ARROW LZ (Lamivudine 150mg and Zidovudine 300mg ) Tablets

देश: मलेशिया

भाषा: अंग्रेज़ी

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

सक्रिय संघटक:

LAMIVUDINE; ZIDOVUDINE

थमां उपलब्ध:

UNIMED SDN BHD

INN (इंटरनेशनल नाम):

LAMIVUDINE; ZIDOVUDINE

पैकेज में यूनिट:

60Tablet Tablets

द्वारा बनाया गया:

Strides Pharma Science Limited

सूचना पत्रक

_Consumer Medication Information Leaflet (RiMUP) _
1
LAMIVUDINE 150MG AND
ZIDOVUDINE 300MG TABLETS
Lamivudine/Zidovudine (150mg/300mg)
WHAT IS IN THIS LEAFLET
1.
What
Lamivudine
150mg
and
Zidovudine
300mg
Tablets are used for
2.
How
Lamivudine
150mg
and
Zidovudine
300mg
Tablets work
3.
Before you use Lamivudine
150mg
and
Zidovudine
300mg Tablets
4.
How
to
take
Lamivudine
150mg
and
Zidovudine
300mg Tablets
5.
While
you
are
using
Lamivudine
150mg
and
Zidovudine 300mg Tablets
6.
Side Effects
7.
Storage
and
Disposal
of
Lamivudine
150mg
and
Zidovudine 300mg Tablets
8.
Product description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of Revision
WHAT LAMIVUDINE 150MG AND
ZIDOVUDINE 300MG TABLETS ARE
USED FOR AND HOW THEY WORK
Lamivudine/Zidovudine tablets
are used to treat HIV (human
immunodeficiency
virus)
infection in adults and children
above 12 years old.
Lamivudine/Zidovudine
tablets
contains two active ingredients
that
are
used
to
treat
HIV
infection:
lamivudine
and
zidovudine.
Both
of
these
belong
to
a
group
of
anti-
retroviral
medicines
called
nucleoside
analogue
reverse
transcriptase inhibitors (NRTIs).
HOW LAMIVUDINE 150MG AND
ZIDOVUDINE
300MG
TABLETS
WORK
Lamivudine/Zidovudine
tablets
do
not
completely
cure
HIV
infection; it reduces the amount
of virus in your body, and keeps
it
at
a
low
level.
It
also
increases the CD4 cell count in
your blood. CD4 cells are a type
of
white
blood
cells
that
are
important in helping your body
to fight infection.
Not
everyone
responds
to
treatment
with
Lamivudine/
Zidovudine tablets in the same
way. Your doctor will monitor
the
effectiveness
of
your
treatment.
BEFORE
YOU
USE
LAMIVUDINE
150MG AND ZIDOVUDINE 300MG
TABLETS
_-When you must not take it _
Do
not
take
Lamivudine/Zidovudine Tablets
if:
•
you are allergic to lamivudine
or
zidovudine,
or
any
of
the
other
ingredients
of
this
medicine
•
you have a very low red blood
cell count (anaemia) or a very
low
white
blood
cell
count
(neutropenia).
Check with your doctor if you
think any of these apply to you.
_-Befo

उत्पाद विशेषताएं

ARROW-LZ
LAMIVUDINE 150MG
&
ZIDOVUDINE 300MG TABLETS USP
PRODUCT DESCRIPTION
White to off - white coloured, oval shaped film-coated tablets, with
LZ debossed on one side
and breakline on other side.
COMPOSITION
Each film coated tablet contains Lamivudine150 mg and Zidovudine300
mg.
PHARMACOLOGY
Lamivudine and zidovudine are potent, selective inhibitors of HIV-1
and HIV-2.
Lamivudine has been shown to be highly synergistic with zidovudine,
inhibiting the
replication of HIV in cell culture. Both active substances are
metabolized sequentially
by intracellular kinases to 5' - triphosphate (TP). Lamivudine-TP and
zidovudine-TP are
substrates for and competitive inhibitors of HIV reverse
transcriptase. However, their main
antiviral activity is through incorporation of the monophosphate form
into the viral DNA
chain, resulting in chain termination. Lamivudine-TP and Zidovudine-TP
show significantly
less affinity for host cell DHA polymerases. In vitro, Lamivudine
demonstrates low
cytotoxicity to peripheral blood lymphocytes, to established
lymphocyte and monocyte-
macrophage cell lines and to a variety of bone marrow progenitor
cells. Lamivudine therefore
has a high therapeutic index in vitro.
PHARMACODYNAMICS
Lamivudine in combination with Zidovudine has been shown to reduce
HIV-1 viral load and
to increase CD4 cell counts. Clinical endpoint data indicate that
Lamivudine in combination
with Zidovudine alone or in combination with Zidovudine – containing
treatment regimens
results in a significant reduction in the risk of disease progression
and mortality.
Individually, Lamivudine and Zidovudine therapy has resulted in HIV
clinical isolates, which
show reduced sensitivity in vitro to the nucleoside analogue to which
they have been exposed.
Evidence from clinical studies show that Lamivudine Plus Zidovudine
delays the emergence
of Zidovudine- resistance isolates in individuals with no prior
antiretroviral therapy.
Lamivudine
and
Zidovudine
have
been
widely
used
as
components
of
antiretroviral
combination therapy with o