Binelol, pills 5mg, 56pcs

Composition

1 tablet contains nebivolol (in the form of nebivolol hydrochloride 5.45 mg) 5 mg; excipients: lactose monohydrate-85.96 mg; crospovidone (type A) — 6.89 mg; poloxamer 188-6.9 mg; povidone K 30-3.5 mg; MCC-119 mg; magnesium stearate-2.3 mg

Pharmacological action

Antianginal, antihypertensive, vasodilating, modulating nitric oxide release, beta_-1-adrenoblocking.

Indications

arterial hypertension; IHD (prevention of angina attacks of tension); chronic heart failure (as part of combination therapy).

Contraindications

• hypersensitivity to nebivolol or one of the components Binella;
• severe disturbances of liver function;
• acute heart failure;
• chronic heart failure in the stage of decompensation (requiring intravenous drugs with inotropic effect);
• cardiogenic shock;
• the syndrome of weakness of the sinus node, including sinoauricular blockade;
• AV blockade II and III degree (without an artificial pacemaker);
• bronchospasm and bronchial asthma;
• untreated pheochromocytoma;
• depression;
• metabolic acidosis;
• bradycardia (heart rate severe hypotension (SBP severe occlusive peripheral vascular disease (intermittent claudication, Raynaud’s syndrome);
• myasthenia gravis;
• the age of 18;
• lactose intolerance, lactase deficiency or glucose-galactose malabsorption.

With caution:

• renal failure;
• diabetes mellitus;
• hyperthyroidism;
• a history of allergic diseases;
• psoriasis;
• grade I AV block;
• Prinzmetal angina pectoris;
• COPD;
• in patients over 65 years of age.

Side effects

From the central and peripheral nervous system: headache, dizziness, fatigue, weakness, paresthesia (from 1 to 10%); in very rare cases: depression, decreased ability to concentrate, drowsiness, insomnia, nightmares, hallucinations, psychosis, convulsions. From the gastrointestinal tract: nausea, constipation, flatulence, diarrhea, dry mouth (more than 1%). From the cardiovascular system: bradycardia, acute heart failure, AV block, orthostatic hypotension, exacerbation of intermittent claudication, shortness of breath; in very rare cases — cardiac arrhythmias, Raynaud’s syndrome, peripheral edema, cardialgia. Allergic reactions: pruritus of the skin, erythematous rash. Others: bronchospasm (including in the absence of obstructive pulmonary diseases in the anamnesis), photodermatosis, hyperhidrosis, rhinitis, exacerbation of psoriasis, visual impairment, dry eyes.

Interaction

Concomitant use of beta-blockers with slow calcium channel blockers (BMCC) (verapamil and diltiazem) increases the negative effect on myocardial contractility and AV conduction. Intravenous use of verapamil with nebivolol is contraindicated. When combined with antihypertensive agents, nitroglycerin or BMCC, severe arterial hypotension may develop (special caution is necessary when combined with prazosin). When used concomitantly with Class I antiarrhythmics and amiodarone, it is possible to increase the negative inotropic effect and prolong the time of atrial excitation. When nebivolol was co-administered with cardiac glycosides, there was no increase in the effect on slowing AV conduction. Concomitant use of nebivolol and general anaesthetic agents may cause suppression of reflex tachycardia and increase the risk of hypotension. There is no clinically significant interaction between nebivolol and NSAIDs. Acetylsalicylic acid as an antiplatelet agent can be used simultaneously with nebivolol. Concomitant use of tricyclic antidepressants, barbiturates and phenothiazine derivatives may increase the hypotensive effect of nebivolol. Pharmacokinetic interaction Nebivolol metabolism slows down when used concomitantly with drugs that inhibit serotonin reuptake or other agents that biotransform with the participation of the CYP2D6 isoenzyme. Concomitant use of nebivolol did not affect the pharmacokinetic parameters of digoxin. When used concomitantly with cimetidine, the concentration of nebivolol in blood plasma increases (there are no data on the effect on the pharmacological effects of the drug). Concomitant use of ranitidine did not affect the pharmacokinetic parameters of nebivolol. Concomitant use of nebivolol and nicardipine resulted in a slight increase in plasma concentrations of active substances, but this is not clinically relevant. Concomitant use of ethanol, furosemide, or hydrochlorothiazide did not affect the pharmacokinetics of nebivolol. There was no clinically significant interaction between nebivolol and warfarin. When used concomitantly, sympathomimetic agents inhibit the activity of nebivolol.

How to take, course of use and dosage

Binelol is taken orally, at the same time of day, regardless of food intake, without chewing and with a sufficient amount of liquid. Arterial hypertension and CHD. The average daily dose for the treatment of arterial hypertension and CHD is 2.5-5 mg (1/2–1 table) once a day. It is possible to use the drug in monotherapy or as part of a combination therapy. In patients with renal insufficiency, as well as in patients over the age of 65 years, the initial dose is 2.5 mg/day (1/2 table of 5 mg). If necessary, the daily dose can be increased to 10 mg (2 tablets of 5 mg each) in one dose. Chronic heart failure. Treatment of chronic heart failure should begin with a gradual increase in the dose until the individual optimal maintenance dose is reached. The dose selection at the beginning of treatment should be carried out according to the following scheme, maintaining weekly intervals and based on the patient’s tolerance to this dose: the dose of 1.25 mg of the drug (1/4 table) 1 time per day can be increased first to 2.5–5 mg (1/2 table -1 tablet), and then to 10 mg (2 tables) 1 time per day.

Overdose

Symptoms: decreased blood pressure, nausea, vomiting, cyanosis, sinus bradycardia, AV block, bronchospasm, cardiogenic shock, loss of consciousness, coma, cardiac arrest. Treatment: gastric lavage, taking activated charcoal. In case of a marked decrease in blood pressure, it is necessary to give the patient a horizontal position with raised legs, if necessary, intravenous use of fluids and vasopressors; as a follow-up,1-10 mg of glucagon may be prescribed. With bradycardia,0.5-2 mg of atropine is administered intravenously, and in the absence of a positive effect, a transvenous or intracardiac electrostimulator is possible. In case of AV block (II and III degrees), intravenous use of beta-adrenostimulants is recommended; if they are ineffective, an artificial pacemaker should be considered. In case of heart failure, treatment begins with the introduction of cardiac glycosides and diuretics, if there is no effect, it is advisable to introduce dopamine, dobutamine or vasodilators. With bronchospasm, intravenous beta-2-adrenomimetics are prescribed. For ventricular extrasystole – lidocaine (class Ia antiarrhythmics should not be administered). For convulsions-IV diazepam.

Special instructions

Beta-blockers should be discontinued gradually over 10 days (up to 2 weeks in patients with CHD). Monitoring of blood pressure and heart rate at the beginning of taking the drug should be daily. In elderly patients, monitoring of renal function is necessary (1 time in 4-5 months). With angina pectoris, the dose of the drug should provide a resting heart rate in the range of 55-60 beats / min, with a load of no more than 110 beats / min. Beta-blockers can cause bradycardia, so the dose should be reduced if the heart rate is less than 50-55 beats / min. When deciding whether to prescribe Binelol to patients with psoriasis, the expected benefit of the drug and the possible risk of exacerbation of psoriasis should be carefully weighed. Patients who use contact lenses should take into account that the use of beta-blockers may reduce the production of tear fluid. When performing surgical procedures, the anesthesiologist should be warned that the patient is taking beta-blockers. Nebivolol does not affect glucose levels in patients with diabetes mellitus. However, caution should be exercised when treating these patients, as Binelol may mask certain symptoms of hypoglycemia (e. g. tachycardia) caused by the use of hypoglycemic agents. In patients with diabetes mellitus, blood glucose monitoring should be performed once every 4-5 months. Beta-blockers should be used with caution in patients with chronic obstructive pulmonary disease, as bronchospasm may increase. Beta-blockers can increase sensitivity to allergens and the severity of anaphylactic reactions. The effectiveness of beta-blockers in smoking patients is lower than in non-smoking patients.

Storage conditions

In a dark place, at a temperature not exceeding 25°C.

Shelf

life is 3 years.

Active ingredient

Nebivolol

Conditions of release from pharmacies

By prescription

Dosage form

Tablets

Purpose

For adults as prescribed by a doctor, Pregnant women as prescribed by a doctor, Nursing mothers as prescribed by a doctor

Indications

Hypertension, Arrhythmia, Heart Failure, Angina