BISOGAMMA PILLS 10MG

Indications

- arterial hypertension;

- CHD: prevention of strokes.

Dosage and administration

The drug is administered orally at a dose of 5 mg 1 time / day, in the morning, on an empty stomach. If necessary, increase the dose to 10 mg 1 time / day. The maximum dose is 20 mg / day.

For elderly patients dose adjustment is not required.

Have patients with impaired renal function with CC <20 ml / min or with severe impaired liver function the maximum daily dose is 10 mg.

Tablets taken without chewing.

Adverse effects

From the side of the central nervous system and peripheral nervous system: fatigue, weakness, dizziness, headache, sleep disorders, depression, anxiety, confusion or short-term memory loss, hallucinations, asthenia, myasthenia gravis, paresthesias in the extremities (in patients with intermittent claudication and Raynaud's syndrome), tremor, convulsions.

From the senses: blurred vision, decreased secretion of tear fluid, dry and sore eyes, conjunctivitis.

Since the cardiovascular system: sinus bradycardia, palpitations, myocardial conduction disturbances, AV-blockade (up to the development of complete transverse blockade and cardiac arrest), weakening of myocardial contractility, development (worsening) of chronic heart failure (ankles swelling,Stop; dyspnea), 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: dry oral mucosa, nausea, vomiting, abdominal pain, constipation or diarrhea, abnormal liver function (dark urine, jaundice of sclera or skin, cholestasis), changes in liver enzymes (increased ALT, ACT) and bilirubin levels, 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.

On the part of the endocrine system: hyperglycemia (in patients with insulin-dependent diabetes mellitus), hypoglycemia (in patients receiving insulin), a hypothyroid state.

From the hemopoietic system: thrombocytopenia (unusual bleeding and hemorrhage), agranulocytosis, leukopenia.

Musculoskeletal system: back pain, arthralgia, cramps in the calf muscles.

From the reproductive system: weakening of libido, reduced potency.

Allergic reactions: skin itch, rash, urticaria.

Dermatological reactions: increased sweating, skin hyperemia, rash, psoriasis-like skin reactions, exacerbation of psoriasis symptoms, alopecia.

Effect on the fetus: intrauterine growth retardation, hypoglycemia, bradycardia.

Other: withdrawal syndrome (increased angina attacks, increased blood pressure), an increase in triglycerides.

Contraindications

- shock (including cardiogenic);

- collapse;

- pulmonary edema;

- acute heart failure;

- chronic heart failure in the stage of decompensation;

- AV blockade II and III degree;

- sinoatrial block;

- SSSU;

- severe bradycardia;

- Prinzmetal angina;

- Cardiomegaly (without signs of heart failure);

- arterial hypotension (systolic pressure <100 mm Hg, especially in myocardial infarction);

- severe forms of bronchial asthma and other obstructive respiratory diseases;

- late stages of impaired peripheral circulation, Raynaud's disease;

- pheochromocytoma (without the simultaneous use of alpha-blockers);

- metabolic acidosis;

- depression;

- simultaneous administration of MAO inhibitors (with the exception of inhibitors of MAO type B);

- children's and teenage age up to 18 years;

- hypersensitivity to the components of the drug and other beta-blockers.

WITH caution It should be prescribed to patients with liver failure, chronic renal failure, myasthenia, thyrotoxicosis, diabetes mellitus, AV-blockade of I degree, psoriasis; with indications of a history of depression, allergic reactions; elderly patients.

Use during pregnancy and lactation

Prescription of the drug during pregnancy and lactation is possible only in the case when the intended benefits to the mother outweigh the potential risk to the fetus or infant.

Application for violations of the liver

Precautions should be prescribed to patients with hepatic insufficiency.

Application for violations of kidney function

Precautions should be prescribed to patients with chronic renal failure.

Use in children

Use in children under 18 years of age is contraindicated.

Use in elderly patients

Precautions should be prescribed medication to elderly patients.

Special notes

Monitoring patients taking the drug Bisogamma®, includes measurement of heart rate and blood pressure (at the beginning of treatment - daily, then 1 time in 3-4 months), ECG, determination of blood glucose levels with concomitant 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 counting 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 severe coronary atherosclerosis with a low ischemic threshold (HR less than 100 beats / min) and an increased end-diastolic volume of the left ventricle, which violates the subendocardial blood flow.

When using the drug in patients with pheochromocytoma, there is a risk of development of paradoxical arterial hypertension (unless an effective blockade of α-adrenoreceptors is previously achieved).

With thyrotoxicosis, Bisoprolol may mask certain clinical symptoms of thyrotoxicosis (for example, tachycardia). Abrupt withdrawal of the drug Bisogamma® in patients with thyrotoxicosis is contraindicated because it can increase symptoms.

In diabetes Bisogamma® may mask tachycardia caused by hypoglycemia. Unlike non-selective beta-adrenergic blockers, insulin-induced hypoglycemia practically does not increase and does not delay the restoration of glucose concentration in the blood to normal levels.

Perhaps increased severity of hypersensitivity reactions and the lack of effect of the usual doses of epinephrine on the background of burdened allergic history.

If it is necessary to conduct a planned surgical treatment, the drug Bisogamma® should be canceled 48 hours before general anesthesia begins. If the patient took the drug before the operation, he should choose a drug for general anesthesia with minimal negative inotropic effect.

Reciprocal activation of the vagus nerve can be eliminated by / in the introduction of atropine (1-2 mg).

Drugs that reduce the supply of catecholamines (including reserpine) can enhance the action of beta-blockers, so patientsthose taking such combinations of drugs should be under constant medical supervision for timely control of pronounced decrease in blood pressure or bradycardia.

Cardioselective adrenoblockers can be prescribed to patients with bronchospastic diseases in case of intolerance and / or ineffectiveness of other antihypertensive drugs. Overdose is dangerous for the development of bronchospasm.

In case of an increase in bradycardia (less than 50 beats / min) in elderly patients, a pronounced decrease in blood pressure (systolic blood pressure below 100 mm Hg), AV blockade, it is necessary to reduce the dose or stop treatment.

It is recommended to stop therapy in the development of depression.

You can not abruptly interrupt treatment because of the risk of severe arrhythmia and myocardial infarction. Cancellation is carried out gradually, reducing the dose for 2 weeks or more (reduce the dose by 25% in 3-4 days).

When used in combination with clonidine, its administration can be stopped only a few days after the abolition of bisoprolol.

In smoking patients, the effectiveness of beta-blockers is lower.

Patients using contact lenses should take into account that with Bisogamma treatment, a reduction in the production of tear fluid is possible.

The drug should be discontinued before the examination of the content in the blood and urine of catecholamines, normetanephrine and vanillimindal acid, titers of antinuclear antibodies.

Influence on ability to drive motor transport and control mechanisms

During the treatment period, patients should take care when driving vehicles and engaging in other potentially hazardous activities that require increased concentration and psychomotor speed.

Overdose

Symptoms: 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 prescription absorbent drugs. Symptomatic therapy: with advanced AV-blockade - in / in the introduction of 1-2 mg of atropine, epinephrine or staging a temporary pacemaker; with ventricular extrasystole - Lidocaine (class IA drugs are not used). With a decrease in blood pressure, the patient should be in the Trendelenburg position; if there are no signs of pulmonary edema - in / in 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.

Drug interaction

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 drugs for IV administration increase the risk of Anaphylactic reactions in patients receiving bisoprolol.

Phenytoin with the on / in the introduction, drugs for inhalation general anesthesia (hydrocarbon derivatives) increase the severity of the cardiodepressive action and the likelihood of blood pressure reduction in patients receiving bisoprolol.

Bisoprolol changes the effectiveness of insulin and oral hypoglycemic drugs, masks the symptoms of developing hypoglycemia (tachycardia, increased blood pressure).

Bisoprolol reduces the clearance of lidocaine and xanthines (except for difillin) and increases their plasma concentration, especially in patients with initially elevated clearance of theophylline under the influence of smoking.

The hypotensive effect of bisoprolol is reduced 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 antiarrhythmics, while used with bisoprolol, increase the risk of developing or worsening bradycardia, AV blockade, cardiac arrest and heart failure.

With simultaneous use with Nifedipine , a significant decrease in blood pressure is possible.

When used simultaneously with bisoprolol, diuretics, clonidine, sympatholytics, hydralazine and other antihypertensive drugs can lead to an excessive decrease in blood pressure.

Bisoprolol prolongs the action of non-depolarizing muscle relaxants and the anticoagulant effect of coumarins.

Three - and tetracyclic antidepressants, antipsychotic drugs (neuroleptics), ethanol, sedatives and hypnotic drugs increase the inhibitory effect of bisoprolol on 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 (including ergotamine) with simultaneous use with bisoprolol increase the risk of developing peripheral circulatory disorders.

Sulfasalazine increases the concentration of bisoprolol in the blood plasma.

Rifampicin reduces T1/2 bisoprolol.

Terms and conditions of storage

List B. The drug should be kept out of the reach of children at a temperature not exceeding 25 ° C.