Aritel Korean Table n / a film about 2.5 mg 30 pcs kanonfarma

Description

Composition
Active substance:
1 tablet coated with a film coating comprising: bisoprolol fumarate 2.5 mg ;.
Excipients:
Colloidal silicon dioxide (Aerosil) 1.5 mg Potato starch 18 mg lactose monohydrate (milk sugar) 54 mg Povidone 3 mg Microcrystalline cellulose 20 mg Magnesium stearate 1 mg.
Composition of coating film: Selekoat AQ-02140 3 mg, including: hypromellose (hydroxypropylmethylcellulose) 1.8 mg Macrogol (polyethylene glycol 400) 0.33 mg macrogol (polyethylene glycol 6000) 0.45 mg titanium dioxide 0.39 mg , sunset yellow dye 0.03 mg.
Description:
Tablets, film-coated, light orange, heart-shaped with a line on both sides. In the cross-sectional two layers: an inner layer nearly white.
Product form:
Tablets, film-coated 2.5 mg.
10, 20 or 30 tablets in blisters of PVC film and aluminum foil printed patent.
At 1, 3, 5, 10 contour cell packs of 10 tablets or 3, 5 contour cell packs of 20 pills, or 1, 2, 3 blisters of 30 tablets together with instructions for use placed in a pile of cardboard.
Contraindications
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); age 18 years (effectiveness and safety have been established).
Carefully. Carrying 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.
Dosage
2.5 mg
Indications
– Chronic heart failure (CHF); – arterial hypertension; – Ischemic heart disease: prevention of attacks of stable angina.
Interaction with other drugs
Simultaneous administration of other drugs may affect the efficacy and tolerability of bisoprolol. Such interaction may also occur in those cases where two drugs taken after a short time. Physician should be informed of the reception of other drugs, even when they are received without a prescription (ie drugs, without a prescription).
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 hypotensive 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 hypotensive 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.
Rifampicin: probably a slight decrease in half-life of bisoprolol because rifampicin induction of hepatic isoenzymes of cytochrome P-450. Typically, a dose adjustment is required.
Ergotamine derivatives: possible worsening of peripheral circulatory disorders.
Overdose
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 alpha and 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.
Pharmacodynamics:
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 are involved in the beta2-adrenergic receptors. 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 uryazhaetsya 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 hypotensive effect of beta-blockers.
Pharmacokinetics:
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 reached after 2-4 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.
Pregnancy and breast-feeding
During pregnancy Aritel® Cor drug should be recommended for 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® Cor is not recommended for women during lactation. If you need the drug Aritel® Cor during lactation, breast-feeding should be discontinued.
Conditions of supply of pharmacies
On prescription.
side effects
Side effects are classified according to the WHO recommendations, in accordance with the frequency of occurrence: very common 1/10; often 1/100,
Mental disorders. Uncommon: depression, insomnia. Rare: hallucinations, nightmares.
Disorders of the nervous system. Common: dizziness, headache. Rare: loss of consciousness.
Violations by the organ of vision.
Rare: decrease in lacrimation (to consider when wearing contact lenses). Very rare: conjunctivitis.
Violations by the organ of hearing and labyrinth disorders. Rare: hearing impairment.
Violations of the heart. Very common: bradycardia (in patients with chronic heart failure). Common: worsening of heart failure symptoms flow (in patients with chronic heart failure). Infrequently: impaired AV conduction; bradycardia (in patients with hypertension or angina pectoris); worsening symptoms of heart failure flow (in patients with hypertension or angina), orthostatic hypotension.
Violations by the vessels. Often: marked reduction of blood pressure, especially in patients with heart failure, cooling sensation and numbness in the extremities.
Violations of the respiratory system, thorax and mediastinum. Uncommon: bronchospasm in patients with asthma or airway obstruction in history. Rare: allergic rhinitis.
On the part of the gastrointestinal tract. Common: nausea, vomiting, diarrhea, constipation. Disorders of the liver and biliary tract. Rare: hepatitis.
For the skin. Rare: hypersensitivity reactions such as pruritus, rash, flushing of the skin. Very rare: alopecia. Beta-blockers can exacerbate psoriasis symptoms or cause flow psoriasiform rash.
Violations by musculoskeletal and connective tissue. Uncommon: muscle weakness, muscle cramps. Violations by the genitals and breast cancer. Rare: violation of potency.
General disorders and the site of injection. Often: asthenia (patients with chronic heart failure), fatigue. Uncommon: asthenia (patients with arterial hypertension or angina).
Rarely: increasing the concentration of triglycerides and activity of the “liver” transaminases in blood (aspartate aminotransferase (ACT), alanine aminotransferase (ALT)).
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 levels to normal.
At the same time taking clonidine his appointment may be terminated only a few days after discontinuation of the drug Aritel® Cor.
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® Cor.
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 case of increasing bradycardia patients (less than 50 / 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.
Effects on ability to drive vehicles and mechanisms.
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
Drug tablets Aritel® Corinthians should be taken once a day with a small amount of liquid in the morning before breakfast, during or after it.
Tablets should not be chewed or triturate.
In all cases, the receiving mode and selects the dose the doctor for each patient individually, in particular, taking into account the heart rate and the patient’s condition.
Chronic heart failure. Начало лечения хронической сердечной недостаточности препаратом Арител® Кор требует обязательного проведения специальной фазы титрования и регулярного врачебного контроля. Предварительным условием для лечения препаратом Арител® Кор является стабильная хроническая сердечная недостаточность без признаков обострения. Лечение хронической сердечной недостаточности препаратом Арител® Кор начинается в соответствии со следующей схемой титрования.
Рекомендуемая начальная доза составляет 1,25 мг (1/2 таблетки по 2,5 мг) один раз в сутки. Необходимо наблюдение за индивидуальной адаптацией пациента к назначенной дозе. В зависимости от индивидуальной переносимости дозу следует постепенно увеличивать до 2,5 мг, 3,75 мг, 5 мг, 7,5 мг и 10 мг 1 раз в сутки. Каждое последующее увеличение дозы должно проводиться не менее чем через две недели.
If an increase in the dose of the drug is poorly tolerated by the patient, may reduce the dose.
Максимально рекомендованная доза при хронической сердечной недостаточности составляет 10 мг препарата Арител® Кор 1 раз в сутки.
Во время титрования рекомендуется регулярный контроль АД, ЧСС и степени выраженности симптомов хронической сердечной недостаточности. Усугубление симптомов течения хронической сердечной недостаточности возможно уже с первого дня применения препарата.
If the patient does not tolerate the maximum recommended dose may gradually decrease the dose.
Во время фазы титрования или после нее может возникнуть временное ухудшение течения хронической сердечной недостаточности, артериальная гипотензия или брадикардия. In this case it is recommended first of all to carry out correction of drug doses of concomitant therapy. Также может потребоваться временное снижение дозы препарата Арител® Кор или его отмена.
После стабилизации состояния пациента следует провести повторное титрование, либо продолжить лечение.
Артериальная гипертензия и стабильная стенокардия. Обычно начальная доза составляет 5 мг бисопролола 1 раз в сутки. При необходимости дозу можно увеличить до 10 мг 1 раз в сутки. При лечении артериальной гипертензии и стабильной стенокардии максимально рекомендованная доза составляет 20 мг бисопролола 1 раз в сутки.
Лечение препаратом Арител® Кор обычно является долговременной терапией.
Information
Appearance may differ from that depicted in the picture. There are contraindications. You need to read the manual or consult with a specialist