BISOPROLOL- bisoprolol fumarate tablet, film coated

País: Estados Unidos

Língua: inglês

Origem: NLM (National Library of Medicine)

Ingredientes ativos:

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

Disponível em:

NuCare Pharmaceuticals,Inc.

Via de administração:

ORAL

Tipo de prescrição:

PRESCRIPTION DRUG

Indicações terapêuticas:

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

Resumo do produto:

Bisoprolol Fumarate Tablets USP are supplied as follows: Bisoprolol Fumarate Tablets, 5 mg, red, film-coated, scored, debossed MP711 NDC 68071-5097-3 BOTTLES OF 30 Store at 20° to 25°C (68° to 77°F). [ See USP Controlled Room Temperature ] Protect from moisture. DISPENSE IN TIGHT, LIGHT-RESISTANT CONTAINER as defined in the USP. Manufactured by FRONTIDA BIOPHARM, INC. Philadelphia, PA 19124 USA Distributed by TruPharma LLC, Tampa Florida 33609 Rev 00, February 2019

Status de autorização:

Abbreviated New Drug Application

Características técnicas

BISOPROLOL- BISOPROLOL FUMARATE TABLET, FILM COATED
NUCARE PHARMACEUTICALS,INC.
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BISOPROLOL TABLETS USP 5MG AND 10MG
RX ONLY
BISOPROLOL FUMARATE TABLETS
DESCRIPTION
Bisoprolol fumarate, USP is a synthetic, beta1-selective
(cardio-selective) 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 (C18H31NO4)2•C4H4O4 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 is available as 5 mg or 10 mg for oral
administration. Inactive
ingredients include carnauba wax, colloidal silicon dioxide, corn
starch, crospovidone,
dibasic calcium phosphate, hydroxypropyl methylcellulose, magnesium
stearate,
microcrystalline cellulose, polydextrose, polyethylene glycol,
titanium dioxide, triacetin.
The 5 mg tablets also contain FD&C Yellow No. 6 Aluminum Lake, FD&C
Red No. 40
Aluminum Lake, FD&C Blue No. 2 Aluminum Lake.
_Meets USP Dissolution Test 2._
CLINICAL PHARMACOLOGY
Bisoprolol fumarate is a beta
-selective (cardioselective) adrenoceptor blocking 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
1
2
The absolute bioavailability after a 10 mg oral dose of bisoprolol
fumarate is about 80%.
Absorption is not