Aritel Tab n / a film about 5mg 30 pcs kanonfarma


Aritel Tab n / a film about 5mg 30 pcs kanonfarma



Active substance:
1 tablet coated with a film coating comprises 5 mg: bisoprolol fumarate 5 mg; 1 tablet, film-coated, 10 mg contains: Active ingredient: 10 mg bisoprolol fumarate ;.
Potato starch, colloidal silicon dioxide, magnesium stearate, lactose monohydrate, povidone K-30, microcrystalline cellulose.
Composition of coating film: selekoat AQ-02140, hypromellose (hydroxypropylmethylcellulose), macrogol 400 (polyethylene glycol 400), macrogol 6000 (polyethylene glycol 6000), titanium dioxide, dye sunset yellow.
The tablets are round, biconvex, film-coated orange light. The cross sectional almost white color.
Product form:
Tablets, film-coated 5 mg, 10 mg.
At 7, 10, 28 or 30 tablets in blisters of PVC film and aluminum foil printed patent.
At 2, 4 blisters of 7 tablets or 3, 5, 10 contour cell packs of 10 tablets, or 1, 2 blisters 28 tablets, or 1, 2, 3 blisters of 30 tablets together with instructions for use placed in a pile of cardboard.
Hypersensitivity to bisoprolol or any of the excipients and other beta-blockers; lactase deficiency, lactose intolerance, glucose-galactose malabsorption; cardiogenic shock; collapse; congestive heart failure; chronic heart failure decompensation requiring inotropic of therapy; atrioventricular block II and III extent without the pacemaker; sinoatrial block; sick sinus syndrome; bradycardia (heart rate less than 50 beats / min); severe asthma or chronic obstructive pulmonary disease; marked decrease in blood pressure (systolic blood pressure less than 90 mm Hg.); expressed by peripheral circulatory disorders or Raynaud’s syndrome; pheochromocytoma (without simultaneous application of alpha-blockers); metabolic acidosis; lactation; simultaneous reception of monoamine oxidase inhibitors (MAO) (except MAO inhibitors (-) B); simultaneous application floctafenine and sultopride; age 18 years (effectiveness and safety have been established).
Precautions: conducting desensitizing therapy; Prinzmetal angina; hyperthyroidism; diabetes type 1 and diabetes with considerable fluctuations in blood glucose concentration; Degree AV block I; severe renal failure (less than 20 ml / min creatinine clearance); expressed human liver; psoriasis; restrictive cardiomyopathy; congenital heart defects or heart disease valve with severe hemodynamic compromise; chronic heart failure, myocardial infarction within the last 3 months; pheochromocytoma (with concomitant use of alpha-adrenergic blockers); strict diet.
Use during pregnancy and lactation: during pregnancy, the drug Aritel® should be advised to use only if the benefit to the mother outweighs the risk of side effects in the fetus. Typically, beta-blockers reduce blood flow to the placenta and affect fetal development. It is necessary to monitor blood flow in the placenta and uterus, as well as to observe the growth and development of the child, in case of occurrence of adverse events in relation to pregnancy and / or fetus – taking alternative therapies. It is necessary to carefully examine the newborn after delivery. In the first three days of life may have symptoms of hypoglycemia and bradycardia.
the allocation of data bisoprolol passes into breast milk is not. Therefore, the drug Aritel® not recommended for women during lactation. If you need the drug Aritel® during lactation, breast-feeding should be discontinued.
5 mg
-hronicheskaya heart failure (CHF); -arterial hypertension; -ishemicheskaya heart disease: prevention of attacks of stable angina.
Interaction with other drugs
Not recommended combinations. – the treatment of chronic heart failure: Class I antiarrhythmics (e.g., quinidine, disopyramide, lidocaine, phenytoin, flecainide, propafenone), while the use of bisoprolol can reduce AV conduction and the contractile ability of the heart. – the treatment of chronic heart failure, hypertension, stable angina blockers “slow” calcium channel (BCCI) verapamil type and to a lesser extent, diltiazem, while the use of bisoprolol can lead to a decrease of myocardial contractility and AV conduction disturbance. In particular, intravenous administration of verapamil in patients receiving beta-blockers may cause severe hypotension and AV blockade.
Centrally acting antihypertensives (such as clonidine, methyldopa, moxonidine, rilmenidine) can lead to slowing of the heart rate and reducing cardiac output and vasodilation due to the reduction of the central sympathetic tone. Abrupt withdrawal, particularly before the abolition of beta-blockers may increase the risk of “rebound” hypertension.
Combinations requiring special care. – in the treatment of hypertension, stable angina: Class I antiarrhythmics (e.g., quinidine, disopyramide, lidocaine, phenytoin, flecainide, propafenone), while the use of bisoprolol can reduce AV conduction and contractility of the myocardium. – the treatment of chronic heart failure, hypertension, stable angina BCCI dihydropyridine derivatives (e.g. nifedipine, felodipine, amlodipine) while the application of bisoprolol can increase the risk of hypotension. In patients with chronic heart failure can not eliminate the risk of further deterioration of the contractile function of the heart.
Class III antiarrhythmics (e.g., amiodarone) may enhance violation AV conduction.
The action of beta-blockers for topical (e.g., eye drops for treating glaucoma) may enhance the systemic effects of bisoprolol (decrease in blood pressure, heart rate slowing).
Parasympathomimetics while the use of bisoprolol can exacerbate violation of AV conduction and increase the risk of bradycardia.
Hypoglycemic effect of insulin or hypoglycemic agents for oral administration may be enhanced. Symptoms of hypoglycaemia – particularly tachycardia – may be masked or suppressed. Such interactions are more likely to occur when using non-selective beta-blockers.
Funds for general anesthesia may increase the risk cardiodepressive action, resulting in hypotension (see. Section “Special Instructions”)
Cardiac glycosides while the use of bisoprolol can lead to an increase of the pulse time, and thus, to the development of bradycardia.
Nonsteroidal anti-inflammatory drugs (NSAIDs) may reduce the antihypertensive effect of bisoprolol.
Simultaneous use of the drug with beta-agonists (e.g., isoprenaline, dobutamine) may reduce the effect of both drugs.
Bisoprolol combination with agonists affecting the beta- and alpha-adrenergic receptors (such as norepinephrine, epinephrine) may enhance vasoconstrictor effects of these agents arising with alpha-adrenoceptors, leading to increased blood pressure. Such interactions are more likely to occur when using non-selective beta-blockers.
Antihypertensives, like other means with possible antihypertensive effect (e.g., tricyclic antidepressants, barbiturates, phenothiazines) may enhance the antihypertensive effect of bisoprolol.
Mefloquine while the use of bisoprolol may increase the risk of bradycardia.
MAO inhibitors (MAO inhibitors with the exception of (-) B) may enhance the antihypertensive effect of beta-blockers. Concomitant use can also lead to the development of hypertensive crisis.
Contra combination. Floctafenine: beta-adrenergic receptors may impede the compensatory cardiovascular reactions with hypotension caused by floctafenine. Sultopride: there is a risk of ventricular arrhythmias.
The most common symptoms of overdose: AV block, bradycardia, decreased blood pressure, bronchospasm, acute cardiac insufficiency and hypoglycaemia.
In the event of overdose, you must first stop taking the drug and start supporting symptomatically.
In severe bradycardia: intravenous administration of atropine. If the effect is insufficient, you can enter with caution agent with positive chronotropic effect. Sometimes it may require temporary staging an artificial pacemaker.
In marked decrease in blood pressure: intravenous plasma-purpose solutions and vasopressors.
When AV blockade: patients should be under constant supervision and be treated with beta-agonists such as epinephrine. If necessary – setting an artificial pacemaker.
During exacerbation flow CHF: intravenous diuretics, drugs with a positive inotropic effect, and vasodilators.
When bronchospasm: the use of bronchodilators including beta2-sympathomimetic agents and / or aminophylline.
When hypoglycemia: intravenous administration of dextrose (glucose).
pharmachologic effect
Pharmacological group:
Beta1-selective blocker.
Of selective beta1-adrenergic blocker, without own sympathomimetic activity, has no membrane stabilizing effect. Has only a negligible affinity for the beta2-adrenoceptor bronchial smooth muscle and blood vessels, as well as the beta2-adrenoceptor involved in metabolic regulation. Therefore, bisoprolol generally does not affect the airway resistance and metabolic processes that involve beta2 adrenoretsetseptory.
Generally, the maximum reduction in blood pressure (BP) reached in 2 weeks after initiation of therapy.
Bisoprolol reduces the activity of sympatic system, blocking the beta1-adrenergic receptors of the heart.
When a single oral administration at bisoprolol slows the heart rate (HR) in patients with coronary artery disease with no evidence of chronic heart failure (CHF), reduces the stroke volume and, consequently, reduces the ejection fraction and myocardial oxygen demand. Prolonged therapy initially increased total peripheral vascular resistance (SVR) is reduced. Reducing the activity of renin in blood plasma, it is regarded as one of the components of the antihypertensive effect of beta-blockers.
Suction. Bisoprolol almost completely (over 90%) is absorbed from the gastrointestinal tract. Its bioavailability is due to low metabolization at “first pass” through the liver (at about 10%) is approximately 90% after oral administration. Eating does not affect the bioavailability. Bisoprolol demonstrates linear kinetics, and its plasma concentration is proportional to the dose in the dose range of 5 to 20 mg. The maximum plasma concentration is achieved in 2-3 hours.
Distribution. Bisoprolol is distributed widely enough. The volume of distribution of 3.5 l / kg. Communication plasma protein reaches about 30%.
Metabolism. Metabolized by oxidative way without subsequent conjugation. All metabolites are polar (water soluble) and excreted by the kidneys. The main metabolites found in blood plasma and urine, does not exhibit pharmacological activity. Data obtained from experiments with liver microsomes in vitro human show that bisoprolol is metabolized primarily via isoenzyme CYP3A4 (about 95%) and CYP2D6 isozyme plays only a minor role.
Withdrawal. bisoprolol Clearance determined by the balance between renal excretion in unmodified form (about 50%) and the metabolism in the liver (50%) to metabolites that are also output by the kidneys. The total clearance is 15 l / h. The half – 10-12 hours.
There is no information on the pharmacokinetics of bisoprolol in patients with chronic heart failure and simultaneous impaired liver or kidney function.
Conditions of supply of pharmacies
side effects
The frequency of adverse reactions listed below, was determined according to the following: very often> 1/10; often> 1/100,
special instructions
Do not interrupt treatment with sharp and do not change the recommended dose without first consulting your doctor, as this may lead to temporary impairment of the heart. Treatment should not be interrupted suddenly, especially in patients with coronary heart disease. If discontinuation is necessary, the dose should be reduced gradually.
Monitoring patients receiving bisoprolol should include monitoring of heart rate and blood pressure (at the beginning of treatment – daily, then 1 every 3-4 months), the ECG, the concentration of blood glucose in patients with diabetes (1 every 4-5 months). In elderly patients it is recommended to monitor renal function (1 every 4-5 months). 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.
Before treatment is recommended to study the external breathing function in patients with a history of bronchopulmonary history.
Approximately 20% of patients with angina, beta-blockers are ineffective. The main reasons – severe coronary atherosclerosis low threshold ischemia (heart rate less than 100 beats / min) and a higher final diastolic volume of the left ventricle, which violates the subendocardial bloodstream.
In “smokers” the effectiveness of beta-blockers lower.
Patients who use contact lenses should bear in mind that during treatment may decrease the production of tear fluid.
When used in patients with pheochromocytoma has a risk of paradoxical hypertension (if not previously reached effective alpha adrenoblockade).
In hyperthyroidism preparation can mask certain clinical signs of hyperthyroidism (hyperthyroidism), such as tachycardia. Abrupt withdrawal of the drug 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.
At the same time taking clonidine his appointment may be terminated only a few days after discontinuation of the drug Aritel®.
May increase the severity of hypersensitivity reactions and the lack of effect of conventional doses of epinephrine (adrenaline) with aggravated allergic history.
In case of need for surgical planning preparation carried cancellation for 48 hours prior to general anesthesia. If a patient has taken the drug before surgery, he should pick up the drug for general anesthesia with minimal negative inotropic effect. It is necessary to warn the anesthetist that you are taking the drug Aritel®.
Reciprocal activation of the vagus nerve can be eliminated intravenous atropine (2.1 mg).
Drugs that reduce stocks catecholamines (including reserpine), may enhance the action of beta-blockers, so patients taking such drug combinations should be under constant medical supervision for detecting bradycardia or hypotension. Patients with diseases bronhospasticheskimi can assign cardioselective blocker in case of intolerance and / or ineffectiveness of other antihypertensive drugs, but should strictly follow the dosage. Overdose risk of developing bronchoconstriction.
In the case of elderly patients increasing bradycardia (less than 50 beats / minute), hypotension (systolic blood pressure below 100 mm Hg. V.), Atrioventricular block, bronchospasm, ventricular arrhythmia, serious liver and kidney functions necessary to reduce the dosage or discontinue treatment. It is recommended to discontinue therapy in the development of depression caused by the intake of beta-blockers.
Do not abruptly discontinue treatment because of the risk of severe arrhythmias and myocardial infarction. Cancellation are gradually reducing the dose for 2 weeks or more (dose reduced by 25% in 3-4 days).
Should be lifted before testing of blood and urine catecholamines, normetanephrine and vanillylmandelic acid; titers of antinuclear antibodies.
During the period of treatment must be careful when driving and occupation of other potentially hazardous activities that require high concentration and psychomotor speed reactions.
Storage conditions
In a dry, dark place at a temperature not higher than 25 C. Keep out of reach of children.
Dosing and Administration
Aritel® The drug is taken orally, 1 time a day with plenty of fluids, in the morning before breakfast, during or after it. Tablets should not be chewed or triturate.
Chronic heart failure. Starting treatment of CHF requires a mandatory drug Aritel® the special titration phase and regular medical supervision.
A prerequisite for treatment with Aritel® is stable chronic heart failure with no signs of aggravation. CHF Aritel® drug treatment is started in accordance with the following scheme titration. This may require individual adaptation depending on how well patients tolerate the prescribed dose, ie dose can be increased only if the previous dose was well tolerated. To ensure proper titration of the process in the initial stages of treatment is recommended to use the drug in smaller doses.
The recommended starting dose is 1.25 mg (1/2 tablet 2.5 mg) once a day. Depending on individual tolerance dose should be gradually increased to 2.5 mg, 3.75 mg (1 tablet 1/2 2.5 mg), 5 mg, 7.5 mg (1 tablet of 5 mg and 1 tablet 2 , 5 mg) and 10 mg 1 time per day at intervals of not less than 2 weeks or more.
If an increase in the dose of the drug is poorly tolerated by the patient, may reduce the dose.
The maximum daily dose for the treatment of CHF is 10 mg 1 time per day.
During titration we recommend regular monitoring of blood pressure, heart rate and severity of symptoms increase of CHF. Worsening of heart failure symptoms is possible from the first day of the drug. During the titration phase, or after it can be a temporary worsening CHF flow, hypotension or bradycardia. In this case it is recommended first of all to carry out correction of the dose of concomitant therapy drugs. you may also need a temporary reduction in dose or withdrawal of treatment Aritel®.
After stabilization of the patient should be a re-titration of the dosage or further treatment.
Arterial hypertension and coronary heart disease (prevention of attacks of stable angina). When hypertension and coronary heart disease the drug is prescribed 5 mg 1 time per day. If necessary to increase the dose of 10 mg 1 time per day. In the treatment of hypertension and angina maximum daily dose is 20 mg 1 time / day. Possible use of the drug bisoprolol in another dosage form (tablets with 2.5 mg Valium).
Во всех случаях режим приема и дозу подбирает врач каждому пациенту индивидуально, в частности, учитывая индивидуальные особенности и состояние пациента.
Special patient groups.
Нарушение функции почек или печени: при нарушении функции печени или почек легкой или умеренной степени обычно не требует коррекции дозы. При выраженных нарушениях функции почек (клиренс креатинина менее 20 мл/мин) и у пациентов с тяжелыми заболеваниями печени максимальная суточная доза составляет 10 мг. Increasing the dose in such patients should be administered with extreme caution.
Elderly patients: no dose adjustment is required.
К настоящему времени недостаточно данных относительно применения препарата Арител® у пациентов с ХСН, сопряженной с сахарным диабетом 1 типа, выраженными нарушениями функции почек и/или печени, рестриктивной кардиомиопатией, врожденными пороками сердца или гемодинамически обусловленным пороком сердца. to also still not enough data has been received with respect to patients with chronic heart failure with myocardial infarction within the last 3 months.
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


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