Prezista Description





DCH Auriga - Healthcare
Four Star
Full Prescribing Info
Each tablet contains darunavir ethanolate equivalent to 400 mg or 600 mg of darunavir.
PREZISTA (darunavir) is an inhibitor of the human immunodeficiency virus (HIV-1) protease.
PREZISTA (darunavir), in the form of darunavir ethanolate, has the following chemical name: [(1S,2R)-3-[[(4-aminophenyl)sulfonyl](2-methylpropyl)amino]-2-hydroxy-1-(phenylmethyl)propyl]-carbamic acid (3R,3aS,6aR)-hexahydrofuro[2,3-b]furan-3-yl ester monoethanolate.
Its molecular formula is C27H37N3O7S · C2H5OH and its molecular weight is 593.73.
Darunavir ethanolate is a white to off-white powder with a solubility of approximately 0.15 mg/mL in water at 20°C.
During storage, partial conversion from ethanolate to hydrate may occur; however, this does not affect product quality or performance.
All dosages for PREZISTA are expressed in terms of the free form of darunavir.
Excipients/Inactive Ingredients: Colloidal silicon dioxide, crospovidone, magnesium stearate, and microcrystalline cellulose.
Film coating: FD&C Yellow No. 6, polyethylene glycol 3350, polyvinyl alcohol-partially hydrolyzed, talc, and titanium dioxide.
400 mg: OPADRY Light Orange.
600 mg: OPADRY Orange.
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