SPL Set ID: c1204fbe-d086-43cf-bbaa-efec9cd0487c
1 drug(s) with this SPL Set ID
Amlodipine and Olmesartan Medoxomil Tablets provided as a tablet for oral administration, is a combination of the calcium channel blocker (CCB) amlodipine besylate and the angiotensin II receptor blocker (ARB) olmesartan medoxomil. The amlodipine besylate component of Amlodipine and Olmesartan Medoxomil Tablets is chemically described as 3-ethyl-5-methyl (±)-2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-1,4-dihydro-6-methyl-3,5-pyridinedicarboxylate, monobenzenesulphonate. Its empirical formula is C 20 H 25 CIN 2 O 5 •C 6 H 6 O 3 S. Olmesartan medoxomil, a prodrug, is hydrolyzed to olmesartan during absorption from the gastrointestinal tract. The olmesartan medoxomil component of Amlodipine and Olmesartan Medoxomil Tablets is chemically described as 2,3-dihydroxy-2-butenyl 4-(1-hydroxy-1-methylethyl)-2-propyl-1-[p-(o-1H-tetrazol-5-ylphenyl)benzyl]imidazole-5-carboxylate, cyclic 2,3-carbonate. Its empirical formula is C 29 H 30 N 6 O 6 . The structural formula for amlodipine besylate is: The structural formula for olmesartan medoxomil is: Amlodipine and Olmesartan Medoxomil Tablets contains amlodipine besylate, a white or almost white powder, and olmesartan medoxomil, a white to off white, crystalline powder. The molecular weights of amlodipine besylate and olmesartan medoxomil are 567.1 and 558.59, respectively. Amlodipine besylate is slightly soluble in water and sparingly soluble in ethanol. Olmesartan medoxomil is practically insoluble in water and sparingly soluble in methanol. Each tablet of Amlodipine and Olmesartan Medoxomil Tablets also contains the following inactive ingredients: silicified microcrystalline cellulose, pregelatinized starch [Botanical source: corn (zea mays)], croscarmellose sodium, stearic acid micronized, magnesium stearate. The color coatings contain polyvinyl alcohol, macrogol/polyethylene glycol 3350, titanium dioxide, talc, iron oxide yellow (5/40 mg, 10/20 mg, 10/40 mg tablets), iron oxide red (10/20 mg and 10/40 mg tablets), and iron oxide black (10/20 mg tablets). "FDA approved dissolution test specifications differ from USP" Aml-Olm-AmlStr aml-olm-olmstr1