B-Card®2.5
B-Card®2.5
Antihypertensive
Indication
B-Card® is indicated for the treatment of:
- High blood pressure (hypertention).
- Coronary heart disease (angina pectoris).
- Stable chronic, moderate to severe heart failure (myocardial insufficiency) with impaired systolic ventricular function (ejection fraction ≤35%, determined by echocardiography) in addition to ACE inhibitors and diuretics, and optionally cardiac glycosides.
Composition
Each film coated tablet of B-Card® 2.5 contains
- Bisoprolol fumarate 2.5 mg
Dosage
¤ B-Card® should be taken as a whole with some liquid in the morning before, during or after breakfast.
Hypertension | Angina
- Adult: 5–10 mg once daily; maximum 20 mg per day.
Adjunct in heart failure
- Adult: Initially 1.25 mg once daily for 1 week, dose to be taken in the morning, then increased if tolerated to 2.5 mg once daily for 1 week,then increased if tolerated to 3.75 mg once daily for 1 week, thenincreased if tolerated to 5 mg once daily for 4 weeks, then increased if tolerated to 7.5 mg once daily for 4 weeks, then increased if tolerated to10 mg once daily; maximum 10 mg per day.
In patient with renal dysfunction (creatinine clearance < 40 ml/min) or hepatic impairment
- use an initial daily dose of 2.5 mg and The dosage should not exceed 10mg daily.
- B-Card® is a B1-selective (cardioselective) adrenoreceptor blocking
agent without significant membrane stabilizing activity or intrinsic sympathomimetic activity in its therapeutic dosage range. Cardioselectivity is not absolute, however, and at higher doses(>/=20mg), bisoprolol fumarate also inhibits B2- adrenoreceptors, chiefly located in the bronchial and vascular musculature; to retain selectivity, it is therefore important to use the lowest effective dose. - The absolute bioavailability after a 10 mg oral dose of bisoprolol fumarate is about 80%.
- Absorption is not affected by the presence of food.
- The first pass metabolism of bisoprolol fumarate is about 20%.
- Binding to serum proteins is approximately 30%. Peak plasma concentration occur within (2- 4 hours of dosing with 5 to 20 mg. The half-life of bisoprolol in plasma is ranging between 9- 12 hours.
- It is metabolised in the liver. Approximately 50% of an orally administered dose is excreted in urine as unchanged drug and the remains appearing in the form of inactive metabolites. In subjects with creatinine clearance < 40 ml/min, the plasma half-life is increased approximately threefold compared to healthy subjects. In subjects with cirrhosis of the liver, the elimination of B-Card® is more variable in rate and slower than that in healthy subjects.
- In normal volunteers bisoprolol therapy resulted in a reduction of exercise, and isoproterenol-induced tachycardia.
- The maximal effect occurred within (1- 4) hours post-dosing. Effects persisted for 24 hours at doses equal to or greater than 5 mg.
Each film coated tablet of B-Card® 2.5 contains
- Bisoprolol fumarate 2.5 mg
B-Card® is indicated for the treatment of:
- High blood pressure (hypertention).
- Coronary heart disease (angina pectoris).
- Stable chronic, moderate to severe heart failure (myocardial insufficiency) with impaired systolic ventricular function (ejection fraction ≤35%, determined by echocardiography) in addition to ACE inhibitors and diuretics, and optionally cardiac glycosides.
B-Card® must not be taken in:
- Hypersensitivity to bisoprolol.
- Acute heart failure.
- Severe disturbance of atrioventricular impulse conduction (second or third degree AV block) without a pacemaker.
- Shock induced by disorders of cardiac function (cardiogenic shock).
- Sinoatrial block, sick sinus syndrome, severe bronchial asthma, metabolic acidosis.
- B-Card® combinations are not recommended in chronic heart failure only class I antiarrhythmic medicinal products (e.g. quinidine, disopyramide, lidocaine, phenytoin, flecainide, propafenone): Effect on atrio-ventricular conduction time may be potentiated and negative inotropic effect increased.
- All indications calcium antagonists of the verapamil type and to a lesser extent of the diltiazem type: Negative influence on contractility and atrio-ventricular conduction. Intravenous administration of verapamil in patients on β-blocker treatment may lead to profound hypotension and atrioventricular block.
- Centrally-acting antihypertensive medicinal products such as clonidine and others (e.g. methyldopa, moxonodine, rilmenidine): Concomitant use of centrally acting antihypertensive medicinal products may worsen heart failure by a decrease in the central sympathetic tonus (reduction of heart rate and cardiac output, vasodilation). Abrupt withdrawal, particularly if prior to beta-blocking agent discontinuation, may increase the risk of “rebound hypertension”.
- B-Card® should be used during pregnancy only if the potential benefit justifies the risk to the fetus.
- it is not known whether B-Card® passes into breast milk. therefore, breastfeeding is not recommended during B-Card® therapy.
B-Card® may cause symptoms in some rare cases
- Bradycardia, heart failure, tirednees, dizziness, mild headache, sleep disturbance, bronchospasm in patient with a history of bronchial asthma, sensation of cold and numb extremities, occasionally nausea, vomiting, diarrhea, constipation. These symptoms occur at the start of treatment. They usually disappear within 1 to 2 weaks after the start of treatment.
¤ B-Card® should be taken as a whole with some liquid in the morning before, during or after breakfast.
Hypertension | Angina
- Adult: 5–10 mg once daily; maximum 20 mg per day.
Adjunct in heart failure
- Adult: Initially 1.25 mg once daily for 1 week, dose to be taken in the morning, then increased if tolerated to 2.5 mg once daily for 1 week,then increased if tolerated to 3.75 mg once daily for 1 week, thenincreased if tolerated to 5 mg once daily for 4 weeks, then increased if tolerated to 7.5 mg once daily for 4 weeks, then increased if tolerated to10 mg once daily; maximum 10 mg per day.
In patient with renal dysfunction (creatinine clearance < 40 ml/min) or hepatic impairment
- use an initial daily dose of 2.5 mg and The dosage should not exceed 10mg daily.
- B-Card® should be used with caution in patients with bronchial asthma, mild disturbances of atrioventricular conduction (first degree AV block).
- Mild disturbances of atrioventricular conduction the coronary vessels (Prinzmetal’s angina) and in impaired liver and renal function the dosage instruction must be observed.
- Blister of 10 tablets, packs of 2 blisters .
- Store in a dry place at a temperature not exceeding 25 ºC.