The instruction for medical use
of Koronal Torgovoye medicine a name
Mezhdunarodnoye the unlicensed
name Bisoprolol Lekarstvennaya the Tablet form, film coated, 5 mg and 10 mg
One tablet contains
active agent – the bisoprolola fumarates 5 mg and 10 mg,
excipients: microcrystalline cellulose, starch corn, sodium lauryl sulfate, silicon colloidal anhydrous, magnesium stearate
structure of a cover: a gipromelloza, a macrogoal 400, the titan dioxide (E171), ferrous oxide yellow (E 172) (for a dosage of 5 mg), ferrous oxide red (E172) (for a dosage of 10 mg)
Biconvex tablets, film coated light yellow color with risky for halving (dosage of 5 mg)
Biconvex tablets, film coated light pink color with risky for halving (dosage of 10 mg)
Beta group adrenoblockers. Selection beta blockers. Bisoprolol.
The ATX C07AB07 code
Bisoprolol Pharmacokinetics Absorption properties almost completely (& gt, 90%) is soaked up from digestive tract with small effect of the first reception (10%), the bioavailability after oral administration is about 90%.
the Volume of distribution makes 3.5 l/kg. Linking with proteins of plasma makes about 30%.
Metabolism and removal
Bisoprolol is removed in two equivalent ways: 50% are metabolized in a liver in inactive metabolites which then are removed through kidneys, and other 50% are removed by kidneys in not changed look. Therefore, patients have no need for correction of a dosage with a renal or liver failure easy or moderate severity. The general clearance of a bisoprolol is about 15 l/hour. Elimination half-life of a bisoprolol makes 10 – 12 hours of blood plasma. The kinetics of a bisoprolol is linear and independent of age.
Bisoprolol – selection β1-адреноблокатор, has no internal sympathomimetic and membrane stabilizing activity. Has low affinity to β2-рецепторам smooth muscles of bronchial tubes and vessels, and β2-рецепторам, participating in regulation of enzymatic metabolism. Therefore, bisoprolol in general does not cause increase in resistance of airways and metabolic activity, managed β2-рецепторами. It β1-селективность exceeds the limit of range therapeutic the dosed
Bisoprolol has no significant inotropic effect. The maximum effect is reached within 3 – 4 hours after oral administration. Elimination half-life provides at 10 – 12 o’clock 24 – hour effect at administration of drug once a day.
The maximum antihypertensive effect of a bisoprolol is reached after two weeks of treatment.
At therapy of acute conditions of patients with coronary heart disease without chronic heart failure, bisoprolol reduces heart rate and reduces stroke output that leads to decrease in fraction of emission and consumption of oxygen. At prolonged use initially increased peripheric resistance decreases. Besides, there is the current discussion concerning effect β – blockers on decrease in plasmatic activity of renin.
Bisoprolol reduces reaction to simpato-adrenergic activity by means of blocking β1 – heart receptors. This effect reduces the heart rate and contractility of heart, thereby reducing oxygen consumption by a cardiac muscle. This effect is desired at patients with stenocardia and with the coronary heart disease (CHD).
– arterial hypertension
– coronary heart disease (stenocardia)
the Route of administration and doses
Koronal of a tablet should be accepted with a small amount of liquid, without chewing, in the morning to or during a breakfast.
Coronary heart disease (stenocardia) and arterial hypertension
According to both indications the dose makes 5 mg of a bisoprolol of the fumarat once in day. If necessary it is possible to increase a dose to 10 mg of a bisoprolol of the fumarat once in day. The maximum recommended daily dose makes 20 mg. The dose is always subject to individual correction on the basis of monitoring of pulse rate and efficiency of treatment.
Usually therapy by Koronal has long character. It is not recommended to interrupt sharply treatment by Koronal as it can lead to passing aggravation of symptoms. Especially dangerously to it at patients with coronary heart disease. The step-by-step dose decline is recommended.
of the Dose in a liver and/or renal failure
the dose adjustment usually is not required From patients with a liver and/or renal failure easy or moderate severity. At patients with a renal failure of heavy degree (the clearance of creatinine less than 20 ml/min.) and a liver failure of heavy degree should not be applied Koronal in the daily doses exceeding 10 mg.
There is only a limited experience of use of Koronal at dialysis patients which does not indicate the need to correction of the mode of dosing.
dose adjustment is not required.
there is no experience of use of a bisoprolol for children, therefore, Koronal is contraindicated to children.
Often (from ≥1/100 to & lt, 1/10)
– a headache *, dizziness *, paresthesia
– deterioration in symptoms of the alternating lameness, deterioration in a syndrome of Reynaud
– a constipation, diarrhea, nausea
– an arthropathy
– fatigue *
Infrequently (from ≥1/1000 to ≤1/100)
– sleep disorders *, suppressed mood *, emotional lability ***
– bradycardia, disturbance of atrioventricular conductivity, deterioration in the available heart failure
– orthostatic hypotension
– a bronchospasm at patients with bronchial asthma
– an abdominal pain
– decrease in tolerance to glucose **, abnormal increase in weight ***
– muscular pains, muscular spasms
Seldom (≥1/10,000 to ≤1/1000)
– nightmares *
– a faint
– amnesia ***
– lacrimation reduction (to consider for the patients carrying contact lenses)
– a hearing disorder ***, a ring in ears ***
– the increased levels of serum of enzymes of a liver (nuclear heating plant, ALT), hepatitis
– rhinitis ***
– hyperaemia, an itching, the increased perspiration
– erectile dysfunction, a chordee ***
– increase in content of triglycerides in blood
is Very rare (≤1/10,000)
– conjunctivitis, disorders of vision
– psoriazopodobny rash, psoriasis or deterioration in its symptoms, an alopecia ***
* These symptoms arise more often at the beginning of therapy. As a rule, have low-intensive character and disappear within the first weeks of treatment.
** At patients with latent or obvious diabetes the tolerance to glucose can decrease. Symptoms of a hypoglycemia can be disguised.
*** These symptoms were observed at the patients receiving β-blockers.
– hypersensitivity or to any of drug components
– an acute heart failure or heart failure in a stage of a decompensation which demands intravenous inotropic therapy
– cardiogenic shock
– atrioventricular block of II and III degree (without pacemaker)
– a sick sinus syndrome
– sinuatrial blockade
– symptomatic bradycardia
– symptomatic hypotension
– severe forms of bronchial asthma and the chronic obstructive pulmonary disease (COPD) in the anamnesis
– late stages of peripheral occlusal diseases of arteries and a Raynaud’s disease
– not treated pheochromocytoma
– a metabolic acidosis
– pregnancy and the period of a lactation
– children’s age up to 18 years (the efficiency and safety are not established)
Bisoprolol should be applied to a bisoprolol with care:
– at patients with hypertensia or stenocardia with the accompanying heart failure
– at patients with diabetes and noted fluctuations of level of sugar in blood. Masking of symptoms of a hypoglycemia (for example, tachycardias, heartbeat or perspiration)
– is possible at observance of a rigid diet
– at the desensibilizing therapy as also other β – blockers, bisoprolol the sensitivity to allergens can raise and increase weight of anaphylactic reactions. Adrenaline use not always renders the expected therapeutic effect
– at atrioventricular block of the first degree
– in Printsmetal’s stenocardia
– in occlusal diseases of peripheral arteries. Increase in intensity of manifestation of symptoms, especially is possible – in an initiation of treatment.
simultaneous use with the following drugs is not recommended:
Antagonists of calcium (verapamil and diltiazem): antagonists of calcium of type of verapamil and, to a lesser extent, like diltiazem: have negative effect on contractility and atrioventricular conductivity.
Intravenous administration of verapamil at the patients receiving β-blockers can lead to heavy hypotension and atrioventricular block.
Antihypertensive substances of the central action (clonidine, Methyldopa, moksonidin, rilmenidin): simultaneous use with bisoprololy can lead to decrease in heart rate and minute warm emission and also to vasodilatation. Sharp cancellation can increase risk of “ricochet” hypertensia.
With care to apply with the following drugs:
Antagonists of calcium of dihydropyridinic type (nifedipine): at simultaneous use with bisoprololy can lead to increase in risk of developing hypotension and increase in risk of further deterioration in sokratitelny ability of ventricles at patients with heart failure.
Antiarrhytmic means of 1 class (quinidine, Disopyramidum, lidocaine, Phenytoinum, flekainid, propafenon): can strengthen influence on time of atrioventricular conductivity and also on increase in negative inotropic effect.
Antiarrhytmic means 3 classes (Amiodaronum): can strengthen influence on time of atrioventricular conductivity.
Parasympathomimetics: at simultaneous use time of atrioventricular conductivity can increase and risk of developing bradycardia increases.
Topical beta-blockers (eye drops for treatment of glaucoma) can enhance system effect of a bisoprolol.
Insulin and oral glyukozosnizhayushchy drugs: strengthening of effect of decrease in level of glucose in blood. Blockade a beta – adrenoceptors can mask hypoglycemia symptoms.
Anesthetics: reduction of reflex tachycardia and increase in risk of developing hypotension.
Cardiac glycosides: decrease in pulse rate, increase in time of atrioventricular conductivity.
Non-steroidal anti-inflammatory drugs (NPVP): NPVP can reduce hypotensive effect of a bisoprolol.
A beta – sympathomimetics: (izoprenalin, Dobutaminum): combination of these drugs with bisoprololy can reduce effect of both substances.
The sympathomimetics activating a beta – and an alpha – adrenoceptors: combination with bisoprololy can lead to increase in arterial blood pressure. Such interactions are considered as more probable for non-selective beta-blockers.
At simultaneous use with antihypertensive drugs and other medicines with a possibility of a lowering of arterial pressure (tricyclic antidepressants, barbiturates, fenotiazin) risk of developing hypotension can increase.
Combinations to consideration:
Meflokhin: the increased risk of developing bradycardia.
instructions Treatment Koronalom should not be interrupted sharply, especially – at patients with coronary heart disease (only in case of availability of indications, accurate to that) as it can lead to passing aggravation of symptoms.
Patients with psoriasis or with suspicion of psoriasis in the anamnesis should accept β-blockers (including and bisoprolol) only after careful assessment of a ratio of risks and advantage.
Treatment by Koronal can mask thyrotoxicosis symptoms. Patients with a pheochromocytoma can accept bisoprolol only after blocking of alpha receptors.
Anesthesiologists should remember risk of development β – blockade at patients at the general anesthesia. If the patient accepts β – blockers, then therapy should be interrupted before operation, it needs to be done step by step and to finish in 48 hours prior to surgical intervention fully.
The accompanying bronkhodilatiruyushchy therapy is necessary in bronchial asthma or other chronic obstructive diseases of the lungs causing these symptoms. At patients with asthma the increase in resistance of airways is sometimes possible, need of use of higher dosages β2-агонистов is possible.
Bisoprolol can render side effects at pregnancy and/or on the fruit/newborn. In general, β – adrenoblockers reduce placentary perfusion that contacts a growth inhibition, pre-natal death, abortions or premature births. Side effects (hypoglycemia and bradycardia) can occur both at a fruit and at newborns. If treatment β – blockers is necessary, use β1-селективных blockers of adrenoceptors is preferable.
Koronal is not recommended to use during pregnancy without accurate need. If treatment bisoprololy is considered necessary really, monitoring of a uterine and placentary blood-groove and growth of a fruit is recommended. If harmful effects on a pregnancy course come to light, it is necessary to consider a question of alternative treatment. The newborn child is subject to careful monitoring. Symptoms of a hypoglycemia and bradycardia generally have to be shown within the first 3 days.
Data on removal of a bisoprolol with human milk are absent, as well as data on safety of impact of a bisoprolol on newborns. Therefore, feeding by a breast is not recommended during Koronal’s use.
Features of influence of medicine on ability to run the vehicle or potentially dangerous mechanisms
Due to the variability of individual reactions, it is necessary to be careful during the driving of motor transport and occupation other potentially dangerous types of activity demanding the increased concentration of attention and speed of psychomotor reactions, generally in an initiation of treatment and in cases if the dosage was changed or alcohol was at the same time taken.
Symptoms: bradycardia, hypotension, bronchospasm, acute heart failure and hypoglycemia. The sensitivity to one high dose of a bisoprolol changes individually, and it is possible to assume that patients with heart failure are very sensitive.
Treatment: to stop treatment bisoprololy and to begin to carry out the supporting and symptomatic therapy. Limited data demonstrate to what bisoprolol hardly is dialyzed.
A form of release and packing
On 10 tablets in blister strip packaging from aluminum / aluminum foil or polyvinylchloride/polyethylene/polyvinyl dichloride of a firm film / aluminum foil.
On 3 or 6 planimetric packs together with the instruction for use in the state and Russian languages put in a pack from cardboard.
To Store storage conditions in the dry place, at a temperature not above 25 °C.
To store out of children’s reach!
3 years not to apply a period of storage after an expiration date!
Prescription status According to the prescription
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