Lopinavir and ritonavir

FDA Drug Profile — Lopinavir and ritonavir

Drug Details

Generic Name
Lopinavir and ritonavir
Brand Names
Lopinavir and ritonavir
Application Number
ANDA091677
Sponsor
Camber Pharmaceuticals, Inc.
NDC Codes
2
Dosage Forms
TABLET, FILM COATED
Routes
ORAL
Active Ingredients
LOPINAVIR, RITONAVIR

Indications and Usage

1 INDICATIONS AND USAGE Lopinavir and ritonavir tablets are 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 lopinavir and ritonavir tablets. The number of baseline lopinavir resistance-associated substitutions affects the virologic response to lopinavir and ritonavir tablets [see Microbiology (12.4)]. Lopinavir and ritonavir tablets are 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)