BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE tablet, film coated

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:

GLENMARK PHARMACEUTICALS INC., USA

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 Tablets, USP 2.5 mg/6.25 mg (bisoprolol fumarate, USP 2.5 mg and hydrochlorothiazide, USP 6.25 mg): Light yellow to yellow, round, film-coated, unscored tablets. Debossed with a “G” on one side and “59” on the other side, supplied as follows: Bottle of 30 Tablets with child resistant closure NDC 68462-878-30 Bottle of 100 Tablets NDC 68462-878-01 Bottle of 500 Tablets NDC 68462-878-05 Bisoprolol Fumarate and Hydrochlorothiazide Tablets, USP 5 mg/6.25 mg (bisoprolol fumarate, USP 5 mg and hydrochlorothiazide, USP 6.25 mg): Light pink to pink, round, film-coated, unscored tablets. Debossed with a “G” on one side and “93” on the other side, supplied as follows: Bottle of 30 Tablets with child resistant closure NDC 68462-879-30 Bottle of 100 Tablets NDC 68462-879-01 Bottle of 500 Tablets NDC 68462-879-05 Bisoprolol Fumarate and Hydrochlorothiazide Tablets, USP 10 mg/6.25 mg (bisoprolol fumarate, USP 10 mg and hydrochlorothiazide, USP 6.25 mg): White to off-white, round, film-coated, unscored tablets. Debossed with a “G” on one side and “95” on the other side, supplied as follows: Store at 20°C to 25°C (68°F to 77°F) [see USP Controlled Room Temperature]. Preserve in tight, light resistant containers. Dispense in a tight container. Manufactured by: Glenmark Pharmaceuticals Limited Pithampur, Madhya Pradesh 454775, India Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430 Questions? 1 [phone] www.glenmarkpharma-us.com January 2024

Status de autorização:

Abbreviated New Drug Application

Características técnicas

BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE- BISOPROLOL FUMARATE
AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED
GLENMARK PHARMACEUTICALS INC., USA
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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, 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--------------------------------------------