Source: European Medicines Agency (EU) Revision Year: 2023 Publisher: AbbVie Deutschland GmbH & Co. KG, Knollstrasse, 67061 Ludwigshafen, Germany
Kaletra 200 mg/50 mg film-coated tablets.
| Pharmaceutical Form |
|---|
|
Film-coated tablet. Red debossed with “AL” on one side. |
Each film-coated tablet contains 200 mg of lopinavir co-formulated with 50 mg of ritonavir as a pharmacokinetic enhancer.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Lopinavir |
Lopinavir is an inhibitor of the HIV-1 and HIV-2 proteases. Inhibition of HIV protease prevents cleavage of the gag-pol polyprotein resulting in the production of immature, non-infectious virus. |
|
| Lopinavir and Ritonavir |
Lopinavir provides the antiviral activity of lopinavir/ritonavir. Lopinavir is an inhibitor of the HIV-1 and HIV-2 proteases. Inhibition of HIV protease prevents cleavage of the gag-pol polyprotein resulting in the production of immature, non-infectious virus. |
|
| Ritonavir |
Ritonavir is an orally active peptidomimetic inhibitor of the HIV-1 and HIV-2 aspartyl proteases. Inhibition of HIV protease renders the enzyme incapable of processing the gag-pol polyprotein precursor which leads to the production of HIV particles with immature morphology that are unable to initiate new rounds of infection. Ritonavir has selective affinity for the HIV protease and has little inhibitory activity against human aspartyl proteases. Pharmacokinetic enhancement by ritonavir is based on ritonavir’s activity as a potent inhibitor of CYP3A-mediated metabolism. |
| List of Excipients |
|---|
|
Tablet contents: Copovidone Film-coating: Hypromellose |
High density polyethylene (HDPE) bottles closed with propylene caps. Each bottle contains 120 tablets.
Two pack sizes are available:
Blisters packs – polyvinyl chloride (PVC) blisters with fluoropolymer foil backing
Two pack sizes are available:
Not all pack sizes may be marketed.
AbbVie Deutschland GmbH & Co. KG, Knollstrasse, 67061 Ludwigshafen, Germany
EU/1/01/172/004
EU/1/01/172/005
EU/1/01/172/007
EU/1/01/172/008
Date of first authorisation: 20 March 2001
Date of latest renewal: 20 March 2011
| Drug | Countries | |
|---|---|---|
| KALETRA | Austria, Australia, Brazil, Canada, Cyprus, Ecuador, Estonia, Spain, Finland, France, Hong Kong, Ireland, Israel, Japan, Lithuania, Mexico, Netherlands, New Zealand, Poland, Romania, Singapore, Tunisia, Turkey, United Kingdom, United States, South Africa |
© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.
