BISOPROLOL FUMARATE tablet, film coated

Država: Sjedinjene Američke Države

Jezik: engleski

Izvor: NLM (National Library of Medicine)

Aktivni sastojci:

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

Dostupno od:

Alembic Pharmaceuticals Inc.

Administracija rute:

ORAL

Tip recepta:

PRESCRIPTION DRUG

Terapijske indikacije:

BISOPROLOL FUMARATE   is 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.

Proizvod sažetak:

 BISOPROLOL FUMARATE is supplied as 5 mg and 10 mg tablets. The 5 mg tablet is White, round, biconvex, film-coated, scored and debossed with 'B' on one side of score line and '3' on other side of score line, plain on the other side. NDC 62332-603-30 bottles of 30 NDC 62332-603-31 bottles of 100 NDC 62332-603-71 bottles of 500  The 10 mg tablet is White, Round, biconvex, film-coated debossed with 'B4' on one side and plain on other side. NDC 62332-604-30 bottles of 30 NDC 62332-604-31 bottles of 100 NDC 62332-604-71 bottles of 500 Dispense in a tight, light-resistant container as defined in the USP with a child-resistant closure, as required. Store at 20º to 25ºC (68º to 77ºF) [See USP Controlled Room Temperature].   Protect from light and moisture. KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.     Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. For more information, call Alembic Pharmaceuticals Limited at 1-866-210-9797.   Manufactured by: Alembic Pharmaceuticals Limited (Formulation Division), Panelav 389350, Gujarat, India    Manufactured for: Alembic Pharmaceuticals, Inc. Bedminster, NJ 07921, USA    Revised: 08/2021  

Status autorizacije:

Abbreviated New Drug Application

Svojstava lijeka

BISOPROLOL FUMARATE - BISOPROLOL FUMARATE TABLET, FILM COATED
ALEMBIC PHARMACEUTICALS INC.
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BISOPROLOL FUMARATE TABLETS, USP
RX ONLY
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 molecular 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 is available as 5 and 10 mg tablets
for oral
administration.
Inactive ingredients include colloidal silicon dioxide, partially
pregelatinized starch,
crospovidone, anhydrous dibasic calcium phosphate, hypromellose,
magnesium
stearate, microcrystalline cellulose, polyethylene glycol, titanium
dioxide and talc.
CLINICAL PHARMACOLOGY
BISOPROLOL FUMARATE is a beta -selective (cardioselective)
adrenoceptor blocking
1
18
31
4 2
4
4
4
1
agent without significant membrane stabilizing activity or intrinsic
sympathomimetic
activity in 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 20%.
Binding to serum proteins is approximately 30%. Peak plasma
concentrati