BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE tablet, film coated

Land: USA

Språk: engelska

Källa: NLM (National Library of Medicine)

Aktiva substanser:

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

Tillgänglig från:

A-S Medication Solutions

Administreringssätt:

ORAL

Receptbelagda typ:

PRESCRIPTION DRUG

Terapeutiska indikationer:

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.

Produktsammanfattning:

Product: 50090-6030 NDC: 50090-6030-0 30 TABLET, FILM COATED in a BOTTLE

Bemyndigande status:

Abbreviated New Drug Application

Produktens egenskaper

BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE- BISOPROLOL FUMARATE
AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED
A-S MEDICATION SOLUTIONS
----------
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, USP 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 766.96 g/mol. Its structural formula is:
Bisoprolol fumarate, USP is a white crystalline powder, approximately
equally hydrophilic
and lipophilic, and very soluble in water, methanol, freely soluble in
alcohol, glacial acetic
acid and chloroform and slightly soluble in acetone and ethyl acetate.
Hydrochlorothiazide (HCTZ), USP is
6-Chloro-3,4-dihydro-2_H_-1,2,4-benzothiadiazine-7-
sulfonamide 1,1-dioxide. It is a white, or almost white, almost
odorless crystalline
powder. It is very slightly soluble in water, soluble in acetone,
freely soluble in n-
butylamine, N,N-dimethylformamide and diluted solutions of alkali
hydroxides, sparingly
soluble in methanol and ethanol, and practically insoluble in ether,
chloroform, and dilute
mineral acids. Its empirical formula is C H ClN O S and it has a
molecular weight of
297.7 g/mol. Its structural formula is:
1
18
31
4 2
4
4
4
7
8
3
4 2
Each Bisoprolol Fumarate and Hydrochlorothiazide Tablet, USP 2.5
mg/6.25 mg for oral
administration contains:
Bisoprolol fumarate,
USP------------------------------------------------------