FORSTAVIR (TENOFOVIR DISOPROXIL FUMARATE TABLETS 300MG)

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

TENOFOVIR DISOPROXIL FUMARATE

Boleh didapati daripada:

UNIMED SDN BHD

INN (Nama Antarabangsa):

TENOFOVIR DISOPROXIL FUMARATE

Unit dalam pakej:

30tablet Tablets

Dikeluarkan oleh:

Aurobindo Pharma Limited (Unit III),

Risalah maklumat

FORSTAVIR
TENOFOVIR DISOPROXIL FUMARATE 300MG
1
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
WHAT IS IN THIS LEAFLET
1.
What FORSTAVIR is used for
2.
How FORSTAVIR works
3.
Before you use FORSTAVIR
4.
How to use FORSTAVIR
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of
FORSTAVIR
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
WHAT FORSTAVIR
IS USED FOR
FORSTAVIR is used for the treatment of
Human Immunodeficiency Virus (HIV)
infection in adults over 12 years of age.
FORSTAVIR is also used to treat
chronic hepatitis B, an infection with
hepatitis B virus (HBV), in adults.
HOW FORSTAVIR WORKS
Tenofovir is a nucleotide reverse
transcriptase inhibitor, generally known
as an NRTI and works by interfering
with the normal working of enzymes (in
HIV: reverse transcriptase; in hepatitis B:
DNA polymerase) that are essential for
the viruses to reproduce themselves.
BEFORE YOU USE FORSTAVIR
-
_When you must not use it _
Do not take FORSTAVIR
If you are allergic (hypersensitive) to
tenofovir, or any of the other ingredients
of FORSTAVIR.
If this applies to you, tell your doctor
immediately and don’t take
FORSTAVIR.
_ _
-
_Before you start use it _
TAKE SPECIAL CARE WITH FORSTAVIR
•
TELL YOUR DOCTOR IF YOU HAVE HAD
KIDNEY DISEASE OR IF TESTS HAVE SHOWN
PROBLEMS WITH YOUR KIDNEYS.
FORSTAVIR may affect your kidneys.
Before starting treatment, your doctor
may order blood tests to check your
kidney function and may advise you to
take the tablets less often. Your doctor
may also order blood tests during
treatment to monitor your kidneys.
FORSTAVIR are not usually taken
with other medicines that can damage
your kidneys (see
_taking other _
_medicines_
). If this is unavoidable, your
doctor will monitor your kidney
function once a week.
•
TALK TO YOUR DOCTOR IF YOU ARE OVER
65.
FORSTAVIR has not been studied
in patients over 65 years of age. If you
are older than this and are prescribed
FORSTAVIR, your doctor will monitor
you carefully.
•
DO NOT GIVE FORST

Ciri produk

FORSTAVIR
TENOFOVIR DISOPROXIL FUMARATE TABLETS 300MG
PRODUCT DESCRIPTION
Tenofovir disoproxil fumarate tablets are off-white, oval shaped,
biconvex, film coated tablets
debossed with ‘I’ on one side and ‘36’ on the other side.
Each film coated tablet contains 245 mg of tenofovir disoproxil (as
fumarate), equivalent to 300
mg of tenofovir disoproxil fumarate.
PHARMACODYNAMIC
In
vivo,
Tenofovir
Disoproxil
Fumarate
hydrolysed
to
tenofovir,
which
is
then
phosphorylated by cellular kinases to the pharmacologically active
metabolite tenofovir
diphosphate. Tenofovir diphosphate inhibits the activity of HIV
reverse transcriptase by
competing with the nucleotide deoxyadenosine 5’-triphosphate for
incorporation into viral
DNA. Once incorporated into viral DNA, it terminates DNA elongation
because of lack of a
ribose ring.
PHARMACOKINETIC
Absorption and Distribution
The oral bioavailability of tenofovir after administration of
tenofovir disoproxil fumarate
300mg/day
was
25%
and
increased
to
39%
when
tenofovir
disoproxil
fumarate
was
administered
with
a
standardized
high
fat
meal.
Median
steady-state
maximum
serum
tenofovir concentrations (Cmax) and area under the serum tenofovir
concentration-time curve
(AUC) were 326ng/ml and 3020ng, h/mL in patients are infected with HIV
who received
tenofovir disoproxil fumarate 300mg/day with food for 28days. The
median time to Cmax
was 2.3 hours.
Metabolism and Elimination
Tenofovir concentrations in serum decline in a biphasic manner.
Administration of tenofovir
disoproxil fumarate 300mg/day with food for 28 days to patients with
HIV infection resulted
in a median serum terminal elimination half-life for tenofovir of 14.4
hours and clearance rate
of 0.51 L/h/kg. In an in vitro study, the half-life of tenofovir
diphosphate inactivated
Peripheral blood mononuclear cells (PBMCs) preincubated with tenofovir
DF or tenofovir
was 11 hours; however, the half-life of tenofovir diphosphate
inresting PBMC preincubated
with tenofovir was 49 hours.
INDICATION
HIV-1 infection;
Fostavir i