Kaletra Tablet 200mg50mg

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

Lopinavir; Ritonavir

Available from:

ABBVIE PTE. LTD.

ATC code:

J05AR10

Dosage:

200.0mg

Pharmaceutical form:

TABLET, FILM COATED

Composition:

Lopinavir 200.0mg; Ritonavir 50.0mg

Administration route:

ORAL

Prescription type:

Prescription Only

Manufactured by:

AbbVie Deutschland GmbH & Co. KG

Authorization status:

ACTIVE

Authorization date:

2007-04-12

Patient Information leaflet

KALETRA®
(LOPINAVIR/RITONAVIR) TABLETS
(LOPINAVIR/RITONAVIR) ORAL SOLUTION
ALERT: FIND OUT ABOUT MEDICINES THAT SHOULD NOT BE TAKEN WITH KALETRA.
Please also read the section "MEDICINES
YOU SHOULD NOT TAKE WITH KALETRA."
PATIENT INFORMATION LEAFLET
KALETRA® (kuh-LEE-tra)
Generic Name: lopinavir/ritonavir (lop-IN-uh-veer/rit-ON-uh-veer)
Read this leaflet carefully before you start taking KALETRA. Also,
read it each time you get your KALETRA prescription
refilled, in case something has changed. This information does not
take the place of talking with your doctor when you start this
medicine and at check ups. Ask your doctor if you have any questions
about KALETRA.
Before taking your medicine, make sure you have received the correct
medicine. Compare the name above with the name
on your bottle and the appearance of your medicine with the
description provided below. Contact your pharmacist
immediately if you believe a dispensing error has occurred.
WHAT IS KALETRA AND HOW DOES IT WORK?
KALETRA is a combination of two medicines. They are lopinavir and
ritonavir. KALETRA is a type of medicine called an HIV
(human immunodeficiency virus) protease (PRO-tee-ase) inhibitor.
KALETRA is always used in combination with other anti-
HIV medicines to treat people with human immunodeficiency virus (HIV)
infection. KALETRA is for adults and for children age
6 months and older.
HIV infection destroys CD
4
(T) cells, which are important to the immune system. After a large
number of T cells are destroyed,
acquired immune deficiency syndrome (AIDS) develops.
KALETRA blocks HIV protease, a chemical which is needed for HIV to
multiply. KALETRA reduces the amount of HIV in your
blood and increases the number of T cells. Reducing the amount of HIV
in the blood reduces the chance of death or infections
that happen when your immune system is weak (opportunistic
infections).
DOES KALETRA CURE HIV OR AIDS?
KALETRA DOES NOT CURE HIV INFECTION OR AIDS. THE LONG-TERM EFFECTS OF
KALETRA ARE NOT KNOWN AT THIS TIME. PEOPLE
TAKING KALETRA MAY STIL

Summary of Product characteristics

1
KALETRA®
(LOPINAVIR/RITONAVIR) TABLETS
(LOPINAVIR/RITONAVIR) ORAL SOLUTION
INDICATIONS AND USAGE
KALETRA is indicated in combination with other antiretroviral agents
for the treatment of HIV-infection. This indication is based
on analyses of plasma HIV RNA levels and CD
4
cell counts in controlled studies of KALETRA of 48 weeks duration and
in
smaller uncontrolled dose-ranging studies of KALETRA of 144-360 weeks
duration.
CLINICAL PHARMACOLOGY
MICROBIOLOGY
MECHANISM OF ACTION
Lopinavir, an inhibitor of the HIV protease, prevents cleavage of the
Gag-Pol polyprotein, resulting in the production of
immature, non-infectious viral particles.
ANTIVIRAL ACTIVITY IN VITRO
The in vitro antiviral activity of lopinavir against laboratory HIV
strains and clinical HIV isolates was evaluated in acutely infected
lymphoblastic cell lines and peripheral blood lymphocytes,
respectively. In the absence of human serum, the mean 50%
effective concentration (EC
50
) of lopinavir against five different HIV-1 laboratory strains ranged
from 10-27 nM (0.006-0.017
µg/mL, 1 µg/mL = 1.6 µM) and ranged from 4-11 nM (0.003-0.007
µg/mL) against several HIV-1 clinical isolates (n = 6). In the
presence of 50% human serum, the mean EC
50
of lopinavir against these five laboratory strains ranged from 65-289
nM (0.04-
0.18 µg/mL), representing a 7- to 11-fold attenuation. Combination
drug activity studies with lopinavir and other protease
inhibitors or reverse transcriptase inhibitors have not been
completed.
RESISTANCE
HIV-1 isolates with reduced susceptibility to lopinavir have been
selected in vitro. The presence of ritonavir does not appear to
influence the selection of lopinavir-resistant viruses in vitro.
The selection of resistance to KALETRA in antiretroviral treatment
naïve patients has not yet been characterized. In a Phase III
study of 653 antiretroviral treatment naive patients (Study 863),
plasma viral isolates from each patient on treatment with
plasma HIV > 400 copies/mL at Week 24, 32, 40 and/or 48 were analyzed.
No evidence