SPL Set ID: 295532b5-65c8-40c3-8d27-cfd334d12802

Bisoprolol Fumarate and Hydrochlorothiazide Tablets, USP Rx only Revised January 2024 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 1 -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 18 H 31 NO 4 ) 2 •C 4 H 4 O 4 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 7 H 8 ClN 3 O 4 S 2 and it has a molecular weight of 297.73. Its structural formula is: Each bisoprolol fumarate and hydrochlorothiazide tablet 2.5 mg/6.25 mg for oral administration contains: Bisoprolol fumarate....................................................... 2.5 mg Hydrochlorothiazide….................................................... 6.25 mg Each bisoprolol fumarate and hydrochlorothiazide tablet 5 mg/6.25 mg for oral administration contains: Bisoprolol fumarate...................................................…. 5 mg Hydrochlorothiazide….................................................... 6.25 mg Each bisoprolol fumarate and hydrochlorothiazide tablet 10 mg/6.25 mg for oral administration contains: Bisoprolol fumarate...................................................... 10 mg Hydrochlorothiazide….................................................... 6.25 mg Inactive ingredients include Anhydrous Lactose, Crospovidone, Hypromellose, Microcrystalline Cellulose, Polyethylene Glycol, Polysorbate 80, Pregelatinized Starch, Stearic Acid, and Titanium Dioxide. The 5 mg/6.25 mg tablet also contains D&C Red #30. The 2.5 mg/6.25 mg tablet also contains D&C Yellow #10 Aluminum Lake and FD&C Yellow #6. BISO API Structure HCTZ API Structure