BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE tablet

País: Estados Unidos

Língua: inglês

Origem: NLM (National Library of Medicine)

Ingredientes ativos:

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

Disponível em:

ANI Pharmaceuticals, Inc.

Via de administração:

ORAL

Tipo de prescrição:

PRESCRIPTION DRUG

Indicações terapêuticas:

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.

Resumo do produto:

Bisoprolol Fumarate and Hydrochlorothiazide - 2.5 mg/6.25 mg Tablets, USP (bisoprolol fumarate 2.5 mg and hydrochlorothiazide 6.25 mg): Yellow, round, uncoated, unscored tablets debossed “N” and “412” on one side and plain on the other side, supplied as follows: Bottle of 30 Tablets NDC 70954-412-10 Bottle of 100 Tablets NDC 70954-412-30 Bottle of 500 Tablets NDC 70954-412-40 Bisoprolol Fumarate and Hydrochlorothiazide - 5 mg/6.25 mg Tablets, USP (bisoprolol fumarate 5 mg and hydrochlorothiazide 6.25 mg): Pink, round, uncoated, unscored tablets debossed “N” and “413” on one side and plain on the other side, supplied as follows: Bottle of 30 Tablets NDC 70954-413-10 Bottle of 100 Tablets NDC 70954-413-30 Bottle of 500 Tablets NDC 70954-413-40 Bisoprolol Fumarate and Hydrochlorothiazide - 10 mg/6.25 mg Tablets, USP (bisoprolol fumarate 10 mg and hydrochlorothiazide 6.25 mg): Blue, round, uncoated, unscored tablets debossed “N” and “414” on one side and plain on the other side, supplied as follows: Bottle of 30 Tablets NDC 70954-414-10 Bottle of 100 Tablets NDC 70954-414-30 Bottle of 500 Tablets NDC 70954-414-40 Store at 20°C to 25°C (68°F to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight container. Manufactured by: Novitium Pharma LLC 70 Lake Drive, East Windsor New Jersey 08520 Issued: 03/2024 LB4310-02

Status de autorização:

Abbreviated New Drug Application

Características técnicas

BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE - BISOPROLOL FUMARATE
AND HYDROCHLOROTHIAZIDE TABLET
ANI PHARMACEUTICALS, INC.
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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 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
formula is C H ClN O S and it has a molecular weight of 297.73. Its
structural formula
1
18
31
4 2
4
4
4
7
8
3
4 2
is:
Each bisoprolol fumarate and hydrochlorothiazide - 2.5 mg/6.25 mg
tablet, USP for oral
administration contains:
Bisoprolol
fumarate…………………………………………..2.5 mg
Hydrochlorothiazide………………………………………..6.25
mg
Each bisoprolol fumarate and hydrochlorothiazide - 5 mg/6.25 mg
tablet, USP for