Zebeta (Bisoprolol Fumarate) - Indications and Dosage

INDICATIONS AND USAGE

ZEBETA is indicated in the management of hypertension. It may be used alone or in combination with other antihypertensive agents.

DOSAGE AND ADMINISTRATION

The dose of ZEBETA must be individualized to the needs of the patient. The usual starting dose is 5 mg once daily. In some patients, 2.5 mg may be an appropriate starting dose (see Bronchospastic Disease in WARNINGS). 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.

Patients with Renal or Hepatic Impairment

In patients with hepatic impairment (hepatitis or cirrhosis) or renal dysfunction (creatinine clearance less than 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 bisoprolol fumarate 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 (see above and Geriatric Use in PRECAUTIONS).

Pediatric Patients

There is no pediatric experience with ZEBETA.

HOW SUPPLIED

ZEBETA^® (bisoprolol fumarate) is supplied as 5 mg and 10 mg tablets.

The 5 mg tablet is pink, heart-shaped, film-coated, vertically scored in half on both sides, with an engraved stylized b/stylized b on one side and 6/0 on the reverse side, supplied as follows:

30 Tablets

Unit-of-use

NDC 51285-060-01

The 10 mg tablet is white, heart-shaped, biconvex, film-coated, with an engraved stylized b on one side and 61 on the reverse side, supplied as follows:

30 Tablets

Unit-of-use

NDC 51285-061-01

Store at 20^o to 25^o C (68^o to 77^oF) [See USP Controlled Room Temperature].
Protect from moisture.
Dispense in tight containers.

DURAMED PHARMACEUTICALS, INC.
Subsidiary of Barr Pharmaceuticals, Inc.
Pomona, New York 10970

Revised MAY 2007
BR-0060, 0061