Biol - instructions for use, reviews, analogs and formulations (tablets 2.5 mg, 5 mg and 10 mg) of the drug for the treatment of IHD, hypertension and pressure reduction in adults, children and in pregnancy

In this article, you can read the instructions for using the drug Biol. Comments of visitors of the site - consumers of this medication, as well as opinions of doctors of specialists on the use of Biola in their practice are presented. A big request is to actively add their feedback on the drug: the medicine helped or did not help get rid of the disease, which were observed complications and side effects, possibly not declared by the manufacturer in the annotation. Analogues of Biol in the presence of existing structural analogues. Use for the treatment of IHD, hypertension and depression in adults, children, as well as during pregnancy and lactation.

Biol - selective beta1-adrenoblocker, without its own sympathomimetic activity, does not have a membrane-stabilizing action. As for other beta1-adrenoblockers, the mechanism of action for arterial hypertension is unclear. At the same time, it is known that Bisoprolol (the active substance of the Biol preparation) reduces the activity of renin in the blood plasma, reduces the need for myocardium in oxygen, and reduces the heart rate. Has antihypertensive, antiarrhythmic and antianginal action.

Blocking in low doses beta1-adrenoreceptors of the heart, reduces the catecholamine-stimulated formation of cAMP from ATP, reduces the intracellular current of calcium ions, inhibits all cardiac functions, reduces AV-conduction and excitability. When the therapeutic dose is exceeded, beta2-adrenergic blocking action exerts. OPSS at the beginning of the use of the drug, in the first 24 hours, increases (as a result of the reciprocal increase in the activity of alpha-adrenoreceptors and elimination of stimulation of beta2-adrenoreceptors), which returns to the initial value after 1-3 days, and decreases with prolonged use.

The antihypertensive effect is associated with a decrease in the minute volume of blood,sympathetic stimulation of peripheral vessels, decreased activity of the sympathoadrenal system (is more important for patients with initial hypersecretion of renin), restoration of sensitivity in response to a decrease in blood pressure and influence on the CNS. With arterial hypertension, the effect occurs after 2-5 days, a stable effect is observed after 1-2 months.

The antianginal effect is due to a decrease in myocardial oxygen demand as a result of decreased contractility and other myocardial functions, diastole lengthening, and improved myocardial perfusion. By increasing the end diastolic pressure in the left ventricle and increasing the tension of the ventricular muscle fibers, the need for oxygen may increase, especially in patients with chronic heart failure.

When used in average therapeutic doses, in contrast to non-selective beta-blockers, it exerts a less pronounced effect on organs containing beta2-adrenoreceptors (pancreas, skeletal muscles, smooth muscle of peripheral arteries, bronchi and uterus) and carbohydrate metabolism.Does not cause retention of sodium ions in the body; the severity of atherogenic action does not differ from that of propranolol.

Composition

Bisoprolol hemifumarate + auxiliary substances.

Pharmacokinetics

Biol is almost completely absorbed from the digestive tract, food intake does not affect absorption. Bioavailability is about 90%. Binding to plasma proteins is 26-33%. Metabolized in the liver, metabolites of bisoprolol do not have pharmacological activity. Permeability through the blood-brain barrier (BBB) ​​and the placental barrier is low, in small amounts is excreted in breast milk. It is excreted by the kidneys (50% unchanged), less than 2% - through the intestines.

Indications

• arterial hypertension;
• IHD: prevention of attacks of stable angina pectoris;
• chronic heart failure (as part of combination therapy).

Forms of release

Tablets coated with 2.5 mg, 5 mg and 10 mg.

Instructions for use and dosing regimen

The drug Biol is taken orally, in the morning on an empty stomach, once a day and with a small amount of liquid, in the morning before breakfast, during or after it. Tablets should not be chewed or ground into a powder.

In all cases, the regimen and dosage are selected by the doctor for each patient individually, in particular, taking into account the heart rate and the patient's condition.

Hypertension and coronary artery disease

With arterial hypertension and ischemic heart disease, Biol is used 5 mg once a day. If necessary, increase the dose to 10 mg once a day.

In the treatment of hypertension and angina, the maximum daily dose is 20 mg once a day.

Chronic heart failure (CHF)

The beginning of treatment with CHF with Biol requires a special phase of titration and regular medical supervision.

A prerequisite for treatment with Biol is stable CHF without signs of exacerbation. Treatment of CHF with Biol begins with the following titration scheme. Individual adaptation may be required depending on how well the patient tolerates the prescribed dose, i. E. The dose can be increased only if the previous dose is well tolerated.

To ensure the appropriate titration process at the initial stages of treatment, it is recommended to use the drug in smaller doses.

The recommended initial dose is 1.25 mg (1/4 tablets of 5 mg) once a day. Depending on the individual tolerability, the dose should be gradually increased to 2.5 mg (1/2 tablets of 5 mg), 3.75 mg (3/4 tablets of 5 mg), 5 mg (1 tablet of 5 mg or 1/2 tablet of 10 mg ), 7.5 mg (3/4 tablets of 10 mg) and 10 mg once a day with an interval of not less than 2 or more weeks. If the increase in the dose of the drug is poorly tolerated by the patient, a dose reduction is possible.

The maximum daily dose for the treatment of CHF is 10 mg once a day.

During titration, regular monitoring of blood pressure, heart rate and symptoms of increased severity of CHF is recommended. The aggravation of symptoms of CHF is possible from the first day of application of the drug.

During the titration phase or after it, temporary deterioration of the course of CHF, arterial hypotension or bradycardia may occur. In this case, it is recommended, first of all, to pay attention to the choice of the dose of concomitant standard therapy. It may also be necessary to temporarily reduce the dose of Biol 5 mg or to cancel treatment.

After stabilization of the patient's condition, a repeated titration of the dose should be performed, or the treatment should be continued.

Impaired renal or hepatic function

Dysfunction of the liver or kidneys of mild or moderate degree usually does not require dose adjustment. At the expressed infringements of function of kidneys (KK less than 20 ml / mines) and at patients with serious diseases of a liver the maximum daily dose makes 10 mg. Increase in the dose in such patients should be carried out with extreme caution.

Older patients are not required to adjust the dose.

To date, there is insufficient data on the use of Biol 5 mg in patients with CHF, associated with type 1 diabetes mellitus, marked renal and / or liver dysfunction, restrictive cardiomyopathy, congenital heart disease, or hemodynamically caused heart failure. Also, sufficient data have not yet been obtained regarding patients with CHF with myocardial infarction during the last 3 months.

Side effect

• loss of heart rate (bradycardia, especially in patients with CHF);
• a feeling of palpitations;
• marked decrease in blood pressure (especially in patients with CHF);
• manifestation of angiospasm (increased violations of peripheral blood circulation, sensation of cold in the extremities (paresthesia);
• violation of AV-conduction (until the development of complete transverse blockade and cardiac arrest);
• arrhythmias;
• orthostatic hypotension;
• aggravation of the course of CHF with the development of peripheral edema (edema of the ankles, stop, dyspnea);
• chest pain;
• dizziness;
• headache;
• asthenia;
• increased fatigue;
• sleep disorders;
• depression;
• anxiety;
• confusion or short-term memory loss;
• nightmarish dreams;
• hallucinations;
• myasthenia gravis;
• tremor;
• muscle cramps;
• impaired vision;
• reduction of tearing (should be considered when wearing contact lenses);
• noise in ears;
• hearing loss;
• earache;
• dryness and soreness of the eyes;
• conjunctivitis;
• violation of taste;
• bronchospasm in patients with bronchial asthma or obstructive airway disease;
• allergic rhinitis;
• nasal congestion;
• nausea, vomiting;
• diarrhea;
• constipation;
• dryness of the oral mucosa;
• abdominal pain;
• change in taste;
• backache;
• violation of potency;
• weakening of libido;
• thrombocytopenia, agranulocytosis, leukopenia;
• itching;
• rash;
• hives;
• increased sweating;
• psoriasis-like skin reactions;
• alopecia;
• beta-blockers can aggravate the course of psoriasis;
• syndrome of "withdrawal" (increased frequency of angina attacks, increased blood pressure).

Contraindications

• acute heart failure and chronic heart failure in the stage of decompensation, requiring inotropic therapy;
• cardiogenic shock;
• collapse;
• AV-blockade of 2 and 3 degrees (without a pacemaker);
• sinoatrial blockade;
• syndrome of weakness of the sinus node;
• bradycardia (heart rate before treatment less than 50 beats per minute);
• severe arterial hypotension (systolic blood pressure less than 90 mm Hg);
• cardiomegaly (no signs of heart failure);
• severe forms of bronchial asthma and COPD in history;
• severe peripheral circulatory disturbances;
• Raynaud's syndrome;
• metabolic acidosis;
• pheochromocytoma (without simultaneous use of alpha-blockers);
• concomitant use of floktaphenin and sultopride;
• age under 18 years (effectiveness and safety not established);
• hypersensitivity to the components of the drug and to other beta-blockers.

Carefully:

• conducting desensitizing therapy;
• hyperthyroidism;
• Type 1 diabetes mellitus and diabetes mellitus with significant fluctuations in blood glucose concentration;
• marked renal failure (CC less than 20 ml / min);
• severe liver dysfunction;
• psoriasis;
• AV-blockade of 1 degree;
• angina of Prinzmetal;
• restrictive cardiomyopathy;
• Congenital heart disease or heart valve disease with severe hemodynamic disorders;
• chronic heart failure with myocardial infarction during the last 3 months;
• depression (including in the anamnesis);
• pheochromocytoma (necessarily simultaneous use of alpha-blockers);
• strict diet.

Application in pregnancy and lactation

Biol does not have direct cytotoxic, mutagenic and teratogenic effects, but it has pharmacological effects that can have harmful effects on the course of pregnancy and / or on the fetus or on the newborn. Usually beta-adrenoblockers reduce placental perfusion, which leads to a slowing of fetal growth, fetal death, miscarriage or premature birth. The fetus and newborn child may experience pathological reactions, such as intrauterine growth retardation, hypoglycemia, bradycardia.

Biol should not be used during pregnancy, it is possible to use it if the benefit to the mother exceeds the risk of side effects in the fetus and / or the child. When treatment with Biol is considered necessary, blood flow in the placenta and uterus should be monitored, and the growth and development of the unborn child monitored, and if alternative pregnancy and / or fetus events occur, alternative therapies should be considered. You should carefully examine the newborn after delivery. Symptoms of hypoglycemia and bradycardia usually arise during the first 3 days of life.

There is no data on the penetration of bisoprolol into breast milk. Therefore, the use of Biol is not recommended for women during lactation. If you need to use the drug during lactation, breastfeeding should be discontinued.

Use in children

Contraindicated in children and adolescents under the age of 18 years (efficacy and safety not established).

special instructions

Do not abruptly discontinue treatment with Biol because of the risk of developing severe arrhythmias and myocardial infarction.Cancellation is carried out gradually, reducing the dose by 25% every 3-4 days.

Monitoring the condition of patients taking Biol should include a measurement of heart rate and blood pressure (at the beginning of treatment - every day, then once every 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 that kidney function be monitored (once every 4-5 months).

You should teach the patient how to calculate heart rate and instruct you about the need for medical consultation at a heart rate of less than 50 beats per minute.

If elderly patients develop an increasing bradycardia (heart rate less than 50 beats per minute), a marked decrease in blood pressure (systolic blood pressure less than 100 mm Hg), AV blockade, it is necessary to reduce the dose or stop treatment.

Before the start of treatment, it is recommended to perform an external respiration function in patients with a history of bronchopulmonary anamnesis.

Patients who use contact lenses should take into account that against the background of drug treatment, a decrease in the production of tear fluid is possible.

When using Biol in patients with pheochromocytoma, there is a risk of developing paradoxical arterial hypertension (unless an effective blockade of alpha-adrenergic receptors is previously achieved).

In hyperthyroidism, bisoprolol may mask certain clinical signs of hyperthyroidism (eg, tachycardia). Abrupt withdrawal of the drug in patients with hyperthyroidism is contraindicated, as it can strengthen symptoms.

With diabetes, bisoprolol can mask tachycardia caused by hypoglycemia. Unlike non-selective beta-blockers, it does not actually increase insulin-induced hypoglycemia and does not delay the restoration of blood glucose to normal levels.

With the simultaneous administration of clonidine, his reception may be terminated only a few days after the abolition of Biol.

It is possible to increase the severity of the reaction of hypersensitivity and the lack of effect from the usual doses of epinephrine against the background of a burdened allergological anamnesis.

If surgical intervention is necessary, the drug should be withdrawn 48 hours before the start of general anesthesia. If the patient has taken 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 administration of atropine (1-2 mg).

Drugs that reduce the reserves of catecholamines (including reserpine) can enhance the action of beta-blockers, so patients taking such combinations of drugs should be under constant medical supervision to detect a marked decrease in blood pressure or bradycardia.

Patients with bronchospastic diseases can be cautiously prescribed cardioselective beta-blockers in the case of intolerance and / or ineffectiveness of other antihypertensive agents. Against the background of taking beta-blockers in patients with concomitant bronchial asthma, airway resistance can increase. When the dose of Biol is exceeded in such patients, there is a danger of developing bronchospasm.

If patients develop an increasing bradycardia (heart rate less than 50 beats per minute), a marked decrease in blood pressure (systolic blood pressure less than 100 mm Hg), AV blockade, it is necessary to reduce the dose or stop treatment.

It is recommended to stop therapy with Biol in the development of depression.

Do 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 concentration in the blood and urine of catecholamines, normetanephrine, vanillin-mandelic acid, antinuclear antibody titers.

In smoking patients, the effectiveness of beta-blockers is lower.

Impact on the ability to drive vehicles and manage mechanisms

During the period of treatment with Biol, caution should be exercised when driving vehicles and engaging in other potentially hazardous activities requiring increased attention and speed of psychomotor reactions.

Drug Interactions

Class 1 antiarrhythmics (eg, quinidine, disopyramide, lidocaine, phenytoin, flecainide, propafenone), while being used with bisoprolol may reduce AV conduction and contractility of the myocardium.

Class 3 antiarrhythmic drugs (eg, amiodarone) may increase the disturbance of AV conduction.

The action of beta-blockers for topical application (eg, eye drops for the treatment of glaucoma) can enhance the systemic effects of bisoprolol (lowering blood pressure, decreasing heart rate).

Parasympatomimetics with simultaneous application with bisoprolol may increase the disturbance of AV conduction and increase the risk of developing bradycardia.

Simultaneous use of Biol with beta-adrenomimetics (for example, isoprenaline, dobutamine) can lead to a decrease in the effect of both drugs.

The combination of Biol with adrenomimetics that affect beta and alpha-adrenergic receptors (eg, norepinephrine, epinephrine), can enhance the vasoconstrictor effects of these agents that occur with alpha-adrenergic receptors, leading to an increase in blood pressure. Such interactions are more likely when using nonselective beta-blockers.

Mefloquine with simultaneous application with bisoprolol may increase the risk of developing bradycardia.

Allergens used for immunotherapy, or allergen extracts for skin tests increase the risk of severe systemic allergic reactions or anaphylaxis in patients receiving bisoprolol.

Iodine-containing radiopaque diagnostic tools for intravenous administration increase the risk of anaphylactic reactions.

Phenytoin with IV introduction, means for inhalation anesthesia (derivatives of hydrocarbons) increase the severity of cardiodepressive action and the likelihood of lowering blood pressure.

The effectiveness of insulin and hypoglycemic agents for oral administration may change with treatment with bisoprolol (masks the symptoms of developing hypoglycemia: tachycardia, increased blood pressure).

The clearance of Lidocaine and xanthines (except theophylline) may decrease due to a possible increase in their concentration in the blood plasma, especially in patients with initially elevated clearance of theophylline under the influence of smoking.

The hypotensive effect weakens non-steroidal anti-inflammatory drugs (NSAIDs) (sodium ion delay and blockade of prostaglandin synthesis by the kidneys), glucocorticosteroids (GCS), and estrogens (sodium ion retention).

Cardiac glycosides, methyldopa, reserpine and guanfacine, slow calcium channel blockers (verapamil, diltiazem), Amiodarone and other antiarrhythmic drugs increase the risk of developing or aggravating bradycardia, AV blockade, cardiac arrest and heart failure.

Nifedipine can lead to a significant reduction in blood pressure.

Diuretics, clonidine, sympatholytics, hydralazine and other antihypertensives can lead to excessive lowering of blood pressure.

The effects of nondepolarizing muscle relaxants and the anticoagulant effect of coumarins during treatment with Biolum may be prolonged.

Tricyclic and tetracyclic antidepressants, antipsychotics (antipsychotics), ethanol (alcohol), sedatives and hypnotics increase the depression of the central nervous system.

It is not recommended simultaneous use with MAO inhibitors due to a significant increase in antihypertensive effect. A break in treatment between taking MAO inhibitors and bisoprolol should be at least 14 days.

Unhydrated ergot alkaloids increase the risk of peripheral circulatory disorders.

Ergotamine increases the risk of peripheral circulatory disorders.

Sulfasalazine increases the concentration of bisoprolol in the blood plasma.

Analogues of the drug Biol

Structural analogs for the active substance:

• Aritel;
• Aritel Cor;
• Bidop;
• Biprol;
• Bisogamma;
• Bisocardium;
• Bisomore;
• Bisoprolol;
• Concor;
• Concor Cor;
• Corbis;
• Cordinorm;
• Coronale;
• Niperten;
• Thyrez.

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