Niperten pills 2.5mg №100

Dosage form

Film Coated Tablets

Composition

1 tab. contains Bisoprolol fumarate 2.5 mg;
Excipients: MCC; carboxymethyl starch sodium; Povidone; silica colloidal anhydrous; Magnesium stearate;
shell: hypromellose; macrogol; titanium dioxide; talc

Packing

100 pieces.

Mechanism of action

Niperten has a hypotensive, antianginal, antiarrhythmic effect.

Indications and usage

• arterial hypertension;
• IHD: prevention of strokes;
• CHF.

Contraindications

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

Pregnancy and Breastfeeding

Use during pregnancy and lactation is possible in the case when the expected benefit of therapy for the mother exceeds the risk of side effects in the fetus or infant. It should be borne in mind that the drug can cause fetal delay, fetal hypoglycemia, bradycardia. There is no data on the allocation of bisoprolol with breast milk. Therefore, if necessary, use of the drug during lactation breastfeeding should be stopped.

Dosage and administration

Niperten is taken orally, in the morning on an empty stomach, without chewing, once. It is recommended to take 5 mg once. If necessary, increase the dose to 10 mg 1 time per day. The maximum daily dose is 20 mg.

Adverse reactions

CNS and peripheral nervous system: fatigue, weakness, dizziness, headache, sleep disorders, depression, anxiety, confusion or short-term memory loss, hallucinations, asthenia, myasthenia gravis, paresthesia in the limbs (in patients with intermittent claudication and Raynaud's syndrome), tremor, convulsions (including calf muscles).
On the part of the organ of vision: blurred vision, decreased secretion of tear fluid, dry and sore eyes, conjunctivitis.
Cardiovascular: sinus bradycardia, palpitations, myocardial conduction disturbance, AV blockade (up to the development of complete transverse blockade and cardiac arrest), arrhythmias, weakening of myocardial contractility, development (worsening) of CHF (swelling of the ankles, feet; shortness of breath), decrease in blood pressure, orthostatic hypotension, manifestation of angiospasm (increased disturbance of peripheral circulation, cooling 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, abnormal liver function (dark urine, sclera or skin yellowness, cholestasis), changes in taste.
On the part of the respiratory system: nasal congestion, difficulty breathing when administered in high doses (loss of selectivity) and / or in predisposed patients - laryngo and bronchospasm.
From the endocrine system: hyperglycemia (in patients with insulin-independent diabetes), hypoglycemia (in patients receiving insulin), a hypothyroid state.
Allergic reactions: itchy skin, rash, urticaria.
Dermatologic: increased sweating, skin hyperemia, exanthema, psoriasis-like skin reactions, exacerbation of psoriasis symptoms, alopecia.
Laboratory values: thrombocytopenia (unusual bleeding and hemorrhage), agranulocytosis, leukopenia, changes in the activity of liver enzymes (increased ALT, ACT, bilirubin levels, triglycerides.
Impact on the fetus: intrauterine growth retardation, hypoglycemia, bradycardia.
Other: back pain, arthralgia, decreased libido, decreased potency, withdrawal syndrome (increased angina attacks, increased blood pressure).

Special notes

The condition of patients receiving Niperten should be monitored: measurement of heart rate and blood pressure (at the beginning of treatment - daily, then - once every 3-4 months), ECG, determination of blood glucose level in patients with diabetes mellitus (1 time in 4-5 months ). In elderly patients, it is recommended to monitor renal function (1 time in 4-5 months). The patient should be trained in the method of calculating heart rate and instructed on the need for medical consultation with a heart rate of less than 50 bpm. Before starting treatment, it is recommended to conduct a study of the function of external respiration in patients with a burdened bronchopulmonary history. In approximately 20% of patients with stenocardia, beta-blockers are ineffective. The main reasons are pronounced coronary atherosclerosis with a low ischemic threshold (HR less than 100 beats / min) and an increased terminal diastolic volume of the left ventricle, which violates the subendocardial blood flow. In smokers, the effectiveness of beta-blockers below. Patients using contact lenses should take into account that a decrease in the production of tear fluid is possible during treatment.

Drug interactions

Allergens used for immunotherapy or allergen extracts for skin tests increase the risk of severe systemic allergic reactions or anaphylaxis in patients receiving bisoprolol.Iodine-containing radiopaque agents for iv administration increase the risk of Anaphylactic reactions. Phenytoin with the on / in the introduction, means for inhalation anesthesia (derivatives of hydrocarbons) increase the severity of the cardiodepressive action of bisoprolol and the likelihood of lowering blood pressure. Nipertenis alters the effectiveness of insulin and hypoglycemic agents for oral administration, masks the symptoms of developing hypoglycemia (tachycardia, increased blood pressure). Bisoprolol reduces the clearance of Lidocaine and xanthines (except for theophylline) and increases their concentration in the blood plasma, especially in patients with initially elevated clearance of theophylline under the influence of smoking. The hypotensive effect is weakened by NSAIDs (sodium ion retention and blockade of prostaglandin synthesis by the kidneys), GCS and estrogens (sodium ion retention). 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-blockade, cardiac arrest and heart failure. Nifedipine can lead to a significant decrease in blood pressure. Diuretics, clonidine, sympatholytic, hydralazine and other antihypertensive drugs can lead to an excessive decrease in blood pressure. It prolongs the action of non-depolarizing muscle relaxants and increases the anticoagulant effect of coumarins. Three - and tetracyclic antidepressants, antipsychotics (neuroleptics), ethanol, sedatives and hypnotic drugs increase the depression of the central nervous system. It is not recommended simultaneous use with MAO inhibitors, due to a significant increase in the hypotensive effect, the interval in treatment between taking MAO inhibitors and bisoprolol should be at least 14 days. Unhydrogenated ergot alkaloids increase the risk of developing disorders of the peripheral circulation. Ergotamine increases the risk of developing impaired peripheral circulation; Sulfasalazine increases the concentration of bisoprolol in the blood plasma; rifampicin reduces.

Symptoms:arrhythmia, ventricular premature beats, severe bradycardia, AV blockade, marked reduction in blood pressure, chronic heart failure, cyanosis of the finger or palm nails, difficulty in breathing, bronchospasm, dizziness, fainting, convulsions.
Treatment:gastric lavage and the appointment of absorbent funds. Symptomatic therapy: with developed AV blockade - in / in the introduction of 1-2 mg of atropine, epinephrine or temporary staging of a pacemaker; for ventricular premature beats, lidocaine (class I A drugs are not used); with a decrease in blood pressure - the patient should be in the position of Trendelenburg; if there are no signs of pulmonary edema - in / in the introduction of plasma-substituting solutions, with ineffectiveness - administration of epinephrine, dopamine, dobutamine (to maintain chronotropic and inotropic action and eliminate pronounced decrease in blood pressure); in heart failure - cardiac glycosides, diuretics, glucagon; with convulsions - in / in diazepam; with bronchospasm - beta₂-adrenostimulators inhalation.

In the dark place at a temperature of no higher than 25 ° C.