BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE tablet, film coated

Land: Vereinigte Staaten

Sprache: Englisch

Quelle: NLM (National Library of Medicine)

Wirkstoff:

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

Verfügbar ab:

Edenbridge Pharmaceuticals LLC.

Verabreichungsweg:

ORAL

Verschreibungstyp:

PRESCRIPTION DRUG

Anwendungsgebiete:

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.

Produktbesonderheiten:

Bisoprolol fumarate and hydrochlorothiazide tablets, 2.5 mg/6.25 mg: Yellow, round, biconvex, film-coated, unscored tablets, debossed with “920” on one side and plain on the reverse side, supplied as follows: Bisoprolol fumarate and hydrochlorothiazide tablets, 5 mg/6.25 mg: Pink, round, biconvex, film-coated, unscored tablets, debossed with “921” on one side and plain on the reverse side, supplied as follows: Bisoprolol fumarate and hydrochlorothiazide tablets, 10 mg/6.25 mg: White to off-white, round, biconvex, film-coated, unscored tablets, debossed with “922” on one side and plain on the reverse side, supplied as follows: Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight container.   Edenbridge Pharmaceuticals, LLC   Parsippany, New Jersey, 07054   Revised January 2024

Berechtigungsstatus:

Abbreviated New Drug Application

Fachinformation

BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE - BISOPROLOL FUMARATE
AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED
EDENBRIDGE PHARMACEUTICALS LLC.
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BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE TABLETS
DESCRIPTION
BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE TABLETS, USP
RX ONLY
REVISED JANUARY 2024
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 empirical 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-2_H_-1,2,4-benzothiadiazine-7-
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 empirical
1
18
31
4 2
4
4
4
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 2.5 mg/6.25 mg
for oral
administration contains:
Bisoprolol
fumarate....................................................... 2.5 mg
Hydrochlorothiazide….....................................