BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE tablet, film coated

Kraj: Stany Zjednoczone

Język: angielski

Źródło: NLM (National Library of Medicine)

Składnik aktywny:

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

Dostępny od:

REMEDYREPACK INC.

Droga podania:

ORAL

Typ recepty:

PRESCRIPTION DRUG

Wskazania:

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.

Podsumowanie produktu:

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: NDC: 70518-3530-00 PACKAGING: 90 in 1 BOTTLE PLASTIC Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight container. Repackaged and Distributed By: Remedy Repack, Inc. 625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762

Status autoryzacji:

Abbreviated New Drug Application

Charakterystyka produktu

BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE- BISOPROLOL FUMARATE
AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED
REMEDYREPACK INC.
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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…....................................................
6