Source: FDA, National Drug Code (US) Revision Year: 2024
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)2âĒC4H4O4 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 | ||||||
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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:
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:
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:
Manufactured for: Teva Pharmaceuticals, Parsippany, NJ 07054 |
Drug | Countries | |
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ZIAC | Ecuador, United States |
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