Description
Release form
Tablets.
Packing
60 pcs.
Pharmacological action
Coronal is a selective beta1-blocker without its own sympathomimetic activity. It does not have a membrane stabilizing effect. Reduces plasma renin activity, reduces myocardial oxygen demand, reduces heart rate at rest and during exercise. It has hypotensive, antiarrhythmic and antianginal effects.
The antihypertensive effect is associated with a decrease in minute blood volume, sympathetic stimulation of peripheral vessels, a decrease in the activity of the renin-angiotensin system (more important for patients with initial hypersecretion of renin), restoration of sensitivity in response to a decrease in blood pressure and effects on the central nervous system. With arterial hypertension, the hypotensive effect develops after 2-5 days, a stable effect – after 1-2 months.
Antianginal effect is due to a decrease in oxygen demand of the myocardium as a result of decreased heart rate and reduced contractility, lengthening of diastole, and improved myocardial perfusion. By increasing the final diastolic pressure in the left ventricle and increasing the stretching of the muscle fibers of the ventricles, oxygen demand may increase, especially in patients with chronic heart failure.
Antiarrhythmic effect is due to the elimination of arrhythmogenic factors (tachycardia, increased activity of the sympathetic nervous system, increased content of cAMP, arterial hypertension), a decrease in the rate of spontaneous excitation of sinus and ectopic pacemakers and a slowdown in AV conduction (mainly in antegrade and, to a lesser extent, in retrograde directions through the AV node) and conduction along additional paths. When used in medium therapeutic doses, unlike non-selective beta-blockers, it has a less pronounced effect on organs containing 2-adrenergic receptors (pancreas, skeletal muscle, smooth muscles of the peripheral arteries, bronchi and uterus) and does not cause carbohydrate metabolism delayed sodium ions in the body. When used in high doses (200 mg or more), it has a blocking effect on both subtypes of -Adrenoreceptors, mainly in the bronchi and smooth muscles of blood vessels.
Indications
– arterial hypertension
– IHD: prevention of angina attacks.
Contraindications
– shock
– collapse
– under 18 years old
– hypersensitivity to nitroglycerin and other organic nitrates.
With caution, the drug should be used in acute circulatory failure, accompanied by severe arterial hypotension (systolic blood pressure less than 90 mm Hg), with orthostatic hypotension, hemorrhagic stroke, acute myocardial infarction and chronic heart failure with low left ventricular filling pressure, hypertrophic cardiomyopathy severe renal and / or liver failure, severe anemia and thyrotoxicosis, alcoholism, epilepsy, traumatic brain injury, intracranial gi ertenzii, angle-closure glaucoma (risk of increased intraocular pressure), migraine. especially with myocardial infarction)
– bronchial asthma and chronic obstructive pulmonary disease with a history of
– concomitant use of MAO inhibitors (except for type B MAO inhibitors)
– late stages of peripheral circulation disturbance
– Raynaud’s disease
– pheochromocytoma blockers)
– metabolic acidosis
– under the age of 18 years (efficacy and safety have not been established)
– hypersensitivity to the drug and other beta-blockers oram.
Special instructions
When prescribing Coronal, heart rate and blood pressure should be regularly monitored (at the beginning of treatment daily, then 1 time every 3-4 months), an ECG should be performed, blood glucose levels should be determined in patients with diabetes mellitus (1 time every 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 advice for heart rate less than 50 bpm.
Before starting treatment, it is recommended to study the function of external respiration in patients with a history of bronchopulmonary burden.
It should be noted that in approximately 20% of patients with angina pectoris, beta-blockers are ineffective due to severe coronary atherosclerosis with a low threshold for ischemia (heart rate less than 100 beats. / min) and increased final diastolic volume of the left ventricle, which violates the subendocardial blood flow.
Beta-blockers are less effective in smokers.
Patients using contact lenses should consider that tear fluid production may be reduced during treatment.
When using Coronal in patients with pheochromocytoma, there is a risk of developing paradoxical hypertension (unless effective alpha-adrenoblockade is previously achieved).
Bisoprolol may mask certain clinical signs of thyrotoxicosis (e.g., tachycardia). Abrupt abolition of Coronal in patients with thyrotoxicosis is contraindicated, since it can enhance the symptoms of the disease.
In diabetes mellitus, bisoprolol may 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.
With the simultaneous administration of clonidine, its administration can be stopped only a few days after the cancellation of the drug Coronal.
It is possible to increase the severity of the hypersensitivity reaction and the lack of effect of the usual doses of epinephrine against the background of a burdened allergic history.
If it is necessary to carry out planned surgical treatment, drug withdrawal is carried out 48 hours before the start of general anesthesia. If the patient took the drug before surgery, he should choose a drug for general anesthesia with minimal negative inotropic effect.
Reciprocal vagus nerve activation can be eliminated iv by administration of 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 concomitant bronchospastic diseases can be prescribed cardioselective adrenergic blockers in case of intolerance and / or ineffectiveness of other antihypertensive drugs. An overdose is dangerous for the development of bronchospasm.
In the case of elderly patients with increasing bradycardia (less than 50 beats / min), a marked decrease in blood pressure (systolic blood pressure below 100 mmHg), AV blockade is necessary to reduce the dose or stop treatment.
It is recommended that therapy be discontinued if depression develops.
The drug should be discontinued before conducting a study of blood and urine levels of catecholamines, normetanephrine, vanillinindic acid, and antinuclear antibody titers.
Do not abruptly interrupt treatment because of the danger of developing severe arrhythmias and myocardial infarction. Cancellation is carried out gradually, reducing the dose for 2 weeks or more (the dose is reduced by 25% in 3-4 days).
Use in pediatrics
The use of the drug Coronal in children under 18 years of age is contraindicated, since efficacy and safety have not been established.
Effect on the ability to drive vehicles and control mechanisms
During treatment, care must be taken when driving vehicles and engaging in other potentially hazardous activities that require increased concentration of attention and speed of psychomotor reactions.
Composition
1 tablet contains 10 mg Bisoprolol fumarate
Excipients: microcrystalline cellulose, corn starch, sodium lauryl sulfate, anhydrous silicon dioxide colloidal anhydrous, magnesium stearate.
Dosage and administration
The drug is prescribed orally 2.5-5 mg 1 time / day. If necessary, increase the dose to 10 mg 1 time / day. The maximum daily dose is 20 mg.
In patients with impaired renal function with CC <20 ml / min or with severe impaired liver function, the maximum daily dose is 10 mg. Tablets should be taken in the morning on an empty stomach, without chewing. Side effects The frequency of occurrence of side effects is defined as follows: very often (? 1/10), often (? 1/100 and From the central nervous system and peripheral nervous system: infrequently – increased fatigue, asthenia, dizziness, headache, drowsiness or insomnia, depression rarely – hallucinations, nightmares, cramps. From the sensory organs: rarely – impaired vision, decreased secretion of lacrimal fluid, dry and sore eyes, hearing impairment is very rare – conjunctivitis. From the cardiovascular system: very often – sinus bradycardia often – decrease in blood pressure, manifestation of angiospasm (increased disturbance of peripheral circulation, cooling of the lower extremities, paresthesia) infrequently – violation of AV conduction, orthostatic hypotension, decompensation of chronic heart failure, peripheral edema. From the digestive system: often – dry mucous membranes of the oral cavity, nausea, vomiting, diarrhea, constipation rarely – hepatitis, increased activity of hepatic transaminases. From the respiratory system: infrequently – difficulty breathing when prescribed in high doses (loss of selectivity) and / or in predisposed patients – laryngo- and bronchospasm rarely – nasal congestion, allergic rhinitis. From the endocrine system: rarely – hyperglycemia (in patients with type 2 diabetes), hypoglycemia (in patients receiving insulin). Allergic reactions: rarely – skin itching, rash, urticaria. Dermatological reactions: rarely – increased sweating, skin hyperemia very rarely – psoriasis-like skin reactions, exacerbation of psoriasis symptoms, alopecia. From the musculoskeletal system: infrequently – muscle weakness, cramps in the calf muscles, arthralgia. From the hemopoietic system: in some cases – thrombocytopenia, agranulocytosis. Other: rarely – hypertriglyceridemia very rarely – impaired potency, rarely – withdrawal syndrome (increased angina attacks, increased blood pressure). 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. When used simultaneously with Coronal, iodine-containing radiopaque drugs for intravenous administration increase the risk of anaphylactic reactions. When used simultaneously with Coronal, phenytoin for iv administration, drugs for inhalation general anesthesia (hydrocarbon derivatives) increase the severity of cardiodepressive action and the likelihood of lowering blood pressure. With the simultaneous use of Coronal changes the effectiveness of insulin and oral hypoglycemic drugs, masks the symptoms of developing hypoglycemia (tachycardia, increased blood pressure). With simultaneous use, Coronal reduces the clearance of lidocaine and xanthines (except diphillin) and increases their concentration in plasma, especially in patients with initially increased clearance of theophylline under the influence of smoking. NSAIDs (due to the delay of sodium ions and blockade of prostaglandin synthesis by the kidneys), GCS and estrogens (due to the delay of sodium ions) weaken the hypotensive effect of Coronal. When used concomitantly with Coronal, cardiac glycosides, methyldopa, reserpine and guanfacine, slow calcium channel blockers (verapamil, diltiazem), amiodarone, and other antiarrhythmic drugs increase the risk of developing or worsening bradycardia, AV blockade, heart failure, and heart failure. When used concomitantly with Coronal, nifedipine can lead to a significant decrease in blood pressure. When used concomitantly with Coronal, diuretics, clonidine, sympatholytics, hydralazine and other antihypertensive drugs can lead to an excessive decrease in blood pressure. Coronal prolongs the action of non-depolarizing muscle relaxants and the anticoagulant effect of coumarins. When used simultaneously with Coronal, tricyclic and tetracyclic antidepressants, antipsychotic drugs (antipsychotics), ethanol, sedative and hypnotic drugs increase CNS depression. The simultaneous use of Coronal with MAO inhibitors is not recommended due to a significant increase in the hypotensive effect, the break in treatment between taking MAO inhibitors and Coronal should be at least 14 days. When used simultaneously with Coronal, non-hydrogenated ergot alkaloids, ergotamine increase the risk of peripheral circulation disorders. When used concomitantly with Coronal, sulfasalazine increases the plasma concentration of bisoprolol. When used simultaneously with Coronal, rifampicin shortens the elimination half-life of bisoprolol. Overdose Symptoms: arrhythmia, ventricular extrasystole, severe bradycardia, AV block, decreased blood pressure, heart failure, cyanosis of fingernails or palms of the fingers, difficulty breathing, bronchospasm, dizziness, fainting, convulsions. Treatment: it is necessary to rinse the stomach and prescribe absorbent drugs. Symptomatic therapy is carried out: in case of developed AV blockade, intravenous administration of 1-2 mg of atropine, epinephrine (adrenaline) or temporary pacemaker in case of ventricular extrasystole – intravenous lidocaine (class I A drugs are not used) with a decrease in blood pressure, the patient should be in the Trendelenburg position in the absence of symptoms of pulmonary edema – iv plasma-replacing solutions, with inefficiency – the introduction of epinephrine (adrenaline), dopamine, dobutamine (to maintain chrono- and inotropic effects and eliminate a pronounced decrease in blood pressure) in heart failure – cardiac glycosides, diuretics, glucagon for seizures – iv diazepam for bronchospasm – beta2-adrenergic agonists. Storage Conditions At 15 ° C to 25 ° C. Expiration 2 years. Active ingredient bisoprolol Terms leave through pharmacies In retseptu lekarstvennaja form tablets
