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Vymada

Vymada Description

sacubitril + valsartan

Manufacturer:

Novartis Singapore

Distributor:

Sandoz
Full Prescribing Info
Description
50 mg: 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: 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: Each film-coated tablet contains 200 mg sacubitril-valsartan, equivalent to 97.2 mg sacubitril and 102.8 mg valsartan as sodium salt complex.
Active substance: A 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.
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).
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