LAMIVOX 150 (Lamivudine tablet 150mg USP)

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

LAMIVUDINE

Boleh didapati daripada:

UNIMED SDN BHD

INN (Nama Antarabangsa):

LAMIVUDINE

Unit dalam pakej:

60tablet Tablets

Dikeluarkan oleh:

Aurobindo Pharma Limited (Unit III),

Risalah maklumat

LAMIVOX 150
Lamivudine tablet 150mg USP
1
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
WHAT IS IN THIS LEAFLET
1.What LAMIVOX is used for
2.How LAMIVOX works
3.Before you take LAMIVOX
4.How to take LAMIVOX
5.While you are using LAMIVOX
6.Side effects
7.Storageand Disposal of LAMIVOX
8.Product description
9.Manufacturer
10. Marketing Authorization Holder
11. Date of Revision
WHAT LAMIVOX IS USED FOR
LAMIVOX is used to treat HIV (human
immunodeficiency
virus)
infection
in
adults and children.
HOW LAMIVOX WORKS
The active ingredient in LAMIVOX is
lamivudine.
LAMIVOX
is
a
type
of
medicine known as an anti-retroviral. It
belongs to a group of medicines called
nucleoside analogue reverse transcriptase
inhibitors (NRTIs).
LAMIVOX
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
LAMIVOX
in
the
same
way.
Your
doctor will monitor the effectiveness of
your treatment.
_BEFORE YOU TAKE LAMIVOX _
_When you must not take it _
DON’T TAKE LAMIVOX
•
if
you’re
ALLERGIC
(
_hypersensitive_
)
to
lamivudine
or any of the other ingredients
of LAMIVOX.
CHECK WITH YOUR DOCTOR
if you think
this applies to you.
_Before you start to take it _
Some people taking LAMIVOX or other
combination treatments for HIV are more
at risk of serious side effects. You
need
to be aware of the extra risks:
•
if
you
have
ever
had
LIVER
DISEASE
, including hepatitis B
or C (if you have hepatitis B
infection,
don’t
stop
LAMIVOX
without
your
doctor’s
advice,
as
your
hepatitis may comeback)
•
if you’re seriously
OVERWEIGHT
(especially
if
you’re
a
woman)
•
if
you’re
DIABETIC
and
using
insulin
•
IF
YOU
OR
YOUR
CHILD
HAS
A
KIDNEY
PROBLEM
, your dose
may be altered.
TALK TO YOUR
DOCTOR IF ANY OF THESE APPLY
TO YOU.
You may need extra
check-ups,
including
blood
tests,
while
you’re
ta

Ciri produk

_PRODUCT PARTICULARS _
_LAMIVUDINE ORAL SOLUTION 10MG/ML _
LAMIVOX 10MG/ML (LAMIVUDINE ORAL SOLUTION 10MG/ML)
LAMIVOX 150 (LAMIVUDINE TABLET 150MG USP)
LAMIVUDINE ORAL SOLUTION 10MG/ML
DESCRIPTION: A clear, colorless to pale yellow, strawberry-banana
flavored liquid.
Each ml contains Lamivudine 10mg.
LAMIVUDINE TABLETS 150 MG
DESCRIPTION: White to off-white film coated, oval shaped, tablets
debossed with ‘C’ on
one side and ‘63’ on the other side.
Each film coated tablet contains Lamivudine USP 150 mg.
PHARMACODYNAMICS:
Lamivudine is a potent, selective inhibitor of HIV-1 and HIV-2
replication _in vitro_. It is
also
active
against
zidovudine-resistant
clinical
isolates
of
HIV.
Lamivudine
is
metabolized intracellularly to the 5’-triphosphate, the active
moiety, which has an intra-
cellular half-life of 16 to 19 h. lamivudine 5’-triphosphate is a
weak inhibitor of the RNA
and DNA dependant activities of HIV reverse transcriptase, its main
mode of action is as
a chain terminator of HIV reverse transcription. Lamivudine has been
shown to act
additively or synergetically with oher anti-HIV agents, particularly
zidovudine, inhibiting
the replication of HIV in cell culture.
Lamivudine does not interfere with cellular deoxynucleotide metabolism
and has little
effect on mammalian cell and mitochondrial DNA content.
_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 _ in vitro_. Lamivudine therefore has, _in
vitro_, a high therapeutic
index.
HIV-1 resistance to lamivudine involves the development of a M184V
amino acid change
close to the active site of the rival reverse transcriptase (RT). This
variant arises both _in _
_vitro_ and in HIV-1 infected patients treated with
lamivudine-containing antiretroviral
therapy. M184V mutants display greatly reduced susceptibility to
lamivudine and show
diminished viral replicative capacity _ in vitro_. _ In vitro_ studies
indicat