Niperten, 30 pcs., 5 mg, film-coated tablets


Compound

Depending on the release form, the chemical composition of one Niperten tablet (INN Bisoprolol) may contain 2.5 mg. 5 mg. or 10 mg. active medicinal compound bisoprolol fumarate .
Povidone , magnesium stearate , carboxymethyl starch , as well as MCC and colloidal silicon dioxide (anhydrous) are included in Niperthene as excipients.

The film shell of Niperthene tablets contains titanium dioxide, macrogol and talc.

Pharmacodynamics and pharmacokinetics

At its core, Niperten is a beta1-adrenergic blocker , which is a selective compound; it does not possess membrane-stabilizing properties without its own sympathomimetic activity . This medicine helps reduce the level of renin in the blood and also reduces the myocardium's need for oxygen .

The drug has a pronounced antiarrhythmic, hypotensive and antianginal effect on the body. Due to its distinctive properties, Niperten can influence the intensity of calcium ion current at the intracellular level, and also blocks beta1-adrenergic receptors formed in small doses in the heart , thereby slowing down the process of formation of cAMP (cyclic adenosine monophosphate) from ATP .

The antiarrhythmic effect of Niperten is due to the ability of the drug to increase the amount of cyclic adenosine monophosphate , as well as eliminate arrhythmogenic factors such as tachycardia , hypertension , and increased activity of the nervous system . Under the influence of Niperthene, the myocardial for oxygen becomes less and, as a result, the contractility of the main cardiac muscle decreases, due to which the antianginal effect of the drug .

The medicinal compound achieves a hypotensive effect by reducing blood volume (in 1 minute), restoring sensitivity (the result of an effect on the central nervous system and lowering blood pressure ), as well as by stimulating peripheral blood vessels . Under the influence of active α-adrenergic receptors , as well as with a decrease in stimulation of β2-adrenergic receptors , TPVR (total peripheral vascular resistance) increases

However, after 3 days the indicators return to normal, and with long-term therapeutic treatment they decrease. It has been noted that, in comparison with similar drugs, Niperten has a less pronounced effect on carbohydrate metabolism , as well as on organs containing β2-adrenergic receptors , such as the bronchi, pancreas, peripheral arteries, and uterus.

The drug compound is absorbed by 80-90%. About half the dose of the drug is metabolized by the liver within 12 hours. Subsequently, the kidneys remove about 98% of the active compound from the body.

Niperten 2.5 mg No. 30 tablet p.p.o.

APPROVED by the Order of the Chairman of the Committee for Control of Medical and Pharmaceutical Activities of the Ministry of Health of the Republic of Kazakhstan dated _________ 201__ No.___________ Instructions for the medical use of the drug NIPERTEN® Trade name Niperten® International nonproprietary name Bisoprolol Dosage form Film-coated tablets 2.5 mg, 5 mg and 10 mg Composition One tablet contains the active substance - bisoprolol fumarate (2: 1) 2.50 mg, 5.00 mg and 10.00 mg, excipients: microcrystalline cellulose, sodium starch glycolate, povidone, colloidal anhydrous silicon dioxide, magnesium stearate, film coating: hypromellose , polyethylene glycol, titanium dioxide E 171, talc. Description Oval, biconvex, white film-coated tablets, scored on one side and smooth on the other (for a dosage of 2.5 mg). Round, biconvex, white film-coated tablets, scored on one side and smooth on the other (for dosages of 5 mg and 10 mg). Pharmacotherapeutic group β-adrenergic blockers, selective. ATC code C07AB07 Pharmacological properties Pharmacokinetics After oral administration, absorption is 80 - 90%, food intake does not affect absorption. The maximum concentration in blood plasma is observed after 1–3 hours, the connection with blood plasma proteins is about 30%. Permeability through the blood-brain barrier and placental barrier is low. Bioavailability is approximately 85 - 90% after oral administration; food intake does not affect bioavailability. Concentrations of bisoprolol in blood plasma are proportional to the dose taken, ranging from 5 mg to 20 mg. 50% of the dose taken is metabolized in the liver with the formation of inactive metabolites, half-life (T1/2) 10–12 hours. About 98% of the dose is excreted by the kidneys, of which 50% is excreted unchanged; less than 2% - with bile. Pharmacodynamics Niperten® is a selective β1-adrenergic blocker, without its own sympathomimetic activity, and does not have a membrane-stabilizing effect. Reduces plasma renin activity, reduces myocardial oxygen demand, and reduces heart rate (heart rate) (at rest and during exercise). Niperten® has hypotensive, antiarrhythmic and antianginal effects. By blocking β1-adrenergic receptors of the heart in low doses, Niperten® reduces the catecholamine-stimulated formation of cyclic adenosine monophosphate (cAMP) from adenosine triphosphate (ATP), reduces the intracellular current of calcium ions (Ca2+), has a negative chrono-, dromo-, bathmo- and inotropic effect, reduces atrioventricular conduction and excitability. When the therapeutic dose is exceeded, it has a β2-adrenergic blocking effect. The total peripheral vascular resistance at the beginning of the use of the drug Niperten®, in the first 24 hours, increases (as a result of a reciprocal increase in the activity of α-adrenergic receptors and the elimination of stimulation of β2-adrenergic receptors), after 1–3 days it returns to the original level, and with prolonged application – decreases. The hypotensive effect is associated with a decrease in minute blood volume, sympathetic stimulation of peripheral vessels, restoration of sensitivity in response to a decrease in blood pressure (BP) and an effect on the central nervous system (CNS). In case of arterial hypertension, the effect occurs after 2–5 days, a stable effect is observed after 1–2 months. The antianginal effect of the drug Niperten® is due to a decrease in myocardial oxygen demand as a result of a decrease in heart rate (HR) and a decrease in myocardial contractility, prolongation of diastole, and improvement of myocardial perfusion. Due to an increase in end-diastolic pressure in the left ventricle and an increase in the stretch of ventricular muscle fibers, the need for oxygen may increase, especially in patients with chronic heart failure (CHF). The antiarrhythmic effect of the drug Niperten® 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 atrioventricular (AV) conduction (mainly in the antegrade and, to a lesser extent) degree, in a retrograde direction through the AV node) and along additional pathways. When used in average therapeutic doses, in contrast to non-selective β-blockers, Niperten® has a less pronounced effect on organs containing β2-adrenergic receptors (pancreas, skeletal muscles, smooth muscles of peripheral arteries, bronchi and uterus) and on carbohydrate metabolism; does not cause retention of sodium ions (Na+) in the body; the severity of the atherogenic effect does not differ from the effect of propranolol. Indications for use - arterial hypertension - coronary heart disease: prevention of angina attacks - chronic heart failure. Method of administration and dosage: Orally, in the morning on an empty stomach, without chewing, once. Arterial hypertension and coronary heart disease: prevention of angina attacks It is recommended to take 5 mg once. If necessary, the dose is increased to 10 mg 1 time per day. The maximum daily dose is 20 mg. In patients with impaired renal function with creatinine clearance (CC) less than 20 ml/min, or with severe liver dysfunction, the maximum daily dose is 10 mg. No dose adjustment is required in elderly patients. Chronic heart failure Beginning treatment of chronic heart failure with Niperten® requires a special period of dose selection. The prerequisites for starting therapy are as follows: - CHF without signs of exacerbation in the previous six weeks - practically unchanged basic therapy in the previous two weeks - treatment with optimal doses of angiotensin-converting enzyme (ACE) inhibitors (and vasodilators, in case of intolerance to ACE inhibitors) , diuretics and, if necessary, cardiac glycosides Treatment is prescribed in accordance with the specified dosage regimen. The patient's individual reaction to the prescribed therapy is possible, i.e. the dose can be increased only if the previous dose was well tolerated. 1st week: 1.25 mg (1/2 tablet of 2.5 mg) 1 time per day 2nd week: 2.5 mg 1 time per day 3rd week: 3.75 mg 1 time per day 4th – 7th week 1: 5 mg once a day week 8 - 11: 7.5 mg once a day week 12 and beyond: 10 mg once a day as maintenance therapy The maximum recommended dose of Niperten® is 10 mg 1 once a day. After starting treatment with the drug at a dose of 1.25 mg (1/2 tablet 2.5 mg), the patient should be observed for about 4 hours (monitoring heart rate, blood pressure, conduction disturbances on the ECG, signs of worsening chronic heart failure). During the period of dose selection or after it, a temporary deterioration in the course of CHF, fluid retention in the body, arterial hypotension or bradycardia may occur. In this case, it is recommended, first of all, to pay attention to the selection of the dose of concomitant basic therapy (optimize the dose of the diuretic and/or ACE inhibitor), before reducing the dose of Niperten®. Treatment with the drug should be interrupted only if absolutely necessary. After stabilization of the patient's condition, re-titration should be carried out, or treatment should be continued. Duration of treatment for all indications Therapy with Niperten® is usually long-term. Side effects Very often (≥ 1/10): - sinus bradycardia - "withdrawal" syndrome (increased angina attacks, increased blood pressure) Often (≥ 1/100 to <1/10): - impaired myocardial conduction, weakened myocardial contractility, - dizziness, headache - dryness of the oral mucosa, changes in taste, nausea, vomiting, abdominal pain, constipation or diarrhea - manifestation of vasospasm (increased peripheral circulatory disorders, coldness of the lower extremities, Raynaud's syndrome) - asthenia, increased fatigue Uncommon (≥ 1 /1000 to <1/100): - impaired atrioventricular conduction, palpitations, arrhythmias, development (worsening) of CHF (swelling of the ankles, feet; shortness of breath), decreased blood pressure - nasal congestion, difficulty breathing when prescribed in high doses (loss of selectivity ) and/or in predisposed patients - laryngo- and bronchospasm - myasthenia gravis, tremor, cramps (including calf muscles) - orthostatic hypotension - sleep disorders, depression Rarely (≥ 1/10,000 to <1/1,000): - anxiety, confusion or short-term memory loss, hallucinations - blurred vision, decreased secretion of tear fluid, dryness and soreness of the eyes (should be taken into account when the patient wears contact lenses) - allergic reactions (rhinitis, itching, rash, urticaria) - changes in enzyme activity liver (increased ALT, AST, bilirubin, triglycerides) - liver dysfunction (dark urine, yellowness of the sclera or skin, cholestasis) - hyperglycemia (in patients with non-insulin-dependent diabetes), hypoglycemia (in patients receiving insulin), hypothyroid state - increased sweating , skin hyperemia - weakened libido, decreased potency, Very rare (<1/10,000): - paresthesia in the extremities (in patients with intermittent claudication and Raynaud's syndrome), - chest pain - conjunctivitis - exanthema, psoriasis-like skin reactions, exacerbation of psoriasis symptoms, alopecia - thrombocytopenia (unusual bleeding and hemorrhage), agranulocytosis, leukopenia - intrauterine growth retardation, hypoglycemia, bradycardia. - back pain, arthralgia Contraindications - hypersensitivity to bisoprolol fumarate, other β-blockers and other components of the drug - shock (including cardiogenic) - collapse - pulmonary edema - acute heart failure - chronic heart failure in the decompensation stage - atrioventricular (AV) ) block II - III degree - sinoatrial block - sick sinus syndrome - severe bradycardia (heart rate less than 50 beats/min) - Prinzmetal's angina - cardiomegaly (without signs of heart failure) - arterial hypotension (systolic blood pressure up to 100 mm Hg, especially with myocardial infarction) - severe forms of bronchial asthma and a history of chronic obstructive pulmonary disease (COPD) - simultaneous use of monoamine oxidase inhibitors (MAO) (with the exception of MAO-B) - late stages of peripheral circulatory disorders - Raynaud's disease - pheochromocytoma (without simultaneous use α-blockers) - metabolic acidosis - children and adolescents under 18 years of age (efficacy and safety have not been established) Drug interactions Allergens used for immunotherapy or allergen extracts for skin testing increase the risk of severe systemic allergic reactions or anaphylaxis in patients receiving bisoprolol . Iodine-containing radiocontrast agents for intravenous administration increase the risk of anaphylactic reactions. Phenytoin, when administered intravenously, and agents for inhalation anesthesia (hydrocarbon derivatives) increase the severity of the cardiodepressive effect and the likelihood of lowering blood pressure. Changes the effectiveness of insulin and hypoglycemic agents for oral administration, masks the symptoms of developing hypoglycemia (tachycardia, increased blood pressure). Reduces the clearance of lidocaine and xanthines (except theophylline) and increases their concentration in the blood plasma, especially in patients with initially increased clearance of theophylline under the influence of smoking. The hypotensive effect is weakened by nonsteroidal anti-inflammatory drugs (NSAIDs) (retention of sodium ions (Na+) and blockade of prostaglandin synthesis by the kidneys), glucocorticosteroids and estrogens (retention of Na+ ions). Cardiac glycosides, methyldopa, reserpine and guanfacine, blockers of “slow” calcium channels (verapamil, diltiazem), amiodarone and other antiarrhythmic drugs increase the risk of developing or worsening bradycardia, AV block, cardiac arrest and heart failure. Nifedipine can lead to a significant decrease in blood pressure. Diuretics, clonidine, sympatholytics, hydralazine and other antihypertensive drugs can lead to an excessive decrease in blood pressure. Prolongs the effect of non-depolarizing muscle relaxants and increases the anticoagulant effect of coumarins. Tri- and tetracyclic antidepressants, antipsychotics (neuroleptics), ethanol, sedatives and hypnotics increase CNS depression. Concomitant use with MAO inhibitors is not recommended, due to a significant increase in the hypotensive effect; the break in treatment between taking MAO inhibitors and bisoprolol should be at least 14 days. Non-hydrogenated ergot alkaloids increase the risk of developing peripheral circulatory disorders. Ergotamine increases the risk of developing peripheral circulatory disorders; sulfasalazine increases the concentration of bisoprolol in the blood plasma; Rifampicin reduces T1/2. Special instructions Do not interrupt treatment abruptly or change the recommended dosage without first consulting your doctor, as this may lead to a temporary deterioration in heart function. Treatment should not be interrupted suddenly, especially in patients with coronary heart disease. If discontinuation of treatment is necessary, the dosage should be reduced gradually. Monitoring of patients taking the drug Niperten® should include measuring heart rate and blood pressure (at the beginning of treatment - daily, then once every 3-4 months), conducting an ECG, determining blood glucose levels in patients with diabetes mellitus (once every 4-4 months). 5 months). In elderly patients, it is recommended to monitor renal function (once every 4–5 months). The patient should be taught how to calculate heart rate and instructed about the need for medical consultation if the heart rate is less than 50 beats/min. Before starting treatment, it is recommended to conduct a study of external respiratory function in patients with a burdened bronchopulmonary history. In approximately 20% of patients with angina, β-blockers are ineffective. The main reasons: severe coronary atherosclerosis with a low ischemic threshold (heart rate less than 100 beats/min) and increased end-diastolic volume of the left ventricle, disrupting subendocardial blood flow. In smokers, the effectiveness of β-blockers is lower. Patients using contact lenses should take into account that during treatment the production of tear fluid may decrease. When used in patients with pheochromocytoma, there is a risk of developing paradoxical arterial hypertension (if effective α-blockade is not previously achieved). In case of thyrotoxicosis, Niperten® can mask certain clinical signs of thyrotoxicosis (for example, tachycardia). Abrupt withdrawal in patients with thyrotoxicosis is contraindicated because it can increase symptoms. In diabetes mellitus, Niperten® can mask tachycardia caused by hypoglycemia. Unlike non-selective beta-blockers, it practically does not enhance insulin-induced hypoglycemia and does not delay the restoration of blood glucose concentrations to normal levels. When taking clonidine simultaneously, it can be discontinued only a few days after discontinuation of the drug Niperten®. It is possible that the severity of the hypersensitivity reaction may increase and there will be no effect from usual doses of epinephrine against the background of a burdened allergic history. If planned surgical treatment is necessary, the drug should be discontinued 48 hours before the start of general anesthesia. If the patient took Niperten® before surgery, he should select a drug for general anesthesia with minimal negative inotropic effect. Reciprocal activation of the vagus nerve can be reversed by intravenous atropine (1–2 mg). Medicines that reduce the reserves of catecholamines (including reserpine) can enhance the effect of beta-blockers, so patients taking such combinations of drugs should be under constant medical supervision to detect a pronounced decrease in blood pressure or bradycardia. Patients with bronchospastic diseases can be prescribed cardioselective β-blockers in case of intolerance and/or ineffectiveness of other antihypertensive drugs. An overdose is dangerous due to the development of bronchospasm. If increasing bradycardia (less than 50 beats/min), a pronounced decrease in blood pressure (systolic blood pressure below 100 mm Hg), or AV blockade is detected in elderly patients, it is necessary to reduce the dose or stop treatment. It is recommended to discontinue therapy with Niperten® if depression develops. Treatment should not be abruptly interrupted due to the risk of developing withdrawal syndrome (severe arrhythmias and myocardial infarction). Cancellation is carried out gradually, reducing the dose over 2 weeks or more (reduce the dose by 25% in 3-4 days). It should be discontinued before testing the content of catecholamines, normetanephrine and vanillinmandelic acid in the blood and urine, and titers of antinuclear antibodies. With caution: liver failure, chronic renal failure, myasthenia gravis, thyrotoxicosis, diabetes mellitus, first degree AV block, depression (including a history), psoriasis, allergic reactions (history), old age. Pregnancy and lactation Possible if the benefit to the mother outweighs the risk of side effects in the fetus and child. In general, beta blockers reduce blood flow to the placenta and may affect fetal development. Blood flow in the placenta and uterus should be closely monitored, as well as the growth and development of the unborn child, and in case of dangerous manifestations in relation to pregnancy or the fetus, alternative therapeutic measures should be taken. The newborn should be carefully examined after birth. In the first three days of life, symptoms of decreased blood glucose and heart rate may occur. There are no data on the excretion of bisoprolol into breast milk or the safety of bisoprolol exposure in infants. Therefore, taking Niperten® is not recommended for women during breastfeeding. Features of the influence of the drug on the ability to drive a vehicle or potentially dangerous mechanisms The question of the possibility of engaging in potentially dangerous activities that require increased attention and speed of psychomotor reactions should be decided only after assessing the patient’s individual response to the drug (especially at the beginning of treatment, due to the possibility development of dizziness). Overdose Symptoms: arrhythmia, ventricular extrasystole, severe bradycardia, AV block, marked decrease in blood pressure, CHF, cyanosis of fingernails or palms, difficulty breathing, bronchospasm, dizziness, fainting, convulsions. Treatment: gastric lavage and administration of adsorbents; symptomatic therapy: in case of developed AV block - intravenous administration of 1-2 mg of atropine, epinephrine or temporary placement of a pacemaker; for ventricular extrasystole - lidocaine (class IA drugs are not used); when blood pressure decreases, the patient should be in the Trendelenburg position; if there are no signs of pulmonary edema, intravenous administration of plasma-substituting solutions; if ineffective, administration of epinephrine, dopamine, dobutamine (to maintain chronotropic and inotropic effects and eliminate a pronounced decrease in blood pressure); for heart failure - cardiac glycosides, diuretics, glucagon; for convulsions - intravenous diazepam; for bronchospasm - β2-adrenergic stimulants by inhalation. Release form and packaging 10 tablets in a blister pack made of polyvinyl chloride film and aluminum foil. 3 contour strip packs together with instructions for use in the state and Russian languages ​​are placed in a cardboard pack. Storage conditions Store at a temperature not exceeding 30 °C. Keep out of the reach of children! Shelf life 2 years Do not use after the expiration of the shelf life Conditions for dispensing from pharmacies By prescription, Russia st. Moscow, 50, 143500, Istra, Moscow Region, Russia, the owner of the registration certificate of the KRKA, D.D., Slovenia, Slovenia address of the organization accepting in the territory of the Republic of Kazakhstan claims from consumers on the quality of products (goods). . New place ”in the Republic of Kazakhstan, 050059, Almaty, Al-Farabi Ave., 5/1, section 3 a, 4th floor of tel. Fax

Contraindications

It is not recommended to use the drug if:

  • collapse;
  • hypersensitivity to beta-blockers and other components of the drug;
  • pulmonary edema;
  • sinoatrial blockade;
  • bradycardia;
  • cardiomegaly;
  • sinus node weakness;
  • Prinzmetal's angina;
  • bronchial asthma;
  • peripheral circulation disorders ;
  • pheochromocytoma;
  • AV block II–III degree.

Niperten is contraindicated in patients under 18 years of age. In addition, patients with diabetes mellitus , as well as renal failure , thyrotoxicosis , psoriasis , myasthenia gravis , as well as elderly people should be especially careful about the dosage and regimen of taking the drug.

Niperten®

The effectiveness and tolerability of bisoprolol may be affected by concomitant use of other medications. This interaction can also occur when two drugs are taken within a short period of time. It is necessary to inform your doctor if you are taking other medications, even if you are taking them without a doctor’s prescription (i.e., over-the-counter medications).

Combinations not recommended

Treatment of chronic heart failure

Class I antiarrhythmic drugs (for example, quinidine, disopyramide, lidocaine, phenytoin, flecainide, propafenone), when used simultaneously with bisoprolol, can reduce AV conduction and myocardial contractility.

All indications for use of the drug Niperten®

Blockers of “slow” calcium channels (SCBC) such as verapamil and, to a lesser extent, diltiazem, when used simultaneously with bisoprolol, can lead to a decrease in myocardial contractility and impaired AV conduction. In particular, intravenous administration of verapamil to patients taking beta-blockers can lead to severe arterial hypotension and AV block.

Centrally acting antihypertensives (such as clonidine, methyldopa, moxonidine, rilmenidine) can lead to a decrease in heart rate and cardiac output, as well as vasodilation due to a decrease in central sympathetic tone.

Abrupt withdrawal, especially before discontinuation of beta-blockers, may increase the risk of developing rebound hypertension.

Combinations requiring special caution

Treatment of arterial hypertension and angina pectoris

Class I antiarrhythmic drugs (for example, quinidine, disopyramide, lidocaine, phenytoin, flecainide, propafenone), when used simultaneously with bisoprolol, can reduce AV conduction and myocardial contractility.

All indications for use of the drug Niperten®

BMCC, dihydropyridine derivatives (for example, nifedipine, felodipine, amlodipine), when used simultaneously with bisoprolol, may increase the risk of developing arterial hypotension. In patients with CHF, the risk of subsequent deterioration in cardiac contractility cannot be excluded.

Class III antiarrhythmic drugs (eg, amiodarone) may worsen AV conduction disturbances.

The effect of topical β-blockers (for example, eye drops for the treatment of glaucoma) may enhance the systemic effects of bisoprolol (lowering blood pressure, lowering heart rate).

Parasympathomimetics, when used simultaneously with bisoprolol, may enhance AV conduction disturbances and increase the risk of developing bradycardia.

The hypoglycemic effect of insulin or oral hypoglycemic agents may be enhanced. Signs of hypoglycemia, in particular tachycardia, may be masked or suppressed. Such interactions are more likely when using non-selective beta-blockers.

General anesthesia agents may increase the risk of cardiodepressive effects, leading to arterial hypotension (see section "Special Instructions").

Cardiac glycosides, when used simultaneously with bisoprolol, can lead to an increase in impulse conduction time and, thus, to the development of bradycardia.

Nonsteroidal anti-inflammatory drugs (NSAIDs) may reduce the antihypertensive effect of bisoprolol.

The simultaneous use of Niperten® with β-adrenergic agonists (for example, isoprenaline, dobutamine) may lead to a decrease in the effect of both drugs.

The use of bisoprolol with adrenergic agonists that affect α- and β-adrenergic receptors (for example, norepinephrine, epinephrine) may enhance the vasoconstrictor effects of these drugs that occur with the participation of α-adrenergic receptors, leading to an increase in blood pressure. Such interactions are more likely when using non-selective beta-blockers.

Antihypertensive drugs, as well as other drugs with a possible antihypertensive effect (for example, tricyclic antidepressants, barbiturates, phenothiazines), may enhance the antihypertensive effect of bisoprolol.

Mefloquine, when used simultaneously with bisoprolol, may increase the risk of bradycardia.

Monoamine oxidase (MAO) inhibitors (except MAO B inhibitors) may enhance the antihypertensive effect of beta-blockers. Concomitant use may also lead to the development of a hypertensive crisis.

Side effects

The use of the drug causes such side effects as:

  • weakness, increased fatigue and dizziness;
  • sleep disorders;
  • headaches and memory impairment;
  • hallucinations and depression;
  • myasthenia gravis;
  • convulsions;
  • decreased vision;
  • conjunctivitis;
  • arrhythmia;
  • Raynaud's syndrome;
  • bradycardia;
  • chest pain;
  • vomiting and nausea;
  • constipation or diarrhea;
  • change in taste;
  • difficulty breathing;
  • hyperglycemia in diabetes;
  • hypoglycemia;
  • hypothyroid condition;
  • skin rashes;
  • alopecia;
  • leukopenia;
  • thrombocytopenia;
  • arthralgia;
  • decreased potency;
  • backache.

Niperthene 10mg n30 tab.

Composition and release form Niperten film-coated tablets: 1 tablet. contains bisoprolol fumarate (2:1) 2.5 mg, 5 mg and 10 mg; excipients: MCC; sodium carboxymethyl starch; povidone; anhydrous colloidal silicon dioxide; magnesium stearate; shell: hypromellose; macrogol; titanium dioxide; talc; per package 20, 30, 50 and 100 pcs.

Pharmacological action Niperten has a hypotensive, antianginal, antiarrhythmic effect.

Niperten, indications for use

arterial hypertension; IHD: prevention of angina attacks; CHF.

Contraindications: hypersensitivity to the components of Niperten and other β-blockers; shock (including cardiogenic); collapse; pulmonary edema; acute heart failure, CHF in the stage of decompensation; AV block II–III degree; sinoatrial block; sick sinus syndrome; severe bradycardia; Prinzmetal's angina; cardiomegaly (without signs of heart failure); arterial hypotension (sBP less than 100 mm Hg, especially with myocardial infarction); severe forms of bronchial asthma and chronic obstructive pulmonary disease (COPD) in history; simultaneous use of MAO inhibitors (with the exception of MAO-B); late stages of peripheral circulatory disorders; Raynaud's disease; pheochromocytoma (without simultaneous use of α-blockers); metabolic acidosis; age under 18 years (efficacy and safety have not been established). With caution: liver failure, chronic renal failure, myasthenia gravis, thyrotoxicosis, diabetes mellitus, AV blockade of the first degree, depression (including a history), psoriasis, allergic reactions (history), old age.

Side effects From the central nervous system and peripheral nervous system: increased fatigue, weakness, dizziness, headache, sleep disorders, depression, anxiety, confusion or short-term memory loss, hallucinations, asthenia, myasthenia, paresthesia in the extremities (in patients with “intermittent” lameness and Raynaud's syndrome), tremors, cramps (including calf muscles). From the organ of vision: blurred vision, decreased secretion of tear fluid, dry and sore eyes, conjunctivitis. From the cardiovascular system: sinus bradycardia, palpitations, myocardial conduction disturbances, AV block (up to the development of complete transverse block and cardiac arrest), arrhythmias, weakening of myocardial contractility, development (worsening) of CHF (swelling of the ankles, feet; shortness of breath), decreased blood pressure, orthostatic hypotension, manifestation of vasospasm (increased peripheral circulatory disorders, coldness of the lower extremities, Raynaud's syndrome), chest pain. From the digestive system: dryness of the oral mucosa, nausea, vomiting, abdominal pain, constipation or diarrhea, liver dysfunction (dark urine, yellowness of the sclera or skin, cholestasis), changes in taste. From the respiratory system: nasal congestion, difficulty breathing when prescribed in high doses (loss of selectivity) and/or in predisposed patients - laryngo- and bronchospasm. From the endocrine system: hyperglycemia (in patients with non-insulin-dependent diabetes), hypoglycemia (in patients receiving insulin), hypothyroid state. Allergic reactions: skin itching, rash, urticaria. From the skin: increased sweating, skin hyperemia, exanthema, psoriasis-like skin reactions, exacerbation of psoriasis symptoms, alopecia. Laboratory indicators: thrombocytopenia (unusual bleeding and hemorrhage), agranulocytosis, leukopenia, changes in the activity of liver enzymes (increased ALT, AST, bilirubin levels, triglycerides. Effect on the fetus: intrauterine growth restriction, hypoglycemia, bradycardia. Others: back pain, arthralgia, weakened libido, decreased potency, withdrawal syndrome (increased angina attacks, increased blood pressure).

Interaction

To avoid complications or side effects when treating with Niperten, you should avoid:

  • allergens that are used in immunotherapy ;
  • iodine-containing radiopaque agents for intravenous administration of drugs;
  • phenytoin, inhalation anesthesia ;
  • antihypertensive drugs;
  • antidepressants , sedatives and hypnotics ;
  • non-hydrogenated ergot alkaloids;
  • ergotamine;
  • antiarrhythmic drugs.

An active drug changes the effectiveness of insulin , and also increases the concentration of xanthines and the clearance of lidocaine .

NIPERTENE

Interaction

The effectiveness and tolerability of bisoprolol may be affected by concomitant use of other medications.
This interaction can also occur when two drugs are taken within a short period of time. It is necessary to inform your doctor if you are taking other medications, even if you are taking them without a doctor’s prescription (i.e., over-the-counter medications). Combinations not recommended

Treatment of chronic heart failure

Class I antiarrhythmic drugs (for example, quinidine, disopyramide, lidocaine, phenytoin, flecainide, propafenone), when used simultaneously with bisoprolol, can reduce AV conduction and myocardial contractility.

All indications for use of the drug Niperten®

Blockers of “slow” calcium channels (SCBC) such as verapamil and, to a lesser extent, diltiazem, when used simultaneously with bisoprolol, can lead to a decrease in myocardial contractility and impaired AV conduction. In particular, intravenous administration of verapamil to patients taking beta-blockers can lead to severe arterial hypotension and AV block. Centrally acting antihypertensives (such as clonidine, methyldopa, moxonidine, rilmenidine) can lead to a decrease in heart rate and cardiac output, as well as vasodilation due to a decrease in central sympathetic tone. Abrupt withdrawal, especially before discontinuation of beta-blockers, may increase the risk of developing rebound hypertension.

Combinations requiring special caution

Treatment of arterial hypertension and angina pectoris

Class I antiarrhythmic drugs (for example, quinidine, disopyramide, lidocaine, phenytoin, flecainide, propafenone), when used simultaneously with bisoprolol, can reduce AV conduction and myocardial contractility.

All indications for use of the drug Niperten®

BMCC, dihydropyridine derivatives (for example, nifedipine, felodipine, amlodipine), when used simultaneously with bisoprolol, may increase the risk of developing arterial hypotension. In patients with CHF, the risk of subsequent deterioration in cardiac contractility cannot be excluded.

Class III antiarrhythmic drugs (eg, amiodarone) may worsen AV conduction disturbances.

The effect of topical β-blockers (for example, eye drops for the treatment of glaucoma) may enhance the systemic effects of bisoprolol (lowering blood pressure, lowering heart rate).

Parasympathomimetics, when used simultaneously with bisoprolol, may enhance AV conduction disturbances and increase the risk of developing bradycardia.

The hypoglycemic effect of insulin or oral hypoglycemic agents may be enhanced. Signs of hypoglycemia, in particular tachycardia, may be masked or suppressed. Such interactions are more likely when using non-selective beta-blockers.

General anesthesia agents may increase the risk of cardiodepressive effects, leading to arterial hypotension (see section "Special Instructions").

Cardiac glycosides, when used simultaneously with bisoprolol, can lead to an increase in impulse conduction time and, thus, to the development of bradycardia.

Nonsteroidal anti-inflammatory drugs (NSAIDs) may reduce the antihypertensive effect of bisoprolol.

The simultaneous use of Niperten® with β-adrenergic agonists (for example, isoprenaline, dobutamine) may lead to a decrease in the effect of both drugs. The use of bisoprolol with adrenergic agonists that affect α- and β-adrenergic receptors (for example, norepinephrine, epinephrine) may enhance the vasoconstrictor effects of these drugs that occur with the participation of α-adrenergic receptors, leading to an increase in blood pressure. Such interactions are more likely when using non-selective β-blockers.

Antihypertensive drugs, as well as other drugs with a possible antihypertensive effect (for example, tricyclic antidepressants, barbiturates, phenothiazines), may enhance the antihypertensive effect of bisoprolol.

Mefloquine, when used simultaneously with bisoprolol, may increase the risk of bradycardia.

Monoamine oxidase (MAO) inhibitors (except MAO B inhibitors) may enhance the antihypertensive effect of beta-blockers. Concomitant use may also lead to the development of a hypertensive crisis.

special instructions

The condition of patients undergoing treatment with Niperten must be constantly monitored by medical personnel. For elderly patients, it is recommended to conduct kidney function tests at least once every 5 months. Doctors are advised to teach patients how to count their heart (HR) so that they can self-monitor their condition if necessary.

Before starting direct treatment, patients with a bronchopulmonary history are recommended to undergo a comprehensive examination of the respiratory tract . During treatment, the secretion of tear fluid may decrease; this should be taken into account by patients using contact lenses.

Niperten, 30 pcs., 5 mg, film-coated tablets

You should not interrupt treatment with Niperten® abruptly and do not change the recommended dose without first consulting your doctor, because this may lead to a temporary deterioration in heart function. Treatment should not be interrupted suddenly, especially in patients with coronary artery disease. If discontinuation of treatment is necessary, the dose should be reduced gradually.

When using clonidine simultaneously, its use can be discontinued only a few days after discontinuation of the drug Niperten®.

At the initial stages of treatment with Niperten®, patients require constant monitoring.

Monitoring the condition of patients taking the drug Niperten® should include measuring heart rate and blood pressure (at the beginning of treatment - daily, then once every 3-4 months), conducting an ECG, determining the concentration of glucose in the blood in patients with diabetes mellitus (once every 4–5 months). In elderly patients, it is recommended to monitor renal function (once every 4–5 months).

The patient should be taught how to calculate heart rate and instructed to consult a doctor if the heart rate is less than 60 beats/min.

Niperten® should be used with caution in the following cases:

- diabetes mellitus with significant fluctuations in plasma glucose concentration: symptoms of a pronounced decrease in glucose concentration (hypoglycemia) such as tachycardia, palpitations or increased sweating may be masked;

- strict diet;

— carrying out desensitizing therapy;

— AV block of the first degree;

- Prinzmetal's angina;

- mild to moderate peripheral arterial circulation disorders (increased symptoms may occur at the beginning of therapy);

- psoriasis (including history).

If increasing bradycardia (heart rate less than 60 beats/min), a pronounced decrease in blood pressure (sBP below 100 mm Hg), AV blockade, bronchospasm, ventricular arrhythmias, severe liver and/or kidney dysfunction is detected in elderly patients, it is necessary to reduce the dose of the drug or stop treatment.

It is recommended to discontinue therapy if depression caused by taking β-blockers develops.

Respiratory system

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

For bronchial asthma or COPD, simultaneous use of bronchodilators is indicated. In patients with bronchial asthma, there may be an increase in airway resistance, which requires a higher dose of β2-adrenergic agonists.

In smokers, the effectiveness of β-blockers is lower.

Allergic reactions

β-blockers, including Niperten®, may increase sensitivity to allergens and the severity of anaphylactic reactions due to weakening of adrenergic compensatory regulation under the influence of β-blockers. Therapy with epinephrine (adrenaline) does not always give the expected therapeutic effect.

General anesthesia

When performing general anesthesia, the risk of β-adrenergic receptor blockade should be taken into account. If it is necessary to discontinue Niperten® therapy before surgery, this should be done gradually and completed 48 hours before general anesthesia. The anesthesiologist should be warned that the patient is taking the drug Niperten®.

Pheochromocytoma

In patients with an adrenal tumor (pheochromocytoma), the drug Niperten® can only be used against the background of simultaneous use of α-blockers.

Hyperthyroidism

When treated with Niperten®, symptoms of hyperthyroidism (hyperthyroidism) may be masked.

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

Impact on the ability to perform potentially hazardous activities that require special attention and quick reactions (for example, driving vehicles, working with moving mechanisms).

The drug Niperten® does not affect the ability to drive vehicles, according to the results of a study in patients with coronary artery disease. However, due to individual reactions, the ability to drive vehicles or operate technically complex mechanisms may be impaired. Particular attention should be paid to this at the beginning of treatment, after changing the dose, and also when consuming alcohol at the same time.

Niperten's analogs

Level 4 ATC code matches:
Biol

Metocard

Metozok

Nebilet

Nebilong

Betaxolol

Bisogamma

Aritel

Cordinorm

Vasocardin

Corvitol

Bidop

Bisoprolol

Nebivolol

Biprol

Bisoprol

Concor Cor

Lokren

Concor

Betaloc ZOK

The main analogues of Niperten include such drugs as:

  • Aritel;
  • Bisocard;
  • Biol;
  • Bidop;
  • Concor;
  • Bisoprolol;
  • Corbis;
  • Tirez;
  • Coronal.

Niperten price, where to buy

The cost of the drug depends primarily on its nominal volume and the number of tablets in the package. The average price of Niperten (5 mg) of 30 tablets per package does not exceed 150 rubles, and 100 tablets - 350 rubles.

  • Online pharmacies in RussiaRussia
  • Online pharmacies in KazakhstanKazakhstan

ZdravCity

  • Niperten tablets p.p.o.
    5 mg 30 pcs. Krka-Rus LLC 154 rub. order
  • Niperten tablets p.p.o. 2.5 mg 30 pcs. Krka-Rus LLC

    122 RUR order

  • Niperten tablets p.p.o. 2.5 mg 100 pcs. Krka-Rus LLC

    RUB 264 order

  • Niperten tablets p.p.o. 10 mg 30 pcs. Krka-Rus LLC

    220 rub. order

  • Niperten tablets p.p.o. 5 mg 100 pcs. Krka-Rus LLC

    RUB 312 order

Pharmacy Dialogue

  • Niperten (tablet p/o cap. 10 mg No. 30) KRKA-RUS

    RUB 201 order

  • Niperten (tab.p.pl/vol. 5mg No. 30) KRKA-RUS

    RUB 142 order

  • Niperten (tab.p.pl/vol. 10mg No. 100) KRKA-RUS

    RUB 447 order

  • Niperten (tablet p/o cap. 5 mg No. 100) KRKA-RUS

    300 rub. order

  • Niperten (tablet p/o cap. 2.5 mg No. 100) KRKA-RUS

    RUB 242 order

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