Bisoprolol ft tablets p/o 2.5mg №10×3

Name:
Bisoprolol-ft.
Description:
of the tablets containing 2.5 mg and 5 mg of bisoprolol fumarate are biconvex film-coated tablets, white in color with a risk on one side (5 mg tablets differ from 2.5 mg tablets in larger size); tablets containing 10 mg of bisoprolol fumarate are biconvex film-coated tablets, yellow in color with a score line on one side. The risk serves to facilitate the division of the tablet into equal doses. The main active ingredient is bisoprolol. Release form Coated tablets. Tablets of 2.5 mg, 5 mg and 10 mg in a blister pack made of PVC film and aluminum foil No. 10×3 and No. 10×5 and in jars No. 100 made of polyethylene terephthalate. Together with the leaflet, blister packs or a can are placed in packs of cardboard. Dosage 5 mg. Pharmacological action Bisoprolol is a selective beta1-blocker without its own sympathomimetic activity, does not have a membrane stabilizing effect. It has antihypertensive, antiarrhythmic and antianginal effects. Blocking in low doses beta1-adrenergic receptors of the heart, it inhibits the conduction and excitability of the myocardium, slows down the conduction of nerve impulses from the atria to the ventricles of the heart. With an increase in the dose above the therapeutic one, it has a beta2-adrenergic blocking effect. The hypotensive effect is associated with a decrease in the minute volume of blood, inhibition of sympathetic stimulation of peripheral vessels, a decrease in the activity of the renin-angiotensin system and an effect on the central nervous system (CNS). With arterial hypertension, the effect occurs after 2–5 days, a stable effect develops after 1–2 months. The antianginal effect is mainly due to a decrease in myocardial oxygen demand as a result of a decrease in heart rate (HR), a slight decrease in contractility, lengthening of diastole, and improvement in myocardial perfusion. Unlike non-selective beta-blockers, when bisoprolol is used in medium therapeutic doses, its less pronounced effect on organs containing beta2-adrenergic receptors (pancreas, skeletal muscles, smooth muscles of peripheral arteries, bronchi and uterus) and on carbohydrate metabolism is observed, there is no delay sodium ions in the body. The selective effect of the drug on beta1-adrenergic receptors persists beyond the therapeutic range. Bisoprolol does not have a pronounced negative inotropic effect. Indications for use Arterial hypertension; ischemic heart disease: prevention of angina attacks; chronic heart failure. Dosage and administration Tablets should be taken with a small amount of liquid in the morning before, during or after breakfast. Tablets should not be chewed or crushed into powder. Treatment of arterial hypertension and angina pectoris. In all cases, the regimen and dosage is selected by the doctor for each patient individually, in particular, taking into account the heart rate and the patient’s condition. The usual starting dose is 5 mg (1 5 mg tablet) once a day. If necessary, the dosage can be increased to 10 mg (2 tablets of 5 mg or 1 tablet of 10 mg) once a day. In the treatment of arterial hypertension and angina pectoris, the maximum recommended dose is 20 mg of bisoprolol FT once a day. Treatment of chronic heart failure. The start of treatment for chronic heart failure with Bisoprolol FT requires a special titration phase and regular medical supervision. Preconditions for treatment are: chronic heart failure with no signs of exacerbation in the previous six weeks; practically unchanged basic therapy in the previous two weeks; treatment with optimal doses of ACE inhibitors (or other vasodilators, in case of intolerance to ACE inhibitors), diuretics and, optionally, cardiac glycosides. Treatment of chronic heart failure Bisoprolol FT begins in accordance with the following titration scheme. This may require individual adaptation depending on how well the patient tolerates the prescribed dose, i.e. the dose can only be increased if the previous dose was well tolerated: 1st week: 1.25 mg / day – ½ tablet of bisoprolol FT 2.5 mg once daily; 2nd week: 2.5 mg / day – 1 tablet of Bisoprolol FT 2.5 mg once a day; 3rd week: 3.75 mg / day – 1½ tablets of Bisoprolol FT 2.5 mg once a day; 4th-7th weeks: 5 mg/day – 1 tablet of Bisoprolol FT 5 mg once a day; 8th-11th weeks: 7.5 mg/day – 1½ tablets of Bisoprolol FT 5 mg once a day or 1 tablet of Bisoprolol FT 2.5 mg + 1 tablet of Bisoprolol FT 5 mg once a day; 12th week and beyond: 10 mg/day. – 1 tablet Bisoprolol FT 10 mg or 2 tablets Bisoprolol FT 5 mg once a day as maintenance therapy. The maximum recommended dose in the treatment of chronic heart failure is 10 mg bisoprolol FT once a day. Patients are advised to take the dose of the drug selected by the doctor if no adverse reactions occur. After starting treatment with the drug at a dose of 1.25 mg (½ tablet of Bisoprolol FT 2.5 mg), the patient should be observed for about 4 hours (control of heart rate, blood pressure, conduction disturbances, signs of worsening heart failure). During the titration phase or after it, a temporary worsening of the course of heart failure, fluid retention in the body, arterial hypotension or bradycardia may occur. In this case, it is recommended, first of all, to pay attention to the selection of the dosage of concomitant basic therapy (optimize the dose of diuretic and / or ACE inhibitor) before reducing the dosage of Bisoprolol FT. Treatment should be interrupted only if absolutely necessary. After stabilization of the patient’s condition, re-titration should be carried out, or treatment should be continued. Special patient groups Renal or hepatic impairment Treatment of hypertension or angina pectoris in mild to moderate hepatic or renal impairment usually does not require dose adjustment; with severe renal impairment (creatinine clearance less than 20 ml / min.) and in patients with severe liver disease, the maximum daily dose is 10 mg. Elderly patients (>65 years) dose adjustment is not required. Children: It is not recommended to prescribe Bisoprolol FT to children and adolescents, since its safety and efficacy in this age group has not been established. Duration of treatment for all indications. Treatment with Bisoprolol FT is usually a long-term procedure. If necessary, treatment can be interrupted and resumed subject to certain rules. Treatment should not be interrupted suddenly, especially in patients with ischemic heart disease. If it is necessary to stop treatment, then the dosage of the drug should be reduced gradually. If the patient has forgotten to take Bisoprolol FT, there is no need to use a double dose to make up for the missed one. The next dose should be taken at the usual time. Use during pregnancy and lactation During pregnancy, the use of Bisoprolol FT can be recommended by a doctor and only if the benefit to the mother outweighs the risk of side effects in the fetus. There are no data on the excretion of bisoprolol into breast milk or the safety of exposure to bisoprolol in infants. Therefore, taking Bisoprolol FT is not recommended for women during breastfeeding. Precautions It is necessary to warn the patient not to interrupt treatment abruptly and not to change the recommended dosage without first consulting a doctor, as this may lead to a temporary deterioration in the activity of the heart. Treatment should not be interrupted suddenly, especially in patients with ischemic heart disease. If discontinuation of treatment is necessary, the dosage should be reduced gradually. Monitoring the condition of patients taking Bisoprolol FT should include measuring heart rate and blood pressure (at the beginning of treatment – daily, then 1 time in 3-4 months), ECG, determination of blood glucose in patients with diabetes mellitus (1 time in 4-5 months .). In elderly patients, it is recommended to monitor kidney function (1 time in 4-5 months). The patient should be taught how to calculate heart rate and instruct him about the need for medical advice if the heart rate is less than 50 beats / min. Before starting treatment, it is recommended to conduct a study of the function of external respiration in patients with a burdened bronchopulmonary history. Patients using contact lenses should take into account that during treatment, a decrease in the production of lacrimal fluid is possible. When used in patients with pheochromocytoma, there is a risk of developing paradoxical arterial hypertension (if effective alpha-blockade has not been previously achieved). In thyrotoxicosis, bisoprolol FT may mask certain clinical signs of thyrotoxicosis (eg, tachycardia). Abrupt discontinuation of the drug in patients with thyrotoxicosis is contraindicated, as it can exacerbate symptoms. In diabetes mellitus, it can mask tachycardia caused by hypoglycemia. Unlike non-selective beta-blockers, it practically does not increase insulin-induced hypoglycemia and does not delay the restoration of blood glucose concentration to normal levels. While taking clonidine, its reception can be stopped only a few days after the abolition of Bisoprolol FT. It is possible to increase the severity of the hypersensitivity reaction and the lack of effect from the usual doses of epinephrine against the background of an aggravated allergic history. If it is necessary to carry out planned surgical treatment, the drug should be discontinued 48 hours before general anesthesia. If the patient took the drug before surgery, he should choose a drug for general anesthesia with a minimally negative inotropic effect. Reciprocal activation of the vagus nerve can be eliminated by intravenous atropine (1-2 mg). Drugs that reduce catecholamine reserves (including reserpine) can enhance the effect of beta-blockers, so patients taking such combinations of drugs should be under constant medical supervision to detect a pronounced decrease in blood pressure or bradycardia. Patients with bronchospastic diseases can be prescribed cardioselective blockers in case of intolerance and / or ineffectiveness of other antihypertensive drugs. If the dose of the drug is exceeded, there is a risk of developing bronchospasm. In case of detection in elderly patients of increasing bradycardia (heart rate less than 50 beats / min.), A pronounced decrease in blood pressure (systolic blood pressure below 100 mm Hg), atrioventricular blockade, it is necessary to reduce the dose or stop treatment. It is recommended to stop therapy if depression develops. You can not abruptly interrupt treatment because of the risk of developing severe arrhythmias and myocardial infarction. Cancellation of the drug is carried out gradually, reducing the dose for 2 weeks or more (reduce the dose by 25% in 3-4 days). It is necessary to cancel the drug before examining the content of catecholamines, normetanephrine and vanillylmandelic acid in the blood and urine; titers of antinuclear antibodies. Patients with a history or family history of psoriasis should be treated with beta-blockers (eg, bisoprolol) only after a careful benefit/risk assessment. The use of the drug Bisoprolol FT can lead to positive results in doping control. Management of transport and mechanisms. Bisoprolol FT does not affect the ability to drive a car in the study of patients suffering from diseases of the coronary vessels of the heart. However, due to individual reactions, the ability to drive a car or work with technically complex mechanisms may be impaired. Particular attention should be paid to this at the beginning of treatment, after changing the dose, and also with the simultaneous use of alcohol. Interaction with other drugs Not recommended combinations Blockers of “slow” calcium channels (BMCK) such as verapamil and, to a lesser extent, diltiazem, while used with bisoprolol, can lead to a decrease in myocardial contractility and impaired AV conduction. In particular, intravenous administration of verapamil to patients taking beta-blockers can lead to severe arterial hypotension and AV blockade. Centrally acting antihypertensives (such as clonidine, methyldopa, moxonidine, rilmenidine) can lead to a decrease in heart rate and a decrease in cardiac output, as well as to vasodilation due to a decrease in central sympathetic tone. Abrupt withdrawal, especially before the withdrawal of beta-blockers, may increase the risk of developing “rebound” arterial hypertension. Class I antiarrhythmics (for example, quinidine, disopyramide, lidocaine, phenytoin; flecainide, propafenone), when used simultaneously with bisoprolol, can reduce AV conduction and myocardial contractility. Combinations requiring special care BMCC derivatives of dihydropyridine (for example, nifedipine, felodipine, amlodipine), while used with bisoprolol, may increase the risk of arterial hypotension. In patients with CHF, the risk of subsequent worsening of the contractile function of the heart cannot be excluded. Class III antiarrhythmics (eg, amiodarone) may exacerbate AV conduction disturbance. The action of topical beta-blockers (for example, eye drops for the treatment of glaucoma) may enhance the systemic effects of bisoprolol (lowering blood pressure, slowing heart rate). Parasympathomimetics, when used simultaneously with bisoprolol, can increase the disturbance of AV conduction and increase the risk of developing bradycardia. The hypoglycemic effect of insulin or oral hypoglycemic agents may be enhanced. Signs of hypoglycemia – in particular tachycardia – may be masked or suppressed. Such interactions are more likely with the use of non-selective beta-blockers. Funds for general anesthesia may increase the risk of cardiodepressive action, leading to arterial hypotension (see section “Special Instructions”). Cardiac glycosides, when used simultaneously with bisoprolol, can lead to an increase in impulse conduction time, and thus to the development of bradycardia. Non-steroidal anti-inflammatory drugs (NSAIDs) may reduce the hypotensive effect of bisoprolol. The simultaneous use of bisoprolol with beta-agonists (eg, isoprenaline, dobutamine) may lead to a decrease in the effect of both groups of drugs. The combination of bisoprolol with adrenomimetics that affect beta- and alpha-adrenergic receptors (for example, norepinephrine, epinephrine) can enhance the vasoconstrictor effects of these drugs that occur with the participation of alpha-adrenergic receptors, leading to an increase in blood pressure. Such interactions are more likely with the use of non-selective beta-blockers. Antihypertensive agents, as well as other agents with a possible antihypertensive effect (for example, tricyclic antidepressants, barbiturates, phenothiazines) may increase the hypotensive effect of bisoprolol. When used together, Mefloquine may be observed while the use of bisoprolol may increase the risk of developing bradycardia. MAO inhibitors (with the exception of MAO B inhibitors) may enhance the hypotensive effect of beta-blockers. Simultaneous use can also lead to the development of a hypertensive crisis. Contraindications The drug Bisoprolol FT should not be used to treat patients with the following conditions: hypersensitivity to bisoprolol or to any of the components of the drug (see section “Composition”) and to other beta-blockers; acute heart failure, chronic heart failure in the stage of decompensation, requiring inotropic therapy; shock caused by impaired cardiac function (cardiogenic shock), collapse; atrioventricular block II and III degree without the use of a pacemaker; sick sinus syndrome; sinoatrial blockade; bradycardia (heart rate less than 50 beats / min.) Before treatment; a pronounced decrease in blood pressure (systolic blood pressure less than 100 mm Hg. Art.); severe forms of bronchial asthma and chronic obstructive pulmonary disease in history; late stages of peripheral circulatory disorders, Raynaud’s disease; pheochromocytoma (without the simultaneous use of alpha-blockers); metabolic acidosis; simultaneous administration of monoamine oxidase (MAO) inhibitors, with the exception of MAO-B; age up to 18 years (efficacy and safety have not been established). With caution: desensitizing therapy, Prinzmetal’s angina, hyperthyroidism, type 1 diabetes mellitus and diabetes mellitus with significant fluctuations in blood glucose concentration, AV block I degree, severe renal failure (CC less than 20 ml / min), severe liver dysfunction, psoriasis , restrictive cardiomyopathy, congenital heart disease or valvular heart disease with severe hemodynamic disorders, CHF with myocardial infarction within the last 3 months, a strict diet. Composition Each tablet contains 2.5 mg, 5 mg and 10 mg of bisoprolol fumarate as the active substance. Excipients: corn starch, crospovidone, anhydrous colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, anhydrous calcium hydrogen phosphate, hypromellose, titanium dioxide (E-171), yellow iron oxide (E-172 – for a dosage of 10 mg), macrogol 400. OverdoseSymptoms: arrhythmia, ventricular extrasystole, severe bradycardia, atrioventricular blockade, marked decrease in blood pressure, acute heart failure, hypoglycemia, shortness of breath, bronchospasm, dizziness, fainting, convulsions. Treatment: If an overdose occurs, it is necessary to stop taking the drug and start symptomatic treatment. Available data suggest a low efficiency of dialysis with an overdose of bisoprolol. Symptomatic therapy: with developed atrioventricular blockade, gastric lavage and the appointment of adsorbing drugs; symptomatic therapy: with developed atrioventricular blockade – intravenous administration of 1-2 mg of atropine, epinephrine or setting up a temporary pacemaker; with ventricular extrasystole – lidocaine (class IA drugs are not used); with a pronounced decrease in blood pressure – the patient should be in the Trendelenburg position; if there are no signs of pulmonary edema – plasma-substituting solutions intravenously, if ineffective – the introduction of epinephrine, dopamine, dobutamine (to maintain the chronotropic and inotropic action and eliminate a pronounced decrease in blood pressure); in heart failure – cardiac glycosides, diuretics, glucagon; with convulsions – intravenous diazepam; with bronchospasm – beta2-adrenergic stimulants by inhalation. With hypoglycemia – intravenous administration of dextrose (glucose). Side effect From the side of the cardiovascular system. Very often: decrease in heart rate (bradycardia, especially in patients with chronic heart failure); often: arterial hypotension (especially in patients with chronic heart failure), the appearance of angiospasm (increased peripheral circulatory disorders, feeling cold in the extremities (paresthesia)); infrequently: impaired AV conduction, orthostatic hypotension, decompensation of heart failure with the development of peripheral edema. From the side of the central nervous system. Common: dizziness*, headache*; rarely: loss of consciousness. Mental disorders. Uncommon: depression, insomnia; rarely: hallucinations, nightmares. From the sense organs. Rarely: blurred vision, decreased tearing (should be taken into account when wearing contact lenses), hearing impairment; very rare: conjunctivitis. From the respiratory system. Rare: allergic rhinitis; infrequently: bronchospasm in patients with bronchial asthma or obstructive airway diseases. From the digestive system. Often: nausea, vomiting, diarrhea, constipation, dryness of the oral mucosa; rarely: hepatitis. From the side of the musculoskeletal system. Infrequently: muscle weakness, cramps in the calf muscles, arthralgia. From the side of the skin. Rare: hypersensitivity reactions such as pruritus, skin redness, sweating, rash; very rare: alopecia. Beta-blockers can exacerbate psoriasis. From the reproductive system. Very rare: violation of potency. Laboratory indicators. Rarely: increased levels of liver enzymes in the blood (ACT, ALT), increased levels of triglycerides in the blood. In some cases: thrombocytopenia, agranulocytosis. Other violations. Often: asthenia (in patients with CHF), increased fatigue *; infrequently: asthenia (in patients with arterial hypertension or angina pectoris). * In patients with arterial hypertension or angina pectoris, these symptoms especially often appear at the beginning of the course of treatment. Usually these phenomena are mild and usually disappear within 1-2 weeks after the start of treatment. If any of the listed side effects occur, or any side effects not listed in the package leaflet, you should consult a doctor. Storage conditions Store in a place protected from light at a temperature not exceeding 25 ° C. Keep out of the reach of children. Shelf life 3 years. The expiration date is indicated on the packaging. This medicinal product must not be used after the date indicated on the package. 10×3