Cilzec-A Description

Telmisartan + Amlodipine (Cilzec-A) is a fixed dose combination of telmisartan and amlodipine.
Telmisartan + Amlodipine (Cilzec-A) tablets contain telmisartan, a non-peptide angiotensin II receptor (type AT1) angiotensin. Telmisartan is a white to slightly yellowish solid. It is practically insoluble in water and in the pH range of 3 to 9, sparingly soluble in strong acid (except insoluble in hydrochloric acid), and soluble in strong base.
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 C₃₃H₃₀N₄O₂.
Telmisartan + Amlodipine (Cilzec-A) tablets contain the Besilate salt of amlodipine, a dihydropyridine calcium-channel blocker (CCB). Amlodipine Besilate is a white to pale yellow crystalline powder, slightly soluble in water and sparingly soluble in ethanol. Amlodipine Besilate'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 C₂₀H₂₅ClN₂O₅·C₆H₆O₃S.
Telmisartan + Amlodipine (Cilzec-A) tablets are formulated in four strengths for oral administration with a combination of amlodipine Besilate, 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 40 mg/5 mg: Blue and white oval shaped two-layer tablet engraved with "139" on blue layer and plain on white layer.
Each uncoated tablet contains: Telmisartan Ph. Eur. 40 mg, Amlodipine Ph. Eur. (as Amlodipine besilate) 5 mg.
Telmisartan and Amlodipine Tablets 40 mg/10 mg: Blue and white oval shaped two-layer tablet engraved with "140" on blue layer and plain on white layer.
Each uncoated tablet contains: Telmisartan Ph. Eur. 40 mg, Amlodipine Ph. Eur. (as Amlodipine besilate) 10 mg.
Telmisartan and Amlodipine Tablets 80 mg/5 mg: Blue and white oval shaped two-layer tablet engraved with "141" on blue layer and plain on white layer.
Each uncoated tablet contains: Telmisartan Ph. Eur. 80 mg, Amlodipine Ph. Eur. (as Amlodipine besilate) 5 mg.
Telmisartan and Amlodipine Tablets 80 mg/10 mg: Blue and white oval shaped two-layer tablet engraved with "142" on blue layer and plain on white layer.
Each uncoated tablet contains: Telmisartan Ph. Eur. 80 mg, Amlodipine Ph. Eur. (as Amlodipine besilate) 10 mg.
Inactive Ingredients: Telmisartan Layer: Sodium Hydroxide (Emprove), Povidone (Plasdone K-25), Meglumine, Mannitol (Pearlitol 200 SD), Purified Water, Magnesium Stearate (Avantor), Sodium Stearyl Fumarate (Alubra PG 100).
Amlodipine Layer: Mannitol (Pearlitol 200 SD), Mannitol (Pearlitol 25 C), Iron Oxide Yellow (Sicovit 10 E172), Black Iron Oxide, Brilliant Blue FCF (Koelow-901), Isopropyl Alcohol, Colloidal SiO2 (Aerosil 200 pharma), Purified Talc, Sodium Stearyl Fumarate (Alubra PG 100).