Coronal, 5 mg 30 pcs

Coronal is a selective beta1-adrenoblocker without sympathomimetic activity of its own. It has no membrane stabilizing effect. It reduces plasma renin activity, decreases myocardial oxygen demand, decreases HR at rest and under load. It has hypotensive, antiarrhythmic and anti-anginal action.

Hypotensive action is associated with the reduction of the blood minute volume, sympathetic stimulation of peripheral vessels, decrease of renin-angiotensin system activity (it is more important for patients with initial renin hypersecretion), restoration of sensitivity in response to lowering blood pressure and the effect on 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), the decrease of spontaneous excitation rate of sinus and ectopic pacemakers and AV conduction slowing (mainly in antegrade and, to smaller extent, in retrograde direction via AV node) and conduction via additional pathways. When used in medium therapeutic doses, unlike non-selective beta-adrenoblockers, it has less pronounced effect on the organs containing β2-adrenoreceptors (pancreas, skeletal muscles, smooth muscles of peripheral arteries, bronchi and uterus) and on carbohydrate metabolism, does not cause retention 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

Active ingredient

Composition

Excipients: 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 concomitantly used with Coronal, tricyclic and tetracyclic antidepressants, antipsychotic drugs (neuroleptics), ethanol, sedatives, and sleeping pills increase CNS suppression.

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

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). It is recommended to control kidney function in elderly patients (once every 4-5 months).
The patient should be instructed to calculate heart rate and to get medical advice if heart rate is less than 50 beats/min.
Before starting treatment, it is recommended to perform an external respiratory function study in patients with a history of bronchopulmonary complications.
Note that in approximately 20% of angina patients beta-adrenoblockers are ineffective because of severe coronary atherosclerosis with low ischemic threshold (heart rate less than 100 bpm.
In patients who smoke, the efficacy of beta-adrenoblockers decreases.
Patients who wear contact lenses should consider that against the background of treatment there may be a decrease in tear fluid production.
When using Coronal in patients with pheochromocytoma there is a risk of paradoxical arterial hypertension (if effective alpha-adrenoblockade has not been previously achieved).
Bisoprololol may mask certain clinical signs of thyrotoxicosis (eg, tachycardia). Abrupt withdrawal of Coronal in patients with thyrotoxicosis is contraindicated because it may exacerbate the symptoms of the disease.
In diabetes mellitus, bisoprolol may mask tachycardia caused by hypoglycemia. Unlike non-selective beta-adrenoblockers it does not practically increase insulin-induced hypoglycemia and does not delay recovery of blood glucose concentration to normal levels.
If clonidine is taken simultaneously its administration may be stopped only after several days after cancellation of Coronal.
The intensity of hypersensitivity reactions may increase and the lack of effect of usual doses of epinephrine against the background of a history of severe allergic reactions may increase.
In case of the necessity of a planned surgical treatment the drug is withdrawn 48 hours before the beginning of general anesthesia. If the patient has taken 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 IV administration of atropine (1-2 mg).
Drugs that reduce catecholamine reserves (including Reserpine) may enhance the effect of beta-adrenoblockers, so patients taking such combinations of drugs should be under constant medical supervision to detect a pronounced decrease in BP 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.
In elderly patients with increasing bradycardia (less than 50 bpm), marked BP decrease (systolic BP below 100 mm Hg), AV-blockade the dose should be reduced or the treatment should be stopped.
The drug should be discontinued before blood and urine tests of catecholamine, normetanephrine, vanillinmindalic acid, antinuclear antibody titers.
The treatment should not be abruptly interrupted because of the risk of severe arrhythmias and myocardial infarction. Discontinuation is carried out gradually, reducing the dose for 2 weeks or more (the dose is decreased by 25% every 3-4 days).
Use in pediatrics
Use of Coronal in children under 18 years old is contraindicated because efficacy and safety have not been established.
Influence on driving and operating machinery
During the treatment it is necessary to be careful while driving motor transport and engaging in other potentially dangerous activities that require high 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 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.

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