SPL Set ID: 5c128ef2-60a6-40f3-b37f-ee139fe27987

Olmesartan medoxomil, amlodipine, and hydrochlorothiazide tablets for oral administration are a fixed combination of olmesartan medoxomil (ARB), amlodipine (CCB), and hydrochlorothiazide (thiazide diuretic). Olmesartan medoxomil, USP, a prodrug, is hydrolyzed to olmesartan during absorption from the gastrointestinal tract. The olmesartan medoxomil, USP component of olmesartan medoxomil, amlodipine, and hydrochlorothiazide tablets is chemically described as 4-(1-hydroxy-1-methylethyl)-2-propyl-1-[2'-(1 H -tetrazole-5-yl) biphenyl-4-ylmethyl] imidazole-5-carboxylic acid 5-methyl-2-oxo-1,3-dioxol-4-ylmethyl ester. The amlodipine besylate, USP component of olmesartan medoxomil, amlodipine, and hydrochlorothiazide tablets is chemically described as 2-[(2-Amino-ethoxy)methyl]- ]-4-(2-chloro-phenyl)-6-methyl-1,4-dihydro-pyridine-3,5-dicarboxilic acid –3-ethyl ester 5- methyl ester, compound with benzonesulfonic acid. The hydrochlorothiazide, USP component of olmesartan medoxomil, amlodipine, and hydrochlorothiazide tablets is chemically described as 6-Chloro-3,4 dihydro- 2H -1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide. The structural formula for olmesartan medoxomil, USP is: C 29 H 30 N 6 O 6 M.W. 558.59 The structural formula for amlodipine besylate, USP is: C 20 H 25 ClN 2 O 5 • C 6 H 6 O 3 S M.W. 567.1 The structural formula for hydrochlorothiazide, USP is: C 7 H 8 ClN 3 O 4 S 2 M.W. 297.74 Olmesartan medoxomil, amlodipine, and hydrochlorothiazide tablets contain olmesartan medoxomil, USP, a white to off-white crystalline powder, amlodipine besylate, USP, a white or almost white powder, and hydrochlorothiazide, USP, a white or practically white, practically odorless crystalline powder. Olmesartan medoxomil, USP is practically insoluble in water and sparingly soluble in methanol. Amlodipine besylate, USP is sparingly soluble in ethanol, slightly soluble in water and 2-propanol and freely soluble in methanol. Hydrochlorothiazide, USP is slightly soluble in water, freely soluble in hydroxide solution, in n-butylamine and in dimethylformamide (DMF), sparingly soluble in methanol and insoluble in ether, in chloroform and in dilute mineral acids. Each olmesartan medoxomil, amlodipine, and hydrochlorothiazide tablet also contains the following inactive ingredients: crospovidone, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol (part hydrolyzed), povidone, silicon dioxide, sodium starch glycolate, talc, and titanium dioxide. In addition: 20 mg/5 mg/12.5 mg, 40 mg/10 mg/12.5 mg, and 40 mg/10 mg/25 mg strengths contain FD&C red #40 aluminum lake and iron oxide black, 40 mg/10 mg/12.5 mg and 40 mg/10 mg/25 mg strengths contain FD&C yellow #6 aluminum lake, 40 mg/5 mg/12.5 mg and 40 mg/5 mg/25 mg strengths contain D&C yellow #10 aluminum lake, 20 mg/5 mg/12.5 mg, 40 mg/5 mg/12.5 mg , and 40 mg/5 mg/25 mg strengths contain iron oxide yellow. Structural formula for olmesartan medoxomil. Structural formula for amlodipine besylate. Structural formula for hydrochlorothiazide.