Coronal, 10 mg 30 pcs

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

It has no membrane stabilizing effect. Reduces plasma renin activity, reduces myocardial oxygen demand, reduces HR at rest and under load. It has hypotensive, antiarrhythmic and antianginal action.

Hypotensive effect is associated with a decrease in the minute blood volume, sympathetic stimulation of peripheral vessels, decrease in the activity of renin-angiotensin system (of greater importance for patients with initial hypersecretion of renin), restoration of sensitivity in response to BP reduction and influence on CNS. In arterial hypertension hypotensive effect develops in 2-5 days, stable effect – in 1-2 months.

The antianginal action is caused by decrease of myocardial oxygen demand as the result of shortening of HR and decrease of contractility, prolongation of diastole, improvement of myocardial perfusion. By increasing left ventricular end-diastolic pressure and increasing ventricular muscle fiber stretch, oxygen demand may increase, particularly in patients with chronic heart failure.

Antiarrhythmic action is caused by the removal of arrhythmogenic factors (tachycardia, increased activity of the sympathetic nervous system, increased content of CAMF, arterial hypertension), reduction of the rate of spontaneous excitation of sinus and ectopic pacemakers and slowing of AV conduction (mainly in the antegrade and, to a lesser extent, in the retrograde direction via the AV node) and conduction along accessory pathways. When administered in medium therapeutic doses, unlike non-selective beta-adrenoblockers, it has less pronounced effect on the organs containing 2 -adrenoreceptors (pancreas, skeletal muscles, smooth muscle of peripheral arteries, bronchi and uterus) and on carbohydrate metabolism, does not cause sodium ions retention in the body. When used in high doses (200 mg and more) it has a blocking effect on both subtypes of ?-adrenoreceptors, mainly in the bronchi and vascular smooth muscle.

Indications

Active ingredient

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 (E171), iron oxide red (E172).

How to take, the dosage

The drug is administered orally at 2.5-5 mg once daily. If necessary, the dose is increased to 10 mg once daily. The maximum daily dose is 20 mg.

The tablets should be taken in the morning on an empty stomach without chewing.

Perhaps with renal dysfunction: or liver In patients with renal dysfunction with a creatinine clearance of less than 20 ml/min or with significant liver dysfunction, the maximum daily dose is 10 mg.

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.

In concomitant use with Coronal, iodine-containing intravenous radiopaque drugs increase the risk of anaphylactic reactions.

Concomitant use of IV phenytoin, drugs for inhalation general anesthesia (hydrocarbon derivatives) increases the severity of cardiodepressive effects and the likelihood of BP reduction with Coronal.

In concomitant use, Coronal alters the effectiveness of insulin and oral hypoglycemic drugs and masks the symptoms of developing hypoglycemia (tachycardia, increased BP).

Concomitant use of Coronal decreases clearance of lidocaine and xanthines (except diphylline) and increases their plasma concentrations, especially in patients with initially increased clearance of theophylline due to smoking.

The NSAIDs (due to retention of sodium ions and blockade of prostaglandin synthesis by the kidneys), GCS and estrogens (due to retention 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 may lead to a significant decrease in BP.

Diuretics, clonidine, sympatholytics, hydralazine and other hypotensive drugs may cause excessive BP reduction when used concomitantly with Coronal.

Coronal prolongs the effects of nondepolarizing myorelaxants and the anticoagulant effect of coumarins.

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

The concomitant use of Coronal with MAO inhibitors is not recommended due to a significant increase in hypotensive effect; a break in treatment between MAO inhibitors and Coronal should be at least 14 days.

When used concomitantly with Coronal, nonhydrogenated ergot alkaloids, ergotamine increase the risk of peripheral circulatory disorders.

Sulfasalazine increases the plasma concentration of bisoprolol when used concomitantly with Coronal.

In concomitant use with Coronal, rifampicin shortens the half-life of bisoprolol.

Special Instructions

When prescribing Coronal, HR and BP should be monitored regularly (daily at the beginning of treatment, then once every 3-4 months), ECG should be performed, blood glucose levels should be determined in diabetic patients (once every 4-5 months). In elderly patients it is recommended to control kidney function (once every 4-5 months). The patient should be taught the method of heart rate calculation and instructed to consult a physician if the heart rate is less than 50 bpm. It is recommended that patients with a poor bronchopulmonary history have an external respiratory function study prior to initiating treatment.

It should be considered that in approximately 20% of angina patients beta-adrenoblockers are ineffective because of severe coronary atherosclerosis with low threshold of ischemia (HR less than 100 bpm) and increased left ventricular end-diastolic volume, which impairs subendocardial blood flow. In patients who smoke, the effectiveness of beta-adrenoblockers is reduced.

Patients who wear contact lenses should be aware that tear fluid production may decrease with treatment. When using Coronal in patients with pheochromocytoma, there is a risk of paradoxical arterial hypertension (if effective alpha-adrenoblockade has not been previously achieved). Bisoprolol may mask certain clinical signs of thyrotoxicosis (e.g., tachycardia). Abrupt withdrawal of Coronal in patients with thyrotoxicosis is contraindicated, since it may exacerbate the symptoms of the disease. In patients with diabetes mellitus, bisoprolol may mask the tachycardia caused by hypoglycemia. Unlike non-selective beta-adrenoblockers, it practically does not increase insulin-induced hypoglycemia and does not delay the recovery of blood glucose concentration to normal levels.

If clonidine is taken concomitantly, its administration may be discontinued only after several days of bisoprolol withdrawal. It is possible to increase the severity of hypersensitivity reactions and lack of effect of usual doses of epinephrine (adrenaline) against the background of a history of aggravated allergy. If planned surgical treatment is necessary, the drug shall be withdrawn 48 hours before the start of general anesthesia. If the patient has taken the drug before the surgery, he should choose the drug for general anesthesia with minimal negative inotropic effect.

The reciprocal activation of the vagus nerve can be eliminated by IV administration of atropine (1-2 mg). Drugs that reduce catecholamine stores (including reserpine ) may potentiate the effects of beta-adrenoblockers, so patients taking such combinations of drugs should be under constant medical supervision for marked BP reduction or bradycardia. Patients with concomitant bronchospastic disorders may be prescribed cardioselective adrenoblockers if other hypotensive drugs are intolerant and/or ineffective. Overdose is dangerous with the development of bronchospasm.

It is recommended to discontinue therapy if depression develops. Treatment should not be abruptly interrupted because of the risk of severe arrhythmias and myocardial infarction. Withdrawal is carried out gradually, reducing the dose over 2 weeks or more (the dose is reduced by 25% every 3 to 4 days). The drug should be discontinued before conducting blood and urine studies of catecholamines, methanephrines, vanillinmindalic acid, and antinuclear antibody titers.

In elderly patients with increasing bradycardia (less than 50 bpm), marked BP decrease (systolic BP below 100 mmHg), AV blockade, the dose should be reduced or the treatment should be stopped.

When treating, caution should be exercised while driving motor vehicle and engaging in other potentially hazardous activities requiring increased concentration and quick psychomotor reactions.

Contraindications

The drug should be prescribed with caution in the following cases:

Side effects

The frequency of side effects is defined as follows: very common (≥1/10), common (≥1/100) and CNS and peripheral nervous system: infrequent – fatigue, asthenia, dizziness, headache, somnolence or insomnia, depression; rare – hallucinations, nightmares, seizures.
The sensory organs: rare – visual impairment, decreased tear fluid secretion, dry and painful eyes, hearing impairment; very rare – conjunctivitis.
Cardio-vascular system: very often – sinus bradycardia, often – decrease of blood pressure, angiospasm symptoms (increase of peripheral circulation disturbance, cooling of lower extremities, paresthesia), rarely – AV-conduction disturbance, orthostatic hypotension, decompensation of chronic heart failure, peripheral edema.
The digestive system: frequently – dry mouth, nausea, vomiting, diarrhea, constipation, rarely – hepatitis, increased liver transaminase activity.
Respiratory system: infrequent – difficulty in breathing when prescribed in high doses (loss of selectivity) and/or in susceptible patients – laryngo- and bronchospasm, rarely – nasal congestion, allergic rhinitis.
Endocrine system: rare – hyperglycemia (in patients with type 2 diabetes), hypoglycemia (in patients receiving insulin).
Allergic reactions: rare – skin itching, rash, urticaria.
Dermatological reactions: rare – increased sweating, flushing, very rare – psoriasis-like skin reactions, exacerbation of psoriasis symptoms, alopecia.
Musculoskeletal system: infrequent – muscle weakness, cramps of the calf muscles, arthralgia.
Blood system: in rare cases – thrombocytopenia, agranulocytosis.
Other: rare – hypertriglyceridemia, very rare – potency disorder, rare – withdrawal syndrome (increased angina pectoris attacks, increased blood pressure).

Overdose

Symptoms: arrhythmia, ventricular extrasystole, marked bradycardia, AV-blockade, decreased BP, heart failure, cyanosis of finger nails or palms, difficulty breathing, bronchospasm, dizziness, fainting, seizures.
Treatment: the stomach should be flushed and adsorptive drugs prescribed.

Symptomatic therapy is administered: in developed AV-blockade – IV injection of 1-2 mg of atropine, epinephrine (adrenaline) or placement of a temporary pacemaker; in ventricular extrasystole – IV lidocaine (Class I A drugs are not used); if BP decreases, the patient should be in Trendelenburg position; if there are no symptoms of pulmonary edema – IV plasma exchange solutions, if ineffective – injection of epinephrine (adrenaline), dopamine, dobutamine (to maintain chrono- and inotropic action and eliminate marked BP decrease); in heart failure – cardiac glycosides, diuretics, glucagon ; in convulsions – IV diazepam ; in bronchospasm – beta 2-adrenomimetics inhaled.

Pregnancy use

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

Bisoprolol administration during pregnancy may cause intrauterine growth retardation, hypoglycemia, and bradycardia in the fetus.

Similarities