ABACAVEX (Abacavir Tablets USP 300 mg)

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

ABACAVIR SULFATE

Boleh didapati daripada:

UNIMED SDN BHD

INN (Nama Antarabangsa):

ABACAVIR SULFATE

Unit dalam pakej:

60Tablet Tablets

Dikeluarkan oleh:

Aurobindo Pharma Limited (Unit III),

Risalah maklumat

ABACAVEX TABLET/ORAL SOLUTION
(Abacavir Sulfate 300mg USP Tablet, 20mg/ml Oral solution)
1
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
WHAT IS IN THIS LEAFLET
1.
What Abacavir Sulfate is used for
2.
How Abacavir Sulfate works
3.
Before you use Abacavir Sulfate
4.
How to use Abacavir Sulfate
5.
While you are using it
6.
Side effects
7.
Storage
and
Disposal
of
Abacavir
Sulfate
8.
Product Description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of revision
WHAT ABACAVIR SULFATE IS USED FOR
Abacavir Sulfate is used in antiretroviral
combination therapy, for, the treatment
of
Human
Immunodeficiency
Virus
(HIV) infection in adults and children.
HOW ABACAVIR SULFATE WORKS
The active ingredient Abacavir Sulfate is
a potent selective inhibitor of HIV. It
works
by
inhibiting
HIV
reverse
transcriptase
enzyme.
Reverse
transcriptase
is
an
enzyme
that
HIV
needs
in
order
to
multiply.
Abacavir
penetrates
the
cerebrospinal
fluid,
and
has been shown to reduce HIV-1 RNA
levels.
BEFORE YOU USE ABACAVIR SULFATE
-
_When you must not use it_
Do not take Abacavir Sulfate if:
•
You
are
allergic
or
hypersensitive
to
Abacavir
Sulfate
or
any
of
the
other
ingredients of this product.
•
You
suffer
from
severe
liver
impairment
_Pregnancy and lactation _
Do not take Abacavir Sulfate if you are
pregnant, trying to get pregnant or think
you may be pregnant.
Do not take Abacavir Sulfate if you are
breast-feeding.
Ask
your
doctor
or
pharmacist for advice before taking any
medicine.
-
_Before you start to use it_
Do not take Abacavir Sulfate if you
have:
•
Buildup of lactate
•
Mitochondrial
dysfunction
(important part of the cell which
fails to produce enough energy for
cell or organ function)
•
Lipodystrophy
(abnormal
distribution of fat in the body)
•
Pancreatitis (inflammation in the
pancreas)
•
Liver disease
•
Kidney disease
•
Hereditary
problems
of
fructose
intolerance
•
Immune
Reactivation
Syndrome
(some
cases
of
AIDS
or
immunosuppression, in which the
immune system begins to recover,
but then responds to

Ciri produk

ABACAVEX (ABACAVIR ORAL SOLUTION 20MG/ML)
ABACAVEX (ABACAVIR TABLET USP 300MG)
ABACAVIR SULFATE ORAL SOLUTION 20MG/ML: DESCRIPTION AND COMPOSITION:
Clear to opalescent yellowish, strawberry-banana flavoured liquid.
Each ml contains abacavir
20mg as abacavir sulfate.
ABACAVIR SULFATE TABLETS USP 300MG
DESCRIPTION AND COMPOSITION:
Yellow colored, biconvex, capsule shaped, coated tablet, debossed with
‘D’ and ‘88’ on either
side of the score line on one side and plain with a score line on
other side.
Each film coated tablet contains: Abacavir Sulfate equivalent to
Abacavir 300mg.
PHARMACODYNAMICS:
Pharmacotherapeutic group: Nucleoside reverse transcriptase
inhibitors, ATC Code: J05A F06
Abacavir is a NRTI. It is a potent selective inhibitor of HIV-1 and
HIV-2, including HIV-1 isolates
with reduced susceptibility to zidovudine, lamivudine, zalcitabine,
didanosine or nevirapine.
Abacavir is metabolised intracellularly to the active moiety, carbovir
5’- triphosphate (TP). In
vitro studies have demonstrated that its mechanism of action in
relation to HIV is inhibition of the
HIV reverse transcriptase enzyme, an event which results in chain
termination and interruption
of the viral replication cycle. Abacavir shows synergy in vitro in
combination with nevirapine
and zidovudine. It has been shown to be additive in combination with
didanosine, zalcitabine,
lamivudine and stavudine.
Abacavir-resistant isolates of HIV-1 have been selected in vitro and
are associated with specific
genotypic changes in the reverse transcriptase (RT) codon region
(codons M184V, K65R, L74V
and Y115F). Viral resistance to abacavir develops relatively slowly in
vitro and in vivo, requiring
multiple mutations to reach an eight-fold increase in IC50 over
wild-type virus, which may be
a clinically relevant level. Isolates resistant to abacavir may also
show reduced sensitivity to
lamivudine, zalcitabine and/or didanosine, but remain sensitive to
zidovudine and stavudine.
Cross-resistance between abacavir and PIs or NNRTIs is unlikely.