ZIAC Film-coated tablet Ref.[10629] Active ingredients: Bisoprolol Bisoprolol and Hydrochlorothiazide Hydrochlorothiazide

Source: FDA, National Drug Code (US)  Revision Year: 2024 

Product 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 beta1-selective (cardioselective) adrenoceptor blocking agent (bisoprolol fumarate) and a benzothiadiazine diuretic (hydrochlorothiazide).

Bisoprolol fumarate is chemically described as (Âą)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 (C18H31NO4)2â€ĒC4H4O4 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-2H-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 C7H8ClN3O4S2 and it has a molecular weight of 297.73.

Its structural formula is:

Each ZIAC 2.5 mg/6.25 mg tablet for oral administration contains:

Bisoprolol fumarat 2.5 mg
Hydrochlorothiazide 6.25 mg

Each ZIAC 5 mg/6.25 mg tablet for oral administration contains:

Bisoprolol fumarate 5 mg
Hydrochlorothiazide 6.25 mg

Each ZIAC 10 mg/6.25 mg tablet for oral administration contains:

Bisoprolol fumarate 10 mg
Hydrochlorothiazide 6.25 mg

Inactive ingredients include Corn Starch, Dibasic Calcium Phosphate, Hypromellose, Magnesium Stearate, Microcrystalline Cellulose, Polyethylene Glycol, Polysorbate 80, and Titanium Dioxide. The 10 mg/6.25mg tablet also contains Colloidal Silicon Dioxide. The 5 mg/6.25 mg tablet also contains Colloidal Silicon Dioxide, and Red and Yellow Iron Oxide. The 2.5 mg/6.25 mg tablet also contains Crospovidone, Pregelatinized Starch, and Yellow Iron Oxide.

How Supplied

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

Manufactured for: Teva Pharmaceuticals, Parsippany, NJ 07054

Drugs

Drug Countries
ZIAC Ecuador, United States

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