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Cardiovascular System

Rizoprol (Tablets)
(Bisoprolol)



CONTENT:
Film coated tablets. Tablet contains bisopropol hemifumarate 5 mg or 10 mg.
 
PHARMACOLOGICAL PROPERTIES:
PHARMACODYNAMICS. Rizoprol is betal-adrenergic blocking agents. It does not have intrinsic sympathomimetic activity, membrane stabilizing properties. Rizoprol has a hypotensive effect due to the cardiac output decrease. With continuous administration Rizoprol lowers the initially increased total peripheral vascular resistance. The preparation has an antianginal action, reduces the need of myocard in oxygen at the expense of heart beat frequency reduction, the cardiac output decrease and the arterial blood pressure lowering. It increases a myocardial oxygen delivery owing to preload lowering and diastole lengthening. At the chronic heart failure, Rizoprol suppresses an activated sympatho-adrenal and rennin-angiotensin-aldosteron system, resulting in the improvement of the disease course. PHARMACOKINETICS. After intake the effect proceeds in 1-3 h. It is continuing within 24 h. The preparation has a good absorption from the gastrointestinal tract. The bioavailability is 90%. The half-life is 10-12 h.
 
THERAPEUTIC INDICATIONS:
- arterial hypertension;
- ischemic heart disease (stenocardia);
- postmyocardial infarction period;
- rhythm disturbance (sinus tachycardia, supraventricular and ventricular premature beats);
- arrhythmias in patients with mitral valve prolapse, thyrotoxicosis;
- chronic heart failure.
 
CONTRAINDICATIONS:
- cardiogenic shock;
- atrioventricular heart block of II and III degrees, gross sinoarterial blockade; sick sinus syndrome;
- arterial hypotension (systolic blood pressure is lower 90 mm Hg.);
- tentency to bronchospasms (bronchial asthma, obstructive respiratory tracts diseases);
- late stages of peripheral circulation insufficiency;
bradycardia (heart rate is less than 60 bits per minute) and arterial hypotension (systolic blood pressure is lower 100 mm of mercury) in patients with chronic heart failure;
- simultaneous treatment with monoaminooxidase inhibitors (except the B type monoaminooxidase inhibitors);
- hypersensitivity to the preparation components.
 
SIDE EFFECTS:
From the CNS: dizziness, unbalanced state, faint, headache, paresthesia, lowered sensitiveness, hyper-reactivity, sense of alarm/ anxiety and attention/memory lowering. From the cardiovascular system side: bradycardia, heart rate increase and other rhythms disturbances, extremity cooling, orthostatic hypotension.
From the gastrointestinal tract: abdominal pain, gastritis, vomiting, diarrhea, constipation, peptic ulcer.
From the locomotor system: artralgia, spinal/neck pain, muscle spam, tremor /tremble. From the skin system: rash, acne, eczema, skin irritation, itch, edema, hyperhydrosis, alopecia, dermatitis, Quincke edema, exfoliative dermatitis and skin vasculitis. From the respiratory system: bronchospasm, bronchitis, cough, shortness of breath, pharyngitis and rhinitis.
 
DOSAGE AND ADMINISTRATION:
Rizoprol is recommended to take in the morning on an empty stomach or while breakfast, not chewing, washing down with a small quantity of water.
The dosage is individual; the dose should be increased under the blood pressure and pulse control. Arterial hypertension: the initial dose is 5 mg/day. If necessary, the dose can be increased to10 mg per day.
Exertional angina: it is prescribed in a dose 5 mg per day. If necessary, the dose can be increased to 10 mg per day.
Chronic heart failure: Rizoprol is assigned with reasonably expressed and heavy chronic heart failure, presenting in the stable condition without worsening during the last 6 weeks. The preparation is prescribed in combination with ACE-I, diuretic, cardiac glycoside. It is recommended to withdraw the preparation gradually. For the patients with the frank kidney dysfunction (if the creatine clearance is less than 20 ml/min) and patients with heavy liver dysfunction the highest daily dose is 10 mg.
 
PACKAGING:
10 tablets in blister.
3 blisters in carton box with enclosed leaflet.
 
 
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