AGENERASE (amprenavir) is an inhibitor of the human immunodeficiency virus (HIV) protease. The chemical name of amprenavir is (3S)-tetrahydro-3-furyl N-[(1S,2R)-3-(4-amino- Nisobutylbenzenesulfonamido)-1-benzyl-2-hydroxypropyl] carbamate. Amprenavir is a single stereoisomer with the (3S)(1S,2R) configuration. It has a molecular formula of C25H35N3O6S and a molecular weight of 505.64.
Amprenavir is a white to cream-colored solid with a solubility of approximately 0.04 mg/mL in water at 25°C.
AGENERASE Capsules are available for oral administration in strengths of 50 and 150 mg. Each capsule contains the inactive ingredients d-a tocopheryl polyethylene glycol 1000 succinate (TPGS), polyethylene glycol 400 (PEG 400), and propylene glycol. The capsule shell contains the inactive ingredients d-sorbitol and sorbitans solution, gelatin, glycerin, and titanium dioxide. The soft gelatin capsules are printed with edible red ink. Each 150-mg AGENERASE Capsule contains 109 IU vitamin E in the form of d-a tocopheryl polyethylene glycol 1000 succinate (TPGS). The total amount of vitamin E in the recommended daily adult dose of AGENERASE is 1744 IU.
AGENERASE Oral Solution is for oral administration. One milliliter (1 mL) of AGENERASE Oral Solution contains 15 mg of amprenavir in solution and the inactive ingredients acesulfame potassium, artificial grape bubblegum flavor, citric acid (anhydrous), TPGS, menthol, natural peppermint flavor, polyethylene glycol 400 (PEG 400), propylene glycol, saccharin sodium, sodium chloride, and sodium citrate (dihydrate). Solutions of sodium hydroxide and/or diluted hydrochloric acid may have been added to adjust pH. Each mL of AGENERASE Oral Solution contains 46 IU vitamin E in the form of d-a tocopheryl polyethylene glycol 1000 succinate.