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Full Prescribing Info

Description

See Table 1.

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Active ingredient: 5.13 mg of elobixibat hydrate (5 mg as elobixibat).
Nonproprietary name: Elobixibat hydrate (JAN).
Chemical name: [(2R)-2-(2-{[3,3-Dibutyl-7-(methylsulfanyl)-1,1-dioxo-5-phenyl-2,3,4,5- tetrahydro-1H-1,5-benzothiazepin-8-yl]oxy}acetamido)-2- phenylacetamido]acetic acid monohydrate.
Molecular formula: C₃₆H₄₅N₃O₇S₂•H₂O.
Molecular weight: 713.90.
Elobixibat hydrate occurs as a white powder. It is freely soluble in N,N-dimethylformamide, sparingly soluble in acetonitrile or methanol, slightly soluble in ethanol (99.5), and practically insoluble in water.
Excipients/Inactive Ingredients: Microcrystalline cellulose, D-mannitol, hypromellose, croscarmellose sodium, light anhydrous silicic acid, magnesium stearate, macrogol 6000, titanium oxide, yellow ferric oxide, and carnauba wax.

Manufacturer:

Eisai