SPL Set ID: 57505d73-f2a8-430b-8703-a0a6bb733c7d
1 drug(s) with this SPL Set ID
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 1 -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 molecular formula is (C 18 H 31 NO 4 ) 2 •C 4 H 4 O 4 and it has a molecular weight of 766.96. Its structural formula is: Bisoprolol fumarate is a white crystalline powder, approximately equally hydrophilic and lipophilic and very soluble in water and methanol; freely soluble in chloroform, glacial acetic acid and ethanol; slightly soluble in ethyl acetate and acetone. 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 practically white crystalline powder. It is very slightly soluble in methanol, sparingly soluble in acetonitrile, soluble in 1% NaOH solution, practically insoluble or insoluble in water, ethanol. Its molecular formula is C 7 H 8 ClN 3 O 4 S 2 and it has a molecular weight of 297.74. Its structural formula is: Each bisoprolol fumarate and hydrochlorothiazide tablets, USP 2.5 mg/6.25 mg for oral administration contains: Bisoprolol fumarate, USP………………………….……………..2.5 mg Hydrochlorothiazide, USP………………………………………..6.25 mg Each bisoprolol fumarate and hydrochlorothiazide tablets, USP 5 mg/6.25 mg for oral administration contains: Bisoprolol fumarate, USP………………………….……………..5 mg Hydrochlorothiazide, USP………………………………………..6.25 mg Each bisoprolol fumarate and hydrochlorothiazide tablets, USP 10 mg/6.25 mg for oral administration contains: Bisoprolol fumarate, USP………………………….……………..10 mg Hydrochlorothiazide, USP………………………………………..6.25 mg Each tablet contains following inactive ingredients: butylated hydroxyanisole, colloidal silicon dioxide, crospovidone, dibasic calcium phosphate anhydrous, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol and titanium dioxide. Additionally, each 2.5 mg/6.25 mg tablet contains iron oxide red and iron oxide yellow and each 5 mg/6.25 mg tablet contains FD&C red #40 Aluminum Lake and D&C yellow #10 Aluminum Lake. Image Image