Koronal

Koronal – _{beta1-adrenoblocker} with antiarrhytmic, anti-hypertensive and anti-anginal action.

Form of release and structure

Dosage form – tablets, film coated: a round biconvex form, with dividing risky, light yellow and light pink color (on 10 pieces in blisters, in a cardboard pack of 1, 3, 6 or 10 blisters).

Active ingredient – a bisoprolola fumarates:

• 1 tablet of light yellow color – 5 mg;
• 1 tablet of light pink color – 10 mg.

Auxiliary components: starch corn, cellulose microcrystallic, sodium lauryl sulfate, magnesium stearate, silicon dioxide colloid.

Structure of a film cover: macrogoal 400, gipromelloza, titanium dioxide (E171).

In addition as a part of a cover:

• Tablets on 5 mg: dye ferrous oxide yellow (E172);
• Tablets on 10 mg: dye ferrous oxide red (E172).

Indications to use

• Arterial hypertension;
• Prevention of attacks of stenocardia at the coronary heart disease (CHD).

Contraindications

• Acute heart failure;
• Cardiogenic shock and other types of depressed cases;
• Chronic heart failure in a decompensation stage;
• Sinuatrial blockade;
• Atrioventricular (AV) blockade of II and III degrees in the absence of an artificial pacemaker;
• Sick Sinus Syndrome (SSS);
• Cardiomegaly (without symptoms of heart failure);
• The expressed bradycardia;
• Arterial hypotension (with a systolic arterial pressure (AP) below 100 mm of a mercury column, especially at a myocardial infarction);
• Chronic form of an obstructive pulmonary disease and bronchial asthma in the anamnesis;
• Raynaud's disease;
• Concomitant use of monoamine oxidase inhibitors (MAO) (except MAO inhibitors of V type), a floktafenina, a sultoprida;
• Disturbance of peripheric circulation in a late stage;
• Breastfeeding period;
• Age up to 18 years;
• Hypersensitivity to beta adrenoblockers and components of drug.

With care Koronal sick with a pheochromocytoma (is recommended to appoint at the accompanying therapy by alpha adrenoblockers), Printsmetal's stenocardia, AV blockade of the I degree, inborn heart disease or defects of valves of heart with the expressed hemodynamic disturbances, a restrictive cardiomyopathy, chronic heart failure against the background of a myocardial infarction within the last 3 months, a renal failure (the clearance of creatinine (CC) less than 20 ml/min.), a metabolic acidosis, a diabetes mellitus in a decompensation stage, psoriasis, a liver failure, a depression (including in the anamnesis), heavy allergic reactions in the anamnesis; to the patients keeping to a rigid diet, to elderly people and in case of carrying out the desensibilizing immunotherapy allergens or their extracts.

Purpose of drug during pregnancy is shown only if the estimated clinical effect for mother surpasses potential risk for a fruit. It is necessary to stop Koronal's reception in 72 hours prior to childbirth to avoid possible development in newborn respiratory depression, arterial hypotension, bradycardia, a hypoglycemia.

Route of administration and dosage

Pill is taken inside, without chewing, washing down with enough liquid, 1 time a day in the morning on an empty stomach.

The recommended dosing for treatment of arterial hypertension and prevention of attacks of stable stenocardia at an ischemic heart disease: an initial dose – 2,5-5 mg, for achievement of clinical effect increase up to 10 mg is shown, the daily dose should not exceed 20 mg.

At a renal failure (KK less than 20 ml/min.) or the expressed abnormal liver function the daily maximum dose has to make no more than 10 mg.

Dose adjustment is not required to patients of advanced age.

Side effects

Koronal's use can cause side effects:

• From cardiovascular system: very often – a sinus bradycardia; often – decrease in the ABP, vasomotor spasm symptoms in the form of aggravation of disturbance of peripheric circulation, paresthesias, cold snaps of the lower extremities; infrequently – peripheral hypostases, orthostatic hypotension, AV conductivity disturbance, a decompensation of chronic heart failure;
• From bodies of a hemopoiesis: in some cases – an agranulocytosis, thrombocytopenia;
• From a nervous system: infrequently – dizziness, drowsiness, increased fatigue, a depression, a headache, sleeplessness, an adynamy; seldom – dreadful dreams, hallucinations, spasms;
• From the alimentary system: often – nausea, vomiting, dryness of an oral cavity, diarrhea or a lock; seldom – increase in activity of liver enzymes, hepatitis;
• From sense bodys: seldom – a hearing disorder, a vision disorder, morbidity and a xerophthalmus, decrease in secretion of the lacrimal liquid; very seldom – conjunctivitis;
• From respiratory system: infrequently – breath difficulty (at purpose of high doses) and/or bronkho-and a laryngospasm (at predisposed patients); seldom – allergic rhinitis, a nose congestion;
• From integuments: seldom – a dermahemia, increase in sweating; very seldom – skin psoriazopodobny reactions, an alopecia, strengthening of symptoms of psoriasis;
• From endocrine system: seldom – a hyperglycemia (at a diabetes mellitus 2 types), against the background of insulin – a hypoglycemia;
• From a musculoskeletal system: infrequently – muscular weakness, an arthralgia, spasms of gastrocnemius muscles;
• Allergic reactions: seldom – an itch, skin rash, a small tortoiseshell;
• Others: seldom – a withdrawal (increase in the ABP, an aggravation of attacks of stenocardia), a gipertriglitseridemiya; very seldom – disturbance of a potentiality.

Special instructions

Koronal's use should be accompanied with regular control of the heart rate (HR) and the ABP, at the beginning of therapy – daily, then – in 3-4 months of 1 times, at least 1 time in 4-5 months it is necessary to do the electrocardiogram and to conduct laboratory researches on definition at patients with a glucose level diabetes mellitus in blood. Patients of advanced age of 1 times in 4-5 months are recommended to check function of kidneys.

At purpose of drug the doctor has to teach the patient to independent calculation of ChSS and warn about need of obligatory medical consultation in case of ChSS lower than 50 beats per minute.

Patients with pathology of bronchial tubes or lungs in the anamnesis at purpose of drug should conduct examination of function of external respiration.

At 20% of patients with stenocardia use of beta adrenoblockers can not reach therapeutic effect, and at the smoking patients their action decreases.

The patients using contact lenses need to consider decrease in products of the lacrimal liquid during treatment.

At a pheochromocytoma development of paradoxical arterial hypertension against the background of Koronal's reception is possible.

At development of a depression it is recommended to cancel drug use.

Contraindicated sharp interruption of treatment because of risk of development of a myocardial infarction and heavy arrhythmias. It is necessary to carry out cancellation within 2 weeks and more, reducing each 3-4 days reception on 1/4 from the appointed dose.

Bisoprolol is capable to mask tachycardia and other characteristic clinical signs of a thyrotoxicosis. Contraindicated sharply to cancel drug at patients with a thyrotoxicosis as it can cause strengthening of symptomatology of a disease.

At patients with a diabetes mellitus drug does not strengthen the hypoglycemia caused by insulin and process of recovery to the normal level of content of glucose in blood does not detain.

At simultaneous use cancellation of a clonidine needs to be made in several days after the termination of administration of drug.

At planned surgery administration of drug should be cancelled in 48 hours prior to the beginning of the general anesthesia. When carrying out an immediate surgery at the patient who already accepted drug for the general anesthesia it is necessary to use medicine with the minimum negative inotropic effect.

For carrying out researches on determination of level of concentration in urine and blood of credits of antinuclear antibodies, a normetanefrina, catecholamines, vanililmindalny acid it is necessary to cancel use of drug in advance.

At Koronal's combination to the drugs reducing stocks of catecholamines (Reserpinum) there is a risk of bradycardia or the expressed decrease in the ABP therefore in need of this combination of the patient has to be under careful control of the doctor.

At the burdened allergological anamnesis there is a risk of strengthening of expressiveness of reaction of hypersensitivity and lack of action of usual doses of Epinephrinum. For elimination of reciprocal activation of a vagus nerve 1-2 mg of atropine, intravenous (in/in) introduction, are shown.

The dose decline or cancellation of treatment at patients of advanced age need to be made in case of the expressed decrease in the ABP (systolic – there is lower than 100 mm of mercury column), the accruing bradycardia (it is less than 50 beats per minute), AV blockade.

During drug use by the patient it is recommended to be careful at control of vehicles and mechanisms or performance of other potentially dangerous types of activity demanding high concentration of attention and speed of psychomotor reactions.

Medicinal interaction

At simultaneous use of Koronal:

• X-ray contrast iodinated contrast agents for in/in introductions, extracts of allergens for skin tests and the allergens applied at an immunotherapy – increase risk of development of heavy system allergic reactions or an anaphylaxis;
• Phenytoinum for in/in introductions, drugs for inhalation general anesthesia (derivatives of hydrocarbons) – is raised by risk of decrease in the ABP and expressiveness of cardiodepressive effect;
• Methyldopum, cardiac glycosides, Reserpinum, гуанфацин, blockers of slow calcium channels, antiarrhytmic means (Amiodaronum) – increase probability of aggravation or development of AV blockade, bradycardia, heart failure, a cardiac standstill;
• Diuretics, sympatholytics, nifedipine, clonidine, гидралазин and other antihypertensives – can cause considerable decrease in the ABP;
• Tetracyclic and tricyclic antidepressants, neuroleptics, ethanol, hypnotic drugs and sedative drugs – strengthen oppression of a nervous system, can exponentiate bradycardia, disturbances of a cordial rhythm and orthostatic hypotension;
• Ergotamine and not hydrogenated ergot alkaloids – increase risk of emergence of disturbances of peripheric circulation;
• Sulfasalazinum – increases the level of concentration of a bisoprolol in a blood plasma;
• Rifampicin – shortens _T1/2 of a bisoprolol;
• Adrenaline and noradrenaline, non-steroidal anti-inflammatory drugs, glucocorticosteroids, are oestrogenic – reduce anti-hypertensive action of a bisoprolol;
• Baclofenum, амифостин – increase anti-hypertensive effect of drug.

Drug influences efficiency of peroral hypoglycemic means and insulin, hides symptoms of development of a hypoglycemia.

Koronal reduces clearance of xanthines (except Diphyllinum) and lidocaine, increases the level of their concentration in plasma, especially at the smoking patients.

Drug prolongs anticoagulating effect of coumarins and effect of not depolarizing muscle relaxants.

It is not recommended to appoint along with monoamine oxidase inhibitors because of risk of considerable strengthening of hypotensive action, the break between administration of drugs has to make 14 days and more.

The risk of disturbances of conductivity, automatism, contractility of heart increases at a combination to hinidinovy means (chloroquine, мефлохин).

The potential risk of the additive action with development of considerable bradycardia and/or hypotension exists at combined use with beta adrenoblockers for topical administration (eye drops).

In case of arterial hypotension or shock against the background of use of a floktafenin the concomitant use of a bisoprolol can promote decrease in compensatory cardiovascular reactions.

Terms and storage conditions

To store at a temperature up to 25 °C. To protect from children.

Period of validity – 3 years.