BISOPROLOL- bisoprolol fumarate tablet, film coated

Nazione: Stati Uniti

Lingua: inglese

Fonte: NLM (National Library of Medicine)

Principio attivo:

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

Commercializzato da:

TruPharma, LLC

Via di somministrazione:

ORAL

Tipo di ricetta:

PRESCRIPTION DRUG

Indicazioni terapeutiche:

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.

Dettagli prodotto:

Bisoprolol Fumarate Tablets USP are supplied as follows: Bisoprolol Fumarate Tablets, 5 mg, red, film-coated, scored, debossed MP711 Bottles of 30             NDC 52817 270 30 Bottles of 100             NDC 52817 270 10 Bisoprolol Fumarate Tablets, 10 mg, white, film-coated, unscored, debossed MP712 Bottles of 30             NDC 52817 271 30 Bottles of 100             NDC 52817 271 10 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 01, December 2019

Stato dell'autorizzazione:

Abbreviated New Drug Application

Scheda tecnica

BISOPROLOL- BISOPROLOL FUMARATE TABLET, FILM COATED
TRUPHARMA, LLC
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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
(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 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
The absolute bioavailability after a 10 mg oral dose of bisoprolol
fumarate is about 80%. Absorption is
not affected by the presenc