Bisoprolol-Teva, pills 10mg 30pcs

Composition

Active ingredient:  

bisoprolol fumarate 10 mg;

Auxiliary substances:

croscarmellose sodium (primellose),

povidone (polyvinylpyrrolidone medium molecular weight),

pregelatinized starch (starch 1500),

colloidal silicon dioxide (aerosil),

talc,

microcrystalline cellulose,

lactose (milk sugar),

magnesium stearate;

Composition of the film shell:

 opadray II (partially hydrolyzed polyvinyl alcohol, titanium dioxide, talc, macrogol (polyethylene glycol 3350), iron oxide (II) dye).

Pharmacological action

Bisoprolol-Teva is a selective beta-1-adrenoblocker with no intrinsic sympathomimetic activity and no membrane-stabilizing activity. Reduces the activity of renin plasma, reduces the need for myocardial oxygen, reduces heart rate (at rest and during exercise) and cardiac output, while the stroke volume does not significantly decrease. Inhibits AV conduction. It has antianginal and antihypertensive effects. In high doses (200 mg or more) it can cause blockade of beta-2-adrenergic receptors mainly in the bronchi and in vascular smooth muscles.

The hypotensive 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 (which is more important for patients with initial hypersecretion of renin), restoration of sensitivity in response to a decrease in blood pressure, and an effect on the central nervous system.

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.

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.

Indications

Arterial hypertension, CHD, heart failure

Use during pregnancy and lactation

It is possible if the expected effect of therapy in the mother exceeds the potential risk to the fetus and child (adequate and strictly controlled studies of the safety of use in pregnant and lactating women have not been conducted).

Since there is a risk of developing bradycardia, hypotension, hypoglycemia and respiratory disorders (neonatal asphyxia) in newborns, treatment with bisoprolol fumarate should be discontinued 48-72 hours before delivery.

If this is not possible, the newborn should be under close medical supervision for 48-72 hours after birth.

The excretion of bisoprolol fumarate in human milk has not been studied, but since it is secreted into human milk in rats (less than 2%), children should be under medical supervision.

Contraindications

Hypersensitivity to Bisoprolol-Teva, cardiac conduction disorders, bronchial asthma

Side effects

The frequency of side effects is indicated when prescribing doses not exceeding 40 mg.

Nervous system and sensory disorders:  dizziness (3.5%), insomnia (2.5%), asthenia (1.5%), hypesthesia (1.5%), depression (0.2%), drowsiness, restlessness, paresthesia (feeling cold in the extremities), hallucinations, impaired thinking, concentration, orientation in time and space, balance, emotional lability, tinnitus, conjunctivitis, visual disturbances, decreased secretion of tear fluid, convulsions.

Cardiovascular and blood disorders (hematopoiesis, hemostasis):  bradycardia (0.5%), arrhythmia, palpitation, AV block, hypotension, heart failure, impaired microcirculation in the myocardium and extremities, intermittent claudication, vasculitis, agranulocytosis, thrombocytopenia, thrombocytopenic purpura.

From the digestive tract:  diarrhea (3.5%), nausea (2.2%), vomiting (1.5%), dry mouth (1.3%), dyspeptic symptoms, constipation, ischemic colitis, mesenteric artery thrombosis.

Respiratory system disorders:  cough (2.5%), shortness of breath (1.5%), bronchospasm and laryngospasm, pharyngitis (2.2%), rhinitis (4%), sinusitis (2.2%), respiratory tract infections (5%), respiratory distress syndrome.

From the genitourinary system:  peripheral edema (3%), decreased libido, impotence, Peyronie’s disease, cystitis, renal colic.

From the side of the skin:  rash, acne, eczema-like reactions, prurigo, redness of the skin, hyperhidrosis, dermatitis, alopecia.

From the side of metabolism:  increased concentration of liver enzymes( AST, ALT), hyperglycemia or increased glucose tolerance, hyperuricemia, changes in the concentration of potassium in the blood.

Other services:  pain syndrome (headache-10.9%, arthralgia-2.7%, myalgia, abdominal pain, chest pain — 1.5%, eyes, ears), weight gain.

Interaction

Amiodarone, diltiazem, verapamil, quinidine drugs, cardiac glycosides, reserpine, and alpha-methyldofa increase the probability of violations of automatism, conduction, and contractility of the heart (mutually).

Concomitant use of dihydropyridine calcium antagonists, especially in patients with latent heart failure, increases the risk of hypotension and decompensation of cardiac activity.

Efficacy is reduced by xanthines and sympathomimetics, rifampicin reduces T1 / 2, ergotamine derivatives potentiate peripheral circulatory disorders. Incompatible with MAO inhibitors.

How to take, course of use and dosage

of Bisoprolol-Teva is taken orally, without chewing, with a small amount of liquid, in the morning on an empty stomach or during breakfast 1.25-10 mg 1 time a day.

The dosage regimen is individual, the dose is increased under the control of blood pressure and pulse. Arterial hypertension and angina pectoris:  5-10 mg; mild arterial hypertension (dBP less than 105 mm Hg): 2.5 mg; chronic heart failure:  1.25 mg/day (for 1 week), then with good tolerability, the dose is increased to 2.5 mg/day (1 week),3.75 mg/day (1 week),5 mg/day (4 weeks),7.5 mg/day (4 weeks), then 10 mg/day (target dose). The maximum daily dose for adults is 20 mg.

Overdose

Symptoms:  bradycardia, arrhythmia, hypotension, heart failure (difficulty breathing, acrocyanosis, edema), hypoglycemia, in severe cases — collapse.

Treatment:  gastric lavage and use of adsorbents, symptomatic therapy: atropine, beta-adrenomimetics (isoprenaline), sedatives (diazepam, lorazepam) and cardiotonic (dobutamine, dopamine, epinephrine, norepinephrine) drugs, cardiac glycosides, diuretics, glucagon, etc. In case of heart block — transvenous stimulation, connection of an artificial pacemaker.

Special instructions

Monitoring of patients taking bisoprolol should include monitoring of heart rate and blood pressure (at the beginning of treatment – daily, then 1 time in 3-4 months), ECG, blood glucose in patients with diabetes mellitus (1 time in 4-5 months). In elderly patients, it is recommended to monitor renal function (1 time in 4-5 months). After starting treatment with CHF at a dose of 1.25 mg, the patient should be examined for 4 hours (heart rate, blood pressure, ECG).

The patient should be trained in the method of calculating heart rate and instructed about the need for medical consultation if the heart rate is less than 50/min.

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

Beta-blockers are ineffective in approximately 20% of patients with angina pectoris. The main causes are severe coronary atherosclerosis with a low threshold of ischemia (heart rate less than 100 / min) and increased LV BWR, which disrupts subendocardial blood flow. In “smokers”, the effectiveness of beta-blockers is lower.

Patients who use contact lenses should take into account that during treatment, there may be a decrease in the production of tear fluid.

When used in patients with pheochromocytoma, there is a risk of developing paradoxical arterial hypertension (if an effective alpha-adrenoblockade is not previously achieved).

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

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

When taking clonidine at the same time, it can be stopped only a few days after the withdrawal of bisoprolol. It is possible to increase the severity of the hypersensitivity reaction and the lack of effect from conventional doses of epinephrine against the background of a burdened allergic history.

If elective surgical treatment is necessary, the drug is withdrawn 48 hours before the start of general anesthesia. If the patient took the drug before surgery, he should choose a drug for general anesthesia with minimal negative inotropic effect.

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

Drugs that reduce the supply of catecholamines (for example, reserpine) can increase the effect of beta-blockers, so patients taking such combinations of drugs should be constantly monitored by a doctor for hypotension or bradycardia.

Form of production

Coated tablets.

Storage conditions

At a temperature not exceeding 25 °C

Shelf life

2 years

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