Cordinorm Cor, tablets 2.5mg 30 pcs

– arterial hypertension;

– CHD (prevention of angina attacks).

Active ingredient

Composition

Tablets are white or almost white, round, biconvex, with a ridge on one side.

1 tablet bisoprolol fumarate 2.5 mg

Supplementary substances:

Prosolv – 75.81 mg (microcrystalline cellulose – 74.294 mg,

colloidal silica – 1.516 mg),

croscarmellose sodium – 1.692 mg,

sodium carboxymethyl starch (type A) – 4.25 mg,

magnesium stearate – 0.748 mg.

How to take, the dosage

The drug is taken orally, in the morning, on an empty stomach. The tablets should be swallowed whole without chewing.

The daily dose is 2.5-5 mg. The usual starting dose is 5 mg once daily. If necessary, the dose is increased to 10 mg once daily. The maximum daily dose for adults is 20 mg.

The treatment of patients with mild or moderate hepatic or renal impairment usually does not require dose adjustment. In patients with severe renal dysfunction (CK < 20 ml/min) or hepatic the maximum daily dose is 10 mg.

In patients the elderly no dose adjustment is required.

Interaction

In patients receiving bisoprolol, allergens used for immunotherapy or allergen extracts for skin tests increase the risk of severe systemic allergic reactions or anaphylaxis.

Iodine-containing X-ray contrast agents for IV administration increase the risk of anaphylactic reactions.

Phenytoin when administered by IV and drugs for inhalation general anesthesia (hydrocarbon derivatives) increase the severity of cardiodepressant effects and the likelihood of BP reduction.

When used concomitantly, bisoprololol changes the effectiveness of insulin and oral hypoglycemic agents and masks the symptoms of developing hypoglycemia (tachycardia, increased BP).

Concomitant use of bisoprolol 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 hypotensive effect of the drug when used together is weakened by NSAIDs (due to sodium ion retention and blockade of prostaglandin synthesis by kidneys), GCS and estrogens (due to retention of sodium ions).

The cardiac glycosides, methyldopa, reserpine and guanfacine, slow calcium channel blockers (verapamil, diltiazem), amiodarone and other antiarrhythmic drugs when combined with bisoprolol increase the risk of developing or worsening bradycardia, AV blockade, heart failure and heart failure.

Concomitant use of nifedipine may lead to a significant decrease in BP.

Diuretics, clonidine, sympatholytics, hydralazine and other hypotensive drugs when used concomitantly may lead to an excessive decrease in BP.

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

Tricyclic and tetracyclic antidepressants, antipsychotics (neuroleptics), ethanol, sedatives and hypnotics increase the CNS depressant effect of bisoprolol.

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

Non-hydrogenated ergot alkaloids increase the risk of peripheral circulatory disorders when used together.

Ergotamine when used together increases the risk of peripheral circulatory disorders.

Sulfasalazine increases the plasma concentration of bisoprolol.

Rifampicin, when used concomitantly, shortens the T1/2 of bisoprolol.

Special Instructions

The patient should know not to abruptly interrupt treatment or change the recommended dose without first consulting a physician.

The monitoring of patients taking Cordinorm should include monitoring of HR and BP (daily at the beginning of treatment, then once every 3-4 months), ECG, determination of blood glucose in diabetic patients (once every 4-5 months). In elderly patients it is recommended to monitor kidney function (once every 4-5 months).

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

In patients with a history of poor bronchopulmonary function, an external respiratory test is recommended before starting treatment.

In about 20% of patients with angina pectoris, beta-adrenoblockers are ineffective. The main reasons for this are 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.

The effectiveness of beta-adrenoblockers is lower with tobacco smoking.

Patients who wear contact lenses should be aware that tear fluid production may decrease with treatment.

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

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

In diabetic patients, the effect of bisoprolol may mask the tachycardia caused by hypoglycemia. Unlike non-selective beta-adrenoblockers, Cordinorm does not increase insulin-induced hypoglycemia and does not delay recovery of blood glucose to normal levels.

In case of concomitant treatment with clonidine, its use may be discontinued only after several days of withdrawal of Cordinorm.

The severity of hypersensitivity reactions and lack of effect of usual doses of epinephrine (adrenaline) against a background of a history of severe allergy may increase. If planned surgical treatment is necessary, the drug shall be withdrawn 48 hours before the start of general anesthesia. If a patient has taken the drug prior to surgery, he should select a drug for general anesthesia with minimally negative inotropic effect.

Reciprocal activation of the vagus nerve can be eliminated by IV administration of atropine (1-2 mg).

Drugs that reduce catecholamine stores (e.g., reserpine) can increase the effects of beta-adrenoblockers, so patients taking these combinations of medications should be under constant medical supervision for arterial hypotension or bradycardia.

Patients with bronchospastic disorders may be prescribed cardioselective adrenoblockers if other hypotensive drugs are intolerant and/or ineffective, but the dose should be strictly controlled. Overdose is dangerous with the development of bronchospasm. In case of increasing bradycardia (less than 50 beats/min), arterial hypotension (systolic BP below 100 mmHg), AV-blockade, bronchospasm, ventricular arrhythmias, severe hepatic and renal dysfunction, the dose should be reduced or the treatment should be stopped.

It is recommended that therapy be discontinued if depression develops as a result of taking beta-adrenoblockers.

Beta-adrenal blockers should not be stopped abruptly because of the risk of severe arrhythmias and myocardial infarction. Withdrawal should be gradual, reducing the dose over 2 weeks or more (reduce the dose by 25% every 3 to 4 days).

The drug should be discontinued before testing the blood and urine levels of catecholamines, normetanephrine, vanillylindalic acid, and antinuclear antibody titers.

Influence on driving and operating machinery

At the time of treatment, caution should be exercised when driving motor vehicles and engaging in other potentially dangerous activities that require increased concentration and rapid psychomotor reactions.

Contraindications

– shock (including.

– cardiogenic;

– collapse;

– pulmonary edema;

– acute heart failure;

– chronic heart failure in decompensation;

– AV block of II and III degree (without pacemaker);

– sinoatrial block;

– CCSU;

– marked bradycardia (HR < 50 bpm./min);

– Prinzmetal angina;

– cardiomegaly (without signs of heart failure);

– arterial hypotension (systolic BP < 100 mm Hg, especially in myocardial infarction);

– a history of bronchial asthma and COPD;

– concomitant use of MAO inhibitors (except for MAO type B);

– late stages of peripheral circulatory disorders;

– Raynaud’s disease;

– pheochromocytoma (without concomitant use of alpha-adrenoblockers);

– metabolic acidosis;

– childhood and adolescence under 18 years of age (efficacy and safety of use have not been established);

– hypersensitivity to other beta-adrenoblockers;

– hypersensitivity to the components of the drug.

Withcautiousness the drug should be used in patients with hepatic insufficiency, chronic renal failure, myasthenia gravis, thyrotoxicosis, diabetes, AV blockade of 1st degree, depression (including anamnesis), psoriasis, elderly patients.

Side effects

CNS: Elevated fatigue, weakness, dizziness, headache, drowsiness or insomnia, nightmares, depression, anxiety, confusion or short-term memory loss, hallucinations, asthenia, myasthenia, paresthesias in the extremities (in patients with claudication and Raynaud’s syndrome), tremor.

Sensory organs: visual impairment, decreased secretion of lacrimal fluid, dry and painful eyes, conjunctivitis.

Cardiovascular system side: sinus bradycardia, palpitations, impaired myocardial conduction, impaired AV conduction (up to development of complete transverse blockade and cardiac arrest), arrhythmias, impaired myocardial contractility, development (worsening) of chronic heart failure (edema of ankles, feet; dyspnea), BP decrease, orthostatic hypotension, manifestation of angiospasm (worsening of peripheral circulatory disorders, coldness of the lower extremities, Raynaud’s syndrome), chest pain.

Digestive system disorders: dry mouth, nausea, vomiting, abdominal pain, constipation or diarrhea, liver function disorders (dark urine, yellowing of the sclerae or skin, cholestasis), changes in liver enzyme activity (increased ALT, ACT), bilirubin content, triglycerides, changes in taste.

In the respiratory system: nasal congestion, difficulty in breathing when prescribed in high doses (due to loss of selectivity) and/or in susceptible patients – laryngo- and bronchospasm.

On the endocrine system: hyperglycemia (in patients with insulin-independent diabetes mellitus), hypoglycemia (in patients receiving insulin), hypothyroidism.

Allergic reactions:skin itching, rash, urticaria.

Dermatological reactions:increased sweating, skin hyperemia, exanthema, psoriasis-like skin reactions, exacerbation of psoriasis symptoms, alopecia.

With the hematopoietic system:thrombocytopenia (unusual bleeding and hemorrhage), agranulocytosis, leukopenia.

Muscular system disorders:muscular weakness, cramps in the calf muscles, back pain, arthralgia.

From the sexual system: weakening of libido and decreased potency.

Others:withdrawal syndrome (increased attacks of angina pectoris, increased BP).

Fetal effects:intrauterine growth retardation, hypoglycemia, bradycardia.

Overdose

Symptoms:arrhythmia, ventricular extrasystole, marked bradycardia, AV-blockade, decreased BP, chronic heart failure, cyanosis of finger nails or palms, difficulty breathing, bronchospasm, dizziness, fainting, seizures.

Treatment:Gastric lavage and administration of adsorptive drugs; symptomatic therapy: if AV-blockade has developed – intravenous injection of 1-2 mg of atropine, epinephrine (adrenaline) or placement of a temporary pacemaker; if ventricular extrasystole – injection of lidocaine (Class IA drugs are not used); if BP decreases – the patient should be in Trendelenburg position; if there are no signs of pulmonary edema, the intravenous plasma exchange solutions should be administered; if ineffective – epinephrine (adrenaline), dopamine, dobutamine (to maintain chronotropic and inotropic action and eliminate marked BP decrease); in heart failure – administration of cardiac glycosides, diuretics, glucagon; in convulsions – intravenous administration of diazepam; in bronchospasm – inhaled beta2-adrenergic stimulants.

Similarities