TENOF 300mg Tablet

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

TENOFOVIR DISOPROXIL FUMARATE

Boleh didapati daripada:

MEDISPEC (M) SDN.BHD

INN (Nama Antarabangsa):

TENOFOVIR DISOPROXIL FUMARATE

Unit dalam pakej:

30tablet Tablets; 30tablet Tablets; 30tablet Tablets

Dikeluarkan oleh:

Hetero Labs Limited

Risalah maklumat

TENOF
® 300MG TABLET
Tenofovir Disoproxil Fumarate (300mg)
1
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
WHAT IS IN THIS LEAFLET
1.
What
_TENOF _
_(Tenofovir _
_DF) _
is
used for
2.
How
_TENOF (Tenofovir DF)_
works
3.
Before you use
_TENOF (Tenofovir _
_DF)_
4.
How to use
_TENOF (Tenofovir DF)_
5.
While you are using it
6.
Side effects
7.
Storage
and
Disposal
of
_TENOF _
_(Tenofovir DF)_
8.
Product Description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of revision
WHAT _ TENOF (TENOFOVIR DF)_ IS USED
FOR
Tenofovir is a prescription medicine used
with
other
antiviral
medicines
to
treat
Human
Immunodeficiency
Virus-1
(HIV-1) in people 12 years of age and
older. HIV is the virus that causes AIDS
(Acquired
Immune
Deficiency
Syndrome).
It
is
also
used
to
treat
chronic hepatitis B in adults.
HOW _TENOF (TENOFOVIR DF)_ WORKS
When used with other HIV medicines,
Tenofovir
may
reduce
the
amount
of
HIV in your blood (called “viral load”).
Tenofovir may also help to increase the
number of CD4 (T) cells in your blood
which
help
fight
off
other
infections.
Reducing
the
amount
of
HIV
and
increasing the CD4 (T) cell count may
improve your immune system. This may
reduce your risk of death or infections
that
can
happen
when
your
immune
system
is
weak
(opportunistic
infections).
BEFORE YOU USE _TENOF (TENOFOVIR DF)_
-
_When you must not use it _
_ _
_Pregnancy and lactation _
Do not take
_TENOF (Tenofovir DF)_
if
you are pregnant, trying to get pregnant
or think you may be pregnant.
Do not take
_TENOF (Tenofovir DF)_
if
you are breast-feeding. Ask your doctor
or pharmacist for advice before taking
any medicine.
_ _
_ _
-
_Before you start to use it _
Talk to your doctor about taking an
HIV test before starting treatment with
tenofovir
disoproxil
fumarate
for
chronic hepatitis B. You should also
get a test for HBV if you are taking
tenofovir
disoproxil
fumarate
for
treatment of HIV.
-
_Taking other medicines _
Tell your doctor if you are taking any
other
medicines,
including
any
that
you buy without a prescr

Ciri produk

TENOF 300MG TABLET
HETERO
NAME OF THE PRODUCT
Tenof 300mg Tablet
NAME AND STRENGTH OF ACTIVE INGREDIENT
Name
: Tenofovir Disoproxil Fumarate
Strength
: 300mg
300 mg of Tenofovir disoproxil fumarate equivalent to 245 mg of
Tenofovir disoproxil.
PRODUCT DESCRIPTION
Light blue coloured, almond shaped, film coated tablets, debossed with
‘H’ on one side and
‘123’ on other side.
PHARMACODYNAMICS/PHARMACOKINETICS
Tenofovir DF is 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.
_ _
PHARMACOKINETICS
_ABSORPTION_ _AND DISTRIBUTION_
The oral bioavailability of tenofovir after administration of
tenofovir DF 300 mg/day was 25%
and increased to 39% when tenofovir DF was administered with a
standardized high fat meal.
Median steady-state maximum serum tenofovir concentrations (Cmax) and
the area under the
serum tenofovir concentration-time curve (AUC) were 326 ng/mL and 3020
ng • h/mL in patients
infected with HIV who received tenofovir DF 300 mg/day with food for
28 days. The median time
to Cmax was 2.3 hours.
_METABOLISM AND ELIMINATION_
Tenofovir concentrations in serum decline in a biphasic manner.
TENOF 300MG TABLET
HETERO
INDICATIONS
HIV-1 INFECTION
Tenofovir is indicated in combination with other antiretroviral agents
for the treatment of HIV-1
infection in adults and pediatric patients 12 years of age and older.
The following points should be considered when initiating therapy with
tenofovir for the treatment
of HIV-1 infection:

TENOF should not be used in combination with other products containing
tenofovir disoproxil
fumarate
.
CHRONIC HEPATITIS B
Tenofovir is indicated for the treatment of chronic hepatitis B in
adults.
The following points should