Kaletra

Product manufactured by Abbvie Inc.

Application Nr Approved Date Route Status External Links
NDA021906 2007-11-09 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Kaletra Is Indicated In Combination With Other Antiretroviral Agents For The Treatment Of Hiv-1 Infection In Adults And Pediatric Patients 14 Days And Older. Limitations Of Use: Genotypic Or Phenotypic Testing And/or Treatment History Should Guide The Use Of Kaletra. The Number Of Baseline Lopinavir Resistance-Associated Substitutions Affects The Virologic Response To Kaletra [see Microbiology (12.4)]. Kaletra Is An Hiv-1 Protease Inhibitor Indicated In Combination With Other Antiretroviral Agents For The Treatment Of Hiv-1 Infection In Adults And Pediatric Patients (14 Days And Older). (1)

All Formulated Excipients (2 Total)

Name Structure Kind Function Status
1. Silicon Dioxide SILICON DIOXIDE Unresolved AC-Anticaking agent , MISC-Miscellaneous , STAB-Stabilizer GRAS-Generally recognized as safe.
2. Copovidone K25-31 COPOVIDONE K25-31 Unresolved

Active Ingredients ( 2 Total)

Name Structure ZINC ID(s)
1. Lopinavir LOPINAVIR ZINC3951740
2. Ritonavir RITONAVIR ZINC3944422

Comments