ALUVIA TABLET

Country: South Africa

Language: English

Source: South African Health Products Regulatory Authority (SAHPRA)

Available from:

Abbvie (Pty) Ltd

Dosage:

See ingredients

Pharmaceutical form:

TABLET

Composition:

EACH TABLET CONTAINS LOPINAVIR 200,0 mg RITONAVIR 50,0 mg

Authorization status:

Registered

Authorization date:

2008-08-02

Patient Information leaflet

Page 1 of 16
SCHEDULING STATUS
S4
PROPRIETARY NAME, STRENGTH AND PHARMACEUTICAL FORM
ALUVIA 100/25
™ FILM-COATED TABLETS
Lopinavir (100 mg) / Ritonavir (25 mg)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING ALUVIA
100/25

Keep this leaflet. You may need to read it again.

If you have further questions, please ask your doctor or your
pharmacist.

ALUVIA 100/25 has been prescribed for you personally and you should
not share your
medicine with other people. It may harm them, even if their symptoms
are the same as
yours.

If any of the side effects gets serious, or if you notice any side
effects not listed in this
leaflet, please tell your doctor or pharmacist.
1.
WHAT ALUVIA 100/25 CONTAINS
ALUVIA 100/25 film-coated tablets contain 100 mg of lopinavir and 25
mg of ritonavir
Other ingredients include copovidone, sorbitan laurate, colloidal
anhydrous silica, sodium
stearyl fumarate, polyvinyl alcohol, titanium dioxide, talc, macrogols
type 3350 (polyethylene
glycol 3350) and red ferric oxide E172.
2.
WHAT ALUVIA 100/25 IS USED FOR
Page 2 of 16
ALUVIA 100/25 is an inhibitor of the human immunodeficiency virus
(HIV) protease enzyme.
It helps control HIV infection by inhibiting or interfering with the
protease enzyme that HIV
needs to multiply.
ALUVIA 100/25 IS used by adults and children with a body surface area
of 1.3 m
2
or greater
who are infected with HIV, the virus which causes AIDS. Your doctor
has prescribed
ALUVIA 100/25 to help control your HIV infection.
ALUVIA 100/25 is prescribed for use in combination with other
antiviral medicines. Your
doctor will determine which medicines are best for you.
DOES ALUVIA 100/25 CURE HIV OR AIDS?
ALUVIA 100/25 is not a cure for HIV infection or AIDS. People taking
ALUVIA 100/25 may
still develop infections or other illnesses associated with HIV
disease and AIDS. It is
therefore important that you remain under the supervision of your
doctor while taking
ALUVIA 100/25.
ALUVIA 100/25 does not reduce the risk of passing HIV to others
through sexual cont

Summary of Product characteristics

Page 1 of 54
SCHEDULING STATUS
Schedule 4
PROPRIETARY NAME AND DOSAGE FORM
COMPOSITION
Each ALUVIA 100/25 film-coated tablet contains 100 mg lopinavir and 25
mg ritonavir.
Other ingredients include copovidone, sorbitan laurate, colloidal
anhydrous silica, sodium
stearyl fumarate, polyvinyl alcohol, titanium oxide, talc, macrogols
type 3350(polyethylene
glycol 3350), red ferric oxide E172
PHARMACOLOGICAL CLASSIFICATION
A 20.2.8 – Antiviral agents
PHARMACOLOGICAL ACTION
_PHARMACODYNAMICS PROPERTIES _
Lopinavir/ritonavir tablets are a co-formulation of lopinavir and
ritonavir. Lopinavir is an
inhibitor of the HIV-1 and HIV-2 proteases. As co-formulated in
lopinavir/ritonavir tablets,
ritonavir inhibits the CYP3A-mediated metabolism of lopinavir, thereby
providing increased
plasma levels of lopinavir.
_Mechanism of action _
Lopinavir prevents cleavage of the _ gag-pol_ polyprotein, resulting
in the production of
immature, non-infectious virus.
Page 2 of 54
_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
concentrate (EC
50
) of lopinavir against five different HIV-1 laboratory strains ranged
from
10 to 27 nM (0.006 to 0.017 micrograms/mL, 1 micrograms/mL equals 1.6
microM) and
ranged from 4 to 11 nM (0.003 to 0.007 micrograms/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
to
289
nM
(0.04
to
0.18
micrograms/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 se