HIVUS - LR 20050 [Lopinavir 200mg and Ritonavir 50mg Film Coated Tablets USP]

Country: Malaysia

Bahasa: Inggeris

Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Bahan aktif:

LOPINAVIR; RITONAVIR

Boleh didapati daripada:

UNIMED SDN BHD

INN (Nama Antarabangsa):

LOPINAVIR; RITONAVIR

Unit dalam pakej:

120 Tablets

Dikeluarkan oleh:

Aurobindo Pharma Limited (Unit III),

Risalah maklumat

HIVUS-LR [ LOPINAVIR AND RITONAVIR FILM COATED
TABLETS USP]
Lopinavir USP / Ritonavir USP (100mg/25mg, 200mg/50mg)
1
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
WHAT IS IN THIS LEAFLET
1.
What HIVUS-LR Tablets is used for
2.
How HIVUS-LR Tablets works
3.
Before you use HIVUS-LR Tablets
4.
How to use HIVUS-LR Tablets
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of HIVUS-LR
Tablets
8.
Product Description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of revision
11.
Serial Number
WHAT HIVUS-LR TABLETS IS USED FOR
HIVUS-LR
Tablets
is
used
as
a
combination
treatment
with
other
antiretroviral agents for the treatment of
HIV infection.
HOW HIVUS-LR TABLETS WORKS
HIVUS-LR
Tablets
prevents
the
formation
of
mature,
infectious
virus,
resulting in the formation of immature,
non-infectious virus instead.
BEFORE YOU USE HIVUS-LR TABLETS
-
_When you must not use it _
Do not take HIVUS-LR Tablets if you
are
hypersensitive
to
Lopinavir
or
Ritonavir or any other ingredients in the
product.
Do not take HIVUS-LR Tablets with any
of the following medicines:
•
astemizole
or
terfenadine
(commonly
used
to
treat
allergy
symptoms – these medicines may
be available without prescription);
•
midazolam taken orally (taken by
mouth), triazolam (used to relieve
anxiety and/or trouble sleeping);
•
pimozide
(used
to
treat
schizophrenia);
•
quetiapine
(used
to
treat
schizophrenia, bipolar disorder and
major depressive disorder);
•
lurasidone
(used
to
treat
depression);
•
ranolazine
(used
to
treat
chronic
chest pain [angina]);
•
cisapride
(used
to
relieve
certain
stomach problems);
•
ergotamine,
dihydroergotamine,
ergonovine,
methylergonovine
(used to treat headaches);
•
amiodarone, dronedarone (used to
treat abnormal heart beat);
•
lovastatin,
simvastatin
(used
to
lower blood cholesterol);
•
lomitapide
(used
to
lower
blood
cholesterol);
•
alfuzosin
(used
in
men
to
treat
symptoms of an enlarged prostate
(benign
prostatic
hyperplasia
(BPH));
•
fusidic
acid
(used
to
treat
skin
infectio

Ciri produk

D3 PROPOSED PACKAGE INSERT
HIVUS - LR 100/25 [LOPINAVIR 100MG AND RITONAVIR 25MG FILM COATED
TABLETS USP]
HIVUS - LR 200/50 [LOPINAVIR 200MG AND RITONAVIR 50MG FILM COATED
TABLETS USP]
DESCRIPTION
HIVUS - LR 100/25 [Lopinavir 100mg and Ritonavir 25mg Film Coated
Tablets USP] are Light Yellow Film-Coated Capsule
Shaped tablets debossed with ‘D91’ on one side and plain on the
other side.
Each film coated tablet contains Lopinavir USP 100 mg and Ritonavir
USP 25 mg
Colouring Agent: Titanium Dioxide, Ferric oxide yellow
HIVUS - LR 200/50 [Lopinavir 200mg and Ritonavir 50mg Film Coated
Tablets USP] are Light Yellow Film-Coated tablets with
ovaloid shape debossed with ‘X’ on one side and ‘28’ on other
side.
Each film coated Tablet contains Lopinavir USP 200 mg and Ritonavir
USP 50 mg.
Colouring Agent: Titanium Dioxide, Ferric oxide yellow
PHARMACODYNAMICS
_MICROBIOLOGY_
_ _
_MECHANISM OF ACTION_
_ _
Lopinavir, an inhibitor of the HIV-1 and HIV-2 proteases, prevents
cleavage of the gag-pol polyprotein, resulting in the production of
immature, non-infectious virus.
_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 to 27 nM (0.006 to 0.017 mcg/mL, 1 mcg/Ml equals 1.6
micro M) and ranged from 4 to 11 nM
(0.003 to 0.007 mcg/mL) against several HIV-1 clinical isolates (n
equals 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 mcg/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 lop