Bisoprolol Fumarate

Indications

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

Dosage and administration (summary)

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 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.

Contraindications

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

Warnings and precautions

WARNINGS Click here to enter Warnings Cardiac Failure Sympathetic stimulation is a vital component supporting circulatory function in the setting of congestive heart failure, and beta-blockade may result in further depression of myocardial contractility and precipitate more severe failure. In general, beta-blocking agents should be avoided in patients with overt congestive failure. However, in some patients with compensated cardiac failure it may be necessary to utilize them. In such a situation, they must be used cautiously.

Pregnancy

Pregnancy In rats, bisoprolol fumarate was not teratogenic at doses up to 150 mg/kg/day which is 375 and 77 times the MRHD on the basis of body weight and body surface area, respectively. Bisoprolol fumarate was fetotoxic (increased late resorptions) at 50 mg/kg/day and maternotoxic (decreased food intake and body weight gain) at 150 mg/kg/day.

Storage and supply

HOW SUPPLIED Bisoprolol fumarate tablets, USP, are supplied as 5 mg and 10 mg tablets. The 5 mg tablet is pink color coated tablet, capsule shaped, convex scored tablets debossed with “6|6” on one side and “S” on the other side, supplied as follows: bottles of 30 (Unit-of-Use) NDC 43547-616-03 bottles of 100 NDC 43547-616-10 bottles of 500 NDC 4354…

Source: Bisoprolol Fumarate (Bisoprolol Fumarate) — US FDA prescribing information, 2023-06-26, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.