Biol tablets: instructions for use, special instructions, price, reviews, analogues

Compound

One tablet may contain 2.5 mg, 5 mg or 10 mg of bisoprolol hemifumarate .
The excipients are: microcrystalline cellulose, calcium hydrogen phosphate, corn starch, croscarmellose sodium, magnesium stearate and colloidal anhydrous silica.

The film shell of the tablets is made of lactose monohydrate, hypromellose, titanium dioxide, macrogol 4000.

The dyes used were: yellow and red iron (III) oxide (for a dosage of 10 mg).

Pharmacodynamics and pharmacokinetics

Bisoprolol is a selective β1-blocker that does not have sympathomimetic activity or membrane-stabilizing effect. The mechanism of action of the active compound in the treatment of arterial hypertension is still unclear. However, bisoprolol in the bloodstream reduces the activity of the proteolytic enzyme - renin , reduces the need of the heart muscle for oxygen and heart rate, and has a hypotensive, antiarrhythmic and antianginal effect.

Low doses of the drug lead to blocking of β1-adrenergic receptors of the heart, which inhibits the conversion of cyclic AMP from ATP , stimulated by catecholamines , which reduces the rate of intracellular flow of calcium ions, inhibits heart function, reducing its excitability and atrioventricular conduction. Taking a larger therapeutic dose of the drug causes a β2-adrenergic blocking effect. Due to the reciprocal increase in the activity of α-adrenergic receptors and the elimination of stimulation of β2-adrenergic receptors, the level of total peripheral vascular resistance increases on the first day of therapy, and then after 2-3 days it returns to the original level, and with prolonged use it decreases.

The antihypertensive effect of Bisoprolol is associated with a decrease in such indicators as minute blood , as well as with sympathetic stimulation of vessels in the periphery, with a decrease in the activity of the sympathetic-adrenal system and restoration of the ability to respond to a decrease in blood pressure . In patients with arterial hypertension, the effect develops on days 2-5 of therapy; 1-2 months are needed to achieve a stable effect.

The antianginal effect of the drug is ensured by a decrease in the oxygen demand of the heart muscle: not only contractility, but also other myocardial functions are reduced, diastole is prolonged and myocardial perfusion is improved. An increase in the final diastolic pressure in the left ventricular chamber and an increase in stretch can increase the need for muscle fibers for oxygen, especially in chronic heart failure (CHF) .

Biol in average therapeutic doses has a less pronounced effect on organs with β2-adrenergic receptors and carbohydrate metabolism, in contrast to non-selective β-blockers .

Pharmacokinetics of Bisoprolol

After oral administration, absorption from the gastrointestinal tract occurs almost completely - approximately 90%, regardless of nutrition. It takes 2 to 4 hours to reach maximum concentration in the bloodstream. The active compound binds to plasma proteins in the blood by 26-33%. After conversion in the liver, metabolites that do not have pharmacological activity. The half-life is 9-12 hours, so Biol can be taken once a day.

Excretion is primarily by the kidneys - up to 50% of unchanged substance, 2% is eliminated through the intestines.

Bisoprolol has low permeability through the blood-brain and placental barriers and is excreted in small quantities in milk.

BIOL

Interaction

The effectiveness and tolerability of bisoprolol may be affected by concomitant use of other medications.
This interaction can also occur when two drugs are taken within a short period of time. The doctor must be informed about taking other medications, even if taken without a doctor's prescription (i.e., over-the-counter drugs). Combinations not recommended

Class I antiarrhythmic drugs

(for example, quinidine, disopyramide, lidocaine, phenytoin; flecainide, propafenone), when used simultaneously with bisoprolol, may reduce AV conduction and myocardial contractility.

Blockers of "slow" calcium channels

(BMCC) such as verapamil and, to a lesser extent, diltiazem, when used simultaneously with bisoprolol, can lead to a decrease in myocardial contractility and impaired AV conduction. In particular, intravenous administration of verapamil to patients taking beta-blockers can lead to severe arterial hypotension and AV block.

Centrally acting
antihypertensives (such as clonidine, methyldopa, moxonidine, rilmenidine) can lead to decompensation of CHF due to a decrease in heart rate and decreased cardiac output, as well as to the appearance of symptoms of vasodilation due to a decrease in central sympathetic tone.

Combinations requiring special caution

BMCA dihydropyridine derivatives

(for example, nifedipine, felodipine, amlodipine) when used simultaneously with bisoprolol may increase the risk of developing arterial hypotension. In patients with CHF, the risk of subsequent deterioration in cardiac contractility cannot be excluded.

Class III antiarrhythmic drugs

(eg, amiodarone) may increase AV conduction disturbances.

Effect of beta-blockers for topical use

(for example, eye drops for the treatment of glaucoma) may enhance the systemic effects of bisoprolol: a pronounced decrease in blood pressure, a decrease in heart rate.

Parasympathetic has iki

when used simultaneously with bisoprolol, they may increase AV conduction disturbances and increase the risk of developing bradycardia.

Simultaneous use of bisoprolol with beta-agonists

(eg, isoprenaline, dobutamine) may reduce the effect of both drugs.

Combination of bisoprolol with adrenergic agonists

affecting beta and alpha adrenergic receptors (for example, norepinephrine, epinephrine), may enhance the vasoconstrictor effects of these drugs that occur with the participation of alpha adrenergic receptors, leading to an increase in blood pressure. Such interactions are more likely when using non-selective beta-blockers.

Allergens

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

Iodine-containing radiopaque diagnostic agents

for intravenous administration increase the risk of anaphylactic reactions.

Phenytoin

when administered intravenously, inhalation anesthesia agents (hydrocarbon derivatives) increase the severity of the cardiodepressive effect and the likelihood of lowering blood pressure.

Insulin effectiveness

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

Lidocaine clearance

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

The antihypertensive effect is weakened by non-steroidal
anti-inflammatory drugs
(sodium ion retention and blockade of prostaglandin synthesis by the kidneys), glucocorticosteroids and estrogens (sodium ion retention).

Cardiac glycosides

increase the risk of developing or worsening bradycardia, AV block, cardiac arrest and heart failure.

Diuretics, clonidine,
sympatholytics, hydralazine
and
other antihypertensive drugs
can lead to an excessive decrease in blood pressure.

Action of non-depolarizing muscle relaxants

and the anticoagulant effect
of coumarins
may be prolonged during treatment with bisoprolol.

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

Non-hydrogenated
ergot
alkaloids increase the risk of developing peripheral circulatory disorders.

Sulfasalazine

increases the concentration of bisoprolol in the blood plasma.

Combinations to
consider
Mefloquine

when used simultaneously with bisoprolol, it may increase the risk of bradycardia.

Monoamine oxidase inhibitors (MAO)

(with the exception of MAO type B inhibitors) may enhance the antihypertensive effect. Simultaneous use may lead to the development of a hypertensive crisis.

Ergotamine

increases the risk of developing peripheral circulatory disorders.

Rifampicin

shortens the half-life of bisoprolol.

Contraindications

hypersensitivity to the constituent components or other β-blockers ;
acute or chronic failure of cardiac function, incl. at the stage of decompensation, which requires inotropic support;
metabolic acidosis;
collapse;
therapy with MAO inhibitors and 14 days after discontinuation (risk of a significant increase in the hypotensive effect);
cardiomegaly;
cardiogenic shock;
Raynaud's syndrome;
sinoatrial, AV blockade, partial (II degree) or complete, without the use of a pacemaker ;
sinus node dysfunction;
bradycardia (with heart rate up to 50 beats per minute);
arterial hypotension with systemic blood pressure up to 90 mm Hg. Art.;
severe form of bronchial asthma or chronic obstructive pulmonary disease , as well as a history;
peripheral circulatory disorders;
pheochromocytoma;
taking Floctafenine or Sultopride ;
age category: persons under 18 years of age;
breastfeeding or pregnant women.

Can be used with caution:

combination with desensitizing therapy ;
hyperthyroidism;
psoriasis;
type 1 diabetes mellitus glucose ;
renal failure with creatinine less than 20 ml per 1 min;
severe liver dysfunction;
partial AV block of the 1st degree;
restrictive cardiomyopathy;
angina ;
congenital heart disease or heart valve , accompanied by hemodynamic disturbances;
chronic failure of cardiac function, recent myocardial infarction (up to 3 months);
depression or a history of depression;
for pheochromocytoma and complex treatment with α-blockers ;
strict diet .

Side effects

Biol tablets can cause unwanted reactions, the frequency of occurrence and manifestations of which differ:

From the side of the cardiovascular system, very often (in ≤10% of patients) there is a decrease in heart rate and the development of bradycardia , a feeling of palpitations ; less than 1% of patients “often” experienced a decrease in blood pressure, vasospasm , paresthesia , infrequently (≤0.1%) - AV conduction disturbances, block and cardiac arrest arrhythmia , orthostatic hypotension , worsening CHF , peripheral edema and chest pain occurred .
“Frequent” adverse reactions of the nervous system and sensory organs: dizziness , headaches , asthenia , fatigue, anxiety, sleep disturbances, depression , rare cases (≤0.01%) of confusion, short-term memory loss, nightmares, hallucinations , myasthenia , tremor , convulsions , visual disturbances, decreased lacrimation and dryness (important to consider when using lenses), possible noise, ear pain and hearing loss, conjunctivitis .
bronchospasm develops against the background of bronchial asthma or COPD ; Allergic rhinitis rarely occurs .
Nausea, vomiting, constipation or diarrhea , dry mouth, hepatitis , increased ALT and AST bilirubin concentrations , and rarely triglycerides .
Cases of arthralgia and back pain are uncommon.
Very rarely, patients complain of impaired potency and weakened libido.
There have been isolated reports of thrombocytopenia , agranulocytosis , and leukopenia .
Rare allergic reactions have manifested themselves in the form of skin itching , rash and urticaria .
On the part of the epidermis , sweating rarely increased, hyperemia , exanthema , and psoriasis-like reactions occurred; even more rarely - alopecia, exacerbation of psoriasis .
After stopping taking Biol tablets, withdrawal syndrome , which leads to an increase in angina and an increase in blood pressure .

Biol tablets, instructions for use (method and dosage)

Biol tablets are recommended to be taken orally, in the morning, before or during breakfast, whole, with a small amount of water, once every 24 hours.

The instructions for use describe standard treatment regimens, however, in each individual case, the attending physician must select therapeutic regimens taking into account the heart rate and condition of the patient.

For arterial hypertension and coronary artery disease:

The daily dose is 5 mg, but can be increased to 10 mg.

Patients suffering from arterial hypertension and angina pectoris are prescribed at least 20 mg per day.

For CHF:

The minimum initial dose is 1.25 mg, which can be increased after analyzing the tolerability of the drug - first to 2.5 mg, then to 3.75 mg, 5 mg, 7.5 mg and a maximum after 2 weeks. – 10 mg. If therapy causes deterioration, it is better to consider reducing the dose.

Selection of dosage requires regular monitoring of blood pressure and heart rate . If the symptoms of CHF , arterial hypotension or bradycardia , it is necessary to select, first of all, standard doses of concomitant therapy and reduce the doses of the drug Biol, up to the discontinuation of treatment.

Biol instructions for use

INSTRUCTIONS for using the drug BIOL

Release form: Film-coated tablets.

Composition 1 tablet contains bisoprolol hemifumarate 2.5, 5 or 10 mg; excipients: microcrystalline cellulose, calcium hydrogen phosphate, corn starch, croscarmellose sodium, magnesium stearate, colloidal anhydrous silicon dioxide.

Characteristics Selective β1-blocker.

Pharmacological action Pharmacological action - antianginal, hypotensive, selective β1-adrenergic blocking. Pharmacodynamics Bisoprolol is a selective beta1-blocker, without its own sympathomimetic activity, and does not have a membrane-stabilizing effect. As with other beta1-blockers, the mechanism of action in hypertension is unclear. At the same time, it is known that bisoprolol reduces the activity of renin in the blood plasma, reduces the myocardial oxygen demand, and reduces heart rate. It has hypotensive, antiarrhythmic and antianginal effects. By blocking beta1-adrenergic receptors of the heart in low doses, it reduces the formation of cAMP from ATP stimulated by catecholamines, reduces the intracellular current of calcium ions, inhibits all functions of the heart, reduces AV conductivity and excitability. When the therapeutic dose is exceeded, it has a beta2-adrenergic blocking effect. OPSS at the beginning of drug use, 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), after 1-3 days it returns to the original value, and with long-term use it decreases. The antihypertensive effect is associated with a decrease in minute blood volume, sympathetic stimulation of peripheral vessels, a decrease in the activity of the sympathoadrenal system (SAS) (of great importance for patients with initial renin hypersecretion), restoration of sensitivity in response to a decrease in blood pressure and an effect on the central nervous system. In arterial hypertension, the effect develops 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, prolongation of diastole, and improved myocardial perfusion. Due to an increase in end-diastolic pressure in the left ventricle and an increase in the stretch of ventricular muscle fibers, oxygen demand may increase, especially in patients with CHF. When used in average 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 peripheral arteries, bronchi and uterus), and on carbohydrate metabolism; does not cause sodium ion retention in the body; the severity of the atherogenic effect does not differ from the effect of propranolol.

Pharmacokinetics Bisoprolol is almost completely absorbed from the gastrointestinal tract; food intake does not affect absorption. Bioavailability - about 90%. Tmax is 2–4 hours after oral administration. Binding to plasma proteins is 26–33%. Metabolized in the liver, bisoprolol metabolites do not have pharmacological activity. T1/2 is 9–12 hours, which makes it possible to use the drug once a day. Excreted by the kidneys - 50% unchanged, less than 2% - through the intestines. Permeability through the BBB and the placental barrier is low, and is excreted in small quantities in breast milk.

Contraindications: severe arterial hypotension (systolic blood pressure less than 90 mm Hg, especially during myocardial infarction); acute heart failure, chronic heart failure in the stage of decompensation; cardiogenic shock; collapse, pulmonary edema; AV block II and III degrees (without installing a pacemaker); sinoatrial block; sick sinus syndrome; severe sinus bradycardia (heart rate less than 50 beats/min); severe stages of peripheral circulatory disorders, Raynaud's disease; simultaneous use of MAO inhibitors (except for MAO type B); metabolic acidosis; severe forms of bronchial asthma and chronic obstructive pulmonary disease (history); age under 18 years (efficacy and safety have not been established); pregnancy and lactation; hypersensitivity to bisoprolol and other components of the drug and to other beta-blockers.

With caution: severe liver failure; severe renal failure; thyrotoxicosis; psoriasis; myasthenia gravis; AV blockade, first degree; Prinzmetal's angina; depression (including history); pheochromocytoma (simultaneous use of alpha-blockers is mandatory); diabetes; general anesthesia/surgery; severe allergic reactions (history).

Use during pregnancy and lactation Bisoprolol does not have a direct cytotoxic, mutagenic or teratogenic effect, but has pharmacological effects that can have a harmful effect on the course of pregnancy and/or on the fetus or newborn. Typically, beta blockers reduce placental perfusion, leading to reduced fetal growth, intrauterine fetal death, miscarriage, or premature birth. The fetus and newborn child may experience pathological reactions, such as intrauterine growth retardation, hypoglycemia, and bradycardia. The drug Biol® should not be used during pregnancy; use is possible if the benefit to the mother outweighs the risk of side effects in the fetus and/or child. In the event that treatment with Biol® is considered necessary, blood flow in the placenta and uterus should be monitored, as well as the growth and development of the unborn child should be monitored and, in the event of adverse events in relation to pregnancy and/or the fetus, alternative methods of therapy should be used. The newborn should be carefully examined after birth. Symptoms of hypoglycemia and bradycardia usually occur during the first 3 days of life. Breastfeeding period. There is no data on the penetration of bisoprolol into breast milk. Therefore, the use of Biol® is not recommended for women during breastfeeding. If it is necessary to use the drug during lactation, breastfeeding should be stopped.

Side effects The frequency of adverse reactions listed below was determined as follows (WHO classification): very often - at least 10%; often - at least 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 cardiovascular system: very often - decrease in heart rate (bradycardia, especially in patients with CHF), sensation of heartbeat; often - a pronounced decrease in blood pressure (especially in patients with CHF), manifestation of vasospasm (increased peripheral circulatory disorders, a feeling of cold in the extremities (paresthesia); infrequently - impaired AV conduction (up to the development of complete transverse block and cardiac arrest), arrhythmias, orthostatic hypotension , worsening 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, sleep disturbance, depression, anxiety; rarely - confusion or short-term memory loss, nightmares, hallucinations, myasthenia gravis, tremors, muscle cramps. Usually these phenomena are mild in nature and usually disappear within 1-2 weeks after the start of treatment. From the senses: rarely - blurred vision, decreased lacrimation (should be taken into account when wearing contact lenses), tinnitus, hearing loss, ear pain; very rarely - dry and sore eyes, conjunctivitis, taste disturbance. 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, dry oral mucosa, abdominal pain; rarely - hepatitis, increased activity of liver enzymes (ALT, AST), increased bilirubin concentration, change in taste. From the musculoskeletal system: infrequently - arthralgia, back pain. From the genitourinary system: very rarely - impaired potency, weakened libido. Laboratory indicators: rarely - increased concentration of triglycerides in the blood; in some cases - thrombocytopenia, agranulocytosis, leukopenia. Allergic reactions: rarely - itching, rash, urticaria. From the skin: rarely - increased sweating, skin hyperemia, exanthema, psoriasis-like skin reactions; very rarely - alopecia; beta blockers can aggravate psoriasis. Other: withdrawal syndrome (increased frequency of angina attacks, increased blood pressure).

Interaction The effectiveness and tolerability of bisoprolol may be affected by the simultaneous use of other drugs. Such interaction can also occur in cases where two drugs are taken after a short period of time. The doctor must be informed about taking other drugs, even if they are taken without a doctor’s prescription (i.e., over-the-counter drugs). Not recommended combinations Class I antiarrhythmic drugs (for example, quinidine, disopyramide, lidocaine, phenytoin; flecainide, propafenone), when used simultaneously with bisoprolol, can reduce AV conduction and myocardial contractility. CCBs such as verapamil, and to a lesser extent diltiazem, when used simultaneously with bisoprolol, can lead to a decrease in myocardial contractility and impaired AV conduction. In particular, intravenous administration of verapamil to patients taking beta-blockers can lead to severe arterial hypotension and AV block. Centrally acting antihypertensives (such as clonidine, methyldopa, moxonidine, rilmenidine) can lead to decompensation of CHF due to a decrease in heart rate and decreased cardiac output, as well as to the appearance of symptoms of vasodilation due to a decrease in central sympathetic tone. Combinations requiring special caution CCBs, dihydropyridine derivatives (for example, nifedipine, felodipine, amlodipine), when used simultaneously with bisoprolol, may increase the risk of arterial hypotension. In patients with CHF, the risk of subsequent deterioration in cardiac contractility cannot be excluded. Class III antiarrhythmic drugs (eg amiodarone) may worsen AV conduction disturbances. The effect of beta-blockers for local use (for example, eye drops for the treatment of glaucoma) can enhance the systemic effects of bisoprolol - a pronounced decrease in blood pressure, a decrease in heart rate. Parasympathomimetics, when used simultaneously with bisoprolol, may enhance AV conduction disturbances and increase the risk of developing bradycardia. The simultaneous use of bisoprolol with beta-agonists (for example, isoprenaline, dobutamine) may lead to a decrease in the effect of both drugs. The combination of bisoprolol with adrenergic agonists that affect beta and alpha adrenergic receptors (for example, norepinephrine, epinephrine) may enhance the vasoconstrictor effects of these drugs that occur with the participation of alpha adrenergic receptors, leading to an increase in blood pressure. Such interactions are more likely when using non-selective beta-blockers. Allergens used for immunotherapy or allergen extracts for skin testing increase the risk of severe systemic allergic reactions or anaphylaxis in patients receiving bisoprolol. Iodine-containing radiopaque diagnostic agents for intravenous administration increase the risk of developing anaphylactic reactions. Phenytoin, when administered intravenously, and agents for inhalation anesthesia (hydrocarbon derivatives) increase the severity of the cardiodepressive effect and the likelihood of lowering blood pressure. The effectiveness of insulin and hypoglycemic agents for oral administration may change during treatment with bisoprolol (masks the symptoms of developing hypoglycemia - tachycardia, increased blood pressure). The clearance of lidocaine and xanthines (except theophylline) may be reduced due to a possible increase in their concentration in the blood plasma, especially in patients with an initially increased clearance of theophylline under the influence of smoking. The antihypertensive effect is weakened by NSAIDs (sodium ion retention and blockade of PG synthesis by the kidneys), corticosteroids and estrogens (sodium ion retention). Cardiac glycosides increase the risk of developing or worsening bradycardia, AV block, cardiac arrest, and heart failure. Diuretics, clonidine, sympatholytics, hydralazine and other antihypertensive drugs can lead to an excessive decrease in blood pressure. The effect of non-depolarizing muscle relaxants and the anticoagulant effect of coumarins may be prolonged during treatment with bisoprolol. Tricyclic and tetracyclic antidepressants, antipsychotics (neuroleptics), ethanol, sedatives and hypnotics increase CNS depression. Non-hydrogenated ergot alkaloids increase the risk of developing peripheral circulatory disorders. Sulfasalazine increases the concentration of bisoprolol in the blood plasma. Combinations that should be taken into account Mefloquine, when used simultaneously with bisoprolol, may increase the risk of developing bradycardia. MAO inhibitors (except MAO type B inhibitors) may enhance the antihypertensive effect. Simultaneous use may lead to the development of a hypertensive crisis. Ergotamine increases the risk of developing peripheral circulatory disorders. Rifampin shortens T1/2 of bisoprolol.

Method of administration and dosage: Orally, in the morning, on an empty stomach, 1 time per day with a small amount of liquid. The tablets should not be chewed or crushed into powder. In all cases, the doctor selects the dosage regimen and dose individually for each patient, in particular taking into account the heart rate and condition of the patient. Arterial hypertension and ischemic heart disease For arterial hypertension and ischemic heart disease, Biol® is used at a dose of 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. CHF Beginning treatment for CHF with Biol® requires a special titration phase and regular medical supervision. The precondition for treatment with Biol® is stable CHF without signs of exacerbation. Treatment of CHF with Biol® 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 only be increased if the previous dose was well tolerated. To ensure an appropriate titration process, it is recommended to use the drug in lower doses in the initial stages of treatment. The recommended starting dose is 1.25 mg (1/4 tablet of 5 mg) once a day. Depending on individual tolerance, the dose should be gradually increased to 2.5 mg (1/2 tablet of the drug Biol®, 5 mg each), 3.75 mg (3/4 tablets, 5 mg each), 5 mg (1 tablet of the drug Biol® 5 mg or 1/2 tablet of 10 mg), 7.5 mg (3/4 tablet of 10 mg) and 10 mg once a day with an interval of at least 2 weeks. If increasing the dose of the drug is poorly tolerated by the patient, a dose reduction may be possible. The maximum daily dose for the treatment of CHF is 10 mg 1 time per day. During titration, regular monitoring of blood pressure, heart rate and symptoms of increasing severity of heart failure is recommended. Worsening of the symptoms of CHF is possible from the first day of using the drug. During the titration phase or after it, a temporary worsening of CHF, arterial hypotension or bradycardia may occur. In this case, it is recommended first of all to pay attention to the selection of the dose of concomitant standard therapy. It may also be necessary to temporarily reduce the dose of Biol® by 5 mg or discontinue treatment. After stabilization of the patient's condition, the dose should be re-titrated or treatment should be continued. Renal or hepatic impairment Mild or moderate hepatic or renal impairment does not usually require dose adjustment. In case of severe renal impairment (Cl creatinine <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. Elderly patients No dose adjustment is required. To date, there is insufficient data regarding the use of Biol® 5 mg in patients with CHF associated with type 1 diabetes mellitus, severe renal and/or liver dysfunction, restrictive cardiomyopathy, congenital heart defects or hemodynamically determined heart disease. Also, sufficient data have not yet been obtained regarding patients with CHF with myocardial infarction within the last 3 months.

Overdose Symptoms: arrhythmia, ventricular extrasystole, severe bradycardia, AV block, marked decrease in blood pressure, acute heart failure, hypoglycemia, acrocyanosis, difficulty breathing, bronchospasm, dizziness, fainting, convulsions. Treatment: if an overdose occurs, first of all you need to stop taking the drug, perform gastric lavage, take adsorbents, and carry out symptomatic therapy. For severe bradycardia, intravenous administration of atropine. If the effect is insufficient, a drug with a positive chronotropic effect can be administered with caution. Sometimes temporary placement of an artificial pacemaker may be necessary. With a pronounced decrease in blood pressure, intravenous administration of plasma-substituting solutions and vasopressors. For hypoglycemia, intravenous administration of glucagon or dextrose (glucose) may be indicated. For AV block, patients should be closely monitored and treated with beta-agonists such as epinephrine. If necessary, install an artificial pacemaker. In case of exacerbation of CHF, intravenous administration of diuretics, drugs with a positive inotropic effect, as well as vasodilators. For bronchospasm - prescribing bronchodilators, incl. beta2-adrenergic agonists and/or aminophylline.

Special instructions Do not abruptly interrupt treatment with Biol® due to 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 the drug Biol® should include measuring heart rate and blood pressure (at the beginning of treatment - daily, then - once every 3-4 months), conducting an ECG, determining the concentration of blood glucose in patients with diabetes mellitus (once every 4 months). -5 months). In elderly patients, it is recommended to monitor renal function (once every 4–5 months). The patient should be taught how to calculate heart rate and instructed about the need for medical consultation if the heart rate is less than 50 beats/min. If increasing bradycardia (heart rate >50 beats/min), a pronounced decrease in blood pressure (sBP <100 mmHg), or AV blockade is detected in elderly patients, it is necessary to reduce the dose or stop treatment. Before starting treatment, it is recommended to conduct a study of external respiratory function in patients with a burdened bronchopulmonary history. Patients who use contact lenses should take into account that during treatment with the drug, the production of tear fluid may decrease. When using the drug Biol® in patients with pheochromocytoma, there is a risk of developing paradoxical arterial hypertension (if effective blockade of alpha-adrenergic receptors is not previously achieved). In hyperthyroidism, bisoprolol may mask certain clinical signs of hyperthyroidism (for example, tachycardia). Abrupt withdrawal of the drug in patients with hyperthyroidism is contraindicated as it can increase symptoms. In diabetes mellitus, it can mask tachycardia caused by hypoglycemia. Unlike non-selective beta-blockers, it practically does not enhance insulin-induced hypoglycemia and does not delay the restoration of blood glucose concentrations to normal values. When using clonidine simultaneously, its use can be discontinued only a few days after discontinuation of the Biol® drug. It is possible that the severity of the hypersensitivity reaction may increase and there will be no effect from usual doses of epinephrine against the background of a burdened allergic history. If planned surgical treatment is necessary, the drug should be discontinued 48 hours before general anesthesia. If the patient took the drug before surgery, he should select a drug for general anesthesia with minimal negative inotropic effect. Reciprocal activation of the vagus nerve can be eliminated by intravenous atropine (1–2 mg). Drugs that deplete the catecholamine depot (including reserpine) can enhance the effect of beta-blockers, so patients taking such combinations of drugs should be under constant medical supervision to detect a pronounced decrease in blood pressure or bradycardia. Patients with bronchospastic diseases may be prescribed cardioselective beta-blockers with caution in case of intolerance and/or ineffectiveness of other antihypertensive drugs. While taking beta-blockers in patients with concomitant bronchial asthma, airway resistance may increase. If the dose of Biol® is exceeded in such patients, there is a risk of developing bronchospasm. If increasing bradycardia (heart rate <50 beats/min), a pronounced decrease in blood pressure (sBP <100 mmHg), or AV blockade is detected in patients, it is necessary to reduce the dose or discontinue treatment. It is recommended to discontinue therapy with Biol® if depression develops. Treatment should not be abruptly interrupted due to the risk of developing severe arrhythmias and myocardial infarction. The drug is discontinued gradually, reducing the dose over 2 weeks or more (reduce the dose by 25% in 3-4 days). The drug should be discontinued before testing the concentrations of catecholamines, normetanephrine, vanillylmandelic acid, and antinuclear antibody titers in the blood and urine. Beta blockers are less effective in smokers.

Impact on the ability to drive vehicles and perform other activities that require concentration and speed of psychomotor reactions. During treatment with Biol®, care must be taken when driving vehicles and performing other potentially hazardous activities that require increased concentration and speed of psychomotor reactions.

Storage conditions Keep out of the reach of children at a temperature not exceeding 25°C.

Shelf life: 4 years.

Overdose

Manifests itself in the form of symptoms such as:

arrhythmia;
severe bradycardia ;
AV block;
ventricular extrasystole;
decrease in blood pressure;
labored breathing;
bronchospasm;
development of acute heart failure, hypoglycemia , acrocyanosis ;
dizziness, fainting and convulsions.

First aid and symptomatic treatment measures

gastric lavage and taking adsorbents;
severe bradycardia is eliminated by intravenous administration of Atropine or, if necessary, a drug with a positive pronounced chronotropic effect;
temporarily install an artificial pacemaker;
a pronounced decrease in blood pressure can be corrected by intravenous administration of plasma replacement drugs and vasopressors ;
hypoglycemia requires intravenous administration of Glucagon or Dextrose ;
exacerbation of CHF - IV diuretics , possibly vasodilators ;
for AV blockade, β-adrenergic agonists are prescribed , for example, Epinephrine ;
when bronchospasm bronchodilators are used , incl. β-adrenergic agonists and/or Aminophylline .

Biol, 30 pcs., 10 mg, film-coated tablets

The effectiveness and tolerability of bisoprolol may be affected by the simultaneous use of other drugs. Such interaction can also occur in cases where two drugs are taken after a short period of time. The doctor must be informed about taking other drugs, even if they are taken without a doctor’s prescription (i.e., over-the-counter drugs).

Combinations not recommended

Class I antiarrhythmic drugs (for example, quinidine, disopyramide, lidocaine, phenytoin; flecainide, propafenone), when used simultaneously with bisoprolol, can reduce AV conduction and myocardial contractility.

CCBs such as verapamil, and to a lesser extent diltiazem, when used simultaneously with bisoprolol, can lead to a decrease in myocardial contractility and impaired AV conduction. In particular, intravenous administration of verapamil to patients taking beta-blockers can lead to severe arterial hypotension and AV block.

Centrally acting antihypertensives (such as clonidine, methyldopa, moxonidine, rilmenidine) can lead to decompensation of CHF due to a decrease in heart rate and decreased cardiac output, as well as to the appearance of symptoms of vasodilation due to a decrease in central sympathetic tone.

Combinations requiring special caution

CCBs, dihydropyridine derivatives (for example, nifedipine, felodipine, amlodipine), when used simultaneously with bisoprolol, may increase the risk of developing arterial hypotension. In patients with CHF, the risk of subsequent deterioration in cardiac contractility cannot be excluded.

Class III antiarrhythmic drugs (eg amiodarone) may worsen AV conduction disturbances.

The effect of beta-blockers for local use (for example, eye drops for the treatment of glaucoma) can enhance the systemic effects of bisoprolol - a pronounced decrease in blood pressure, a decrease in heart rate.

Parasympathomimetics, when used simultaneously with bisoprolol, may enhance AV conduction disturbances and increase the risk of developing bradycardia.

The simultaneous use of bisoprolol with beta-agonists (for example, isoprenaline, dobutamine) may lead to a decrease in the effect of both drugs. The combination of bisoprolol with adrenergic agonists that affect beta and alpha adrenergic receptors (for example, norepinephrine, epinephrine) may enhance the vasoconstrictor effects of these drugs that occur with the participation of alpha adrenergic receptors, leading to an increase in blood pressure. Such interactions are more likely when using non-selective beta-blockers.

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

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

Phenytoin, when administered intravenously, and agents for inhalation anesthesia (hydrocarbon derivatives) increase the severity of the cardiodepressive effect and the likelihood of lowering blood pressure.

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

The clearance of lidocaine and xanthines (except theophylline) may be reduced due to a possible increase in their concentration in the blood plasma, especially in patients with an initially increased clearance of theophylline under the influence of smoking.

The antihypertensive effect is weakened by NSAIDs (sodium ion retention and blockade of PG synthesis by the kidneys), corticosteroids and estrogens (sodium ion retention).

Cardiac glycosides increase the risk of developing or worsening bradycardia, AV block, cardiac arrest, and heart failure.

Diuretics, clonidine, sympatholytics, hydralazine and other antihypertensive drugs can lead to an excessive decrease in blood pressure.

The effect of non-depolarizing muscle relaxants and the anticoagulant effect of coumarins may be prolonged during treatment with bisoprolol.

Tricyclic and tetracyclic antidepressants, antipsychotics (neuroleptics), ethanol, sedatives and hypnotics increase CNS depression.

Non-hydrogenated ergot alkaloids increase the risk of developing peripheral circulatory disorders.

Sulfasalazine increases the concentration of bisoprolol in the blood plasma.

Combinations to Consider

Mefloquine, when used simultaneously with bisoprolol, may increase the risk of bradycardia.

MAO inhibitors (except MAO type B inhibitors) may enhance the antihypertensive effect. Simultaneous use may lead to the development of a hypertensive crisis.

Ergotamine increases the risk of developing peripheral circulatory disorders.

Rifampin shortens T1/2 of bisoprolol.

Interaction

With class I antiarrhythmic drugs (for example, Quinidine , Disopyramide , Lidocaine , Phenytoin , Flecainide , Propafenone ), AV conductivity and myocardial contractility may decrease.
class III antiarrhythmic drugs Amiodarone ), atrioventricular conduction disturbances increase.
local β-blockers of glaucoma ), the systemic effects of the drug Biol are enhanced.
In combination with parasympathomimetics, AV conduction disturbances increase and the risk of bradycardia .
With β-adrenergic agonists (taken with Isoprenaline or Dobutamine ), the effect of both drugs may decrease.
With Norepinephrine and Epinephrine, the vasoconstrictor effect may increase and an increase in blood pressure may occur.
With mefloquine, bradycardia increases .
With allergens and their extracts used for immunotherapy and skin testing, the likelihood of systemic and severe allergic reactions and anaphylaxis .
With iodine-containing radiocontrast agents used in diagnostics, the likelihood of anaphylactic reactions .
intravenous phenytoin anesthesia the severity of the cardiodepressive effect and the likelihood of a decrease in blood pressure increases.
Biol will change the effectiveness of insulin , hypoglycemic agents, masking symptoms of hypoglycemia such as: tachycardia and increased blood pressure; of lidocaine and xanthines decreases (exception: Theophylline ).
With NSAIDs , corticosteroids and estrogens, the hypotensive effect is weakened.
Combination with cardiac glycosides , Methyldopa , Reserpine and Guanfacine , BMCC ( Verapamil , Diltiazem ), Amiodarone and other antiarrhythmic drugs can provoke worsening or occurrence of bradycardia , atrioventricular block and even cause cardiac arrest.
With Nifedipine there is a significant decrease in blood pressure.
With diuretics , Clonidine , sympatholytics , Hydralazine , an excessive decrease in blood pressure may occur, and the effect of non-depolarizing muscle relaxants and the anticoagulant effect of coumarins may increase.
With antidepressants , antipsychotics ( neuroleptics ), ethanol , sedatives and hypnotics, CNS depression increases.
With non-hydrogenated ergot alkaloids and Ergotamine , the risk of circulatory disorders in the periphery increases.
With Sulfasalazine, the concentration of plasma bisoprolol in the bloodstream increases.
With Rifampicin , T1/2 of bisoprolol is shortened.

Biol®

The effectiveness and tolerability of bisoprolol may be affected by concomitant use of other medications. This interaction can also occur when two drugs are taken within a short period of time. The doctor must be informed about taking other medications, even if taken without a doctor's prescription (i.e., over-the-counter drugs).

Combinations not recommended

Class I antiarrhythmic drugs (for example, quinidine, disopyramide, lidocaine, phenytoin, flecainide, propafenone), when used simultaneously with bisoprolol, can reduce AV conduction and cardiac contractility.

Blockers of “slow” calcium channels (SCBC) such as verapamil and, to a lesser extent, diltiazem, when used simultaneously with bisoprolol, can lead to a decrease in myocardial contractility and impaired AV conduction. In particular, intravenous administration of verapamil to patients taking beta-blockers can lead to severe arterial hypotension and AV block.

Centrally acting antihypertensives (such as clonidine, methyldopa, moxonidine, rilmenidine) can lead to a decrease in heart rate and cardiac output, as well as vasodilation due to a decrease in central sympathetic tone.

Abrupt withdrawal, especially before discontinuation of beta-blockers, may increase the risk of developing “rebound” arterial hypertension.

Combinations requiring special caution

BMCC dihydropyridine derivatives (for example, nifedipine, felodipine, amlodipine) when used simultaneously with bisoprolol may increase the risk of arterial hypotension. In patients with CHF, the risk of subsequent deterioration in cardiac contractility cannot be excluded.

Class III antiarrhythmic drugs (eg, amiodarone) may worsen AV conduction disturbances.

The effect of beta-blockers for topical use (for example, eye drops for the treatment of glaucoma) may enhance the systemic effects of bisoprolol (lowering blood pressure, lowering heart rate).

Parasympathomimetics, when used simultaneously with bisoprolol, may enhance AV conduction disturbances and increase the risk of developing bradycardia.

The hypoglycemic effect of insulin or oral hypoglycemic agents may be enhanced. Signs of hypoglycemia - in particular tachycardia - may be masked or suppressed. Such interactions are more likely when using non-selective beta-blockers.

General anesthesia agents may increase the risk of cardiodepressive effects, leading to arterial hypotension (see section "Special Instructions").

Cardiac glycosides, when used simultaneously with bisoprolol, can lead to an increase in impulse conduction time, and thus to the development of bradycardia.

Nonsteroidal anti-inflammatory drugs (NSAIDs) may reduce the hypotensive effect of bisoprolol.

The simultaneous use of Biol® with beta-agonists (for example, isoprenaline, dobutamine) may lead to a decrease in the effect of both drugs.

The combination of bisoprolol with adrenergic agonists that affect beta and alpha adrenergic receptors (for example, norepinephrine, epinephrine) may enhance the vasoconstrictor effects of these drugs that occur with the participation of alpha adrenergic receptors, leading to an increase in blood pressure. Such interactions are more likely when using non-selective beta-blockers.

Antihypertensive drugs, as well as other drugs with a possible antihypertensive effect (for example, tricyclic antidepressants, barbiturates, phenothiazines) may enhance the hypotensive effect of bisoprolol.

Mefloquine, when used simultaneously with bisoprolol, may increase the risk of bradycardia.

MAO inhibitors (except MAO B inhibitors) may enhance the hypotensive effect of beta-blockers. Concomitant use may also lead to the development of a hypertensive crisis.

special instructions

If planned surgical treatment is necessary, the drug should be discontinued at least 2 days before the upcoming general anesthesia or another drug should be selected that has minimal negative inotropic effects.

Stop taking Biol also before testing the level in the blood or urine of such drugs as: catecholamines , Normetanephrine , vanillinmandelic acid , titers of antinuclear antibodies .

In patients who smoke, the effectiveness of β-blockers is reduced.

Biol®

Treatment with Biol® should not be abruptly interrupted due to 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 the drug Biol® should include measuring heart rate and blood pressure (at the beginning of treatment - daily, then once every 3-4 months), conducting an ECG, determining the concentration of blood glucose in patients with diabetes mellitus (once every 4-5 months)

In elderly patients, it is recommended to monitor renal function (once every 4-5 months).

The patient should be taught how to calculate heart rate and instructed about the need for medical consultation if the heart rate is less than 50 beats/min.

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

Before starting treatment, it is recommended to conduct a study of external respiratory function in patients with a burdened bronchopulmonary history.

Patients who use contact lenses should take into account that during treatment with the drug, the production of tear fluid may decrease.

When using the drug Biol® in patients with pheochromocytoma, there is a risk of developing paradoxical arterial hypertension (if effective blockade of alpha-adrenergic receptors is not previously achieved).

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

In diabetes mellitus, bisoprolol can mask tachycardia caused by hypoglycemia. Unlike non-selective beta-blockers, it practically does not enhance insulin-induced hypoglycemia and does not delay the restoration of blood glucose concentrations to normal levels.

When taking clonidine simultaneously, it can be discontinued only a few days after discontinuation of the Biol® drug.

It is possible that the severity of the hypersensitivity reaction may increase and there will be no effect from usual doses of epinephrine against the background of a burdened allergic history.

If surgical intervention is necessary, the drug should be discontinued 48 hours before the start of general anesthesia. If the patient took the drug before surgery, he should select a drug for general anesthesia with minimal negative inotropic effects.

Reciprocal activation of the vagus nerve can be eliminated by intravenous atropine (1-2 mg).

Medicines that reduce the supply of catecholamines (including reserpine) may enhance the effect of beta-blockers, so patients taking such combinations of drugs should be under constant medical supervision to detect a pronounced decrease in blood pressure or bradycardia.

Patients with bronchospastic diseases can be prescribed cardioselective beta-blockers with caution in case of intolerance and/or ineffectiveness of other antihypertensive drugs. While taking beta-blockers in patients with concomitant bronchial asthma, airway resistance may increase. If the dose of Biol® is exceeded in such patients, there is a risk of developing bronchospasm.

If increasing bradycardia (heart rate less than 50 beats/min), a pronounced decrease in blood pressure (systolic blood pressure less than 100 mmHg), or AV blockade is detected in patients, it is necessary to reduce the dose or stop treatment.

It is recommended to discontinue therapy with Biol® if depression develops.

Treatment should not be abruptly interrupted due to the risk of developing severe arrhythmias and myocardial infarction. The drug is discontinued gradually, reducing the dose over 2 weeks or more (reduce the dose by 25% in 3-4 days).

The drug should be discontinued before testing the concentrations of catecholamines, normetanephrine, vanillinmandelic acid, and antinuclear antibody titers in the blood and urine.

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

Impact on the ability to drive vehicles and operate machinery

During treatment with Biol®, care must be taken when driving vehicles and engaging in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions.

Analogs

Level 4 ATX code matches:
Metocard

Metozok

Nebilet

Nebilong

Betaxolol

Bisogamma

Aritel

Cordinorm

Vasocardin

Corvitol

Bidop

Bisoprolol

Nebivolol

Biprol

Bisoprol

Concor Cor

Lokren

Concor

Niperten

Betaloc ZOK

The most available substitute drugs:

Bisoprolol-Teva;
Biprol;
Coronal.

Price, where to buy

The price of Biola differs depending on the dosage and number of tablets:

2.5 mg, package No. 30 – 120 rubles;
5 mg, package No. 50 – 310 rubles;
10 mg, package No. 30 – 210 rubles, package No. 50 – 320 rubles.

Online pharmacies in RussiaRussia
Online pharmacies in UkraineUkraine
Online pharmacies in KazakhstanKazakhstan

LuxPharma* special offer

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ZdravCity

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3 UAH order
Biolong 50ml skin antiseptic (foam) TOV "Infox", Ukraine
24 UAH order

PaniPharmacy

Biolectra Magnesium Direct with orange flavor package No. 20 Germany, Hermes Arzneimittel
185 UAH order
Biolectra Magnesium Direct with lemon flavor packages No. 20 Germany, Hermes Arzneimittel
174 UAH order
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25 UAH order
Biolact Forte powder 3000 mg sticks No. 10 DPRK, Ildong Pharmaceutical
293 UAH. order
Biolong Skin antiseptic 50ml Ukraine, Infox LLC
19 UAH order