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Probis is a preparation of Bisoprolol Fumarate. Bisoprolol is a potent highly [31-selective adrenoceptor blocking agent. As with other Ph-blocking agents, the method of acting in hypertension is unclear. However, it is known that Bisoprolol reduces plasma renin activity markedly. Bisoprolol by inhibiting the cardiac beta-receptors inhibits the response given to sympathetic activation. That results in the decrease of heart rate and contractility this way decreasing the oxygen demand of the cardiac muscle.
Adults: The dose should be individually adjusted. It is recommended to start with 5 mg per day. The usual dose is 10 mg once daily with a maximum recommended dose of 20 mg per day. Treatment should not be stopped abruptly. The dose should be diminished slowly by a weekly halving of the dose.
Renal impairment: In patients with severe renal impairment (creatinine clearance < 20 ml/min) the dose should not exceed 10 mg once daily. This dose may eventually be divided into halves.
Stable chronic heart failure: Patients should be stable (without acute failure) when bisoprolol treatment is initiated. Uptitration steps:
Renal or hepatic impairment: Uptitration should be made with additional caution.
Non-dihydropyridine calcium channel blockers (verapamil, diltiazem) precipitate severe bradycardia and AV block; antiarrhythmics (amiodarone) aggravate negative inotropic and dromotropic effects; NSAIDs attenuate antihypertensive action; masks hypoglycemia signs.
Bisoprolol is contraindicated in patients with known hypersensitivity to bisoprolol or any other components of this product. Bisoprolol is also contraindicated in Chronic heart failure patients with: • Acute heart failure or during episodes of heart failure decompensation requiring IV inotropic therapy • Cardiogenic shock • Second or third degree AV block (without a pacemaker) • Sick sinus syndrome • Sinoatrial block • Symptomatic bradycardia • Symptomatic hypotension Severe bronchial asthma or severe chronic obstructive pulmonary disease • Late stages of peripheral arterial occlusive disease and Raynaud's syndrome • Untreated phaeochromocytoma • Metabolic acidosis
Common: Bradycardia, hypotension, bronchospasm, fatigue, dizziness, headache.
Overdose
The most common signs expected with overdose of a beta-blocker are bradycardia, hypotension, bronchospasm, acute cardiac insufficiency and hypoglycemia. If overdose occurs, discontinuation of bisoprolol treatment and supportive and symptomatic treatment is recommended.
Category C (Avoid in pregnancy). Beta-blockers reduce placental perfusion and cause fetal growth retardation/bradycardia; use only if clearly necessary. Lactation: Excretion in milk unknown; nursing not recommended.
Store below 25°C in a cool, dry place protected from light. Keep away from the reach of children.