amlodipine, valsartan and hydrochlorothiazide - Medication Listings

Amlodipine, valsartan and hydrochlorothiazide tablets USP are a fixed combination of amlodipine, valsartan, and hydrochlorothiazide. Amlodipine, valsartan and hydrochlorothiazide tablets USP contain the besylate salt of amlodipine, a dihydropyridine calcium channel blocker (CCB). Amlodipine besylate USP is a white to almost white powder, freely soluble in methanol, slightly soluble in water and 2-propanol; and sparingly soluble in ethanol. Amlodipine besylate's chemical name is 3-ethyl 5-methyl (±)-2-[(2-aminoethoxy)methyl]-4-( o -chlorophenyl)-1,4-dihydro-6-methyl-3,5-pyridinedicarboxylate, monobenzenesulfonate ; its structural formula is: Its empirical formula is C 20 H 25 ClN 2 O 5 •C 6 H 6 O 3 S and its molecular weight is 567.1. Valsartan USP is a nonpeptide, orally active, and specific angiotensin II antagonist acting on the AT 1 receptor subtype. Valsartan is a white to off white fine hygroscopic powder, soluble in ethanol and methanol; and slightly soluble in water. Valsartan's chemical name is N-(1-oxopentyl)-N-[[2′-(1 H -tetrazol-5-yl) [1,1′-biphenyl]-4-yl]methyl]-L-valine; its structural formula is: Its empirical formula is C 24 H 29 N 5 O 3 and its molecular weight is 435.5. Hydrochlorothiazide USP is a white, or practically white, practically odorless, crystalline powder. It is slightly soluble in water; freely soluble in sodium hydroxide solution, in n -butylamine, and in dimethylformamide; sparingly soluble in methanol; and insoluble in ether, in chloroform, and in dilute mineral acids. Hydrochlorothiazide is chemically described as 6-chloro-3,4-dihydro-2 H -1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide. Hydrochlorothiazide is a thiazide diuretic. Its empirical formula is C 7 H 8 ClN 3 O 4 S 2 , its molecular weight is 297.73, and its structural formula is: Amlodipine, valsartan and hydrochlorothiazide film-coated tablets USP are formulated in five strengths for oral administration with a combination of amlodipine besylate, valsartan and hydrochlorothiazide, providing for the following available combinations: 5/160/12.5 mg, 10/160/12.5 mg, 5/160/25 mg, 10/160/25 mg and 10/320/25 mg amlodipine besylate/valsartan/hydrochlorothiazide. The inactive ingredients for all strengths of the tablets include colloidal silicon dioxide, croscarmellose sodium, crospovidone, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, titanium dioxide. Additionally, the 10/160/12.5 mg strength contains yellow iron oxide; the 5/160/25 mg strength contains red iron oxide and yellow iron oxide, the 10/160/25 mg strength contains black iron oxide, red iron oxide and yellow iron oxide and the 10/320/25 mg strength contains iron oxide red. Amlodipine, valsartan and hydrochlorothiazide tablets USP meets USP Dissolution Test 2. 01 02 03

Amlodipine, valsartan and hydrochlorothiazide tablets USP are a fixed combination of amlodipine, valsartan, and hydrochlorothiazide. Amlodipine, valsartan and hydrochlorothiazide tablets USP contain the besylate salt of amlodipine, a dihydropyridine calcium channel blocker (CCB). Amlodipine besylate, USP is a white or almost white powder, slightly soluble in water and sparingly soluble in ethanol. Amlodipine besylate’s chemical name is 3-Ethyl 5-methyl (±)-2-[(2-aminoethoxy)methyl]-4-( o -chlorophenyl)-1,4-dihydro-6-methyl-3,5-pyridinedicarboxylate, monobenzenesulfonate; its structural formula is: Its molecular formula is C 20 H 25 ClN 2 O 5 •C 6 H 6 O 3 S and its molecular weight is 567.1. Valsartan, USP is a nonpeptide, orally active, and specific angiotensin II antagonist acting on the AT 1 receptor subtype. Valsartan, USP is a white, fine hygroscopic powder, soluble in ethanol and methanol and slightly soluble in water. Valsartan’s chemical name is N-(1-oxopentyl)-N-[[2′-(1 H -tetrazol-5-yl) [1,1′-biphenyl]-4-yl]methyl]-L-valine; its structural formula is: Its molecular formula is C 24 H 29 N 5 O 3 and its molecular weight is 435.5. Hydrochloro­thiazide, USP is a white or practically white, practically odorless, crystalline powder. It is slightly soluble in water; freely soluble in sodium hydroxide solution, in n -butylamine, and in dimethylformamide; sparingly soluble in methanol; and insoluble in ether, in chloroform, and in dilute mineral acids. Hydrochlorothiazide is chemically described as 6-chloro-3,4-dihydro-2 H -1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide. Hydrochlorothiazide is a thiazide diuretic. Its molecular formula is C 7 H 8 ClN 3 O 4 S 2 , its molecular weight is 297.73, and its structural formula is: Amlodipine, valsartan and hydrochlorothiazide is available as film-coated tablets containing amlodipine besylate USP (6.9 mg or 13.9 mg, equivalent to 5 mg or 10 mg of amlodipine respectively), with valsartan USP 160 mg or 320 mg, and hydrochlorothiazide USP 12.5 mg or 25 mg, providing for the following available combinations: 5 mg/160 mg/12.5 mg, 10 mg/160 mg/12.5 mg, 5 mg/160 mg/25 mg, 10 mg/160 mg/25 mg, and 10 mg/320 mg/25 mg. The inactive ingredients for all strengths of the tablets include colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch (maize), sodium starch glycolate, talc, and titanium dioxide. Additionally, the 10 mg/160 mg/12.5 mg strength contains red iron oxide and yellow iron oxide; the 5 mg/160 mg/25 mg, 10 mg/160 mg/25 mg and 10 mg/320 mg/25 mg strengths contain yellow iron oxide. USP Organic Impurities Test pending. Amlodipine Molecular Structure Valsartan Molecular Structure Hydrochlorothiazide Molecular Structure