SPL Set ID: 15b438b4-4874-43f4-a50a-4e6f3e5530ac
1 drug(s) with this SPL Set ID
Telmisartan and amlodipine tablets are a fixed dose combination of telmisartan and amlodipine. Telmisartan and amlodipine tablets contain telmisartan, a non-peptide angiotensin II receptor (type AT 1 ) antagonist. Telmisartan is a white to slightly yellow crystalline powder. It is sparingly soluble in methylene chloride, slightly soluble in methanol and practically insoluble in water. It dissolves in 1M sodium hydroxide. Telmisartan is chemically described as 4’-[(1,4’-dimethyl-2’-propyl [2,6’-bi-1H-benzimidazol]-1’-yl)methyl]-[1,1’-biphenyl]-2-carboxylic acid. Its empirical formula is C 33 H 30 N 4 O 2 and its structural formula is: Telmisartan and amlodipine tablets contain the besylate salt of amlodipine, a dihydropyridine calcium-channel blocker (CCB). Amlodipine besylate is a white or almost white powder, freely soluble in methanol, sparingly soluble in ethanol, slightly soluble in 2-propanol and in water. Amlodipine besylate’s chemical name is 3-Ethyl-5-methyl(4RS)-2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-6-methyl-1,4-dihydropyridine-3,5-dicarboxylate benzenesulphonate. Its empirical formula is C 20 H 25 ClN 2 O 5 •C 6 H 6 O 3 S and its structural formula is: Telmisartan and amlodipine tablets are formulated in four strengths for oral administration with a combination of amlodipine besylate, equivalent to 5 mg or 10 mg of amlodipine free-base, with 40 mg, or 80 mg of telmisartan provided in the following four combinations: 40/5 mg, 40/10 mg, 80/5 mg, and 80/10 mg. Telmisartan and amlodipine tablets also contain the following inactive ingredients: mannitol, sodium hydroxide, meglumine, povidone, sodium stearyl fumarate, microcrystalline cellulose, corn starch, crospovidone, magnesium stearate, black iron oxide and FD&C blue #1 - Alumium lake. Telmisartan and amlodipine tablets are hygroscopic and require protection from moisture. Telmisartan and amlodipine tablets require protection from light. Structure Structure