Coronal is a drug with antiarrhythmic, antihypertensive and antianginal effects.
Release form and composition
Coronal is produced in the form of film-coated tablets: round, biconvex, light yellow (5 mg tablets) or light pink (10 mg tablets) in color, with a risk (10 pieces in blisters, 1, 3, 6 or 10 blisters in a carton box).
The composition of 1 tablet includes:
- Active ingredient: bisoprolol fumarate - 5 or 10 mg;
- Auxiliary components (tablets 5/10 mg, respectively): microcrystalline cellulose - 133/128 mg, corn starch - 7.5 mg each; sodium lauryl sulfate - 1 mg; colloidal silicon dioxide - 2 mg; magnesium stearate - 1.5 mg.
The composition of the film shell: titanium dioxide (E171) - 2.3 mg; macrogol 400 - 1.28 mg; hypromellose - 6.4 mg; iron dye oxide yellow (for tablets of 5 mg) or red (for tablets of 10 mg) - 0.020 mg.
Indications for use
- Arterial hypertension;
- Coronary heart disease (for the prevention of strokes).
- Acute heart failure;
- Sick sinus syndrome;
- Shock (including cardiogenic);
- Chronic heart failure (decompensation stage);
- AV block II-III degree (without an artificial pacemaker);
- Severe bradycardia;
- Sinoatrial blockade;
- Hypotension (with systolic pressure below 100 mm Hg, especially with myocardial infarction);
- Raynaud's disease;
- Chronic obstructive pulmonary disease and bronchial asthma in history;
- Late stages of impaired peripheral circulation;
- Cardiomegaly (without symptoms of heart failure);
- Concomitant use of sultopride and phloctaphenine;
- Simultaneous use with monoamine oxidase inhibitors (MAO), except for the use of MAO inhibitors of type B;
- Lactation period;
- Age up to 18 years (safety and efficacy of the drug in patients of this age group have not been established);
- Hypersensitivity to the components of the drug and other beta-blockers.
Coronal should be taken with caution in the following diseases / conditions:
- Liver failure;
- Diabetes in the stage of decompensation;
- Renal failure (creatinine clearance less than 20 ml per minute);
- Metabolic acidosis;
- Pheochromocytoma (with simultaneous use with alpha-blockers);
- AV block I degree;
- Restrictive cardiomyopathy;
- Printsmetal angina;
- Chronic heart failure with myocardial infarction in the last three months;
- Congenital heart disease or valvular heart disease with severe hemodynamic disorders;
- Depression (including in history);
- Severe allergic reactions in history.
Also, the drug is prescribed with caution to pregnant women, elderly patients, patients on a strict diet, as well as during desensitizing immunotherapy with allergen extracts and allergens.
Dosing and Administration
Coronal is taken orally, without chewing, on an empty stomach in the morning with a small amount of liquid.
The initial single dose is usually 2.5-5 mg, the frequency of administration is 1 time per day. If necessary, a single dose can be increased to 10 mg. The maximum dose is 20 mg per day.
In patients with renal impairment with creatinine clearance less than 20 ml per minute or with severe impaired liver function, Coronal should be taken in a dose of up to 10 mg per day.
Elderly patients do not need to adjust the dose.
During therapy may develop disorders of some body systems:
- The digestive system: often - nausea, dryness of the oral mucosa, diarrhea, vomiting, constipation; rarely, hepatitis, an increase in liver transaminase activity;
- Central Nervous System: Infrequently - depression, asthenia, fatigue, headache, dizziness, insomnia or drowsiness; rarely, convulsions, nightmares and hallucinations;
- Cardiovascular system: very often - sinus bradycardia; often - lowering blood pressure, manifestation of angiospasm (paresthesia, cooling of the lower extremities, increased disturbance of the peripheral circulation); infrequently - orthostatic hypotension, impaired AV conduction, peripheral edema, decompensation of chronic heart failure;
- Hematopoietic system: in some cases - agranulocytosis, thrombocytopenia;
- Endocrine system: rarely - hypoglycemia (in patients receiving insulin), hyperglycemia (in patients with type 2 diabetes);
- Musculoskeletal system: infrequently - cramps localized in the calf muscles, muscle weakness, arthralgia;
- Respiratory system: infrequently - difficulty breathing (when used in high doses) and / or in predisposed patients - laryngo and bronchospasm; rarely - allergic rhinitis, nasal congestion;
- Sense organs: rarely - impaired hearing, reduced secretion of tear fluid, impaired vision, soreness and dryness of the eyes; very rarely - conjunctivitis;
- Skin: rarely - hyperemia of the skin, increased sweating; very rarely - exacerbation of the course of psoriasis, psoriasis-like skin reactions, alopecia;
- Allergic reactions: rarely - rash, pruritus, urticaria;
- Other: rarely - withdrawal syndrome, accompanied by increased blood pressure and increased angina attacks, hypertriglyceridemia; very rarely - a violation of potency.
While taking Coronal, an electrocardiogram should be performed regularly, heart rate and blood pressure should be monitored (at the beginning of the therapy - daily, later - once every 3-4 months), blood glucose should be determined in patients with diabetes mellitus (1 time in 4 5 months). Elderly patients should monitor kidney function (1 every 4-5 months).
Before starting therapy, it is recommended to conduct a study of the function of external respiration in patients with a burdened bronchopulmonary history.
It must be borne in mind that in some patients with stenocardia (approximately in 20% of cases) beta-blockers may be ineffective, which is associated with severe coronary atherosclerosis with a low ischemia threshold (heart rate less than 100 beats per minute) and an increased end-diastolic volume of the left ventricle, disrupting subendocardial blood flow.
In smokers, Coronal efficacy decreases.
Patients who use contact lenses need to consider that it is possible to reduce the production of tear fluid during therapy.
When using Coronal in patients with pheochromocytoma, there is a risk of paradoxical arterial hypertension (if an effective alpha adrenoblockade has not been achieved in advance).
Patients with thyrotoxicosis cannot be abruptly discontinued, as this may increase the symptoms of the disease.
In case of diabetes mellitus, bisoprolol may mask tachycardia caused by hypoglycemia.
With simultaneous use of Coronal with clonidine, the latter can be stopped only a few days after the end of therapy.
With an allergic history, it is possible to increase the severity of hypersensitivity reactions and the lack of effect from the usual doses of epinephrine.
Before performing a planned surgical treatment, Coronal should be canceled 48 hours before general anesthesia begins. If the patient has taken the drug before the operation, a medicine with minimal negative inotropic effect is selected for general anesthesia.
With the development of depression therapy is recommended to interrupt.
Lowering stocks of catecholamines drugs (including reserpine) can enhance the action of beta-blockers, so patients taking such combinations of drugs should be under constant medical supervision for the timely detection of bradycardia or marked lowering of blood pressure.
When elderly patients develop increasing bradycardia (less than 50 beats per minute), AV blockade, pronounced lowering of blood pressure (systolic pressure below 100 mm Hg), the daily dose should be reduced or therapy should be interrupted.
Before conducting a study of the content of catecholamines, vanillimindal acid, normetanephrine, and titers of antinuclear antibodies in the urine and blood, the preparation should be canceled.
To avoid the development of myocardial infarction and severe arrhythmias, it is impossible to abruptly interrupt the treatment. Cancellation should be carried out gradually, reducing the dose for 14 days or more (every 3-4 days, reduce the dose by 25%).
During the period of therapy, care should be taken when driving vehicles and machinery, as well as when performing other potentially dangerous types of work that require increased concentration and psychomotor reactions.
With simultaneous use of Coronal with certain drugs, undesirable effects may occur:
- Allergens or allergen extracts for skin tests used for immunotherapy increase the risk of severe systemic allergic reactions or anaphylaxis in patients using bisoprolol;
- Phenytoin for intravenous administration, drugs for general inhalation anesthesia - increased severity of the cardiodepressive effect and the likelihood of lowering blood pressure;
- Iodine radiopaque drugs for intravenous administration - an increased risk of anaphylactic reactions;
- Insulin and oral hypoglycemic drugs - changing their effectiveness, as well as masking the symptoms of developing hypoglycemia (tachycardia, increased blood pressure);
- Lidocaine and xanthines (except diphillin) - decrease in their clearance and increase in plasma concentration, especially in patients with initially increased clearance of theophylline due to smoking;
- Nonsteroidal anti-inflammatory drugs, glucocorticosteroids and estrogens - a weakening of the antihypertensive effect of Coronal;
- Nifedipine - a significant reduction in blood pressure;
- Cardiac glycosides, guanfacine and reserpine, methyldopa, slow calcium channel blockers (diltiazem, verapamil), amiodarone and other antiarrhythmic drugs - an increased risk of developing or worsening AV blockade, bradycardia, heart failure and cardiac arrest;
- Ethanol, antipsychotic drugs (antipsychotics), tetracyclic and tricyclic antidepressants, hypnotics and sedatives - increased central nervous system depression, heart rhythm disturbances, the development of bradycardia and orthostatic hypotension;
- Sympatholytics, clonidine, diuretics, hydralazine and other antihypertensive drugs - marked lowering of blood pressure;
- Ergotamine, non-hydrogenated ergot alkaloids - an increased risk of developing disorders of the peripheral circulation;
- Monoamine oxidase inhibitors - a significant increase in the hypotensive effect (simultaneous use is not recommended, the interval between taking the drugs should be at least 14 days);
- Local beta-blockers (eye drops) - an increase in the likelihood of an additive effect with the development of significant bradycardia and / or hypotension;
- Sulfasalazine - increasing the concentration of bisoprolol in the blood plasma;
- Quinidine drugs (chloroquine, mefloquine) - an increase in the likelihood of violations of automaticity, contractility and conduction of the heart;
- Epinephrine and norepinephrine - a decrease in the antihypertensive effect;
- Baclofen or amifostine - increased antihypertensive action.
In the case of arterial hypotension or shock due to floctafenin, with simultaneous use with Coronal, a decrease in compensatory cardiovascular reactions is possible.
Terms and conditions of storage
Store at temperatures up to 25 ° C out of the reach of children.
Shelf life - 3 years.