Bisoprolol-VERTEX 2,5mg tablets 60
Women's clothing size
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Active substance: bisoprolol (in the form of fumarate) 2.5 mg.
Excipients: lactose monohydrate - 61.5 mg; microcrystalline cellulose 102 - 30,0 mg; silicon dioxide colloidal - 2.0 mg; crospovidone - 3.0 mg; magnesium stearate - 1.0 mg;
Film shell: [hypromellose - 1.8 mg, talc - 0.6 mg, titanium dioxide - 0.31 mg, macrogol 4000 (polyethylene glycol 4000) - 0.27 mg, iron oxide yellow dye (iron oxide) - 0.02 mg] or [dry film coating mixture containing hypromellose (60%), talc (20%), titanium dioxide (10.33%), macrogol 4000 (polyethylene glycol 4000) (9%), dye iron oxide yellow (iron oxide) (iron oxide) (0.67%)] - 3.0 mg.
Selective beta 1 -adrenergic blocker without internal sympathomimetic activity, does not have membrane-stabilizing activity. Reduces plasma renin activity, reduces myocardial oxygen demand, reduces heart rate (at rest and under load) and cardiac output, while the stroke volume does not decrease significantly. Inhibits AV conduction. It has an antianginal and hypotensive effect. In high doses (200 mg or more) can cause blockade and β 2 Adrenergic receptors mainly in the bronchi and in the smooth muscles of the vessels.
The hypotensive effect is associated with a decrease in the minute volume of blood, sympathetic stimulation of peripheral vessels, a decrease in the activity of the renin-angiotensin system (of greater importance for patients with initial hypersecretion of renin), restoration of sensitivity in response to a decrease in blood pressure and an effect on the central nervous system.
The antianginal effect is due to a decrease in myocardial oxygen demand as a result of reduction of heart rate and reduction of contractility, prolongation of diastole, improvement of myocardial perfusion.
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 pacemakers and a slowdown in AV conduction (mainly in the antegrade and, to a lesser extent, in retrograde directions through the AV node) and along additional pathways.
Absorption - 80-90%, food intake does not affect absorption.
C max in the blood plasma is achieved after 2-4 h. Binding to plasma proteins - 26-33%. Bisoprolol penetrates the BBB and placental barrier to a small extent; excreted in breast milk.
It is metabolized in the liver.
T 1/2 - 9-12 h. Excreted by the kidneys - 50% in unchanged, less than 2% - with bile.
Indications for use
- Arterial hypertension,
- prevention of angina attacks,
- chronic heart failure.
- Acute heart failure, chronic heart failure in the stage of 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 circulation disorders, Raynaud's disease, pheochromocytoma (without the simultaneous use of alpha-blockers), metabolic acidosis, simultaneous administration of MAO inhibitors (with the exception of MAO inhibitors) type B),
- 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 functionDo not exceed a dose of 10 mg / day for severe impairment 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.
It is used with caution in psoriasis and when indicating psoriasis in a 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 insufficiency (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 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.
While the use of sympathomimetics (including those included in the composition of cough remedies, nasal drops, eye drops) reduces the effectiveness of bisoprolol.
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 enhance the antihypertensive effect of bisoprolol.
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 migraine treatment products containing ergotamine), the symptoms of peripheral circulatory disorders increase.
Dosage and Administration
Individual. For oral administration, the daily dose is 2.5-10 mg, the frequency of administration is 1 time / day. The maximum daily dose is 10 mg.
From the nervous system: weakness, fatigue, dizziness, headache, sleep disorders, mental disorders (depression, rarely hallucinations), a feeling of cold and paresthesia in the limbs.
From the cardiovascular system: orthostatic hypotension, bradycardia, impaired AV-conduction, the appearance of symptoms of heart failure, aggravation of intermittent claudication and the main clinical symptoms in Raynaud's syndrome.
From the side of the organ of vision: a decrease in the secretion of tear fluid, conjunctivitis.
From the digestive system: diarrhea, constipation, nausea, abdominal pain.
From the musculoskeletal system: muscle weakness, muscle cramps.
From the skin and subcutaneous tissues: skin itching; in some cases - increased manifestations of psoriasis, the appearance of psoriasis-like rashes.
From the respiratory system: predisposed patients may experience symptoms of bronchial obstruction.
Other: sweating, hot flashes, impaired potency, decreased glucose tolerance in patients with diabetes, allergic reactions.
The drug should be stored out of the reach of children, protected from light at a temperature not exceeding 25 ° C.
- Dosage form
- 10 mg
- Number of tablets
- INN Russian