Betabis-5 mg Tablet

Betabis-5 mg Tablet

DESCRIPTION

Bisoprolol is the most potent β1-selective β-blocker. It has the highest level of β1-selectivity and by blocking the heart’s β1 adrenergic receptors it reduces heart rate & force of contraction of the heart, thus lowers blood pressure.

COMPOSITION

Betabis 2.5: Each film-coated tablet contains Bisoprolol hemifumarate USP 2.5 mg.

Betabis 5: Each film-coated tablet contains Bisoprolol hemifumarate USP 5 mg.

INDICATIONS

Betabis (Bisoprolol) is indicated in the management of hypertension, angina. It may be used alone or in combination with other antihypertensive agents.

DOSAGE AND ADMINISTRATION

The dose of Betabis must be individualized to the needs of the patient.

The usual starting dose is Betabis 5 mg once daily. In some patients,

Betabis 2.5 mg may be an appropriate starting dose. If the antihypertensive effect of Betabis 5 mg is inadequate, the dose may be increased to Betabis 10 mg and then, if necessary, to 20 mg once daily.

Patients with renal or Hepatic Impairment : In patients with hepatic impairment (hepatitis or cirrhossis) or renal dysfunction (creatinine clearance <40 mL/min), the initial daily dose should be 2.5 mg and caution should be used in dose-titration Since limited data suggest that Bisopolol hemifumarate is not dialyzable, drug replacement is not necessary in patients undergoing dialysis. Geriatric Patients : It is not necessary to adjust the dose in the elderly, unless there is also significant renal or hepatic dysfunction.

OR AS DIRECTED BY THE PHYSICIAN.

SIDE EFFECTS

Fatigue, dizziness, headache, sleep disturbance, bronchospasm, peripheral vasoconstriction, gastro-intestinal disturbances, bradycardia and worsening of heart failure. Less commonly depression, muscle weakness, cramp; rarely hypertriglyceridaemia, syncope, hearing impairment; and very rarely conjunctivitis.

CONTRAINDICATIONS

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

PRECAUTIONS

Impaired renal or hepatic function : Use caution in adjusting the dose of Bisoprolol in patients with renal or hepatic impairment. Risk of anaphylactic reaction: While taking beta-blockers, patients with a history of severe anaphytlactic reaction to a variety of allergens may be more reactive to repeated challenge, accidental, diagnostic or therapeutic. Such patients may be unresponsive to the usual doses of epinephrine used to treat allergic reaction.

USE IN PREGNANCY & LACTATION

There are no adequate and well controlled studies of safety evidence in pregnant women. Therefore, Bisoprolol should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. It is not known whether this drug is excreted in human milk and therefore caution should be exercised when Bisoprolol is administered to nursing women.

USE IN CHILDREN

Safety and effectiveness have not been established in children.

DRUG INTERACTION

Bisoprolol should not be combined with other β-blocking agents. Patients receiving catecholamine-depleting drugs (e.g. Reserpine or Guanethidine) should be closely monitored. In patients receiving concurrent therapy with Clonidine, if therapy is to be discontinued, it is suggested that Bisoprolol be discontinued for several days before the withdrawal of Clonidine. Bisoprolol should be used with care when myocardial depressants or inhibitors of AV conduction, such as certain calcium antagonists (e.g. Verapamil, Diltiazem) or antiarrhythmic agents (e.g. Disopyramide) are used concurrently. Concurrent use of Rifampin increases the metabolic clearance of Bisoprolol resulting in a shortened elimination half-life of Bisoprolol.

OVER DOSE

The most common signs expected with overdose (max. 2000 mg) of a β-blocker are bradycardia, hypotension, congestive heart failure, bronchospasm, and hypoglycemia.

SUPPLY

Betabis 2.5: Each box contains 3 X 10 tablets in Alu-Alu blister Strips.

Betabis 5: Each box contains 3 X 10 tablets in Alu-Alu blister Strips.