Fosamprenavirdrug info
fosamprenavir 700 MG Oral Tablet
What it is used for
Fosamprenavir calcium tablets are indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus (HIV-1) infection. The following points should be considered when initiating therapy with fosamprenavir plus ritonavir in protease inhibitor-experienced patients:
The protease inhibitor-experienced patient trial was not large enough to reach a definitive conclusion that fosamprenavir plus ritonavir and lopinavir plus ritonavir are clinically equivalent.
Once-daily administration of fosamprenavir plus ritonavir is not recommended for adult protease inhibitor-experienced patients or any pediatric patients.
Dosing of fosamprenavir plus ritonavir is not recommended for protease inhibitor-experienced pediatric patients younger than 6 months. Fosamprenavir calcium tablets are an HIV protease inhibitor indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection.
Text above is quoted in full from the FDA-approved drug label published by openFDA, effective September 15, 2023. Matched to this product by RxNorm code. Cross-references to other sections of the full prescribing information have been removed, since they point to a document not shown here. Nothing else is changed: no sentence is shortened, reworded or summarised.
Description
Fosamprenavir calcium, USP is a prodrug of amprenavir, an inhibitor of HIV protease. The chemical name of fosamprenavir calcium is (3 S )-tetrahydrofuran-3-yl (1 S,2 R )-3-[[(4-aminophenyl) sulfonyl](isobutyl)amino]-1-benzyl-2-(phosphonooxy) propylcarbamate monocalcium salt. Fosamprenavir calcium is a single stereoisomer with the (3 S )(1 S,2 R ) configuration. It has a molecular formula of C 25 H 34 CaN 3 O 9 PS and a molecular weight of 623.67. It has the following structural formula: Fosamprenavir calcium is a white to cream color powder with a solubility of approximately 0.31 mg per mL in water at 25°C. Fosamprenavir calcium tablets, USP are available for oral administration in a strength of 700 mg of fosamprenavir as fosamprenavir calcium (equivalent to approximately 600 mg of amprenavir). Each 700-mg tablet contains the inactive ingredients colloidal silicon dioxide, croscarmellose sodium, hypromellose, magnesium stearate, microcrystalline cellulose, povidone, red iron oxide, silicified microcrystalline cellulose, titanium dioxide and triacetin. Meets USP Dissolution Test 2 Fosamprenavir Structural Formula
Text above is quoted in full from the FDA-approved drug label published by openFDA, effective September 15, 2023. Matched to this product by RxNorm code. Cross-references to other sections of the full prescribing information have been removed, since they point to a document not shown here. Nothing else is changed: no sentence is shortened, reworded or summarised.
This page reproduces regulatory text for reference. It is not medical advice, and KenyRx is not a pharmacy or a prescriber. Talk to a doctor or pharmacist about whether a medicine is right for you.
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