Bisoprolol 5mg tablets 50
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Active substance: bisoprolol fumarate 5 mg.
Excipients: croscarmellose sodium (primellose), povidone (polyvinylpyrrolidone medium molecular weight), pregelatinized starch (starch 1500), silicon dioxide colloidal (aerosil), talc, microcrystalline cellulose, lactose (milk sugar), magnesium stearate.
Composition of the film shell: opadrai II (polyvinyl alcohol, partially hydrolyzed, titanium dioxide, talc, macrogol (polyethylene glycol 3350), dye iron oxide (II)).
Selective beta1-blocker, without its own sympathomimetic activity, does not have a membrane-stabilizing effect. Reduces the activity of renin of blood plasma, reduces myocardial oxygen demand, reduces heart rate (at rest and under load).
It has a hypotensive, antiarrhythmic and antianginal effect. Blocking in low doses beta1-adrenergic receptors of the heart, reduces the formation of cAMP from ATP stimulated by catecholamines, reduces the intracellular current of calcium ions, has a negative chrono-, dromo-, batmo- and inotropic effect, inhibits the conductivity and excitability of the myocardium, reduces AV-conductivity.
When the dose is increased above the therapeutic dose, it has a beta2-adrenergic blocking effect.
OPSS at the beginning of the use of the drug, in the first 24 hours, increases (as a result of a reciprocal increase in the activity of alpha-adrenergic receptors and the elimination of stimulation of beta2-adrenergic receptors), which after 1-3 days returns to the original, and with prolonged administration decreases.
The hypotensive effect is associated with a decrease in the minute volume of blood, sympathetic stimulation of peripheral vessels, a decrease in activity of the renin-angiotensin system (of great importance for patients with initial hypersecretion of renin), restoration of sensitivity in response to a decrease in blood pressure and effects on the central nervous system. With arterial hypertension, the effect occurs in 2-5 days, a stable effect - after 1-2 months.
The antianginal effect is due to a decrease in myocardial oxygen demand as a result of a decrease in heart rate and a decrease in contractility, lengthening of diastole, improvement of myocardial perfusion. By increasing the final diastolic pressure in the left ventricle and increasing the stretching of the muscle fibers of the ventricles, it can increase the need for oxygen, especially in patients with chronic heart failure.
The antiarrhythmic effect is due to the elimination of arrhythmogenic factors (tachycardia, increased activity of the sympathetic nervous system, increased content of cAMP, arterial hypertension), a decrease in the rate of spontaneous excitation of sinus and ectopic drivers rhythm and deceleration of AV-conduction (mainly in antegrade and, to a lesser extent, in retrograde directions through the AV-node) and along additional paths.
When used in medium therapeutic doses, in contrast to non-selective beta-blockers, it has a less pronounced effect on organs containing beta2-adrenergic receptors (pancreas, skeletal muscles, smooth muscles of the peripheral arteries, bronchi and uterus) and on carbohydrate metabolism, does not cause a delay in sodium ions (Na +) in the body; the severity of the atherogenic action does not differ from the action of propranolol.
Indications for use
- Arterial hypertension,
- prevention of angina attacks,
- chronic heart failure.
- Acute heart failure, chronic heart failure in stage decompensation, cardiogenic shock, collapse, AV-blockade of II and III degrees (without a pacemaker), SSSU;
- sinoatrial blockade, severe bradycardia (heart rate <50 beats / min), Prinzmetal's angina, a pronounced decrease in blood pressure (systolic blood pressure <90 mm Hg), severe forms of bronchial asthma and COPD in the anamnesis, late stages of peripheral circulatory disorders, Raynaud's disease, pheochromocytoma (without the simultaneous use of alpha-blockers), metabolic acidosis, simultaneous administration of MAO inhibitors (with the exception of MAO type B inhibitors), children and adolescents under 18 years of age, hypersensitivity to bisoprolol and other beta-blockers.
Use in pregnancy and lactation
Use during pregnancy and lactation is not recommended and is possible when the expected benefit to the mother exceeds the potential risk of side effects in the fetus and child.
In exceptional cases of use during pregnancy, bisoprolol should be canceled 72 hours before the expected date of birth due to the possibility of bradycardia, arterial hypotension, hypoglycemia and respiratory depression in a newborn. If cancellation is not possible, then it is necessary to carefully monitor the condition of the newborn within 72 hours after childbirth.
If it is necessary to use bisoprolol during lactation, breastfeeding should be discontinued.
Use in case of impaired liver function
Do not exceed the dose of 10 mg / day in severe violations of liver function.
Use in renal dysfunction
Do not exceed the dose of 10 mg / day in renal failure (QC less than 20 ml / min).
Use in children
It is not recommended for use in children.
Use with caution in psoriasis and when indicating psoriasis in the family history, diabetes mellitus in the phase of decompensation, with a predisposition to allergic reactions. With pheochromocytoma, the use of bisoprolol is possible only after taking alpha-blockers. Do not allow sudden withdrawal of bisoprolol, the course of treatment should be completed slowly with a gradual decrease in dose. Before surgery, the anesthesiologist should be informed about the treatment with bisoprolol.
Bisoprolol at a dose of more than 10 mg / day should be used only in exceptional cases.
Do not exceed this dose in renal failure (QC less than 20 ml / min) and severe impairment of liver function.
During the period of treatment, do not allow the use of alcohol.
Influence on the ability to drive vehicles and control mechanisms
With caution it is used in patients whose activities are associated with the need to concentrate attention and high speed of psychomotor reactions.
With the simultaneous use of antacid and antidiarrheal agents, it is possible to reduce the absorption of beta-blockers.
With the simultaneous use of antiarrhythmic drugs, a sharp decrease in blood pressure, a decrease in heart rate, the development of arrhythmia and / or heart failure are possible.
With the simultaneous use of antihypertensive drugs, it is possible to enhance the antihypertensive effect.
With the simultaneous use of cardiac glycosides, conduction disorders are possible.
With the simultaneous use of sympathomimetics (including those included in the composition of cough remedies, nose drops, eye drops), the effectiveness of bisoprolol decreases.
With the simultaneous use of verapamil, diltiazem, a sharp decrease in blood pressure, a decrease in heart rate, the development of arrhythmia and / or heart failure are possible.
With the simultaneous use of guanfacine, pronounced bradycardia, conduction disorders are possible.
With the simultaneous use of insulin, hypoglygemic agents for oral administration, the effect of insulin or other hypoglygemic agents is enhanced (regular monitoring of the level of glucose in the blood plasma is necessary).
With the simultaneous use of clonidine, pronounced bradycardia, arterial hypotension, conduction disorders are possible.
In the case of sudden withdrawal of clonidine in patients receiving bisoprolol, a sharp increase in blood pressure is possible.
With the simultaneous use of nifedipine, other calcium channel blockers, dihydropyridine derivatives, the antihypertensive effect of bisoprolol is enhanced.
With the simultaneous use of reserpine, alpha-methyldopa, pronounced bradycardia is possible.
With the simultaneous use of rifampicin, a slight decrease in T is possible. 1/2 bisoprolol.
With the simultaneous use of ergotamine derivatives (including drugs for treatment migraines containing ergotamine) exacerbate the symptoms of peripheral circulatory disorders.
Dosage and Administration
The drug is taken orally, in the morning, on an empty stomach, without chewing, in an initial dose of 5 mg 1 time / day. If necessary, the dose is increased to 10 mg 1 time / day. The maximum daily dose is 20 mg / day.
In patients with impaired renal function with QC less than 20 ml / min or pronounced violations of liver function, the maximum daily dose should be 10 mg.
Dose adjustment in elderly patients is not required.
From the side of the central nervous system: increased fatigue, weakness, dizziness, headache, sleep disorders, depression, anxiety, confusion or short-term memory loss, hallucinations, asthenia, myasthenia gravis, paresthesia in the limbs (in patients with intermittent claudication and Reino syndrome), tremor.
From the outside sensory organs: visual impairment, decreased secretion of tear fluid, dryness and soreness of the eyes, conjunctivitis.
From the cardiovascular system: sinus bradycardia, palpitations, myocardial conduction disorders, AV blockade (up to the development of complete transverse blockade and cardiac arrest), arrhythmias, weakening of myocardial contractility, development (aggravation) of chronic heart failure (swelling of the ankles, feet, shortness of breath), decreased blood pressure, orthostatic hypotension, manifestation of angiospasm (increased peripheral circulatory disorders, cooling of the lower extremities, Raynaud's syndrome), pain in the chest.
From the digestive system: dryness of the oral mucosa, nausea, vomiting, abdominal pain, constipation or diarrhea, impaired liver function (dark urine, yellowness of the sclera or skin, cholestasis), changes in taste.
From the respiratory system: nasal congestion, difficulty breathing when administered in high doses (loss selectivity) and / or in predisposed patients - laryngo- and bronchospasm.
From the endocrine system: hyperglycemia (in patients with insulin-dependent diabetes insipidus), hypoglycemia (in patients receiving insulin), hypothyroid condition.
Allergic reactions: skin itching, rash, urticaria.
Dermatological reactions: increased sweating, skin flushing, exanthema, psoriasis-like skin reactions, exacerbation of psoriasis symptoms.
On the part of laboratory indicators: thrombocytopenia (unusual bleeding and hemorrhage), agranulocytosis, leukopenia, changes in the activity of liver enzymes (increased ALT, ACT), bilirubin levels, triglycerides.
Effect on the fetus: intrauterine growth retardation, hypoglycemia, bradycardia.
Other: back pain, arthralgia, weakening of libido, decreased potency, withdrawal syndrome (increased attacks of angina pectoris, increased blood pressure).
In a dry, dark place at a temperature not exceeding 25 ° C. Keep out of the reach of children.
Shelf life - 3 years.
- Izvarino pharma
- Dosage form
- 10 mg
- Number of tablets
- INN Russian