Nebilong tablets 2,5mg, no. 30

Arterial hypertension;

Chronic heart failure (in combination with other drugs);

Ischemic heart disease (for the prevention of attacks of stable angina pectoris).

Used internally.

The dosage regimen is set individually, depending on the indications, the clinical situation and the patient's age.

The average daily dose is 2.5-5 mg.

The maximum daily dose is 10 mg.

active substance:

nebivolol - 5 mg;

auxiliary components: microcrystalline cellulose, lactose monohydrate, betadex, sodium docusate, croscarmellose sodium, povidone, colloidal silicon dioxide, talc, magnesium stearate.

Absolute contraindications:

severe liver dysfunction;

acute heart failure;

cardiogenic shock;

decompensated chronic heart failure (requiring inotropic therapy);

atrioventricular block II and III degree (without an artificial pacemaker);

sick sinus syndrome, including sinoatrial block;

pheochromocytoma (without the use of alpha-blockers);

broncho-obstructive syndrome in bronchial asthma or chronic obstructive pulmonary disease;

bronchial asthma and chronic obstructive pulmonary disease in severe form in history;

metabolic acidosis;

depression;

bradycardia [heart rate (HR) 60 beats / min];

severe arterial hypotension (systolic blood pressure 90 mm Hg);

severe peripheral atherosclerosis;

lactose intolerance,

lactase deficiency

glucose-galactose malabsorption;

joint reception with floktaphenin,

sultopride;

age under 18;

increased sensitivity to the components of Nebilong or other beta-blockers.

Relative contraindications:

liver dysfunction;

renal failure;

diabetes;

hyperthyroidism;

history of bronchospasm episodes;

history of allergic diseases (due to the risk of increased sensitivity to allergens, aggravation of allergic reactions,

decreased response to adrenaline);

atrioventricular block I degree, Prinzmetal angina;

psoriasis;

chronic obstructive pulmonary disease;

peripheral atherosclerosis;

age over 65.

Nebilong is a selective beta1-blocker.

Dosage form:

Nebilonga - tablets: flat-cylindrical, white or almost white, with a chamfer and a notch on one side (10 pcs. In a blister, in a cardboard box 1, 3 or 5 blisters; 15 pcs. In a blister, in a cardboard box 1, 4 or 7 blisters).

Composition of 1 tablet:

active substance:

nebivolol hydrochloride - 2.78 / 5.56 / 11.11 mg, which corresponds to the content of nebivolol - 2.5 / 5/10 mg;

auxiliary components: microcrystalline cellulose, lactose monohydrate, betadex, sodium docusate, croscarmellose sodium, povidone, colloidal silicon dioxide, talc, magnesium stearate.

Pharmacological properties:

Pharmacodynamics.

Nebivolol is a cardioselective beta1-blocker with vasodilating properties.

The drug blocks beta1-adrenergic receptors, transforming the production of endothelial relaxing factor.

A decrease in blood pressure (BP) is achieved by reducing: total peripheral vascular resistance (OPSR), cardiac output, circulating blood volume, inhibition of the renin formation process, and a decrease in the sensitivity of beroreceptors.

The antihypertensive effect of the drug is achieved, as a rule, within 1Ц2 weeks of taking it, and the pressure stabilization is achieved in 4 weeks.

Nebilong lowers the heart rate both during exercise and at rest, lowers the oxygen demand of the heart muscle, improves diastolic filling, reduces the mass and myocardial mass index, and has a positive effect on the circadian rhythm of blood pressure.

Does not affect lipid metabolism.

Pharmacokinetics.

Nebivolol is rapidly absorbed from the gastrointestinal tract. The connection with plasma proteins is 98%.

The drug crosses the blood-brain barrier.

Nebivolol is metabolized in the liver. Nebivolol is excreted in the form of glucuronides in urine and feces.

Indications for use:

arterial hypertension;

chronic heart failure (in combination with other drugs);

ischemic heart disease (for the prevention of attacks of stable angina pectoris).

Contraindications:

Absolute contraindications:

severe liver dysfunction;

acute heart failure;

cardiogenic shock;

decompensated chronic heart failure (requiring inotropic therapy);

atrioventricular block II and III degree (without an artificial pacemaker);

sick sinus syndrome, including sinoatrial block;

pheochromocytoma (without the use of alpha-blockers);

broncho-obstructive syndrome in bronchial asthma or chronic obstructive pulmonary disease;

bronchial asthma and chronic obstructive pulmonary disease in severe form in history;

metabolic acidosis;

depression;

bradycardia [heart rate (HR) 60 beats / min];

severe arterial hypotension (systolic blood pressure 90 mm Hg);

severe peripheral atherosclerosis;

lactose intolerance,

lactase deficiency

glucose-galactose malabsorption;

joint reception with floktaphenin,

sultopride;

age under 18;

increased sensitivity to the components of Nebilong or other beta-blockers.

Relative contraindications:

liver dysfunction;

renal failure;

diabetes;

hyperthyroidism;

history of bronchospasm episodes;

history of allergic diseases (due to the risk of increased sensitivity to allergens, aggravation of allergic reactions,

decreased response to adrenaline);

atrioventricular block I degree, Prinzmetal angina;

psoriasis;

chronic obstructive pulmonary disease;

peripheral atherosclerosis;

age over 65.

Method of administration and dosage:

Used internally.

The dosage regimen is set individually, depending on the indications, the clinical situation and the patient's age.

The average daily dose is 2.5-5 mg.

The maximum daily dose is 10 mg.

Side effects:

From the immune system: very rarely - angioedema, hypersensitivity reactions.

From the side of the psyche: infrequently - depression, 'nightmares', psychosis; very rarely - hallucinations, confusion.

From the nervous system: very often - dizziness; often - headache, dizziness, weakness, paresthesia; very rarely - fainting.

From the side of the organ of vision: infrequently - visual impairment; rarely dry eyes.

From the side of the cardiovascular system: very often - bradycardia; often - aggravation of the course of chronic heart failure, AV-blockade of the I degree, orthostatic hypotension; infrequently - peripheral edema, bradycardia, heart failure, AV block, marked decrease in blood pressure, progression of concomitant 'intermittent' claudication; very rarely - Raynaud's syndrome.

From the respiratory system: often - shortness of breath; infrequently - bronchospasm (including in the absence of a history of obstructive pulmonary disease).

From the digestive system: often - nausea, constipation, diarrhea; infrequently - dyspepsia, flatulence, vomiting.

On the part of the skin and subcutaneous tissues: infrequently - an erythematous skin rash, itching; very rarely - aggravation of the course of psoriasis, urticaria; frequency unknown - alopecia.

Others: often - increased fatigue; infrequently - photodermatosis, hyperhidrosis; erectile disfunction; very rarely - cold snap / cyanosis of the extremities.

Application during pregnancy and lactation:

The use of Nebilong during pregnancy can cause bradycardia, arterial hypotension, hypoglycemia and respiratory paralysis in a newborn, and is possible only for health reasons, in the case when the expected benefit to the mother outweighs the possible risk to the fetus. Stop taking Nebilong 48Ц72 hours before delivery. If this is not possible, the newborn should be closely monitored for the first 48Ц72 hours after delivery. If it is necessary to use the drug during lactation, breastfeeding should be discontinued.

Special instructions:

Cancellation of the drug should be done gradually, over 10-14 days.

At the beginning of taking Nebilong, daily monitoring of blood pressure and heart rate is required.

Elderly patients need monitoring of renal function every 4Ц5 months.

In patients with exertional angina, the selected dose of Nebilong should provide a resting heart rate of 55Ц60 beats / min, with a load of up to 110 beats / min.

Before using Nebilong, patients with psoriasis should carefully correlate the expected benefit from the drug and the possible risk of exacerbation of the course of psoriasis.

When taking beta-blockers, it is possible to reduce the production of tear fluid, which should be taken into account when using contact lenses.

In the event of an upcoming surgery, it is necessary to inform the surgeon and anesthesiologist about the appointment of Nebilong.

Patients with diabetes should be aware that nebivolol, although it does not affect blood glucose concentration, may mask some symptoms of hypoglycemia, such as tachycardia.

In patients with hyperfunction of the thyroid gland, Nebilong levels tachycardia.

Smoking reduces the effectiveness of beta-blockers.

Drug interactions:

Simultaneous use with floktaphenin is contraindicated. Nebivolol is able to interfere with the compensatory reactions of the cardiovascular system associated with arterial hypotension or shock, which can be caused by floctaphenin.

The simultaneous use of nebivolol and sultopride is contraindicated, since with their simultaneous use there is an increased risk of ventricular arrhythmias, especially polymorphic ventricular tachycardia of the 'pirouette' type.

With simultaneous use with class I antiarrhythmic drugs (quinidine, hydroquinidine, flecainide, cybenzoline, disopyramide, lidocaine, mexiletine, propafenone), it is possible to increase the negative inotropic effect and lengthen the time of excitation through the AV node.

ѕри одновременном применении бета-адреноблокаторов с блокаторами 'медленных' кальциевых каналов (верапамил и дилтиазем) усиливаетс¤ отрицательное действие на сократимость миокарда и AV-проводимость. ѕротивопоказано в/в введение верапамила на фоне приема небиволола.

ѕри одновременном применении с гипотензивными средствами центрального действи¤ (клонидин, гуанфацин, моксонидин, метилдопа, рилменидин) возможно ухудшение течени¤ сердечной недостаточности за счет снижени¤ симпатического тонуса (снижение „—— и сердечного выброса, симптомы вазодилатации). ¬ случае резкой отмены данных препаратов, особенно до отмены небиволола, возможно развитие 'рикошетной' артериальной гипертензии (синдрома 'отмены').

ѕри одновременном применении с антиаритмическими средствами III класса (амиодарон) может усиливатьс¤ вли¤ние на врем¤ проведени¤ через AV-узел.

ѕри одновременном применении небиволола с инсулином и гипогликемическими средствами дл¤ приема внутрь могут маскироватьс¤ симптомы гипогликемии (учащенное сердцебиение, тахикарди¤).

ќдновременное применение небиволола и лекарственных средств дл¤ общей анестезии может вызывать подавление рефлекторной тахикардии и увеличить риск развити¤ артериальной гипотензии.

ќдновременный прием небиволола с баклофеном, амифостином, с гипотензивными препаратами может вызвать значительное падение ј?, поэтому требуетс¤ коррекци¤ доз гипотензивных препаратов.

ѕри одновременном применении небиволола с сердечными гликозидами возможно замедление AV-проводимости. Ќебиволол не вли¤ет на фармакокинетические параметры дигоксина.

ќдновременное применение небиволола и блокаторами 'медленных' кальциевых каналов дигидропиридинового р¤да (амлодипин, фелодипин, лацидипин, нифедипин, никардипин, нимодипин, нитрендипин) может повышать риск развити¤ артериальной гипотензии. Ќельз¤ исключать возрастание риска дальнейшего снижени¤ сократительной способности миокарда у пациентов с сердечной недостаточностью.

ѕри одновременном применении небиволола с гипотензивными средствами, нитроглицерином может развитьс¤ выраженна¤ артериальна¤ гипотензи¤ (особа¤ осторожность необходима при сочетании с празозином).

ќдновременное применение трициклических антидепрессантов, барбитуратов и производных фенотиазина, анксиолитиков, снотворных средств может усиливать антигипертензивное действие небиволола.

 линически значимого взаимодействи¤ небиволола и Ќѕ¬— не установлено. јцетилсалицилова¤ кислота в качестве антиагрегантного средства может примен¤тьс¤ одновременно с небивололом. ѕри одновременном применении симпатомиметические средства могут подавл¤ть активность бета-адреноблокаторов.

ѕри применении небиволола в сочетании с препаратами, ингибирующими обратный захват серотонина, или другими препаратами, метаболизирующимис¤ с участием изофермента CYP2D6 (например, пароксетин, флуоксетин, тиоридазин, хинидин), метаболизм небиволола замедл¤етс¤, повышаетс¤ концентраци¤ небиволола в плазме крови, что может привести к риску возникновени¤ брадикардии и других побочных эффектов.

–ифампицин усиливает метаболизм небиволола.

With the simultaneous use of nebivolol with nicardipine, the concentration of active substances in the blood plasma slightly increases without changing the clinical effect.

Terms and conditions of storage:

Store in a dry place away from light.

At a temperature not higher than 25 ? C.

Keep out of the reach of children.

Shelf life is 3 years.

Terms of dispensing from pharmacies:

Dispensed by prescription.