BISOPROLOL FUMARATE- bisoprolol fumarate tablet, film coated

מדינה: ארצות הברית

שפה: אנגלית

מקור: NLM (National Library of Medicine)

מרכיב פעיל:

BISOPROLOL FUMARATE (UNII: UR59KN573L) (BISOPROLOL - UNII:Y41JS2NL6U)

זמין מ:

Bryant Ranch Prepack

מסלול נתינה (של תרופות):

ORAL

סוג מרשם:

PRESCRIPTION DRUG

סממני תרפויטית:

Bisoprolol fumarate tablets are indicated in the management of hypertension. It may be used alone or in combination with other antihypertensive agents. Bisoprolol fumarate is contraindicated in patients with cardiogenic shock, overt cardiac failure, second or third degree AV block, and marked sinus bradycardia.

leaflet_short:

NDC: 71335-9755-3: 180 FILM COATED TABLETs in a BOTTLE NDC: 71335-9755-1: 30 FILM COATED TABLETs in a BOTTLE NDC: 71335-9755-2: 120 FILM COATED TABLETs in a BOTTLE NDC: 71335-9755-4: 90 FILM COATED TABLETs in a BOTTLE

מצב אישור:

Abbreviated New Drug Application

מאפייני מוצר

BISOPROLOL FUMARATE - BISOPROLOL FUMARATE TABLET, FILM COATED
BRYANT RANCH PREPACK
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BISOPROLOL FUMARATE TABLETS, USP
DESCRIPTION
Bisoprolol fumarate is a synthetic, beta
-selective (cardioselective) adrenoceptor
blocking agent. The chemical name for bisoprolol fumarate is
(±)-1-[4-[[2-(1-
Methylethoxy)ethoxy]methyl]phenoxy]-3-[(1-methylethyl)amino]-2-propanol(
_E_)-2-
butenedioate (2:1) (salt). It possesses an asymmetric carbon atom in
its structure and is
provided as a racemic mixture. The S(-) enantiomer is responsible for
most of the beta-
blocking activity. Its empirical formula is (C
H
NO
)
•C
H
O
and its structure is:
Bisoprolol fumarate has a molecular weight of 766.97. It is a white
crystalline powder
which is approximately equally hydrophilic and lipophilic, and is
readily soluble in water,
methanol, ethanol, and chloroform.
Bisoprolol fumarate tablets, USP are available as 5 and 10 mg tablets
for oral
administration.
Inactive ingredients include Colloidal Silicon Dioxide, Corn Starch,
Dibasic Calcium
Phosphate, Hypromellose, Magnesium Stearate, Microcrystalline
Cellulose, Polyethylene
Glycol, Polysorbate 80, and Titanium Dioxide. The 5 mg tablets also
contain FD&C Red #
40/Allura Red AC aluminum lake, FD&C Yellow # 6/Sunset Yellow FCF
aluminum lake.
CLINICAL PHARMACOLOGY
Bisoprolol fumarate is a beta
-selective (cardioselective) adrenoceptor blocking agent
without significant membrane stabilizing activity or intrinsic
sympathomimetic activity in
1
18
31
4
2
4
4
4
1
its therapeutic dosage range. Cardioselectivity is not absolute,
however, and at higher
doses (≥ 20 mg) bisoprolol fumarate also inhibits beta
-adrenoceptors, chiefly located
in the bronchial and vascular musculature; to retain selectivity it is
therefore important to
use the lowest effective dose.
PHARMACOKINETICS AND METABOLISM
The absolute bioavailability after a 10 mg oral dose of bisoprolol
fumarate is about 80%.
Absorption is not affected by the presence of food. The first pass
metabolism of
bisoprolol fumarate is about 2