CADROL® – Bisoprolol Fumarate USP
Composition:
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 adrener¬gic receptor thus reduces heart rate and cardiac output resulting a decreased arterial hypertension.
Indications:
• Treatment of high blood pressure (hypertension)
• Treatment of coronary heart disease (angina pectoris)
• Treatment of stable chronic heart failure
Dosage & 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 & 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 Effects:
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.
Overdosage:
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.
Cadrol 2.5 Tablet: Each box contains 3 x 10’s film coated tablets in Alu-Alu blister pack.
