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Bisoprolol (Bisoprolol Fumarate) - Indications and Dosage

 
 



INDICATIONS AND USAGE

Bisoprolol fumarate tablets USP are indicated in the management of hypertension. It may be used alone or in combination with other antihypertensive agents.

DOSAGE AND ADMINISTRATION

The dose of bisoprolol fumarate tablets 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 WARNINGS, Bronchospastic Disease). 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 PRECAUTIONS, Geriatric Use).

Pediatric Patients

There is no pediatric experience with bisoprolol fumarate tablets.

HOW SUPPLIED

Bisoprolol Fumarate Tablets USP for oral administration are available as:

5 mg: Pink, round, biconvex, film-coated, debossed “E” over “771” and bisected on the other side and supplied as:

NDC 0185-0771-30 bottles of 30

NDC 0185-0771-01 bottles of 100

10 mg: White, round, biconvex, film-coated, debossed “E” over “774” and plain on the other side and supplied as:

NDC 0185-0774-30 bottles of 30

NDC 0185-0774-01 bottles of 100

Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

Protect from moisture.

Dispense in a tight, light-resistant container as defined in the USP with a child-resistant closure, as required.

KEEP TIGHTLY CLOSED.

KEEP THIS AND ALL MEDICATION OUT OF THE REACH OF CHILDREN.

To report SUSPECTED ADVERSE REACTIONS, contact Sandoz Inc. at 1-800-525-8747 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Sandoz Inc.

Princeton, NJ 08540

OS8898

Rev. 09/12

MF0771REV09/12

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