LAMIZIDO 150300 film coated Tablet

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

ZIDOVUDINE/AZIDOTHYMIDINE; LAMIVUDINE

Boleh didapati daripada:

Paxten Sdn Bhd

INN (Nama Antarabangsa):

ZIDOVUDINE/AZIDOTHYMIDINE; LAMIVUDINE

Unit dalam pakej:

60tablet Tablets

Dikeluarkan oleh:

Macleods Pharmaceuticals Ltd.

Risalah maklumat

LAMIZIDO 150/300 FILM COATED TABLET
LAMIVUDINE 150MG, ZIDOVUDINE 300MG
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
_ _
1
WHAT IS IN THIS LEAFLET?
1.
What LAMIZIDO 150/300 is used
for?
2.
How LAMIZIDO 150/300 works
3.
Before
you
use
LAMIZIDO
150/300
4.
How to use LAMIZIDO 150/300
5.
While you are using it
6.
Side effects
7.
Storage
and
Disposal
of
LAMIZIDO 150/300
8.
Product Description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of revision
WHAT LAMIZIDO 150/300 IS USED FOR
LAMIZIDO
150/300
is
used
in
combination
with
other
antiretroviral
agent is indicated for the treatment of
immunodeficiency
virus
(HIV)
infection.
HOW LAMIZIDO 150/300 WORKS
Lamivudine
and
zidovudine,
both
of
these
belong
to
a
group
of
anti-
retroviral medicines called
_nucleoside _
_analogue _
_reverse _
_transcriptase _
_inhibitors _(_NRTIs_)_. _
It
does
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 LAMIZIDO 150/300 in the same
way.
Your
doctor
will
monitor
the
effectiveness of your treatment.
BEFORE YOU USE LAMIZIDO 150/300
-
_When you must not use it _

If you are ALLERGIC to lamivudine or
zidovudine,
or
any
of
the
other
ingredients of this medicine.

If 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.
_ _
_PREGNANCY AND LACTATION _
If
you
are
pregnant,
if
you
become
pregnant
or
if
you
are
planning
to
become pregnant talk to
your doctor
about the risks and benefits to you and
your baby of taking Lamivudine 150mg
+ Zidovudine 300mg .
PREGNANCY
LAMIZIDO
150/300
and
similar
medicines
may
cause
side
effects
in
unborn babies. If you become pregnant
while
you
are
taking
Lamivudine
150mg + Zidovudine 300mg, your baby
may
be
given
extra
check-ups
(

Ciri produk

SECTION D ARTWORKS
D3 PACKAGE INSERT
For the use only of a Registered Medical Practitioner or a Hospital or
a Laboratory
LAMIZIDO 150/300 FILM COATED TABLET
(LAMIVUDINE AND ZIDOVUDINE TABLETS USP)
COMPOSITION:
Each film coated Tablet contains:
Lamivudine USP………. 150mg
Zidovudine USP……….. 300 mg
DESCRIPTION:
White coloured, biconvex modified capsule shaped, film coated tablet
having score on
one side and ‘ML 6’ debossed on other side of the tablet.
PHARMACODYNAMICS EFFECT:
Lamivudine and Zidovudine are potent selective inhibitor 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
substrate 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)
shows
significantly less affinity for host cell DHA polymerase.
_In vitro_, Lamivudine demonstrate 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.
LAMIZIDO 150/300 FILM COATED TABLET
MACLEODS PHARMACEUTICALS LTD.
SECTION D ARTWORKS
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.