DOSAGE AND ADMINISTRATION
The dose of bisoprolol fumarate 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 bisoprolol fumarate.
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HOW SUPPLIED
Bisoprolol fumarate is supplied as 5 mg and 10 mg tablets.
Bisoprolol Fumarate Tablets, USP 5 mg are pink colored, circular, biconvex, film coated tablets, debossed with ‘C and break line’ on one side and ‘86’ on the other side.
Bottles of 30 NDC 65862-086-30
Bottles of 100 NDC 65862-086-01
Bisoprolol Fumarate Tablets, USP 10 mg are white, circular, biconvex, film coated tablets, debossed with ‘C’ on one side and ‘87’ on the other side.
Bottles of 30 NDC 65862-087-30
Bottles of 100 NDC 65862-087-01
Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature].
Protect from light and moisture.
Dispense in tight, light-resistant containers as defined in the USP.
Manufactured for:
Aurobindo Pharma USA, Inc.
2400 Route 130 North
Dayton, NJ 08810
Manufactured by:
Aurobindo Pharma Limited
Hyderabad–500 072, India
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