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Dolutegravir tablets contains dolutegravir, as dolutegravir sodium, an HIV INSTI. The chemical name of dolutegravir sodium is sodium (4R,12as)-9-((2,4-difluorobenzyl)carbamoyl)-4-methyl-6,8-dioxo-3,4,6,8,12,12a- hexahydro-2H-pyrido[1', 2': 4,5] pyrazino [2,1-b][1,3]oxazin-7-olate. The molecular formula is C20H18F2N3NaO5 and the molecular weight is 441.37.
Dolutegravir sodium is an off-white or white to light yellow colour powder and is very slightly soluble in methanol and practically insoluble in acetonitrile.
Each film-coated tablet of dolutegravir for oral administration contains 52.6 mg of dolutegravir sodium, which is equivalent to 50 mg dolutegravir free acid, and the following inactive ingredients: black iron oxide, mannitol, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, red iron oxide, sodium starch glycolate, sodium stearyl fumarate, talc, titanium dioxide and yellow iron oxide.
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