Betalok tab 100mg fl.plast 100 pcs

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Betalok tab 100mg fl.plast 100 pcs

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Description

Composition
Active substance:
One tablet contains 100 mg of metoprolol tartrate.
Excipients:
Lactose monohydrate 35 mg Magnesium stearate 4 mg 120 mg microcrystalline cellulose, sodium carboxymethyl starch 40 mg Colloidal anhydrous silica 9 mg, 7 mg povidone.
Description:
Biconvex tablets circular shape, from white to almost white color, with the notch at one side and engraving A above and Valium mE at risk.
Product form:
100 mg tablets. 100 tablets in a plastic bottle with a plastic screw cap with tamper-evident, 1 vial is placed in a cardboard box with instructions for use.
Contraindications
Atrioventricular block II and III degree, heart failure decompensation, patients receiving long-term or intermittent therapy inotropic agents and acting on beta-adrenergic receptors, clinically significant sinus bradycardia, sinus syndrome, cardiogenic shock expressed by peripheral circulatory disorders, arterial hypotension.
Betalok contraindicated in patients with acute myocardial infarction at a heart rate less than 45 beats per minute, PQ interval of 0.24 seconds or systolic blood pressure less than 100 mm Hg. Art.
Known hypersensitivity to metoprolol and its components or to other beta-blockers.
In severe peripheral vascular disease with gangrene threat.
Patients receiving beta-blockers, intravenous blockers are contraindicated “slow” verapamil type calcium channel.
Age 18 years (effectiveness and safety have been established).
Precautions: I degree atrioventricular block, Prinzmetal angina, chronic obstructive pulmonary disease (emphysema, chronic obstructive bronchitis, bronchial asthma), diabetes, severe renal insufficiency.
Dosage
100 mg
Indications
Hypertension: blood pressure reduction and a decrease in the risk of cardiovascular and coronary death (including sudden death).
Angina.
Cardiac arrhythmias, including supraventricular tachycardia.
In the treatment of post-myocardial infarction.
Functional heart disorders accompanied by tachycardia.
Prevention of migraine attacks.
Hyperthyroidism (complex therapy).
Interaction with other drugs
Avoid joint appointment of the drug Betalok with the following medications:
Barbituric acid derivatives: barbiturates (phenobarbital study was conducted) slightly increase the metabolism of metoprolol, due to enzyme induction.
Propafenone: when assigning propafenone four patients treated with metoprolol, there was an increase in plasma concentrations of metoprolol 2-5 times, with two patients had side effects typical of metoprolol. This interaction was confirmed during studies on 8 volunteers. Probably due to inhibition of the interaction of propafenone, like quinidine, metoprolol metabolism by cytochrome R4502D6. Taking into account the fact that propafenone has the properties of a beta blocker, metoprolol, and co-administration of propafenone is not feasible.
Verapamil: Combination of Beta-blockers (atenolol, propranolol and pindolol) and verapamil may cause bradycardia and lead to a reduction in blood pressure. Verapamil and beta-blockers have mutually inhibitory effect on atrio-ventricular conduction and sinus node function.
Betalok combination preparation with the following medications may require dose adjustments:
Class I antiarrhythmic agents: class I antiarrhythmics and beta-blockers can lead to the summation of negative inotropic effect, which may lead to serious adverse hemodynamic effects in patients with impaired left ventricular function. You should also avoid such a combination in patients with sick sinus syndrome and AV conduction disorders. The reaction described in Example disopyramide.
Amiodarone: the combined use of amiodarone and metoprolol can lead to severe sinus bradycardia. Taking into account the extremely long half-life of amiodarone (50 days), you should take into account possible interactions take place some time after discontinuation of amiodarone.
Diltiazem: Diltiazem and beta-blockers reinforce inhibitory effect on AV conduction and sinus node function. With the combination of metoprolol with diltiazem there were cases of severe bradycardia.
Nonsteroidal anti-inflammatory drugs (NSAIDs): NSAIDs weaken the antihypertensive effect of beta-blockers. This reaction is most documented for indomethacin. There was no interaction for sulindac described. In studies with diclofenac described reactions were noted.
Diphenhydramine: diphenhydramine metoprolol clearance reduces to alpha gidroksimetoprolola 2.5 times. At the same time strengthening the metoprolol action observed.
Epinephrine (adrenaline) reported 10 cases of severe hypertension and bradycardia in patients treated with non-selective beta-adrenergic blockers (including pindolol and propranolol) and treated with epinephrine (adrenaline). The interaction observed in healthy volunteers group. It is assumed that similar reactions may occur and the application of epinephrine with local anesthetic together with a random contact with the bloodstream. It is expected that this risk is much lower with cardioselective beta-blockers.
Phenylpropanolamine: phenylpropanolamine (norephedrine) a single dose of 50 mg may cause an increase in diastolic blood pressure to pathological values ​​in healthy volunteers. Propranolol generally prevents the increase in blood pressure caused by phenylpropanolamine. However, beta-blockers can cause paradoxical reaction of hypertension in patients receiving high doses of phenylpropanolamine. It reported several cases of hypertensive crisis while taking phenylpropanolamine.
Quinidine: Quinidine inhibits the metabolism of metoprolol have a special group of patients with rapid hydroxylation (in Sweden about 90% of the population), causing mostly a significant increase in the plasma concentration of metoprolol and increased beta-blockade. It is believed that this interaction is typical for other beta-blockers in the metabolism involving cytochrome R4502D6.
Clonidine: hypertensive reactions during abrupt cancellation of clonidine can be amplified when combined reception beta-blockers. In a joint application, in the case of clonidine, the termination of receiving beta-blockers should start several days before clonidine.
Rifampicin: rifampicin may enhance metabolism of metoprolol, reducing the plasma concentration of metoprolol.
The concentration of metoprolol in the blood plasma can rise in the combined use with cimetidine, hydralazine, selective serotonin inhibitors, such as paroxetine, fluoxetine and sertraline. Patients concurrently taking metoprolol and other beta blockers (eye drops) or inhibitors of monoamine oxidase (MAO) should be monitored carefully. While taking beta-blockers, inhalation anesthetics enhance cardiodepressive action. On a background of reception of beta-blockers in patients receiving oral hypoglycemic agents may require dose correction last.
Cardiac glycosides when used in conjunction with beta-blockers can prolong the atrioventricular conduction and cause bradycardia.
Overdose
symptoms
The consequences of an overdose of the drug can be Betalok marked reduction of blood pressure, sinus bradycardia, atrioventricular block, congestive heart failure, cardiogenic shock, heart failure, bronchospasm, impaired consciousness / coma, nausea, vomiting, and cyanosis.
The concomitant use of alcohol, taking antihypertensives, quinidine or barbiturates may aggravate the patient’s condition.
The first signs of an overdose may occur within 20 minutes – 2 hours after ingestion.
Treatment
Take activated charcoal, if necessary gastric lavage. In case of significant decrease in blood pressure, bradycardia, or the threat of heart failure should be injected beta1-agonists (such as dobutamine) intravenously at intervals of 2-5 minutes or by infusion to achieve a therapeutic effect. In the case of unavailability of selective beta1-agonist may be administered intravenously or dopamine atropine sulfate to block the vagus nerve.
If the therapeutic effect is not achieved, it is possible to use other sympathomimetics such as dobutamine or noradrenaline.
You can enter glucagon in a dose of 1-10 mg. Sometimes you may need to use a cardiac pacemaker. For the relief of bronchospasm should be administered intravenously beta2-agonists.
It is necessary to take into account that doses of antidotes needed to relieve symptoms that occur with an overdose of beta-blockers, much higher therapeutic as beta-adrenergic receptors are bound with a beta-blocker.
pharmachologic effect
Pharmacological group:
Selective beta-blocker.
Pharmacodynamics:
Metoprolol – beta1-adrenergic blocker blocking beta1 receptor in much lower doses than the doses required to block the beta2-receptors. Metoprolol has negligible membrane stabilizing effect and does not exhibit partial agonist activity. Metoprolol reduces or inhibits the agonistic effect that has on cardiac function catecholamines released during neural and physical stress. This means that metoprolol has the ability to inhibit increase in heart rate (HR), minute volume and increased cardiac contractility, and blood pressure (BP) caused by abrupt release of catecholamines.
Patients with symptoms of obstructive lung disease when necessary metoprolol can be administered in combination with a beta2-agonists. When combined with beta2-agonists in therapeutic doses Betalok less effect on beta2- agonists induced bronchodilation than non-selective beta-blockers.
Metoprolol to a lesser extent than non-selective beta-blockers affect the production of insulin and carbohydrate metabolism. Effect of the drug on the reaction Betalok cardiovascular system under conditions of hypoglycemia is much less pronounced when compared to non-selective beta-blockers.
Clinical studies have shown that Betaloc may cause a slight increase in triglycerides and a decrease in the content of free fatty acids in the blood. In some cases there was a slight decrease in the fraction of high density lipoprotein (HDL), which is less pronounced than in the case of nonselective beta-blockers. However, in any of the clinical studies have shown a significant reduction in total cholesterol levels in the blood serum of metoprolol in the treatment for several years.
The quality of life during treatment with Betaloc not improving or deteriorating. Improving the quality of life in the treatment of drug Betalok observed in patients after myocardial infarction.
Pharmacokinetics:
Metoprolol is almost completely absorbed after oral administration. Before the drug within the therapeutic dose in the blood plasma concentration of the drug is in linear dependence on the dose. The maximum plasma concentration is reached in 1.5-2 hours after administration.
After receiving the first dose of metoprolol into the systemic circulation reaches about 50% of the dose. Repeated receptions indicator systemic bioavailability increased to 70%. The drug with food can increase systemic bioavailability of 30-40%. Relation to plasma proteins is low, approximately 5-10%.
Metabolism and excretion
Metoprolol undergoes oxidative metabolism in the liver to form the 3 major metabolites, none of which has no clinically significant beta-blocking effect.
About 5% of the dose excreted in the urine in an unmodified form, in some cases, this figure may reach 30%.
The average half-life of metoprolol from the blood plasma is about 3.5 hours (minimum – 1 hour maximum – 9 hours). Plasma clearance is approximately 1 l / min.
Elderly patients are not observed significant changes in the pharmacokinetics of metoprolol as compared to young patients.
Systemic bioavailability and elimination of metoprolol is unchanged in patients with reduced renal function. Excretion of metabolites in these patients, however, reduced. Significant accumulation of metabolites observed in patients with glomerular filtration rate of less than 5 ml / min. However, such an accumulation of metabolites does not increase the beta-blocking effect.
In patients with impaired hepatic function The pharmacokinetics of metoprolol (due to low association with proteins) varies slightly. However, in patients with severe liver cirrhosis or portacaval anastomosis, metoprolol bioavailability can be increased, and the total clearance to decrease. Patients with portocaval anastomosis total clearance was approximately 300 ml / min, and the area under the concentration in plasma – time (AUC) was 6 times greater as compared with that of healthy subjects.
Pregnancy and breast-feeding
Like most drugs Betalok should not be administered during pregnancy and during breast-feeding, unless the expected benefit to the mother outweighs the potential risk to the fetus and / or the child. As with other antihypertensive agents, beta-blockers may cause side effects such as bradycardia in the fetus, infants or children who are breastfed.
The amount of metoprolol liberated into breast milk, and beta-blocking effect in a child who is breastfed (if mother metoprolol in therapeutic doses), are insignificant.
Conditions of supply of pharmacies
On prescription.
side effects
Betalok well tolerated by patients, the side effects are mostly mild and reversible.
As a result of clinical trials or application Betalok drug (metoprolol tartrate), the following undesirable side effects have been described in clinical practice. In many instances, a causal relationship with the reception Betalok the drug has not been established. To assess the frequency of cases we used the following criteria: very common (> 10%), often (1-9,9%), not frequent (0.1-0.9%), rarely (0,01-0,09%) and very rare (
The cardiovascular system
Common: bradycardia, postural disorders (very rarely accompanied by syncope), cold extremities, palpitations;
Not often: a temporary increase of symptoms of heart failure, AV block of I degree; cardiogenic shock in patients with acute myocardial infarction;
Rare: other cardiac conduction, arrhythmias;
Very rare: Gangrene in patients with previous severe impairment of the peripheral circulation.
central nervous system
Very common: fatigue;
Common: dizziness, headache;
Rare: irritability, anxiety, impotence / sexual dysfunction;
Not often: paresthesia, convulsions, depression, weakening of attention, drowsiness or insomnia, nightmares;
Very rare: Amnesia / memory impairment, depression, hallucinations.
Digestive tract
Common: nausea, abdominal pain, diarrhea, constipation;
Not often vomiting;
Rare: dry mouth.
Liver
Rare: abnormal liver function;
Very rare: hepatitis.
skin
Not often: rash (in the form of urticaria), increased sweating;
Rare: hair loss;
Very rare: photosensitivity, exacerbation of psoriasis.
Respiratory system
Common: shortness of breath on exertion;
Not often: bronchospasm;
Rare: Rhinitis.
senses
Rare: blurred vision, dry and / or irritated eyes, conjunctivitis;
Very rare: Tinnitus, taste disturbance.
From the musculoskeletal
Very rarely arthralgia.
Metabolism
Not often: weight gain.
Blood
Very rare: thrombocytopenia.
special instructions
Patients taking beta-blockers should not be administered intravenously blockers “slow” calcium channels such as verapamil.
Patients suffering from obstructive pulmonary disease, is not recommended for beta-blockers. In case of poor tolerability of other antihypertensive agents or their ineffectiveness, metoprolol can be administered as it is a selective drug. It is necessary to assign the minimum effective dose, if necessary, you can assign beta2-agonists.
When using the beta1-adrenergic blockers risk of their influence on carbohydrate metabolism or the ability to mask the symptoms of hypoglycemia is much less than with nonselective beta-blockers.
In patients with chronic heart failure decompensation is necessary to achieve the stage of compensation, both before and during treatment with the drug.
Patients suffering from angina Prinzmetal, is not recommended for non-selective beta-blockers.
Очень редко у пациентов с нарушением AV проводимости может наступать ухудшение (возможный исход – AV блокада). Если на фоне лечения развилась брадикардия, дозу Беталока необходимо уменьшить или следует постепенно отменить препарат.
Метопролол может ухудшать симптомы нарушения периферического кровообращения в основном вследствие снижения артериального давления.
Следует проявлять осторожность при назначении препарата пациентам, страдающим тяжелой почечной недостаточностью, при метаболическом ацидозе, совместном назначении с сердечными гликозидами.
Пациентам, страдающим феохромоцитомой, параллельно с препаратом Беталок следует назначать альфа-адреноблокатор.
У пациентов с циррозом печени биодоступность метопролола увеличивается.
В случае хирургического вмешательства следует проинформировать врача-анестезиолога, что пациент принимает бета-адреноблокатор.
Следует избегать резкой отмены препарата. При необходимости отмены препарата, отмену следует проводить постепенно. У большинства пациентов прием препарата можно отменить за 14 дней. Дозу препарата снижают постепенно, в несколько приёмов, до достижения конечной дозы 25 мг один раз в сутки. Пациенты с ишемической болезнью сердца должны находиться под тщательным наблюдением врача во время отмены препарата. У пациентов, принимающих бета-адреноблокаторы, анафилактический шок протекает в более тяжелой форме.
Влияние на способность водить машину и работать с техническими устройствами
При применении препарата возможны эпизоды головокружения или общей слабости, в связи с чем необходимо воздержаться от вождения автотранспорта и занятий потенциально опасными видами деятельности, требующими повышенной концентрации внимания и быстроты психомоторных реакций.
Storage conditions
At a temperature of not higher than 25C. Keep out of the reach of children.
Dosing and Administration
Таблетки можно принимать как вместе с пищей, так и натощак.
Артериальная гипертензия 100-200 мг препарата Беталок однократно утром или в два приема; утром и вечером. При необходимости дозу можно увеличить или добавить другое антигипертензивное средство.
Длительная антигипертензивная терапия 100-200 мг препарата Беталок в сутки позволяет снизить общую смертность, включая внезапную смерть, а также частоту возникновения мозговых инсультов и нарушений коронарного кровообращения у пациентов с артериальной гипертензией.
Стенокардия 100-200 мг в сутки в два приема; утром и вечером. При необходимости к терапии может быть добавлен другой антиангинальный препарат.
Нарушения ритма сердца 100-200 мг в сутки в два приема; утром и вечером. При необходимости к терапии может быть добавлен другой антиаритмический препарат.
Поддерживающая терапия после инфаркта миокарда
Поддерживающая доза составляет 200 мг в сутки в два приема; утром и вечером. Назначение Беталока в дозе 200 мг в сутки позволяет снизить смертность у пациентов, перенесших инфаркт миокарда, и снизить риск развития повторного инфаркта миокарда (в том числе и у пациентов с сахарным диабетом).
Функциональные нарушения сердечной деятельности, сопровождающиеся тахикардией 100 мг препарата Беталок один раз в сутки, рекомендуется принимать таблетку утром. the dose may be increased if necessary.
Профилактика приступов мигрени 100-200 мг в сутки в два приема; утром и вечером.
Гипертиреоз 150-200 мг в сутки в 3-4 приема.
Renal function
Нет необходимости корректировать дозу у пациентов с нарушением функции почек.
Abnormal liver function
Обычно из-за низкой степени связи с белками плазмы коррекция дозы метопролола не требуется. Однако при тяжелом нарушении функции печени (у пациентов с тяжелой формой цирроза печени или портокавальным анастомозом) может потребоваться снижение дозы.
Пожилой возраст
Нет необходимости корректировать дозу у пациентов пожилого возраста.
Children
Опыт применения препарата Беталок у детей ограничен.
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

ASTRAZENECA

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