Nebilet is a drug with antiarrhythmic, hypotensive and antianginal effects.
Release form and composition
Nebilet is produced in the form of tablets: white, biconvex, round, with a cross-shaped incision for dividing (7 or 14 pieces in blisters, 1, 2, 4 blisters in a cardboard box).
The composition of 1 tablet includes:
- Active ingredient: nebivolol - 5 mg (in the form of micronized nebivolol hydrochloride - 5.45 mg);
- Auxiliary components: microcrystalline cellulose — 16.1 mg, lactose monohydrate — 141.75 mg, corn starch — 46 mg, hypromellose 15 mPa × s — 4.6 mg, croscarmellose sodium — 13.8 mg, polysorbate 80 - 0.46 mg, colloidal silicon dioxide - 0,69 mg, magnesium stearate - 1.15 mg.
Indications for use
- Coronary heart disease (for the prevention of strokes);
- Arterial hypertension;
- Chronic heart failure (concurrently with other drugs).
- Bradycardia (with a heart rate of less than 60 beats per minute);
- Severe arterial hypotension (with systolic pressure less than 90 mm Hg);
- Acute heart failure;
- Chronic heart failure in the stage of decompensation (if necessary, intravenous administration of drugs with inotropic action);
- Severe functional disorders of the liver;
- Sick sinus syndrome, incl. sinoatrial blockade;
- Severe obliterating diseases of peripheral vessels (for example, Raynaud's syndrome, intermittent claudication);
- Bronchial asthma and bronchospasm in history;
- AV block II and III degree (without artificial pacemaker);
- Myasthenia gravis;
- Cardiogenic shock;
- Pheochromocytoma (without joint use with alpha-blockers);
- Metabolic acidosis;
- Lactase deficiency, lactose intolerance and galactose / glucose malabsorption syndrome;
- Age up to 18 years (the safety and efficacy of Nebilet in this age group of patients has not been studied);
- Hypersensitivity to the drug.
Nebilet is prescribed to pregnant women only for health reasons when the health benefits of the mother are higher than the potential threat to the fetus. During lactation at the time of therapy, breastfeeding should be interrupted.
Nebitlet is prescribed with caution in the presence of the following diseases / conditions:
- Printsmetal angina;
- Renal failure;
- Allergic diseases in history;
- AV block I degree;
- Chronic obstructive pulmonary disease;
- Age from 75 years.
Dosing and Administration
Nebiet taken orally, drinking plenty of fluids, regardless of the meal. The drug should be taken 1 time a day, preferably at the same time of day.
In the treatment of hypertension and coronary heart disease, the average dose is 1 / 2-1 tablet (2.5-5 mg) per day. Nebilet may be used simultaneously with other blood pressure lowering drugs.
In case of kidney failure, as well as in patients over 65 years old, therapy is recommended to start with 1/2 tablet. If necessary, increase the dose to a maximum of 2 tablets per day.
Therapy for chronic heart failure should begin with a slow increase in dose until the optimal maintenance dose is reached. At the beginning of treatment, the selection of the dose should be carried out with its gradual increase and compliance with the intervals between such increases of 7-14 days (taking into account the tolerance of therapy by the patient): 1.25 mg (initial); 2.5-5 mg; 10 mg (maximum).
At the beginning of Nebilet use and at each dose increase, the patient must be under medical supervision for at least 2 hours (to make sure that the clinical condition, especially blood pressure, conduction disturbances, heart rate, and signs of worsening chronic heart failure, remain stable ).
During the use of Nebilet, the following side effects may develop (> 10% - very often;> 1% and <10% - often;> 0.1% and <1% - infrequently;> 0.01% and <0.1% - rarely; <0.01%, including some cases - very rarely):
- Cardiovascular system: infrequently - acute heart failure, bradycardia, orthostatic hypotension, AV-blockade, Raynaud's syndrome;
- Central and peripheral nervous system: often - dizziness, headache, weakness, fatigue, paresthesia; infrequently - depression, confusion, nightmares; very rarely - hallucinations, fainting;
- Skin and subcutaneous tissue: infrequently - itching, skin rash, having an erythematous character; very rarely - aggravation of the course of psoriasis; in some cases, angioedema;
- The digestive system: often - diarrhea, constipation, nausea; infrequently - flatulence, dyspepsia, vomiting;
- Other: infrequently - bronchospasm; rarely - dry eyes.
The cancellation of Nebilet should be carried out gradually (for 10 days, in patients with coronary heart disease - 14 days).
At the beginning of therapy, monitoring of blood pressure and heart rate should be daily.
With angina, Nebilete dose should provide a heart rate at rest within 55-60 beats per minute, with a load - no more than 110 beats per minute.
Elderly patients need to control the functional state of the kidneys (1 time in 4-5 months).
Nebilet can cause bradycardia. The dose should be reduced in case the heart rate is less than 50-55 beats per minute.
When prescribing the drug to patients with psoriasis, it is necessary to carefully relate the perceived benefits of therapy with the possible risk of its exacerbation.
Patients using contact lenses should take into account that the use of Nebilet can lead to a decrease in the production of tear fluid.
Before performing surgical interventions, the anesthesiologist should be warned about taking the drug.
Nebilet may mask some signs of hypoglycemia (for example, tachycardia) associated with the use of oral hypoglycemic agents and insulin. Therefore, in the treatment of patients with diabetes should be careful. Also during therapy 1 time in 4-5 months it is necessary to control the concentration of glucose in the blood plasma.
In patients with hyperfunction of the thyroid gland, Nebilet may mask tachycardia.
Because of the risk of increasing bronchospasm, therapy should be carried out with caution against the background of chronic obstructive pulmonary disease.
It must be borne in mind that Nebilet can increase the sensitivity to allergens, as well as the severity of anaphylactic reactions.
During the period of therapy, care must be taken when driving vehicles and performing potentially hazardous types of work that require high concentration of attention and fast psychomotor reactions.
When co-prescribing Nebilet with some drugs, the following effects may occur:
- Slow calcium channel blockers (diltiazem, verapamil): increased negative effects on AV conduction and myocardial contractility;
- Antihypertensive drugs, nitroglycerin, blockers of slow calcium channels: the development of severe arterial hypotension (special care should be taken when combined with prazosin);
- Nicardipine: a slight increase in the concentration of active substances in the blood plasma (it has no clinical significance);
- Antiarrhythmic drugs of class I, amiodarone: lengthening the time of excitation in the atria and enhance the negative inotropic effects;
- Cimetidine: an increase in plasma nebivolol concentration;
- Preparations for general anesthesia: suppression of reflex tachycardia and an increase in the likelihood of arterial hypotension;
- Tricyclic antidepressants, barbiturates, phenothiazine derivatives: increased hypotensive effect of nebivolol;
- Drugs that inhibit serotonin reuptake, or other drugs biotransforming with the participation of the CYP2D6 isoenzyme: an increase in plasma nebivolol concentration, slowing its metabolism, which increases the likelihood of developing bradycardia;
- Insulin, oral hypoglycemic agents: the likelihood of masked symptoms of hypoglycemia (tachycardia).
Intravenous administration of verapamil during therapy is contraindicated.
Terms and conditions of storage
Keep out of reach of children at temperature up to 25 ° C.
Shelf life - 3 years.