Important note: Information in this article was accurate in 2004. The state of the art may have changed since the publication date. 
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Food and Drug Administration - December 17, 2004
Richard Klein, Kimberly Struble
FDA approved, on December 17, 2004, a new 500 mg tablet formulation of the HIV protease inhibitor, INVIRASE (saquinavir mesylate). The dosage and administration for INVIRASE in adults (over the age of 16 years) is 1000 mg twice a day (taken as either two 500 mg tablets or five 200 mg capsules) in combination with ritonavir 100 mg twice a day, after a meal. The new tablet formulation reduces the pill burden compared to the capsule formulation.
Below is the DOSAGE AND ADMINISTRATION section as it appears in the package insert.
DOSAGE AND ADMINISTRATION
INVIRASE (saquinavir mesylate) capsules and FORTOVASE (saquinavir) soft gelatin capsules are not bioequivalent and cannot be used interchangeably. INVIRASE may be used only if it is combined with ritonavir, because it significantly inhibits saquinavir's metabolism to provide plasma saquinavir levels at least equal to those achieved with FORTOVASE at the recommended dose of 1200 mg tid. When using saquinavir as the sole protease inhibitor in an antiretroviral regimen, FORTOVASE is the recommended formulation (see CLINICAL PHARMACOLOGY: Drug Interactions )
Adults (Over the Age of 16 Years):
A pdf copy of the complete labeling is attached here: invirasefinal.pdf
Invirase is a product of Roche Laboratories, Inc., of Nutley, New Jersey.
Click here to read Roche Laboratorie's press release: invirase500mg.pdf
To view or print the document, you can use the free Adobe Acrobat, available directly from Adobe's Website(www.adobe.com/products/acrobat/readstep2.html) with full installation instructions.
--Richard Klein Office of Special Health Issues Food and Drug Administration
--Kimberly Struble Division of Antiviral Drug Products Food and Drug Administration
041217
FD041204
SOURCE: Food and Drug Administration (FDA).
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