Coronal, 5 mg 60 pcs

Coronal reduces plasma renin activity, decreases myocardial oxygen demand, reduces HR at rest and during exercise. It has hypotensive, antiarrhythmic and antianginal action.

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

Antianginal action is due to decrease of myocardial oxygen demand as a result of slow heart rate and decreased contractility, prolongation of diastole, improvement of myocardial perfusion. Due to increased end diastolic pressure in the left ventricle and increased stretching of ventricular muscle fibers, oxygen demand may increase, especially 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 spontaneous excitation rate of sinus and ectopic pacemakers and slowing of AV conduction (mainly in antegrade and, to a lesser extent, in retrograde direction via AV node) and conduction via additional pathways.

In medium therapeutic doses, in contrast to non-selective beta-adrenoblockers, it has less pronounced effect on the organs containing β2-adrenoreceptors (pancreas, skeletal muscles, smooth muscle of peripheral arteries, bronchi and uterus) and carbohydrate metabolism, does not cause delay of sodium ions in the body. When used in high doses (200 mg and more) it has a blocking effect on both subtypes of β-adrenoreceptors, mainly in the bronchi and vascular smooth muscle.

Indications

– arterial hypertension;
– CHD: prevention of angina attacks.

Active ingredient

Composition

1 tablet contains 5 mg Bisoprolol fumarate;

Supplementary substances:

Microcrystalline cellulose,

Corn starch,

sodium lauryl sulfate,

colloidal anhydrous silica,

magnesium stearate.

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. Maximal daily dose is 20 mg.

In patients with impaired renal function at CKR < 20 ml/min or with manifest liver dysfunction, maximal daily dose is 10 mg.

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

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 X-ray drugs for intravenous administration increase the risk of anaphylactic reactions.

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

With concomitant use Coronal changes the effectiveness of insulin and oral hypoglycemic drugs, masks the symptoms of developing hypoglycemia (tachycardia, BP increase).

Simultaneous 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 under the influence of smoking.

NSAIDs (due to retention of sodium ions and blockade of prostaglandin synthesis by kidneys), GCS and estrogens (due to retention of sodium ions) weaken the hypotensive effect of Coronal.

When concomitantly used 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 result in a significant decrease in BP.

When used concomitantly with Coronal, diuretics, clonidine, sympatholytics, hydralazine and other hypotensive medications may result in excessive BP decreases.

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

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

Simultaneous use of Coronal with MAO inhibitors is not recommended due to significant increase in hypotensive effect, the treatment interval between MAO inhibitors and Coronal should be at least 14 days.

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

In concomitant use with Coronal, sulfasalazine increases the plasma concentration of bisoprolol.

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

Special Instructions

The patient should be taught how to calculate the heart rate and instructed to consult a physician if the heart rate is less than 50 bpm.

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).

Before starting treatment it is recommended to carry out a study of external respiratory function in patients with a history of complicated bronchopulmonary disease.

It should be considered that in approximately 20% of angina patients beta-adrenoblockers are ineffective because of severe coronary atherosclerosis with low ischemic threshold (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 the treatment may decrease tear fluid production.

When using Coronal in patients with pheochromocytoma, there is a risk of paradoxical arterial hypertension (unless effective alpha-adrenoblockade has first been achieved).

Bisoprolol may mask certain clinical signs of thyrotoxicosis (e.g., tachycardia). Abrupt withdrawal of Coronal in patients with thyrotoxicosis is contraindicated because it may exacerbate the symptoms of the disease.

In diabetics 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 recovery of blood glucose concentration to normal levels.

If clonidine is taken at the same time, it may be discontinued only after several days of withdrawal of Coronal.

The severity of hypersensitivity reactions and lack of effect of the usual doses of epinephrine with a history of allergy may increase.

If planned surgical treatment is necessary, the drug should be withdrawn 48 hours before the start of general anesthesia. If the patient has taken the drug prior to surgery, the drug for general anesthesia should be selected 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) can potentiate the effects of beta-adrenoblockers, so patients taking these combinations of drugs should be under constant medical supervision for signs of marked lowering of BP or bradycardia.

Patients with concomitant bronchospastic disorders may be prescribed cardioselective adrenoblockers if other hypotensive medications are intolerant and/or ineffective. Overdose is dangerous with the development of bronchospasm.

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

The drug should be discontinued before blood and urine tests of catecholamines, normetanephrine, vanillylmindalic acid, and antinuclear antibody titers.

The treatment should not be abruptly interrupted because of the risk of severe arrhythmias and myocardial infarction. Withdrawal is done gradually, reducing the dose over 2 weeks or more (the dose is reduced by 25% every 3 to 4 days).

Pediatric use

The use of Coronal in children under 18 years of age is contraindicated because efficacy and safety have not been established.

Impact on driving and operating machinery

When using the drug, caution must be exercised while driving vehicles and engaging in other potentially dangerous activities requiring increased concentration and quick psychomotor reactions.

Contraindications

– pulmonary edema;
– acute cardiac insufficiency;
– shock (including. Acute heart failure;
– shock (including cardiogenic);
– collapse;
– Chronic heart failure in decompensation stage;
– AV-blockade of degree II and III;
– sinoatrial block;
– CCSU;
– expressed bradycardia;
– angiospastic angina (Prinzmetal angina);
– cardiomegaly (without signs of heart failure);
– arterial hypotension (systolic BP below 100 mm Hg).sts, Especially in myocardial infarction;
– history of bronchial asthma and chronic obstructive pulmonary disease;
– concurrent use of MAO inhibitors (except for MAO type B inhibitors);
– advanced peripheral circulatory disorders;
– Raynaud’s disease;
– pheochromocytoma (without simultaneous use of alpha-adrenoblockers);
– metabolic acidosis;
– age under 18 years (efficacy and safety not established);
– hypersensitivity to the drug components and other beta-adrenoblockers.

Side effects

The incidence 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, drowsiness or insomnia, depression; rare – hallucinations, nightmares, seizures.

Sensory organs: rare – visual impairment, decreased tear fluid secretion, dry and painful eyes, hearing impairment; very rare – conjunctivitis.

Cardiovascular system: very common – sinus bradycardia; common – decrease of BP, angiospasm manifestation (increase of peripheral circulation disturbance, coldness of lower extremities, paresthesia); infrequent – AV conduction disturbance, orthostatic hypotension, decompensation of chronic heart failure, peripheral edema.

Digestive system disorders: frequently – dry mouth, nausea, vomiting, diarrhea, constipation; rarely – hepatitis, increased liver transaminase activity.

Respiratory system disorders: 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: rarely – hyperglycemia (in patients with type 2 diabetes), hypoglycemia (in patients receiving insulin).

Allergic reactions: rare – skin itching, rash, urticaria.

Dermatological reactions: rare – increased sweating, skin hyperemia; very rare – psoriasis-like skin reactions, exacerbation of psoriasis symptoms, alopecia.

Muscular system disorders: infrequent – muscle weakness, cramps of the calves, arthralgia.

Hematopoietic system: in rare cases – thrombocytopenia, agranulocytosis.

Others: rarely – hypertriglyceridemia; very rarely – potency disorder, rarely – withdrawal syndrome (increased angina pectoris attacks, increased BP).

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 should be 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 to eliminate marked BP decrease); in heart failure – cardiac glycosides, diuretics, glucagon; in convulsions – IV diazepam; in bronchospasm – beta2adrenomimetics by inhalation.

Similarities