lexiva fosamprenavir calcium 700 mg
1 INDICATIONS AND USAGE LEXIVA is 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 LEXIVA plus ritonavir in protease inhibitor-experienced patients: • The protease inhibitor-experienced patient trial was not large enough to reach a definitive conclusion that LEXIVA plus ritonavir and lopinavir plus ritonavir are clinically equivalent [see Clinical Studies ( 14.2 )] . • Once-daily administration of LEXIVA plus ritonavir is not recommended for adult protease inhibitor-experienced patients or any pediatric patients [see Dosage and Administration ( 2.2 , 2.3 ), Clinical Studies ( 14.2 , 14.3 )] . • Dosing of LEXIVA plus ritonavir is not recommended for protease inhibitor-experienced pediatric patients younger than 6 months [see Clinical Pharmacology ( 12.3 )]. LEXIVA is an HIV protease inhibitor indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection. ( 1 )
viiv healthcare company
OVAL PINK GXLL7
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16 HOW SUPPLIED/STORAGE AND HANDLING LEXIVA tablets, 700 mg, are pink, film-coated, capsule-shaped, biconvex tablets, with “GX LL7” debossed on one face. Bottle of 60 with child-resistant closure (NDC 49702-207-18). Store at controlled room temperature of 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) (see USP Controlled Room Temperature). Keep container tightly closed. LEXIVA oral suspension, a white to off-white grape-bubblegum-peppermint–flavored suspension, contains 50 mg of fosamprenavir as
FOSAMPRENAVIR CALCIUM equivalent to approximately 43 mg of amprenavir in each 1 mL. Bottle of 225 mL with child-resistant closure (NDC 49702-208-53). This product does not require reconstitution. Store in refrigerator or at room temperature (5° to 30°C; 41° to 86°F). Shake vigorously before using. Do not freeze.
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