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.