Full Prescribing Info
Bisoprolol hemifumarate.
Each film-coated tablet contains bisoprolol hemifumarate 2.5 mg and 5 mg, respectively.
Pharmacology: Bisoprolol hemifumarate is the most selective β1-blocker. It has highest level of affinity for the β1-receptor than any other β-blocker. It selectively blocks β1-adrenergic receptor in the heart and vascular smooth muscle and reduces heart rate and cardiac output resulting in decrease of arterial hypertension. Lipid metabolism can be adversely affected by β1-blockers, in patients with non-selective blocker, but Bisoprolol does not cause any change in the cholesterol fraction including the cardioprotective high-density lipoprotein (HDL) cholesterol in long-term therapy.
Hypertension, angina and adjunct in stable moderate to severe heart failure.
Dosage/Direction for Use
Hypertension: Usual Starting Dose: 5 mg once daily. The dose of Bisoprolol must be individualized to the needs of the patient. In some patients, 2.5 mg maybe an appropriate starting dose. If the antihypertensive effect of 5 mg is inadequate, the dose may be increased to 10 mg and then, if necessary, to 20 mg once daily.
Angina: Usual Dose: 10 mg once daily (5 mg may be adequate in some patients). Maximum Dose: 20 mg daily.
Heart Failure: Initially, 1.25 mg once daily (in the morning) for 1 week then, if well tolerated, increased to 2.5 mg once daily for 1 week, then 3.75 mg once daily for 1 week, then 5 mg once daily for 4 weeks, then 7.5 mg once daily for 4 weeks, then 10 mg once daily. Maximum Dose: 10 mg daily.
In patients with cardiogenic shock, overt heart failure, second or third degree AV-block, right ventricular failure secondary to pulmonary hypertension and sinus bradycardia.
Special Precautions
Monitoring of renal, hepatic and hematopoietic function should be performed at regular intervals during long-term treatment with bisoprolol hemifumarate.
Use in pregnancy: The safety of bisoprolol hemifumarate during pregnancy has not been established.
Use in lactation: No data is available for lactation.
Use in children: Safety and effectiveness in children have not been established.
Use In Pregnancy & Lactation
Pregnancy: The safety of bisoprolol hemifumarate during pregnancy has not been established.
Lactation: No data is available for lactation.
Adverse Reactions
Gastrointestinal disturbances, bradycardia, hypotension, peripheral vasoconstriction, headache, fatigue, sleep disturbances, dizziness, vertigo, thrombocytopenia; visual disturbances, alopecia may be occurred.
Drug Interactions
Bisoprolol hemifumarate should not be combined with other β1-blockers.
Store below 30°C. Protect from light.
MIMS Class
ATC Classification
C07AB07 - bisoprolol ; Belongs to the class of selective beta-blocking agents. Used in the treatment of cardiovascular diseases.
FC tab 2.5 mg x 3 x 10's, 5 mg x 3 x 10's.
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