Bisoprolol 5mg tablets 30
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Bisoprolol is a selective β1-blocker, without its own sympathomimetic activity, does not have a membrane-stabilizing effect. As with other β1-blockers, the mechanism of action for hypertension is unclear.
At the same time, it is known that bisoprolol reduces the activity of renin in the blood plasma, reduces the need for myocardium in oxygen, reduces the heart rate (heart rate). It has an antihypertensive, antiarrhythmic and antianginal effect.
By blocking the heart's β1-adrenergic receptors in low doses, it reduces the catecholamine-stimulated formation of cyclic adenosine monophosphate (cAMP) from adenosine triphosphate (ATP), reduces the intracellular flow of calcium ions, inhibits all functions of the heart, reduces atrioventricular (AV) conductivity and excitability. When the therapeutic dose is exceeded, it has a β2-adrenergic blocking effect.
The total peripheral vascular resistance 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 α-adrenergic receptors and the elimination of stimulation of β2-adrenergic receptors), after 1-3 days it returns to its original value, and with prolonged use it decreases.
The antihypertensive effect is associated with a decrease in the minute volume of blood, sympathetic stimulation of peripheral vessels, a decrease in the activity of the sympathoadrenal system (ASC) (of great importance for patients with initial hypersecretion of renin), the restoration of sensitivity in response to a decrease in blood pressure (BP) and an effect on the central nervous system.
With arterial hypertension, the effect develops after 2-5 days, a stable effect is noted after 1-2 months.
The antianginal effect is due to a decrease in myocardial oxygen demand as a result of a decrease in contractility and other functions of the myocardium, 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, the need for oxygen may increase, especially in patients with chronic heart failure (CHF).
When used in medium therapeutic doses, in contrast to non-selective β-blockers, it has a less pronounced effect on organs containing β2-adrenergic receptors (pancreas, skeletal muscles, smooth muscles of peripheral arteries, bronchi and uterus) and on carbohydrate metabolism; does not cause retention of sodium ions in the body; the severity of the atherogenic action does not differ from the action of propranolol.
- Arterial hypertension;
- ischemic heart disease: prevention of angina attacks;
- chronic heart failure.
- Hypersensitivity to bisoprolol, other components of the drug and to other β-blockers;
- acute heart failure or CHF in the stage of decompensation, requiring inotropic therapy;
- shock (including cardiogenic);
- pulmonary edema;
- atrioventricular blockade (AV) blockade of II-III degree, without a pacemaker;
- sinoatrial blockade;
- syndrome of weakness of the sinus node;
- bradycardia (heart rate less than 60 beats / min.);
- severe arterial hypotension (systolic blood pressure (BP) 100 mm Hg);
- severe forms of bronchial asthma and chronic obstructive pulmonary disease (COPD) in the anamnesis;
- pronounced disorders of peripheral circulation, Raynaud's syndrome;
- metabolic acidosis;
- pheochromocytoma (without the simultaneous use of α-blockers),
- simultaneous administration of monoamine oxidase inhibitors (MAO) (with the exception of MAO type B inhibitors);
- age up to 18 years (efficacy and safety have not been established);
- lactose intolerance, lactase deficiency or glucose-galactose malabsorption syndrome.
Dosage and Administration
The drug Bisoprolol is taken orally, in the morning on an empty stomach, once, without chewing, washed down with a small amount of liquid. Tablets should not be chewed or ground 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 therapeutic response. With arterial hypertension and coronary heart disease, usually the initial dose is 5 mg 1 time per day.
If necessary, the dose is increased to 10 mg 1 time per day. In the treatment of arterial hypertension and angina pectoris, the maximum daily dose is 20 mg 1 time / day. It is possible to divide the daily dose into 2 doses.
Treatment of stable chronic heart failure
The standard treatment regimen for CHF includes the use of angiotensin-converting enzyme (ACE) inhibitors or angiotensin II receptor antagonists (in case of intolerance to ACE inhibitors), β-blockers, diuretics and, optionally, cardiac glycosides.
The beginning of treatment with CHF with Bisoprolol requires a special phase of titration and regular medical supervision.
A prerequisite for treatment with Bisoprolol is stable chronic heart failure without signs of exacerbation.
Treatment of CHF with Bisoprolol 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 be increased only if the previous dose was well tolerated.
The recommended initial dose is 1.25 mg (1/2 tablet of 2.5 mg) once daily. Depending on individual tolerance, the dose should be gradually increased to 2.5 mg, 3.75 mg (11/2 tablets of 2.5 mg), 7.5 mg (3 tablets of 2.5 mg) and 10 mg 1 time per day.
Each subsequent dose increase should be carried out at least two weeks later. If an increase in the dose of the drug is poorly tolerated by the patient, a dose reduction is possible. The maximum recommended dose for CHF is 10 mg of bisoprolol 1 time per day.
During titration, regular monitoring of blood pressure, heart rate and the severity of symptoms of CHF is recommended. Aggravation of the symptoms of CHF is possible from the first day of use of the drug.
If the patient does not tolerate the maximum recommended dose of the drug, a gradual decrease in the dose is possible. During the titration phase or after it, a temporary deterioration in the course of CHF, arterial hypotension or bradycardia may occur. In this case, it is recommended, first of all, to adjust the doses of concomitant therapy drugs.
It may also be necessary to temporarily reduce the dose of the drug Bisoprolol or its cancellation. After stabilizing the patient's condition, re-titration of the dose should be carried out, or treatment should be continued.
Special groups of patients
Impaired kidney or liver function:
• In case of violation mild or moderate liver or kidney function is usually not required to adjust the dose.
• With severe renal dysfunction (QC less than 20 ml / min.) and in patients with severe liver disease, the maximum daily dose is 10 mg.
Increasing the dose in such patients should be carried out with extreme caution.
To date, there is insufficient data on the use of Bisoprolol in patients with CHF associated with type 1 diabetes mellitus, severe impaired renal and / or liver function, restrictive cardiomyopathy, congenital heart defects or heart valve defects with pronounced hemodynamic disorders.
Also, so far, not enough data have been obtained regarding patients with CHF with myocardial infarction within the last 3 months.
The frequency of adverse reactions given below was determined accordingly. the following (classification of the World Health Organization): very often - at least 10%; often - not less than 1%, but less than 10%; infrequently - not less than 0.1%, but less than 1%; rarely - not less than 0.01%, but less than 0.1%; very rarely - less than 0.01%, including individual messages.
From the heart and blood vessels: very often - a decrease in the heart rate (bradycardia, especially in patients with CHF); sensation of palpitations; often - a pronounced decrease in blood pressure (especially in patients with CHF), the manifestation of angiospasm (increased peripheral circulatory disorders, a feeling of cold in the limbs (paresthesia); infrequently - a violation of AV conduction (up to the development of a complete transverse blockade and cardiac arrest), arrhythmia, orthostatic hypotension, aggravation of the course of CHF with the development of peripheral edema (swelling of the ankles, feet, shortness of breath), chest pain.
From the nervous system: often - dizziness headache, asthenia, increased fatigue, disorders sleep, depression, anxiety; rarely - confusion or short-term memory loss, "nightmare" dreams, hallucinations, myasthenia gravis, tremors, muscle cramps. Usually these phenomena are mild and disappear, as a rule, within 1-2 weeks after the start of treatment.
From the senses: rarely - visual impairment, decreased tearing (should be taken into account when wearing contact lenses), tinnitus, hearing loss, ear pain; very rarely - dry and sore eyes, conjunctivitis, taste disorders.
From the respiratory system: infrequently - bronchospasm in patients with bronchial asthma or obstructive airway diseases; rarely - allergic rhinitis; nasal congestion.
From the digestive system: often - nausea, vomiting, diarrhea, constipation, dryness of the oral mucosa, abdominal pain; rarely - hepatitis, increased activity of liver enzymes (alanine aminotransferase, aspartate aminotransferase), increased concentration of bilirubin, change in taste.
From the musculoskeletal system: infrequently - arthralgia, back pain.
From the genitourinary system: very rarely - a violation of potency, weakening of libido.
Laboratory indicators: rarely - an increase in the concentration of triglycerides in the blood; in some cases - thrombocytopenia, agranulocytosis, leukopenia.
Allergic reactions: rarely - skin itching, rash, urticaria.
From the skin: rarely - increased sweating, skin flushing, exanthema, psoriasis-like skin reactions; very rarely - alopecia, β-blockers can exacerbate the course of psoriasis.
Other: "withdrawal" syndrome (increased frequency of angina attacks, increased blood pressure).
Store at room temperature 15-25 degrees. Keep out of reach of children. Store in a dark place.
- Dosage form
- 10 mg
- Number of tablets
- INN Russian