Acubis®2.5

Acubis®2.5 Tablet: Each film coated tablet contains- Bisoprolol Fumarate BP 2.5 mg. Acubis®5 Tablet: Each film coated tablet contains- Bisoprolol Fumarate BP 5 mg.

PHARMACOLOGY

Bisoprolol is the most selective beta-1 blocker. It displays highest level of affinity for the beta-1 receptor than any other beta-blocker available up to now. Selectively blocks beta-1 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 beta-blockers, in patients with non-beta 1 selective beta-blocker, but Bisoprolol does not cause any change in the cholesterol fraction including the cardioprotective HDL-cholesterol, in long-term therapy.

INDICATION

Bisoprolol is indicated in the treatment of hypertension, angina and heart failure. It may be used alone or in combination with other antihypertensive agents.

DOSAGE AND ADMINISTRATION

Hypertension and angina: Usually 5-10 mg once daily, maximum 20 mg daily, Moderate to severe 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 10 mg daily.

SIDE-EFFECTS

Fatigue, dizziness, headache, disturbances of the gut such as nausea, vomiting, diarrhoea, constipation or abdominal pain, cold or numb extremities, e.g. hands and feet, muscle weakness or cramps, slower than normal heart beat (bradycardia), worsening of heart failure, sleep disturbance, depression, breathing difficulties due to a narrowing of the airways (bronchospasm) in people with asthma or COPD.

CONTRAINDICATIONS

Bisoprolol is contraindicated in patients with cardiogenic shock, overt cardiac failure, second or third degree AV block and marked sinus bradycardia.

USE IN PREGNANCY & LACTATION

Pregnancy Category C. There are no adequate and well-controlled studies in pregnant women. Bisoprolol should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Lactating Mothers: Small amounts of Bisoprolol (< 2% of the dose) have been detected in the milk of lactating rats. It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk caution should be exercised when Bisoprolol is administered to lactating women.

OVERDOSE

The most common signs expected with over dosage of a beta-blocker are bradycardia, hypotension, congestive heart failure, bronchospasm, and hypoglycemia. To date, a few cases of overdose (maximum: 2000 mg) with Bisoprolol have been reported. Bradycardia and/or hypotension were noted. Sympathomimetic agents were given in some cases, and all patients recovered. In general, if overdose occurs, Bisoprolol therapy should be stopped and supportive and symptomatic treatment should be provided. Limited data suggest that Bisoprolol is not dialyzable. Based on the expected pharmacologic actions and recommendations for other beta-blockers, the following general measures should be considered when clinically warranted.

PRECAUTIONS

Monitoring of renal, hepatic, and hematopoietic function should be performed at regular intervals during long-term treatment with Bisoprolol.

DRUG INTERACTION

Bisoprolol should not be combined with other beta-blocking agents.

STORAGE

Store in a cool (Below 30⁰ C Temp.) and dry place, away from light. Keep out of the reach of children.

COMMERCIAL SUPPLY

Acubis®2.5 Tablet : Each box contains 3x10’s tablets in blister strip. Acubis®5 Tablet : Each box contains 3x10’s tablets in blister strip.

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