WARNING:
INVIRASE® capsules and tablets and FORTOVASE® soft gelatin capsules are not
bioequivalent and cannot be used interchangeably.
INVIRASE may be used only if it is combined with ritonavir, which significantly inhibits Invirase(Saquinavir) 500 mg 's metabolism to provide plasma Invirase(Saquinavir) 500 mg levels at least equal to those achieved with FORTOVASE.
When using Invirase(Saquinavir) 500 mg as the sole protease inhibitor in an antiviral regimen, FORTOVASE is the recommended formulation.
* Invirase(Saquinavir) 500 mg is an inhibitor of HIV protease.
* The protease is an enzyme required for "the proteolytic cleavage of viral polyprotein precursors into individual functional
proteins found in infectious HIV.
* Invirase(Saquinavir) 500 mg is a peptide-like substrate that binds to the protease active site and inhibits the activity of the enzyme".
* Invirase(Saquinavir) 500 mg inhibition prevents cleavage of the viral polyproteins resulting in the formation of immature noninfectious virus particles.
Indications and usage:
Invirase(Saquinavir) 500 mg is indicated for use in combination with other anti-retroviral drugs for the treatment of HIV infection.
This indication is based on clinical data that showed a reduction in both mortality and AIDS-related disease for patients
who recieved fortovase in combination with zalcitabine, and/or other drug regiments.
- The recommended dosage is three 200 mg capsules daily.
Invirase(Saquinavir) 500 mg should be taken within two hours of completing a meal.
Lower dosages have shown little or no therapeutic effect.
Precautions:
New cases of diabetes mellitus, worsening of pre-existing diabetes mellitus and hyperglycemia have been reported
during posmarketing surveillance in HIV infected patients recieving protease-inhibitor treatment.
In some severe cases, diabetic ketacidosis has occured.
Contraindications:
Invirase(Saquinavir) 500 mg is contrainicated for patients with known hypersensitivity to Invirase(Saquinavir) 500 mg or its components.
It should NOT be administered concomitantly with terfenadine, casapride, astmiazole, triazolam, midazolam, or ergot derivatives.
Potential Adverse Effects:
The most frequently reported treatment emergent adverse events among patients receiving fortovase in combination with other antiretroviral agents were diarrhea, nausea, abdominal discomfort, and dyspepsia.
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