Biol pills 10mg 50pcs

Composition

1 tablet contains bisoprolol hemifumarate 10 mg;

excipients:

microcrystalline cellulose,

calcium hydrophosphate,

corn starch,

croscarmellose sodium,

magnesium stearate,

colloidal anhydrous silicon dioxide.

Pharmacological action

Biol is a selective beta-1-adrenoblocker without its own sympathomimetic activity. It does not have a membrane-stabilizing effect. Reduces the activity of blood plasma renin, reduces the need for myocardial oxygen, reduces heart rate at rest and during exercise. It has antihypertensive, antiarrhythmic and antianginal effects. Blocking the beta-1-adrenergic receptors of the heart in low doses, it reduces the catecholamine-stimulated formation of cAMP from ATP, reduces the intracellular flow of calcium ions, and has a negative chrono -, dromo -, batmo-and inotropic effect. Inhibits conduction and excitability, slows down AV conduction. OPSS in the first 24 hours of drug use increases (as a result of a reciprocal increase in the activity of α-adrenergic receptors and elimination of stimulation of β2-adrenergic receptors), which returns to its original value after 1-3 days, and decreases with prolonged use.

The antihypertensive effect is associated with a decrease in minute blood volume, sympathetic stimulation of peripheral vessels, a decrease in the activity of the renin-angiotensin system (it is more important for patients with initial hypersecretion of renin), restoration of sensitivity of the aortic arch baroreceptors (there is no increase in their activity in response to a decrease in blood pressure and influence on the central nervous system). With arterial hypertension, the effect occurs in 2-5 days, a stable hypotensive effect in 1-2 months.

The antianginal effect is due to a decrease in the myocardial oxygen demand as a result of a decrease in heart rate and contractility, an elongation of the diastole, and an improvement in 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 cAMP content, 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 the retrograde directions through the AV node) and along additional pathways.

When used in medium therapeutic doses, in contrast to non-selective beta-blockers, it has a less pronounced effect on the organs containing beta-2-adrenergic receptors (pancreas, skeletal muscles, smooth muscles of peripheral arteries, bronchi and uterus) and on carbohydrate metabolism. It does not cause retention of sodium ions in the body. When the dose is increased above the therapeutic dose, it has a beta-2-adrenoblocking effect.

Indications

• Arterial hypertension.
• IHD (prevention of angina attacks).

Contraindications

• severe hypotension (systolic BP less than 90 mm Hg. century, especially in myocardial infarction);
• acute heart failure, chronic heart failure in the stage of decompensation;
• cardiogenic shock; collapse, pulmonary edema,
• AV-block II and III degree (without installing pacemaker);
• sinoatrial block;
• sick sinus syndrome node;
• severe sinus bradycardia (heart rate less than 50 beats/min);
• severe stage of peripheral circulatory disorders, Raynaud’s disease;
• simultaneous reception of MAO inhibitors (except MAO-b);
• metabolic acidosis;
• severe forms of bronchial asthma and chronic obstructive pulmonary disease (history);
• the age of 18 years (effectiveness and safety not established);
• pregnancy and lactation;
• hypersensitivity to bisoprolol and other components of the drug and to other beta-blockers.

With caution:

• severe hepatic insufficiency;
• severe renal insufficiency;
• thyrotoxicosis;
• psoriasis;
• myasthenia gravis;
• AV block I degree;
• Prinzmetal angina pectoris;
• depression (including in the anamnesis);
• pheochromocytoma (simultaneous use of alpha-blockers is mandatory);
• diabetes mellitus;
• general anesthesia/surgery;
• severe allergic reactions (in the anamnesis).

Side effects

From the central nervous system: increased fatigue, weakness, asthenia, dizziness, headache, sleep disorders, nightmares, mental disorders (depression), paresthesia in the extremities (in patients with intermittent claudication and Raynaud’s syndrome), impaired concentration, myasthenia gravis, tremor.

From the side of the visual organ: visual disturbances, decreased lacrimal fluid secretion (should be considered when wearing contact lenses), dry and painful eyes, conjunctivitis.

From the cardiovascular system: orthostatic hypotension, pain behind the sternum, sinus bradycardia, impaired myocardial conduction, AV block, withdrawal syndrome (increased angina attacks, increased blood pressure), angiospasm (increased peripheral circulatory disorders, cold of the lower extremities, Raynaud’s syndrome), development (aggravation) of the course of chronic heart failure.

From the digestive system:  dryness of the oral mucosa, nausea, vomiting, dyspepsia, diarrhea, changes in taste, liver function disorders (symptoms of cholestasis), hepatitis, increased levels of ALT, AST, bilirubin.

Respiratory system disorders: nasal congestion, pharyngitis, rhinitis, sinusitis, cough, in predisposed patients – laryngo-and bronchospasm.

From the side of the skin:  increased sweating, hyperemia of the skin, exanthema, psoriasis-like skin reactions, exacerbation of psoriasis symptoms, alopecia.

From the hematopoietic system:  thrombocytopenia, agranulocytosis, leukopenia. Allergic reactions: skin pruritus, rash, urticaria. Other services: increased sweating, back pain, arthralgia, muscle pain, sexual dysfunction, dysuria, hyperglycemia (in patients with non-insulin-dependent diabetes mellitus), hypoglycemia (in patients receiving insulin), hypothyroidism, increased triglyceride levels.

Interaction

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

Cardiac glycosides, methyldopa, reserpine and guanfacine, slow calcium channel blockers verapamil, diltiazem, amiodarone, and other antiarrhythmic drugs increase the risk of developing or worsening bradycardia, AV block, cardiac arrest, and heart failure.

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

Iodine-containing radiopaque agents for intravenous use increase the risk of anaphylactic reactions.

Phenytoin with intravenous use, drugs for inhaled general anesthesia (hydrocarbon derivatives) increase the severity of cardiodepressive effects and the likelihood of lowering blood pressure.

Bisoprolol masks the adrenergic symptoms of thyrotoxicosis and hypoglycemia (for example, tachycardia).

Reduces the clearance of lidocaine and xanthines (except diphylline) and increases their concentration in blood plasma, especially in patients with initially increased clearance of theophylline under the influence of tobacco smoking.

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

It prolongs the action of non-depolarizing muscle relaxants and the anticoagulant effect of coumarins.

Tri-and tetracyclic antidepressants, antipsychotics (neuroleptics), ethanol, sedatives, and sleeping pills increase CNS depression.

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

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

Sulfasalazine increases the concentration of bisoprolol in the blood plasma.

Rifampicin shortens T 1/2 bisoprolol.

How to take it, course of use and dosage

Tablets should be taken in the morning, regardless of food intake, do not chew, drink a small amount of liquid

In all cases of arterial hypertension and angina, the doctor sets the dosage regimen individually, taking into account the patient’s heart rate and condition. The initial daily dose is 5 mg (sometimes 2.5 mg) once a day, if necessary, the dose is increased to 10 mg once a day. The maximum daily dose is 20 mg.

In patients with severe renal insufficiency (creatinine clearance less than 20 ml/min) or with severe hepatic impairment, the maximum daily dose should not exceed 10 mg.

No dose adjustment is usually required for elderly patients, but for some patients, the optimal dose may be 5 mg per day.

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: gastric lavage and use of adsorbent drugs. Symptomatic therapy is performed: if AV block develops, intravenous use of atropine (1-2 mg), epinephrine, or a temporary pacemaker; with ventricular extrasystole, lidocaine (Class I A drugs are not used); with a decrease in blood pressure, the patient should be in the Trendelenburg position; if there are no signs of pulmonary edema, intravenous plasma-substituting solutions; if ineffective, use of epinephrine, dopamine, dobutamine (to maintain chronotropic and functional state). inotropic effect); in case of heart failure – cardiac glycosides, diuretics, glucagon ; in case of convulsions – intravenous diazepam; in case of bronchospasm – beta – 2 – adrenomimetics by inhalation.

Special instructions

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

Monitoring of patients taking Biol should include measurement of heart rate and blood pressure (at the beginning of treatment – daily, then – once every 3-4 months), ECG, determination of glucose levels in patients with diabetes mellitus.

Storage conditions

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

Active ingredient

Bisoprolol

Conditions of release from pharmacies

By prescription

Dosage form

Tablets

Purpose

For adults as directed by your doctor

Indications

Hypertension, Heart Failure, Arrhythmia