Tenolon 300mg Film Coated 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:

30 Tablets

Dikeluarkan oleh:

SHIJIAZHUANG LONZEAL PHARMACEUTICALS CO., LTD

Risalah maklumat

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
TENOLON 300MG FILM COATED TABLET
Tenofovir Disoproxil Fumarate (300mg)
1
WHAT IS IN THIS LEAFLET
1.
What
_Tenolon_
is used for
2.
How
_Tenolon_
works
3.
Before you use
_Tenolon_
4.
How to use
_Tenolon_
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of
_Tenolon_
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
WHAT _TENOLON_ IS USED FOR
_ _
_Tenolon_
is indicated in combination with
other antiretroviral agents for the
treatment of Human Immunodeficiency
Virus (HIV) infection in adults and
pediatric patients over 12 years of age.
_ _
_Tenolon_
is also indicated for the
treatment of chronic hepatitis B in adults.
HOW _TENOLON_ WORKS
_In vivo_
, 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
_._
BEFORE YOU USE _TENOLON_
-
_When you must not use it _
_ _
Tell your doctor immediately and do not
take
_Tenolon_
if you are allergic
(hypersensitive) to tenofovir, or any of
the other ingredients of
_Tenolon_
.
_ _
-
_Before you start to use it _
Do not give
_Tenolon_
to children and
adolescents under 12 years of age.
Take special care with
_Tenolon_
-
_Patients with history of liver disease, _
_including hepatitis. _
Caution should be observed when
nucleoside analogs are used in patients
with known risk factors for liver disease.
-
_Patients co-infected with HIV and _
_HBV. _
If you are coinfected with HIV-1 and
HBV, your doctor will prescribe Tenolon
as part of an appropriate antiretroviral
combination regimen.
-
_Impaired Renal Function _
Your doctor will recommended that the
dosing interval for tenofovir DF be
modified in patients with cre

Ciri produk

For the use only of a Registered Medical Practitioner
or a Hospital or a Laboratory
TENOLON 300MG FILM COATED TABLET
TENOFOVIR DISOPROXIL FUMARATE
300 mg Film-Coated Tablet
Antiviral
(Nucleoside
and
Nucleotide
Reverse
Transcriptase Inhibitor)
WARNINGS
Lactic
acidosis
and
severe
hepatomegaly
with
steatosis, including fatal cases, have been reported
with
the
use
of
nucleoside
analogs
including
Tenofovir disoproxil fumarate in combination with
other antiretrovirals (see warning and precautions).
Severe acute exacerbations of hepatitis have been
reported in hepatitis B virus (HBV)-infected patients
who
have
discontinued
anti-hepatitis
B
therapy,
including Tenofovir disoproxil fumarate. Hepatic
function
should
be
monitored
closely with
both
clinical and laboratory follow-up for at least several
months in patients who discontinue anti-hepatitis B
therapy, including Tenofovir disoproxil fumarate if
appropriate, resumption of anti-hepatitis B therapy
may be warranted (see warning and precautions).
COMPOSITION
Each film coated tablet contains:
Tenofovir Disoproxil Fumarate 300mg
Equivalent to Tenofovir Disoproxil 245mg
DESCRIPTION
Blue, almond-shaped, film coated tablets with white
cores, and debossed with “LZ30” on one side and
with “300” on the other side.
PHARMACOLOGY
PHARMACODYNAMICS
_In vivo_
, 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
standardised
high
fat
meal.
Median
steady-state
maximum
serum
tenofovir
concentrations (Cmax