Coronal, pills 10mg, 30pcs

Composition

1 coated tablet contains:

bisoprolol fumarate 10 mg.

Auxiliary substances:

microcrystalline cellulose,

corn starch,

sodium lauryl sulfate,

colloidal anhydrous silicon dioxide,

magnesium stearate.

Shell composition:

hypromellose, macrogol 400, titanium dioxide (E 171), iron oxide red (E 172).

Pharmacological action

Coronal is a selective beta-1-adrenoblocker without its own sympathomimetic activity.

It does not have a membrane-stabilizing effect. Reduces the activity of plasma renin, reduces the need for myocardial oxygen, reduces heart rate at rest and during exercise. It has antihypertensive, 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 (it is more important for patients with initial hypersecretion of renin), restoration of sensitivity in response to a decrease in blood pressure, and an effect on the central nervous system. With arterial hypertension, the hypotensive effect develops in 2-5 days, and a stable effect-in 1-2 months.

The antianginal effect is caused by a decrease in the myocardial oxygen demand as a result of a decrease in heart rate and contractility, an elongation of the diastole, and an improvement in 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.

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 conduction along additional pathways. When used in medium therapeutic doses, unlike non-selective beta-blockers, it has a less pronounced effect on the organs containing 2-adrenergic receptors (pancreas, skeletal muscles, smooth muscles of peripheral arteries, bronchi and uterus) and on carbohydrate metabolism, does not cause sodium ion retention in the body. When used in high doses (200 mg or more), it has a blocking effect on both subtypes ?- adrenoreceptors, mainly in the bronchi and vascular smooth muscles.

Indications

• Arterial hypertension.
• IHD: prevention of angina attacks.

Use during pregnancy and lactation

The use of Coronal during pregnancy and lactation is possible if the intended benefit to the mother exceeds the risk of side effects in the fetus or child.

When taking bisoprolol during pregnancy, the fetus may have intrauterine growth retardation, hypoglycemia, and bradycardia.

Contraindications

• Shock.
• Collapse.
• Pulmonary edema.
• Acute heart failure.
• Chronic heart failure in the stage of decompensation.
• AV blockage of II and III degrees.
• Sinoatrial blockade.
• SSSU.
• Severe bradycardia.
• Angiospastic angina pectoris.
• Cardiomegaly.
• Arterial hypotension (systolic blood pressure below 100 mm Hg, especially in myocardial infarction).
• A history of bronchial asthma and chronic obstructive pulmonary disease.
• Simultaneous use of MAO inhibitors.
• Late stages of peripheral circulatory disorders.
• Raynaud’s disease.
• Pheochromocytoma.
• Metabolic acidosis.
• Under 18 years of age.
• Hypersensitivity to the components of the drug and other beta-blockers.

Caution should be exercised when prescribing the drug in the following cases: :

• Liver failure.
• Chronic renal failure.
• Myasthenia gravis.
• Thyrotoxicosis.
• Diabetes mellitus.
• AV blockage of the first degree.
• Psoriasis.
• Depression.
• Elderly patients.

Side effects

The frequency of side effects is determined as follows: very common (≥1/10), common (≥1/100) from the central nervous system and peripheral nervous system: infrequently-increased fatigue, asthenia, dizziness, headache, drowsiness or insomnia, depression; rarely-hallucinations, nightmares, convulsions. From the sensory organs: rarely-visual impairment, decreased secretion of tear fluid, dry and painful eyes, hearing impairment; very rarely-conjunctivitis. From the cardiovascular system: very often – sinus bradycardia; often-a decrease in blood pressure, angiospasm (increased peripheral circulatory disorders, cold of the lower extremities, paresthesia); infrequently – violation of AV conduction, orthostatic hypotension, decompensation of chronic heart failure, peripheral edema. From the digestive system: often – dryness of the oral mucosa, 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 mellitus), hypoglycemia (in patients receiving insulin). Allergic reactions: rarely-skin pruritus, rash, urticaria. Dermatological reactions: rarely-increased sweating, hyperemia of the skin; 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 hematopoietic system: in some cases – thrombocytopenia, agranulocytosis. Other: rarely-hypertriglyceridemia; very rarely-violation of potency, rarely-withdrawal syndrome (increased angina attacks, increased blood pressure).

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.

When used concomitantly with Coronal, iodine-containing radiopaque drugs for intravenous use increase the risk of anaphylactic reactions.

When used concomitantly with Coronal phenytoin for intravenous use, drugs for inhaled general anesthesia (hydrocarbon derivatives) increase the severity of cardiodepressive effects and the likelihood of lowering blood pressure.

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

When used concomitantly, Coronal reduces the clearance of lidocaine and xanthines (except diphylline) and increases their plasma concentrations, especially in patients with an initially increased clearance of theophylline under the influence of smoking.

NSAIDs (by delaying sodium ions and blocking prostaglandin synthesis by the kidneys), corticosteroids and estrogens (by delaying sodium ions) weaken the hypotensive effect of Coronal.

When used concomitantly with Coronal, cardiac glycosides, methyldopa, reserpine and guanfacine, slow calcium channel blockers Other antiarrhythmic medications (verapamil, diltiazem ), amiodarone, and other antiarrhythmic medications increase the risk of developing or worsening bradycardia, AV block, cardiac arrest, 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 effect of non-depolarizing muscle relaxants and the anticoagulant effect of coumarins.

When used concomitantly with Coronal, tricyclic and tetracyclic antidepressants, antipsychotic drugs (neuroleptics), ethanol, sedatives and hypnotic drugs increase CNS depression.

Concomitant use of Coronal with MAO inhibitors is not recommended due to a significant increase in the antihypertensive effect, a break in treatment between taking MAO inhibitors and Coronal should be at least 14 days.

When used concomitantly with Coronal, non-hydrogenated ergot alkaloids and ergotamine increase the risk of developing peripheral circulatory disorders.

When used concomitantly with Coronal, sulfasalazine increases the concentration of bisoprolol in plasma.

When used concomitantly with Coronal, rifampicin shortens the half-life of bisoprolol.

How to take it, course of use and dosage

The drug is prescribed orally at 2.5-5 mg 1 time/day. If necessary, the dose is increased to 10 mg 1 time/day. The maximum daily dose is 20 mg.

Tablets should be taken in the morning on an empty stomach, without chewing.

Use in patients with impaired renal or hepatic function In patients with impaired renal function with creatinine clearance less than 20 ml / min or with severe hepatic impairment, the maximum daily dose is 10 mg.

Overdose

Symptoms: arrhythmia, ventricular extrasystole, severe bradycardia, AV block, decreased blood pressure, heart failure, cyanosis of the fingernails or palms, difficulty breathing, bronchospasm, dizziness, fainting, convulsions. Treatment: it is necessary to wash the stomach and prescribe adsorbent drugs.

Symptomatic therapy is performed: if AV block develops, intravenous use of 1-2 mg of atropine, epinephrine (epinephrine) or setting up a temporary pacemaker; with 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, intravenous plasma-substituting solutions, if ineffective – use of epinephrine (epinephrine), dopamine, dobutamine (to maintain chrono – and inotropic effects and eliminate a pronounced decrease in blood pressure); in heart failure – cardiac glycosides, diuretics, glucagon ; in convulsions – IV diazepam ; in bronchospasm – beta – 2 – adrenomimetics by inhalation.

Special instructions

When prescribing Coronal, you should regularly monitor your heart rate and blood pressure (at the beginning of treatment – daily, then – 1 time in 3-4 months), conduct an ECG, and determine the 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 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 the function of external respiration in patients with a burdened bronchopulmonary history.

It should be taken into account that beta-blockers are ineffective in approximately 20% of patients with angina pectoris due to severe coronary atherosclerosis with a low ischemic threshold (heart rate less than 100 beats/min) and an increased end diastolic volume of the left ventricle, which disrupts subendocardial blood flow. In smoking patients, the effectiveness of beta-blockers decreases.

Patients who use contact lenses should take into account that during treatment, there may be a decrease in the production of tear fluid. When using Coronal in patients with pheochromocytoma, there is a risk of developing paradoxical arterial hypertension (if an effective alpha-adrenoblockade is not achieved beforehand). Bisoprolol may mask certain clinical signs of thyrotoxicosis (for example, tachycardia). Abrupt withdrawal of Coronal in patients with thyrotoxicosis is contraindicated, since it can increase the symptoms of the disease. In diabetes mellitus, bisoprolol can mask tachycardia caused by hypoglycemia. Unlike non-selective beta-blockers, it practically does not increase insulin-induced hypoglycemia and does not delay the restoration of blood glucose concentration to normal levels.

When taking clonidine at the same time, it can be stopped only a few days after the withdrawal of bisoprolol. It is possible to increase the severity of the hypersensitivity reaction and the lack of effect from conventional doses of epinephrine (epinephrine) against the background of a burdened allergic history. If elective surgical treatment is necessary, the drug is withdrawn 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 activation of the vagus nerve can be eliminated by intravenous use of atropine (1-2 mg). Drugs that reduce the supply of catecholamines (including reserpine) can increase the effect of beta-blockers, so patients taking such combinations of drugs should be constantly monitored by a doctor for a pronounced decrease in blood pressure or bradycardia. Patients with concomitant bronchospastic diseases can be prescribed cardioselective adrenoblockers in case of intolerance and / or ineffectiveness of other antihypertensive drugs. Overdose is dangerous for the development of bronchospasm.

It is recommended to stop therapy if depression develops. Do not abruptly interrupt treatment due to the risk of developing severe arrhythmias and myocardial infarction. Withdrawal is carried out gradually, reducing the dose for 2 weeks or more (the dose is reduced by 25% in 3-4 days). The drug should be discontinued before testing the content of catecholamines, metanephrines, vanillinmindalic acid, and anti-nuclear antibody titers in the blood and urine.

If elderly patients develop increasing bradycardia (less than 50 beats / min), a marked decrease in blood pressure (systolic blood pressure below 100 mm Hg), AV-blockade, the dose should be reduced or treatment should be discontinued.

During the treatment period, care should be taken when driving vehicles and engaging in other potentially dangerous activities that require increased concentration of attention and speed of psychomotor reactions.

Form of production

Pills.

Storage conditions

In a dark place, at a temperature of 15-25 °C

Shelf life

2 years

Active ingredient

Bisoprolol

Conditions of release from pharmacies

By prescription

Dosage form

Tablets