Niperten tablets p / o 5mg, No. 100

arterial hypertension;

ischemic heart disease: stable angina pectoris;

chronic heart failure.

Inside, 1 time per day with a small amount of liquid, in the morning, regardless of the time of the meal. The tablets should not be chewed or powdered.

Arterial hypertension and stable angina pectoris. In all cases, the regimen and dose are selected by the doctor for each patient individually, in particular, taking into account the heart rate and the patient's condition. Usually the initial dose is 5 mg of NipertenЃ once a day. If necessary, the dose can be increased to 10 mg once a day. In the treatment of arterial hypertension and stable angina pectoris, the maximum recommended dose is 20 mg of NipertenЃ once a day.

CHF: The standard treatment regimen for CHF includes the use of ACE inhibitors or angiotensin II receptor antagonists (in case of intolerance to ACE inhibitors), ?-blockers, diuretics and, optionally, cardiac glycosides. The beginning of CHF treatment with NipertenЃ requires a special titration phase and regular medical supervision.

A precondition for treatment with NipertenЃ is stable CHF without signs of exacerbation.

Treatment of CHF with NipertenЃ begins in accordance with the following titration schedule. In this case, individual adaptation may be required depending on how well the patient tolerates the prescribed dose, i.e. the dose can be increased only if the previous dose was well tolerated.

The recommended initial dose is 1.25 mg (1/2 table. 2.5 mg) 1 time per day. Depending on individual tolerance, the dose should be gradually increased to 2.5; 3.75; five; 7.5 and 10 mg once a day. Each subsequent dose increase should be carried out at least 2 weeks later.

If an increase in the dose of the drug is poorly tolerated by the patient, a dose reduction is possible.

The maximum recommended dose for the treatment of CHF is 10 mg of NipertenЃ 1 time per day.

During titration, regular monitoring of blood pressure, heart rate and the severity of CHF symptoms is recommended. Aggravation of the symptoms of CHF is possible from the first day of using the drug.

If the patient does not tolerate the maximum recommended dose of NipertenЃ, a gradual dose reduction should be considered.

During the titration phase or after it, a temporary deterioration in the course of CHF, arterial hypotension or bradycardia may occur. In this case, it is recommended, first of all, to adjust the doses of concomitant therapy drugs. You may also need to temporarily reduce the dose of NipertenЃ or cancel it.

After stabilization of the patient's condition, titration of the dose should be repeated, or treatment should be continued.

Treatment with NipertenЃ is usually a long-term therapy.

Special patient groups

Impaired kidney or liver function. In case of mild to moderate hepatic or renal impairment, dose adjustment is usually not required.

In severe renal impairment (Cl creatinine less than 20 ml / min) and in patients with severe liver disease, the maximum daily dose is 10 mg. Increasing the dose in these patients should be done with extreme caution.

Elderly patients.

No dose adjustment is required.

Children.

Since there is not enough data on the use of NipertenЃ in children, it is not recommended to use the drug in children under 18 years of age.

Currently, there is insufficient data on the use of NipertenЃ in patients with CHF in combination with type 1 diabetes mellitus, severe renal and / or liver dysfunction, restrictive cardiomyopathy, congenital heart defects or heart valve disease with severe hemodynamic disturbances. Also, until now, there has not been enough data on patients with CHF with myocardial infarction during the last 3 months.

Active ingredient: bisoprolol fumarate 2.5 mg;

Excipients:

microcrystalline cellulose,

sodium carboxymethyl starch,

povidone,

anhydrous colloidal silicon dioxide,

magnesium stearate.

The composition of the film shell:

hypromellose,

macrogol,

titanium dioxide,

talc.

hypersensitivity to bisoprolol or to any of the excipients of the drug;

acute heart failure, chronic heart failure in the stage of decompensation, requiring inotropic therapy;

cardiogenic shock;

AV block II Ц III degree, without pacemaker;

sick sinus syndrome;

sinoatrial blockade;

severe bradycardia (heart rate less than 60 beats / min);

severe arterial hypotension (SBP less than 100 mm Hg);

severe forms of bronchial asthma and chronic obstructive pulmonary disease;

severe peripheral arterial circulation disorders or Raynaud's syndrome;

pheochromocytoma (without the simultaneous use of? -adrenergic blockers);

metabolic acidosis;

age up to 18 years (efficacy and safety have not been established).

Carefully:

desensitizing therapy,

Prinzmetal angina,

hyperthyroidism,

type 1 diabetes mellitus and diabetes mellitus with significant fluctuations in blood glucose concentration,

AV blockade I degree, severe renal failure (Cl creatinine less than 20 ml / min),

severe liver dysfunction,

psoriasis,

restrictive cardiomyopathy,

congenital heart defects or heart valve disease, with severe hemodynamic disturbances,

CHF with myocardial infarction within the last 3 months,

strict diet.

Description:

Niperten is a selective beta1-blocker.

Film-coated tablets, white, round, biconvex, with a line on one side.

Composition:

Active ingredient: bisoprolol fumarate 2.5 mg;

Excipients:

microcrystalline cellulose,

sodium carboxymethyl starch,

povidone,

anhydrous colloidal silicon dioxide,

magnesium stearate.

The composition of the film shell:

hypromellose,

macrogol,

titanium dioxide,

talc.

Pharmachologic effect:

Selective beta1-blocker without intrinsic sympathomimetic activity, does not have membrane stabilizing activity.

Reduces the activity of plasma renin, reduces myocardial oxygen demand, reduces heart rate (at rest and during exercise) and cardiac output, while the stroke volume does not significantly decrease. Inhibits AV conduction.

It has antianginal and hypotensive effects.

In high doses (200 mg or more), it can cause blockade and? 2-adrenergic receptors, mainly in the bronchi and vascular smooth muscles.

The hypotensive effect is associated with a decrease in the minute blood volume, sympathetic stimulation of peripheral vessels, a decrease in the activity of the renin-angiotensin system (it is of greater importance for patients with initial renin hypersecretion), restoration of sensitivity in response to a decrease in blood pressure and an effect on the central nervous system.

The antianginal effect is due to a decrease in myocardial oxygen demand as a result of a decrease in heart rate and a decrease in contractility, an increase in diastole, and an improvement in myocardial perfusion. The antiarrhythmic effect 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 AV conduction (mainly in the antegrade and, to a lesser extent, in the retrograde directions) through the AV node) and along additional paths.

Pharmacokinetics:

Absorption - 80-90%, food intake does not affect absorption. Cmax in blood plasma is reached after 2-4 hours.

Plasma protein binding - 26-33%.

Bisoprolol to a small extent crosses the BBB and the placental barrier; excreted in breast milk.

It is metabolized in the liver. T1 / 2 - 9-12 hours

It is excreted by the kidneys - 50% unchanged, less than 2% - with bile.

Indications:

• Arterial hypertension,

• prevention of angina attacks,

• chronic heart failure.

  Dosing regimen:

  Niperten tablets are taken orally, swallowing whole (without chewing), drinking a sufficient amount of liquid, 1 time per day in the morning, regardless of the meal.

  The doctor prescribes the dose of the drug individually, taking into account the patient's condition and heart rate.

  Recommended dosage for the treatment of arterial hypertension and stable angina pectoris: the initial dose is 5 mg once a day.

  If it is necessary to achieve the desired therapeutic effect, the daily dose can be increased to 10 mg.

  A prerequisite for the appointment of Niperten for the treatment of chronic heart failure is the absence of signs of exacerbation.

  The standard regimen for its treatment, in addition to the use of beta-blockers, includes angiotensin-converting enzyme inhibitors, if they are intolerant - angiotensin II receptor antagonists, cardiac glycosides.

  Treatment with the drug should be started in accordance with a special dose titration regimen under regular medical supervision.

  Doctor's supervision allows to determine the degree of tolerance of the prescribed dose and the possibility of its increase after individual adaptation.

  It is possible to increase the dose only if the previous one is well tolerated.

  Recommended dosage of Niperten: initial dose - 1.25 mg (1/2 tablet in a dose of 2.5 mg) once a day.

  With good individual tolerance of the initial dose within 14 days, it can be increased to 2.5 mg (each subsequent dose increase should be carried out with an interval of at least 14 days), then to 3.75 mg, to 5 mg, to 7.5 mg and with good tolerance - up to 10 mg.

  If the patient's condition worsens after increasing the dose of the drug, it is necessary to continue treatment with the previous dose.

  The maximum daily dose for the treatment of chronic heart failure is 10 mg.

  During the titration period, the patient should be provided with regular monitoring of heart rate and blood pressure.

  Since against the background of the use of Niperten, the aggravation of the symptoms of the disease is possible from the first days of treatment, it is necessary to carefully monitor the degree of their severity.

  If the maximum recommended dose of the drug is poorly tolerated, it can be gradually reduced.

  With a temporary worsening of the course of the disease, the development of arterial hypotension or bradycardia during or after titration of the dose of the drug, it is first of all necessary to adjust the doses of concomitant therapy.

  If necessary, a temporary decrease in the dose of bisoprolol or its cancellation is indicated.

  Treatment can be continued or resumed only after the patient's condition has stabilized.

  The duration of treatment for all indications is usually long-term.

  Dose adjustment in elderly patients, as well as in case of impaired renal or liver function of mild to moderate severity, is usually not required.

  In severe liver disease and impaired renal function with creatinine clearance (CC) less than 20 ml / min, the maximum daily dose of Niperten should not exceed 10 mg.

  With extreme caution , the dose should be increased in this category of patients.

  Contraindications:

• acute heart failure;

• the stage of decompensation of chronic heart failure, which requires inotropic therapy; atrioventricular (AV) block II Ц III degree (without pacemaker);

• sinoatrial blockade;

• sick sinus syndrome;

• cardiogenic shock;

• bradycardia with a heart rate of less than 60 beats per minute;

• severe arterial hypotension (systolic blood pressure below 100 mm Hg);

• chronic obstructive pulmonary disease, severe bronchial asthma;

• Raynaud's syndrome (severe peripheral arterial circulation disorders);

• pheochromocytoma (in the absence of concomitant therapy with alpha-blockers);

• metabolic acidosis;

• breastfeeding period; age under 18;

• гиперчувствительность к компонентам препарата.

  —ледует соблюдать осторожность при назначении Ќипертена:

• пациентам, примен¤ющим десенсибилизирующую терапию,

• при стенокардии ѕринцметала,

• AV-блокаде I степени,

• рестриктивной кардиомиопатии,

• пороке клапана сердца с выраженными гемодинамическими нарушени¤ми,

• врожденном пороке сердца,

• больным с хронической сердечной недостаточностью, которые перенесли инфаркт миокарда в течение ближайших 3 мес¤цев,

• при гипертиреозе,

• сахарном диабете 1 типа,

• сахарном диабете со значительными колебани¤ми уровн¤ глюкозы в крови,

• т¤желой почечной недостаточности,

• т¤желых нарушени¤х функции печени,

• псориазе (включа¤ анамнез),

• в случае необходимости соблюдени¤ строгой диеты.

  ¬ период беременности

  Ќазначение Ќипертена возможно только в случа¤х, когда ожидаема¤ польза от терапии дл¤ матери превосходит угрозу развити¤ нежелательных эффектов у плода.

  ѕрименение при беременности и лактации:

  ѕоскольку бета-адреноблокаторы способствуют понижению кровотока в плаценте и могут повли¤ть на развитие плода, назначение Ќипертена в период беременности возможно только в исключительном случае, когда предполагаемый терапевтический эффект, по мнению врача, превосходит потенциальную угрозу развити¤ нежелательных эффектов у плода

  ¬ случае применени¤ бисопролола необходимо следить за кровотоком в матке и плаценте, ростом и развитием плода.

  ѕри по¤влении угрожающих беременности и/или плоду симптомов больную рекомендуетс¤ перевести на альтернативную терапию с использованием препаратов с подтвержденным профилем безопасности при лечении беременных.

  After giving birth, the newborn should be carefully examined, since during the first three days of life, he may develop symptoms of bradycardia and hypoglycemia.

  According to the instructions, Niperten is contraindicated for breastfeeding.

  If necessary, the appointment of the drug during lactation, breastfeeding should be discontinued.

  Childhood use:

  Due to the lack of sufficient information on the use of the drug in children, the appointment of Niperten is contraindicated in patients under the age of 18 years.

  Terms and conditions of storage:

  Keep out of the reach of children.

  Store at temperatures up to 25 ? C.

  Shelf life is 2 years.

  Terms of dispensing from pharmacies:

  Dispensed by prescription.