CADROL® – Bisoprolol Fumarate USP
COMPOSITION
Available in single dosage form:
Cadrol 2.5 Tablet: Each film coated tablet contains Bisoprolol Fumarate USP 2.5 mg. Cadrol 5 Tablet: Each film coated tablet contains Bisoprolol Fumarate USP 5 mg.
PHARMACOLOGY
Bisoprolol is a cardio-selective inhibitor of beta-1 adrenoceptor. It shows highest affinity for the 13 receptor than other beta-blocker and selectively blocks 13 adrenergic receptor thus reduces heart rate and cardiac output resulting a decreased arterial hypertension.
INDICATION
Treatment of high blood pressure (hypertension)
Treatment of coronary heart disease (angina pectoris) Treatment of stable chronic heart failure
DOSAGE AND ADMINISTRATION
Hypertension: The usual starting dose is 5 mg once daily. In some patients, 2.5 mg may be 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. Dose may be individualized as per patient condition.
Angina: Usually 10 mg once daily (5 mg may be adequate in some patients) max 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 10 mg daily.
USE IN PREGNANCY AND LACTATION
US FDA Pregnancy Category: ‘C’.
In Pregnancy: Bisoprolol should not be used during pregnancy unless clearly necessary. If necessary the uteroplacental blood flow and the foetal growth should be monitored.
In Lactation: It is not known whether this drug is excreted in human milk. Therefore, breast-feeding is not recommended during administration of Bisoprolol.
CONTRAINDICATION
Bisoprolol is contraindicated in patients with cardiogenic shock, explicit cardiac failure, second or thirddegree AV block and marked sinus bradycardia.
SIDE EFFECT
In some patients, gastro-intestinal disturbances, bradycardia, hypotension, headache, fatigue, sleep disturbances, dizziness, vertigo, thrombocytopenia, visual disturbances, alopecia may be occurred.
PRECAUTION
In case of long term treatment with Bisoprolol and its combination, monitoring of renal, hepatic and hematopoietic function should be performed at regular intervals.
OVERDOSE
The most common signs expected with overdose of a beta-blocker are bradycardia, hypotension, congestive heart failure, bronchospasm, and hypoglycemia. Only a few cases of overdose with Bisoprolol have been reported.
STORAGE
Store in a cool, dry place & below 30° C. Protected from light. Keep out of reach of children.
PACKAGING
Cadrol 2.5 Tablet: Each box contains 3 x 10’s film coated tablets in Alu-Alu blister pack.
Cadrol 5 Tablet: Each box contains 3 x 10’s film coated tablets in Alu-Alu blister pack.
