Entresto Description

Active substance: A crystalline salt complex of the anionic forms of sacubitril and valsartan, sodium cations, and water molecules in the molar ratio of 1:1:3:2.5 respectively. The empirical formula of the complex (hemipentahydrate) is C₄₈H₅₅N₆O₈Na₃ 2.5 H₂O. Its molecular mass is 957.99.
Following oral administration, the complex dissociates into sacubitril (which is further metabolized to LBQ657) and valsartan.
50 mg: Violet white ovaloid biconvex film-coated tablet with beveled edges, unscored, debossed with "NVR" on one side and "LZ" on the other side.
Each film-coated tablet contains 50 mg sacubitril-valsartan, equivalent to 24.3 mg sacubitril and 25.7 mg valsartan as sodium salt complex.
100 mg: Pale yellow ovaloid biconvex film-coated tablet with beveled edges, unscored, debossed with "NVR" on one side and "L1" on the other side.
Each film-coated tablet contains 100 mg sacubitril-valsartan, equivalent to 48.6 mg sacubitril and 51.4 mg valsartan as sodium salt complex.
200 mg: Light pink ovaloid biconvex film-coated tablet with beveled edges, unscored, debossed with "NVR" on one side and "L11" on the other side.
Each film-coated tablet contains 200 mg sacubitril-valsartan, equivalent to 97.2 mg sacubitril and 102.8 mg valsartan as sodium salt complex.
Excipients/Inactive Ingredients: Tablet core: Microcrystalline cellulose, low-substituted hydroxypropylcellulose, crospovidone type A, magnesium stearate (vegetable origin), talc and colloidal anhydrous silica.
Film coat: Hypromellose substitution type 2910 (3 mPa-s), titanium dioxide (E 171), Macrogol 4000, talc, iron oxide red (E 172).
For 50 and 200 mg: Iron oxide black (E 172).
For 100 mg: Iron oxide yellow (E 172).