groove.
At disturbances of a warm rhythm (supraventricular tachycardia, an atrial fibrillation and ventricular premature ventricular contraction) metoprolol lowers the heart rate and number of ventricular extrasystoles).
In a myocardial infarction metoprolol reduces mortality, reducing risk of sudden death. This effect first of all is connected with prevention of episodes of ventricular fibrillation. Mechanism of this effect double:
(1) the central excitement of vagus nerve renders favorable effect on electric stability of a myocardium,
(2) blocking of effects of sympathetic nervous system reduce contractility of a myocardium, heart rate and arterial blood pressure. Decline in mortality is possible also is observed at reception of a metoprolol both in early, and in a late phase and also patients have groups of high risk (having cardiovascular diseases) and patients with diabetes. Use of drug after a myocardial infarction reduces the probability not of a fatal repeated heart attack.
Metoprolol can be applied to treatment of functional disorders of heart with heartbeat.
Metoprolol can be applied to prevention of attacks of migraine.
In a hyperthyroidism metoprolol reduces clinical manifestations of a disease, thus, it can be applied as additional therapy.

Indications
– arterial hypertension (as monotherapy or in combination with other antihypertensive drugs,
– stable and unstable stenocardia (as monotherapy or in combination with other anti-anginal means and also for prevention of attacks of stenocardia)
– secondary prevention after a myocardial infarction (maintenance therapy)
– disturbances of a warm rhythm (sinus tachycardia, supraventricular tachycardia, ventricular extrasystoles)
– prevention of attacks of migraine

the Route of administration and doses
of the Tablet it is possible to accept the functional disturbances of warm activity which are followed by tachycardia (including in a hyperthyroidism) irrespective of meal. If necessary the tablet can be divided into identical doses. The dose is selected individually in order to avoid excessive bradycardia.
In arterial hypertension: the recommended initial dose – 25-50 mg two times a day (in the morning and in the evening). At insufficient clinical effect it is possible to raise a daily dose to 100 mg two times a day, or to apply Egilok in a combination with other antihypertensive drugs. The maximum dose of 200 mg a day divided into several receptions.
In stenocardia: the recommended initial dose – 25-50 mg 2-3 times a day. At insufficient clinical effect this dose can be raised gradually to 200 mg a day or to apply Egilok in a combination with other anti-anginal drugs.
Maintenance therapy after a myocardial infarction: the recommended dose

of 50-100 mg two times a day (in the morning and in the evening).
In arrhythmias: the recommended initial dose of 25-50 mg 2-3 times a day. At insufficient clinical effect this dose can be raised gradually to 200 mg or to apply Egilok in a combination with other antiarrhythmic drugs.
For prevention of attacks of migraine: the recommended dose of 50 mg two times a day (in the morning and in the evening), in need of it it is possible to raise to 100 mg two times a day.
At the functional disturbances of warm activity which are followed by tachycardia (including in a hyperthyroidism): the recommended daily dose of 50 mg two times a day (in the morning and in the evening), in need of it it is possible to raise to 100 mg two times a day.
Special groups of patients:
When prescribing drug the patients with renal failures or to elderly people do not have need to adjust the dosing mode.
When prescribing drug the decrease in its dose can be required by patients with the profound abnormal liver functions (for example, at the patients with cirrhosis who underwent shunting operations). Patients with cirrhosis have no need for correction of the mode of dosing in connection with low linking of a metoprolol with proteins of blood plasma (5-10%).
Children and teenagers aged up to 18 years
there Is a limited experience of use of drug for children and teenagers. There are no data on efficiency and safety of use of the tablets Egilok.

Side effects
the Listed below side effects are registered in clinical trials and at therapeutic use of a metoprolol. In certain cases connection of the undesirable phenomenon using drug is authentically not established.
Very often (≥1/10)
– increased fatigue
Often (≥1/100 – & lt, 1/10)
– dizziness, a headache
– bradycardia, a cold snap of extremities, heartbeat strengthening, orthostatic hypotension which is very seldom connected with faints
– nausea, abdominal pain, diarrhea, a constipation
– dispnoe tension
Infrequently (≥1/1000 – & lt, 1/100)
– strengthening of symptoms of heart failure, atrioventricular blockade of the I degree, peripheral hypostases, pains in heart, cardiogenic shock at patients with an acute myocardial infarction
– a depression, disturbance of concentration of attention, a sleep disorder, drowsiness, insomnia, nightmares
– paresthesia, muscular spasms
– a skin itching, rash, a small tortoiseshell, psoriazopodobny damage of skin, dystrophic skin defeats, sweating strengthening
– a bronchospasm (even in the absence of the diagnosed obstructive disease of lungs)
– increase in body weight
– vomiting
Seldom (≥1/10,000 – & lt, 1/1000)
– dryness in a mouth
– complaints to paresthesias, muscular spasms, nervous irritability, uneasiness
– disturbance of potency, disturbance of sexual function
– arrhythmia, disturbance of conductivity of a myocardium
– change of functional hepatic trials, hepatitis
– the hair loss
– rhinitis
– conjunctivitis, dryness and irritation of eyes (that can cause difficulties in the persons applying contact lenses), illegibility of sight
Is very rare (≥1/10,000)
– amnesia, disturbance or memory loss, confusion of consciousness, a hallucination, sonitus, deterioration in hearing
– strengthening of earlier existing disturbance of peripheric circulation, strengthening of symptoms of the alternating lameness or Raynaud’s diseases, gangrene at patients with the previous heavy disturbances of peripheric circulation
– a photosensitization
– exacerbation of psoriasis
– change of flavoring feelings
– thrombocytopenia
– joint pains (arthralgia)
Administration of drug Egilok should be stopped if any of the listed above effects reaches clinically significant intensity, and his reason authentically cannot be established.

Contraindications
– hypersensitivity to a metoprolol or other components of drug and also to other β-adrenoblockers
– arterial hypotension
– atrioventricular block of II or III degree
– dekompensirovanny heart failure
– clinically significant sinus bradycardia
– a sick sinus syndrome
– cardiogenic shock
– the significant disturbances of peripheric circulation
– an acute myocardial infarction if:
heart rate is lower than 45 beats per minute,
the interval of P-Q exceeds 240 m/s,
systolic arterial blood pressure is lower than 100 mm Hg.
– the patients needing continuous or periodic treatment by inotropic means (β-agonists)
– simultaneous intravenous administration of verapamil or other similar blockers of calcium channels
– serious peripheral vascular diseases at threat of gangrene
– the I trimester of pregnancy and the period of a lactation
– children’s age up to 18 years (due to the lack of enough clinical data).

Medicinal interactions
Antihypertensive effects of the drug Egilok and other antihypertensive drugs are usually summarized therefore in order to avoid development of arterial hypotension the careful observation of a condition of the patients receiving combinations of such means is necessary. However summation of effects of antihypertensive drugs can be used if necessary for achievement of more effective control of arterial blood pressure.
Intravenous administration of blockers of calcium channels of type of verapamil is not recommended to the patients accepting β-adrenoblockers. Simultaneous use of a metoprolol with blockers of calcium channels of type of verapamil or diltiazem leads to increase in negative inotropic and chronotropic effects.
Simultaneous use of a metoprolol with inhibitors of a monoaminooxidase (iMAO) is not recommended.
It is necessary to be careful at a combination with the following means
At simultaneous use with oral antiarrhytmic drugs (like quinidine and Amiodaronum) and also parasympathomimetics risk of developing arterial hypotension, bradycardia, atrioventricular blockade is possible.
At simultaneous use with glycosides of a foxglove the risk of developing bradycardia, carrying out disturbances is possible, metoprolol does not affect positive inotropic effect of drugs of a foxglove.
At simultaneous use with other antihypertensive drugs (a guanetidina, reserpine, Methyldopa, a clonidine, a guanfatsin) development of the profound bradycardia is possible.
At combination therapy with a clonidine the reception of the last should be stopped in several days after cancellation of a metoprolol, in order to avoid hypertensive crisis.
At simultaneous use with barbiturates, tranquilizers, three – and tetracyclic antidepressants, neuroleptics and ethanol risk of developing arterial hypotension is possible.
Means for an inhalation anesthesia (derivatives of hydrocarbons) at simultaneous use with Egilok increase risk of oppression of sokratitelny function of a myocardium and development of arterial hypotension.
At simultaneous use with a- and b-sympathomimetics the risk of developing the arterial hypertension expressed to bradycardia is possible, the risk of cardiac arrest is possible.
At simultaneous use with ergotamine strengthening of peripheric circulation is possible.
At simultaneous use with b2-sympathomimetics the functional antagonism is possible.
At simultaneous use with non-steroidal anti-inflammatory drugs (indometacin) reduction of hypotensive action of a metoprolol is possible.
At simultaneous use with estrogen the antihypertensive action of a metoprolol decreases.
At a concomitant use with oral hypoglycemic drugs the decrease in their effect, with insulin – increase in risk of development of a hypoglycemia, strengthening of its expressiveness and lengthening, masking of symptoms of a hypoglycemia is possible.
At simultaneous use Egilok strengthens action of kurarepodobny muscle relaxants.
At simultaneous use of Egilok with inhibitors of microsomal enzymes of a liver (Cimetidinum, ethanol, gidralazin, inhibitors of the return serotonin reuptake – paroksetin, fluoxetine and sertraline) strengthening of effects of a metoprolol owing to increase in its concentration in plasma is possible.
At simultaneous use of Egilok with inductors of microsomal enzymes of a liver CYP2D6 (rifampicin and barbiturates) the acceleration of metabolism of a metoprolol is possible that leads to decrease in concentration of a metoprolol in blood plasma and to reduction of effect of Egilok.
During therapy by Egilok the patients who are at the same time accepting ganglioblokator, other β-adrenoblockers (including in the form of eye drops) or MAO inhibitors, have to be under careful medical observation.

Special instructions
Clinical experience of use of a metoprolol for children is limited.
At the patients accepting metoprolol an acute anaphylaxis proceeds more hard.
Very seldom against the background of therapy by Egilok at patients with disturbance of conductivity there can sometimes occur aggravation of symptoms with development of atrioventricular blockade. If against the background of treatment the bradycardia developed, the dose of drug needs to be reduced or it is necessary to cancel drug gradually.
Against the background of Egilok’s use the aggravation of symptoms of disturbance of peripheric arterial circulation is possible.
Drug withdrawal is carried out gradually, reducing a dose approximately within 14 days. At the sharp termination treatment strengthening of symptoms of stenocardia and increase in risk of coronary disturbances is possible. Special attention at drug withdrawal needs to be paid to patients with coronary artery disease.
In spite of the fact that cardioselective β-adrenoblockers make smaller impact on breath function, in comparison with non-selective β-adrenoblockers, Egilok with care appoint to patients with chronic obstructive respiratory diseases. When assigning a metoprolol the patients with bronchial asthma need simultaneous use β2-адреномиметиков (in the form of tablets or aerosol).
Selection β-adrenoblockers unlike non-selective rather seldom influence carbohydrate metabolism or mask hyperglycemia symptoms. At the patients with diabetes accepting Egilok it is regularly necessary to control glucose level in blood and if necessary to carry out dose adjustment of insulin or oral hypoglycemic drugs.
At patients with a pheochromocytoma Egilok it is necessary to apply in combination with a-adrenoblockers.
In need of performing surgical intervention it is necessary to warn the anesthesiologist about the carried-out therapy by Egilok (the choice of drug for the general anesthesia with the minimum negative inotropic effect), drug withdrawal is not required.
Pregnancy and the period of a lactation
Use of drug during pregnancy demands careful assessment of risk and advantage. In need of prescribing of drug during this period the careful observation of a condition of a fruit and the newborn within 48-72 hours after the delivery as the pre-natal growth inhibition, bradycardia, arterial hypotension, respiratory depression, a hypoglycemia are possible is necessary. Metoprolol only in small amounts gets into breast milk, nevertheless, it is recommended to stop breastfeeding.
Features of influence of medicine on ability to run the vehicle or potentially dangerous mechanisms.
Metoprolol adversely affects ability of the patient to run vehicles and to perform work with the increased risk of accidents, especially in an initiation of treatment and at a concomitant use of alcohol (development of dizziness and fatigue is possible). At patients whose activity requires special attention and speed psychomotor reaction the selection of a dose should be solved only after assessment of individual reaction of the patient to drug.

Overdose
Symptoms: arterial hypotension, the profound sinus bradycardia, heart failure, an asystolia, nausea, vomiting, a bronchospasm, cyanosis, a hypoglycemia, at acute overdose – a loss of consciousness, cardiogenic shock, atrioventricular blockade, a coma. The first symptoms of overdose are shown in 20 minutes – 2 hours after administration of drug.
Above-mentioned symptoms can be aggravated at a concomitant use of drug with alcohol, other antihypertensives, quinidine and barbiturates.
Treatment: Gastric lavage (if washing is impossible and if the patient in consciousness can cause vomiting) prescribing of adsorbents, symptomatic therapy. Intensive care and careful control of parameters of blood circulation and breath, function of kidneys, glucose level in blood, blood serum electrolytes is necessary. Atropini sulfas (0.25-0.5mg in/in for adults, 10-20¼¬ú/kg for children) has to be appointed before gastric lavage (because of risk of stimulation of vagus nerve). In heavy arterial hypotension, bradycardia and the menacing heart failure – intravenous administration of β-adrenostimulyator with an interval of 2-5 minutes or by infusion before achievement of desirable effect or intravenous administration of atropine. In the absence of positive effect apply – a dopamine, Dobutaminum or noradrenaline. Introduction of a glucagon in doses 1-10mg can be also useful to achievement of reversibility of effects of strong blockade of β-receptors. In the profound bradycardia resistant to pharmacotherapy, implantation of the driver of a warm rhythm can be required. At a bronchospasm – intravenous administration of b2-agonist (for example, a terbutalina). These antidotes can be applied in the doses exceeding therapeutic. Metoprolol cannot be effectively removed with a hemodialysis.

A form of release and packing
On 60 tablets (for a dosage of 25 mg, 50 mg) and on 30 or 60 tablets (for a dosage of 100 mg) in bottles from brown glass with polyethylene covers, with control of the first opening and the supplied shock-absorber accordion. On one bottle together with the instruction for medical use in the state and Russian languages from cardboard

to Store Storage conditions in a pack at a temperature not above 25 °C
to Store out of children’s reach!

Not to apply a period of storage of 5 years after an expiration date.
Prescription status
According to the prescription

BUDAPEST CJSC EGIS PHARMACEUTICAL PLANT Producer 1106, Keresturi St., 30-38 Hungary
Phone number: (36-1) 803-5555, the fax: (36-1) 803-5529

Owner of the registration certificate
of CJSC Pharmaceutical Plant Egis, Hungary

the Address of the organization accepting in the territory of the Republic of Kazakhstan claims from consumers on quality of products (goods) Representation in RK CJSC EGIS Pharmaceutical Plant 050060, Almaty, Zharokov St. of 286 G ph. + 7 (727) 247 63 34, + 7 (727) 247 63 33, fax: + 7 (727) 247 61 41, e-mail:
To Develop egis@egis.kz

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