Kordinorm - selective beta 1 -adrenoblocker with hypotensive, antiarrhythmic and antianginal effects.
Release form and composition
Dosage form Kordinorm - coated tablets (round biconvex, white, with a risk on one side, engraved and side risks on the other):
- 10 pcs. in blisters, in a cardboard box of 3, 6 or 9 blisters;
- 100 pcs. in containers, in a cardboard pack 1 container.
The active ingredient of the drug - bisoprolol fumarat: in 1 tablet 5 or 10 mg.
Auxiliary components: mannitol, hypromellose, microcrystalline cellulose, magnesium stearate, croscarmellose sodium, macrogol 6000, titanium dioxide.
Indications for use
- Treatment of arterial hypertension;
- Prevention of angina attacks with coronary heart disease.
- Cardiomegaly with no signs of heart failure;
- AV block II and III degree (without pacemaker);
- Chronic heart failure in the stage of decompensation;
- Acute heart failure;
- Severe bradycardia (heart rate <50 beats per minute);
- Sick sinus syndrome;
- Sinoatrial blockade;
- Hypotension (systolic blood pressure <100 mmHg), especially in myocardial infarction;
- Printsmetal angina;
- Bronchial asthma and chronic obstructive pulmonary disease in history;
- Pulmonary edema;
- Raynaud's disease;
- Late stages of impaired peripheral circulation;
- Shock (including cardiogenic);
- Metabolic acidosis;
- Pheochromocytoma (without simultaneous use of alpha-blockers);
- Age up to 18 years;
- Simultaneous administration of monoamine oxidase inhibitors (except for type B) and 14 days after their withdrawal;
- Hypersensitivity to the components of the drug or other beta-blockers.
Relative (special caution required):
- Liver failure;
- Chronic renal failure;
- AV block I degree;
- Myasthenia gravis;
- Depression, incl. in the anamnesis;
- Elderly age.
During pregnancy and lactation, Kordinorm can be prescribed only if the expected benefit to the woman exceeds the possible risks to the fetus / child (bradycardia and hypoglycemia are possible, intrauterine growth retardation).
Dosing and Administration
The drug is taken orally, without chewing, drinking water, in the morning on an empty stomach.
The initial dose, as a rule, is 5 mg once a day, if necessary it is increased to 10 mg.
The maximum permissible daily dose is 20 mg, for patients with severe impaired renal / liver function, 10 mg.
- Central nervous system: anxiety, drowsiness or insomnia, hallucinations, nightmares, weakness, fatigue, dizziness, depression, headache, confusion or short-term memory loss, myasthenia, asthenia, tremor, paresthesia in limbs (in patients with Raynaud's syndrome and intermittent claudication);
- Cardiovascular system: myocardial conduction disturbance, heartbeat, arrhythmias, sinus bradycardia, development / aggravation of chronic heart failure (shortness of breath, swelling of the ankles and feet), orthostatic hypotension, chest pain, weakening of myocardial contractility, reduction of blood pressure, violation of AV conduction (up to the development of complete transverse blockade and cardiac arrest), angiospasm (Raynaud's syndrome, cooling of the lower extremities, increased disturbance of the peripheral circulation);
- Respiratory system: difficulty breathing when taking the drug in high doses, nasal congestion, in susceptible patients - laryngo - and bronchospasm;
- Musculoskeletal system: back pain, cramps in the calf muscles, arthralgia, muscle weakness;
- Digestive system: abdominal pain, nausea, vomiting, changes in taste, dryness of the oral mucosa, constipation / diarrhea, abnormal liver function (jaundice of sclera or skin, dark urine, cholestasis), changes in bilirubin and triglycerides, activity of liver enzymes;
- Endocrine system: hypothyroid state, in patients receiving insulin - hypoglycemia, in patients with insulin-dependent diabetes mellitus - hyperglycemia;
- Blood system: leukopenia, agranulocytosis, thrombocytopenia (hemorrhage, unusual bleeding);
- The reproductive system: decreased libido, decreased potency;
- Sense organs: reduced secretion of tear fluid, conjunctivitis, dry and sore eyes, blurred vision,
- Dermatological reactions: skin hyperemia, exacerbation of psoriasis symptoms, psoriasis-like skin reactions, exanthema, increased sweating, alopecia;
- Allergic reactions: rash, itching, urticaria;
- Other: withdrawal syndrome, manifested by increased angina attacks, increased blood pressure;
- Effect on the fetus: hypoglycemia, bradycardia, growth retardation.
In approximately 20% of patients with angina pectoris, the use of beta-blockers is ineffective. The main reasons are severe coronary atherosclerosis with a low ischemic threshold (heart rate less than 100 beats per minute) and an increased end-diastolic volume of the left ventricle that violates the subendocardial blood flow.
All patients without exception during the period of treatment need monitoring, including monitoring of heart rate (HR) and blood pressure (at the beginning of treatment - daily, then - once every 3-4 months), regular electrocardiogram. Older people, in addition, need to monitor kidney function (1 time in 4-5 months), patients with diabetes mellitus - to determine the concentration of glucose in the blood (1 time in 4-5 months).
Patients who are prescribed Kordinorm should be trained in the method of counting the heart rate and warned that the dose prescribed by the doctor cannot be changed independently and the treatment should be abruptly interrupted, and in the case of a heart rate less than 50 beats per minute, they should consult a doctor.
You can not abruptly cancel Kordinorm, because there is a danger of severe arrhythmias and myocardial infarction. Treatment is stopped gradually, reducing the dose for at least 2 weeks (25% every 3-4 days).
Tobacco reduces the effectiveness of beta-blockers.
In patients with thyrotoxicosis, Cordinorm may mask some clinical symptoms of thyrotoxicosis (for example, tachycardia). Abrupt withdrawal of the drug may increase their severity.
Patients with a burdened bronchopulmonary history should begin to investigate respiratory function before starting treatment.
In the case of taking Kordinorm with pheochromocytoma without simultaneous use of alpha-blockers, there is a likelihood of the development of paradoxical arterial hypertension.
In diabetes mellitus, bisoprolol may mask tachycardia caused by hypoglycemia. At the same time, the hypoglycemia caused by insulin practically does not increase and the restoration of the glucose content in the blood to a normal level does not delay.
Patients taking clonidine at the same time can stop taking it only a few days after Kordinorm is canceled.
In the case of a burdened allergic history, bisoprolol may increase the severity of hypersensitivity reactions and reduce the effectiveness of the usual doses of epinephrine. For this reason, if it is necessary to conduct a planned surgical procedure 48 hours before general anesthesia, Kordinorm should be abolished. If the patient took the drug before the operation, it is necessary to select a remedy with a minimally negative inotropic effect.
Patients who wear contact lenses should consider that there may be a decrease in the production of tear fluid during the treatment period.
Cardioselective adrenergic blockers can be prescribed to patients with bronchospastic diseases only in case of ineffectiveness and / or intolerance to other antihypertensive drugs, while it is important to strictly control the dose, since overdose is fraught with the development of bronchospasm.
In the event of depression, as well as the need to conduct a study on the content in the urine and blood of vanilline-alindic acid, normetanephrine, catecholamines, antinuclear antibody titers, the drug should be canceled.
Patients receiving monoamine oxidase inhibitors, Kordinorm can be appointed no earlier than 14 days after their cancellation.
During the period of treatment, care should be taken when driving and engaging in any potentially hazardous activities.
When taking bisoprolol in combination with other medicinal substances there is a likelihood of undesirable reactions:
- Cardiac glycosides, slow calcium channel blockers (diltiazem, verapamil), methyldopa, guanfacine, glycosides, reserpine, amiodarone and other antiarrhythmic drugs - risk of developing / worsening bradycardia, AV blockade, heart failure, cardiac arrest;
- Iodine-containing radiopaque agents for intravenous administration - the risk of anaphylactic reactions;
- Allergen extracts for skin tests and allergens used for immunotherapy - the risk of severe systemic allergic reactions or anaphylaxis;
- Diuretics, sympatholytics, clonidine, hydralazine and other antihypertensive drugs - excessive reduction in blood pressure;
- Ethanol, hypnotics, sedatives and antipsychotics, tricyclic and tetracyclic antidepressants - increased inhibitory action of bisoprolol on the central nervous system;
- Ergotamine, non-hydrogenated ergot alkaloids - impaired peripheral circulation;
- Sulfasalazine - increasing the concentration of bisoprolol in plasma;
- Lidocaine and xanthines (except diphillin) - a decrease in their clearance and an increase in plasma concentration, especially in patients with initially increased clearance of theophylline under the influence of smoking;
- Rifampicin - reducing the half-life of bisoprolol;
- Non-polarizing muscle relaxants - prolonging their action;
- Coumarins - increased anticoagulant effect;
- Phenytoin (intravenously) and agents for general inhalation anesthesia (hydrocarbon derivatives) - increased severity of the cardiodepressive action, lowering blood pressure;
- Nonsteroidal anti-inflammatory drugs, glucocorticosteroids and estrogens - reducing the hypotensive effect of bisoprolol;
- Insulin and oral hypoglycemic agents - changing their effect, masking the symptoms of developing hypoglycemia;
- Monoamine oxidase inhibitors - a significant increase in the hypotensive effect.
Terms and conditions of storage
Store at temperatures up to 30 ºC in a place with limited access to children.
Shelf life - 2 years.