BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE tablet

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

HYDROCHLOROTHIAZIDE (UNII: 0J48LPH2TH) (HYDROCHLOROTHIAZIDE - UNII:0J48LPH2TH), BISOPROLOL FUMARATE (UNII: UR59KN573L) (BISOPROLOL - UNII:Y41JS2NL6U)

Tilgjengelig fra:

Bryant Ranch Prepack

Administreringsrute:

ORAL

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

Bisoprolol fumarate and hydrochlorothiazide tablets are indicated in the management of hypertension. Bisoprolol fumarate and hydrochlorothiazide tablets are contraindicated in patients in cardiogenic shock, overt cardiac failure (see WARNINGS), second or third degree AV block, marked sinus bradycardia, anuria, and hypersensitivity to either component of this product or to other sulfonamide-derived drugs.

Produkt oppsummering:

Bisoprolol Fumarate and Hydrochlorothiazide Tablets USP 5 mg/6.25 mg salmon pink coloured, biconvex, round, film coated tablets debossed with UL on one side and | | on other side. NDC: 71335-0595-4: 100 Tablets in a BOTTLE, PLASTIC NDC: 71335-0595-1: 30 Tablets in a BOTTLE, PLASTIC NDC: 71335-0595-2: 90 Tablets in a BOTTLE, PLASTIC NDC: 71335-0595-3: 28 Tablets in a BOTTLE, PLASTIC Store at 200 to 250C (680 to 770F) [see USP Controlled Room Temperature]. Dispense in a tight container. Repackaged/Relabeled by: Bryant Ranch Prepack, Inc. Burbank, CA 9150

Autorisasjon status:

Abbreviated New Drug Application

Preparatomtale

BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE- BISOPROLOL FUMARATE
AND HYDROCHLOROTHIAZIDE TABLET
BRYANT RANCH PREPACK
----------
BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE TABLETS USP
RX ONLY
DESCRIPTION
Bisoprolol fumarate and hydrochlorothiazide tablets USP are indicated
for the treatment
of hypertension. It combines two antihypertensive agents in a
once–daily dosage: a
synthetic beta -selective (cardioselective) adrenoceptor blocking
agent (bisoprolol
fumarate) and a benzothiadiazine diuretic (hydrochlorothiazide).
Bisoprolol fumarate is chemically described as (±)-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 it has a molecular
weight of 766.97. Its structural formula is:
Bisoprolol fumarate is a white crystalline powder, approximately
equally hydrophilic and
lipophilic, and readily soluble in water, methanol, ethanol, and
chloroform.
Hydrochlorothiazide (HCTZ) is
6-Chloro-3,4-dihydro-_2H_-1,2,4-benzothiadiazine-7-
1
18
31
4 2
4
4
4
sulfonamide 1,1-dioxide. It is a white, or practically white,
practically odorless crystalline
powder. It is slightly soluble in water, sparingly soluble in dilute
sodium hydroxide
solution, freely soluble in n-butylamine and dimethylformamide,
sparingly soluble in
methanol, and insoluble in ether, chloroform, and dilute mineral
acids. Its molecular
formula is C H ClN O S and it has a molecular weight of 297.73. Its
structural formula
is:
Each Bisoprolol Fumarate and Hydrochlorothiazide tablet USP 2.5
mg/6.25 mg for oral
administration contains:
Bisoprolol fumarate USP….. 2.5 mg
Hydrochlorothiazide USP…. 6.25 mg
Each Bisoprolol Fumarate and Hydrochlorothiazide tablet USP 5 mg/6.25
mg for oral
administration contains:
Bisoprolol fumarate USP….. 5 mg
Hydrochlorothiazide USP…. 6.25 mg
Ea