ZIAC- bisoprolol fumarate and hydrochlorothiazide tablet, film coated

Nazione: Stati Uniti

Lingua: inglese

Fonte: NLM (National Library of Medicine)

Principio attivo:

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

Commercializzato da:

Teva Women's Health LLC

INN (Nome Internazionale):

BISOPROLOL FUMARATE

Composizione:

BISOPROLOL FUMARATE 2.5 mg

Via di somministrazione:

ORAL

Tipo di ricetta:

PRESCRIPTION DRUG

Indicazioni terapeutiche:

ZIAC (bisoprolol fumarate and hydrochlorothiazide) is indicated in the management of hypertension. ZIAC is 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.

Dettagli prodotto:

ZIAC® -2.5 mg/6.25 mg Tablets (bisoprolol fumarate 2.5 mg and hydrochlorothiazide 6.25 mg): Yellow, round, film-coated, unscored tablets. Debossed with stylized b within an engraved heart shape on one side and 47 on the other side, supplied as follows: Bottle of 100 Tablets NDC 51285-047-02 ZIAC® -5 mg/6.25 mg Tablets (bisoprolol fumarate 5 mg and hydrochlorothiazide 6.25 mg): Pink, round, film-coated, unscored tablets. Debossed with stylized b within an engraved heart shape on one side and 50 on the other side, supplied as follows: Bottle of 100 Tablets NDC 51285-050-02 ZIAC® -10 mg/6.25 mg Tablets (bisoprolol fumarate 10 mg and hydrochlorothiazide 6.25 mg): White, round, film-coated, unscored tablets. Debossed with stylized b within an engraved heart shape on one side and 40 on the other side, supplied as follows: Bottle of 30 Tablets with child resistant closure NDC 51285-040-01 Store at 20°C to 25°C (68°F to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight container. Manufactured for: Teva Pharmaceuticals Parsippany, NJ 07054 ZIAC-004 Rev. 12/2023

Stato dell'autorizzazione:

New Drug Application

Scheda tecnica

ZIAC- BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED
TEVA WOMEN'S HEALTH LLC
----------
ZIAC
(BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE) TABLETS
RX ONLY
DESCRIPTION
ZIAC (bisoprolol fumarate and hydrochlorothiazide) is 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
is:
®
®
1
18
31
4 2
4
4
4
7
8
3
4 2
Each ZIAC -2.5 mg/6.25 mg tablet for oral administration contains:
Bisoprolol
fumarate…………………………………………..2.5 mg
Hydrochlorothiazide………………………………………..6.25
mg
Each ZIAC -5 mg/6.25 mg tablet for oral administration contains:
Bisoprolol
fumarate……………………………………………5 mg
Hydrochlorothi