Bisoprolol 10 mg tablets 30
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bisoprolol fumarate 10 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 the need for myocardium in oxygen, 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 the activity of 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 pacemakers and slowing down 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.Pharmacokinetics
Suction and distribution
Absorption - 80-90%, food intake does not affect absorption. Cmax in the blood plasma is observed after 1-3 hours.
The connection with blood plasma proteins is about 30%. It passes through the BBB and placental barrier to a small extent, in small quantities it is excreted in breast milk.
Metabolism and excretion
50% of the dose is metabolized in the liver to form inactive metabolites.
T1 / 2 - 10-12 h. About 98% is excreted in the urine - 50% unchanged, less than 2% - with bile.
Indications for use
- arterial hypertension;
- IHD: prevention of angina attacks.
- shock (including cardiogenic);
- pulmonary edema;
- acute heart failure;
- chronic heart failure in the stage of decompensation;
– AV blockade of II and III degrees;
- sinoatrial blockade;
- pronounced bradycardia;
- Prinzmetal's angina;
- cardiomegaly (without signs of heart failure);
- arterial hypotension (systolic blood pressure less than 100 mm Hg, especially with myocardial infarction);
- severe forms of bronchial asthma and chronic obstructive pulmonary disease in the anamnesis;
- simultaneous administration of MAO inhibitors (with the exception of MAO-B);
- late stages of peripheral circulatory disorders, Raynaud's disease;
- Pheochromocytoma (without the simultaneous use of alpha-blockers);
- metabolic acidosis;
– age up to 18 years (efficacy and safety have not been established);
- Hypersensitivity to the components of the drug and other beta-blockers.
With caution, the drug should be prescribed for liver failure, chronic renal failure, myasthenia gravis, thyrotoxicosis, diabetes mellitus, AV blockade of the I degree, depression (including in the anamnesis), psoriasis, as well as elderly patients.
Dosage and Administration
The drug is taken inside, 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 senses: visual impairment, decreased secretion of tear fluid, dryness and soreness of the eyes, conjunctivitis.
From the cardiovascular system: sinus bradycardia, palpitations, impaired myocardial conduction, 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), decrease in blood pressure, orthostatic hypotension, manifestation of angiospasm (increased peripheral circulatory disorders, cooling of the lower extremities, Raynaud's syndrome), chest pain.
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 of 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).
- Izvarino pharma
- Dosage form
- 10 mg
- Number of tablets
- INN Russian