Crixivan® (indinavir sulfate) Capsules

CRIXIVAN®
(indinavir sulfate) Capsules

DRUG DESCRIPTION

CRIXIVAN* (indinavir sulfate) isan 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 has the following structural formula:

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.