Agenerase Oral Solution
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Agenerase Oral Solution
(Generic versions may still be available.)
(amprenavir) Oral Solution
Because of the potential risk of toxicity from the large amount of the excipient, propylene glycol, AGENERASE Oral Solution (amprenavir oral solution) is contraindicated in infants and children below the age of 4 years, pregnant women, patients with hepatic or renal failure, and patients treated with disulfiram or metronidazole (see CONTRAINDICATIONS AND WARNINGS). AGENERASE Oral Solution (amprenavir oral solution) should be used only when AGENERASE Capsules or other protease inhibitor formulations are not therapeutic options.
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-N-isobutylbenzenesulfonamido)-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. It has the following structural formula:
Amprenavir is a white to cream-colored solid with a solubility of approximately 0.04 mg/mL in water at 25°C.
AGENERASE Oral Solution (amprenavir 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), d-alpha tocopheryl polyethylene glycol 1000 succinate (TPGS), menthol, natural peppermint flavor, polyethylene glycol 400 (PEG 400) (170 mg), propylene glycol (550 mg), 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 TPGS. Propylene glycol is in the formulation to achieve adequate solubility of amprenavir. The recommended daily dose of AGENERASE Oral Solution (amprenavir oral solution) of 22.5 mg/kg twice daily corresponds to a propylene glycol intake of 1,650 mg/kg/day. Acceptable intake of propylene glycol for pharmaceuticals has not been established.
Last reviewed on RxList: 7/18/2008
This monograph has been modified to include the generic and brand name in many instances.
Additional Agenerase Oral Solution Information
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