LAMIVUDINE RBX

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

Lamivudine

Available from:

Sun Pharma ANZ Pty Ltd

INN (International Name):

Lamivudine

Patient Information leaflet

1
LAMIVUDINE RBX CMI V3 Jan 2012
LAMIVUDINE RBX
_LAMIVUDINE TABLETS _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common questions about LAMIVUDINE RBX. It
does
not contain all of the available information.
It does not take the place of talking to your doctor or pharmacist.
This leaflet was last updated on the date at the end of this leaflet.
More
recent information may be available. The latest Consumer Medicine
Information is available from
https://www.ebs.tga.gov.au/ and may contain
important information about the medicine and its use of which you
should be
aware.
All medicines have benefits and risks. Your doctor has weighed the
risks of
you taking LAMIVUDINE RBX against the benefits it is expected to have
for
you.
IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR
OR
PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT LAMIVUDINE RBX IS USED FOR
LAMIVUDINE RBX contains the medicine lamivudine which belongs to a
group of
medicines called antivirals.
LAMIVUDINE RBX is used together with other antivirals to slow down the
progression of human immunodeficiency virus (HIV) infection, which can
lead
to Acquired Immune Deficiency Syndrome (AIDS) and other related
illnesses
(eg AIDS-related Complex or ARC).
LAMIVUDINE RBX does not cure AIDS or kill the HIV virus, but prevents
further
damage to the immune system by stopping production of new viruses.
LAMIVUDINE RBX does not reduce the risk of passing the infection to
others.
You will still be able to pass on the HIV virus by sexual activity or
by
contamination with infected blood. You should still use proper
precautions.
While taking LAMIVUDINE RBX and/or any other therapy for HIV disease,
you
may continue to develop other infections and other complications of
HIV
infection. You should keep in regular contact with the doctor who is
looking after you.
LAMIVUDINE RBX tablets are not addictive.
Your doctor may have prescribed LAMIVUDINE RBX for another reason.
ASK YOUR DOCTOR IF YOU HAVE

Summary of Product characteristics

LAMIVUDINE RBX PI V5 Sept 2013
Page 1 of 24
LAMIVUDINE RBX
LAMIVUDINE 150 MG & 300 MG TABLETS
NAME OF THE MEDICINE
Lamivudine
Structural formula:
HO
N
N
O
NH
2
O
S
Molecular formula: C
8
H
11
N
3
O
3
S
Chemical name:
(2R-cis)-4-amino-1-(2-hydroxymethyl-1,3-oxathiolan-5-yl)-(1H)-pyrimidin-
2-one
Molecular weight: 229.26
CAS Number: 134678-17-4
DESCRIPTION
Lamivudine is a white or almost white powder which is soluble in
water.
Each film-coated tablet of
LAMIVUDINE RBX
contains 150 mg or 300 mg of lamivudine,
and the inactive ingredients microcrystalline cellulose, sodium starch
glycollate type A and
magnesium stearate. Lamivudine tablets also contain Opadry 13B28444
White (Proprietary
Ingredient
#
107104)
for
150
mg
strength,
and
Opadry
16B57534
Grey
(Proprietary
Ingredient # 107103) for 300 mg strength.
PHARMACOLOGY
MODE OF ACTION:
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.
_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,
_in vitro_
, a high therapeutic index.
Lamivudine is metabolised intracellularly to the 5’-triphosphate
which has an intracellular
half-life of 10.5 - 15.5 hours. Lamivudine 5’-triphosphate is a weak
inhibitor of the RNA and
DNA-dependent activities of HIV reverse transcriptase; its main mode
of action is as a chain
terminator of HIV reverse transcription.
LAMIVUDINE RBX PI V5 Sept 2013
Page 2 of 24
Lamivudine does not interfere with cellular deoxynucleotide metabolism
and has little effect
on mammalian cell and mitochondrial DNA content.
The relationships between
_in vitro_
susceptibility of HIV to lamivudine and the clinical
response to therapy remain under investigation.
_In vitro_
sensitivity testing has not been
standardised and results may vary according to methodological factors.
Reduced
_in vitro_