Binelol, tablets 5 mg 14 pcs.

Binelol has hypotensive, antianginal, and antiarrhythmic effects.

Indications

Angina, Heart palpitations, Hypertension (high blood pressure), Tachycardia, Heart failure, Arrhythmia, Cardialgia (heart pain)

• Arterial hypertension;
• Ischemic heart disease (IHD): prevention of angina attacks.
• Chronic heart failure (as part of combination therapy).
  

Active ingredient

Nebivolol

Composition

1 tablet contains the active ingredient:

nebivololol (in the form of nebivololol hydrochloride) – 5.00 mg;

auxiliary substances:

Lactose monohydrate,

crospovidone (type A),

poloxamer 188,

povidone K-30,

microcrystalline cellulose,

magnesium stearate.

How to take, the dosage

Binelol should be taken orally at the same time of the day, regardless of meals, without chewing and with plenty of fluid.

Interaction

Concomitant use of beta-adrenoblockers with BMCCs (verapamil and diltiazem) increases adverse effects on myocardial contractility and AV conduction.

Intravenous verapamil administration with nebivololol is contraindicated. Significant arterial hypotension may develop in combination with hypotensive agents, nitroglycerin or BMCC (special caution is required in combination with prazosin). Concomitant use with class I antiarrhythmic agents and amiodarone may increase negative inotropic effect and prolongation of the excitation time through the atria. Concomitant use of nebivolol and cardiac glycosides showed no increased effect on delayed AV conduction.

The concomitant use of nebivolol and drugs for general anesthesia may inhibit reflex tachycardia and increase the risk of arterial hypotension. Clinically significant interaction of nebivolol and NSAIDs has not been established. Acetylsalicylic acid as an antiplatelet agent may be used concomitantly with nebivololol. Concomitant use of tricyclic antidepressants, barbiturates and phenothiazine derivatives may increase the hypotensive effect of nebivolol.

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Special Instructions

The withdrawal of beta-adrenoblockers should be done gradually, over 10 days (up to 2 weeks in patients with CHD). Monitoring of BP and HR at the beginning of the drug should be daily.

In elderly patients, renal function control is necessary (once every 4-5 months). In angina pectoris, the drug dose should provide a resting HR of 55-60 bpm, and not more than 110 bpm during exercise. Beta-adrenoblockers may cause bradycardia: the dose should be reduced if HR is less than 50-55 bpm. When deciding whether to prescribe Binelol in patients with psoriasis, the prospective benefit of the drug should be carefully weighed against the possible risk of psoriasis exacerbation.

Patients who wear contact lenses should be aware that the use of beta-adrenoblockers may decrease tear fluid production.

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Contraindications

• high sensitivity to nebivololol or one of the drug components,
• explicit hepatic dysfunction,
• acute cardiac failure,
• chronic heart failure under decompensation (requiring intravenous administration of drugs with inotropic effect./Chronic heart failure in decompensation (requiring intravenous administration of drugs with inotropic effect),
• cardiogenic shock
• cardiogenic shock,
• syndrome of weak sinus node including sinoauricular block,
• trioventricular (AV) block of degree II and III (without artificial pacemaker),
• untreated pheochromocytoma,
• depression,
• metabolic acidosis,
• explicit bradycardia (HR less than 50 beats/min,
• delirium.
• expressed arterial hyotension (systolic BP less than 90 mmHg),
• depressed arterial hyotension (systolic BP less than 90 mmHg).Severe peripheral occlusive vascular disease (intermittent claudication, Raynaud’s syndrome).myasthenia,
• age below 18 years of age,
• lactose intolerance, lactase deficiency or glucose-galactose malabsorption.

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Side effects

Central and peripheral nervous system: headache, dizziness, fatigue, weakness, paresthesias (from 1% to 10%); very rarely – depression, decreased ability to concentrate, drowsiness, insomnia, nightmares, hallucinations, psychosis, seizures.

Digestive system disorders: nausea, constipation, flatulence, diarrhea, dry mouth (>1%).

Cardiovascular system: bradycardia, acute heart failure, AV-blockade, orthostatic hypotension, worsening of intermittent claudication, dyspnea; very rarely – heart rhythm disorders, Raynaud’s syndrome, peripheral edema, cardialgia.

Allergic reactions: skin itching, erythematous rash.

Other: bronchospasm (including in the absence of obstructive lung disease in the anamnesis), photodermatosis, hyperhidrosis, rhinitis, exacerbation of psoriasis, visual disorders, dry eyes.

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Overdose

Symptoms: BP decrease, nausea, vomiting, cyanosis, sinus bradycardia, AV blockade, bronchospasm, cardiogenic shock, loss of consciousness, coma, cardiac arrest.

treatment: gastric lavage, administration of activated charcoal. If BP is significantly decreased, the patient should be placed in a horizontal position with elevated legs, if necessary, IV fluids and vasopressors; 1-10 mg of glucagon may be administered as a follow-up. In bradycardia, 0.5-2 mg of atropine is administered by IV, and if there is no positive effect, a transvenous or intracardiac pacemaker may be used. In AV blockade of II-III degree it is recommended to inject beta-adrenostimulators by IV, if they are ineffective, the issue of setting an artificial pacemaker should be considered. In case of cardiac insufficiency, treatment begins with administration of cardiac glycosides and diuretics, in the absence of effect it is reasonable to administer dopamine, dobutamine or vasodilators. In case of bronchospasm, IV β-adrenomimetics are prescribed. In ventricular extrasystole, lidocaine (class IA antiarrhythmic agents should not be administered). For seizures, intravenous diazepam.

Pregnancy use

In pregnancy, Binelol is prescribed only under strict indications, when the benefit to the mother exceeds the risk to the fetus (due to the possible development of bradycardia, arterial hypotension, hypoglycemia and respiratory paralysis in the newborn).

The treatment should be stopped 48-72 hours before delivery.

In cases where this is not possible, strict monitoring of the newborn for 48-72 hours after delivery should be ensured.

Similarities

Nebilet, Binelol, Nebilong, Nebivolol, Nebivolol-Teva, Nebivator, Nebivololol-SZ