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Crixivan®

(indinivir sulfate) Capsules

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Crixivan* (indinavir sulfate) is an inhibitor of the human immunodeficiency virus (HIV) protease. Crixivan Capsules are formulated as a sulfate salt and are available for oral administration in strengths of 100, 200, 333, and 400 mg of indinavir (corresponding to 125, 250, 416.3, and 500 mg indinavir sulfate, respectively). Each capsule also contains the inactive ingredients anhydrous lactose and magnesium stearate. The capsule shell has the following inactive ingredients and dyes: gelatin, titanium dioxide, silicon dioxide and sodium lauryl sulfate.

The chemical name for indinavir sulfate is:

[1(1S,2R),5(S)]-2,3,5-trideoxy-N-(2,3-dihydro-2-hydroxy-1H- inden-1-yl)-5-[2-[[(1,1-dimethylethyl)amino]carbonyl]-4-(3-pyridinylmethyl)-1-piperazinyl]-2-(phenylmethyl)- D-erythro-pentonamide sulfate (1:1) salt.

Indinavir sulfate is a white to off-white, hygroscopic, crystalline powder with the molecular formula C36H47N5O4 • H2SO4 and a molecular weight of 711.88. It is very soluble in water and in methanol.