BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE tablet, film coated

Pays: États-Unis

Langue: anglais

Source: NLM (National Library of Medicine)

Ingrédients actifs:

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

Disponible depuis:

A-S Medication Solutions

Mode d'administration:

ORAL

Type d'ordonnance:

PRESCRIPTION DRUG

indications thérapeutiques:

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.

Descriptif du produit:

Product: 50090-5849 NDC: 50090-5849-0 30 TABLET, FILM COATED in a BOTTLE NDC: 50090-5849-2 90 TABLET, FILM COATED in a BOTTLE

Statut de autorisation:

Abbreviated New Drug Application

Résumé des caractéristiques du produit

BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE - BISOPROLOL FUMARATE
AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED
A-S MEDICATION SOLUTIONS
----------
BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE TABLETS
DESCRIPTION
BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE TABLETS, USP
RX ONLY
REVISED MARCH 2021
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…................................................