TENOF-EM Tablet

País: Malasia

Idioma: inglés

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

Ingredientes activos:

EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE

Disponible desde:

MEDISPEC (M) SDN.BHD

Designación común internacional (DCI):

EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE

Unidades en paquete:

30tablet Tablets

Fabricado por:

Hetero Labs Limited

Información para el usuario

TENOF-EM TABLET
Emtricitabine and Tenofovir Disoproxil Fumarate (200mg/300mg)
1
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
WHAT IS IN THIS LEAFLET
1.
What TENOF-EM (Emtricitabine
and Tenofovir Disoproxil Fumarate
Tablets 200mg/300mg) is used for
2.
How TENOF-EM (Emtricitabine
and Tenofovir DF) works
3.
Before you use TENOF-EM
(Emtricitabine and Tenofovir DF)
4.
How to use TENOF-EM
(Emtricitabine and Tenofovir DF)
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of TENOF-
EM (Emtricitabine and Tenofovir
DF)
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
WHAT TENOF-EM (EMTRICITABINE AND
TENOFOVIR DF) IS USED FOR
TENOF-EM
_ _
is indicated in combination
with other antiretroviral agents for the
treatment of HIV-1 in adults.
TENOF-EM
_ _
is indicated in combination
with safer sex practices for pre-exposure
prophylaxis to reduce the risk of sexually
acquired HIV-1 infection in adults.
HOW TENOF-EM (EMTRICITABINE AND
TENOFOVIR DF) WORKS
TENOF-EM
contains
two
active
substances,
emtricitabine
and
tenofovir
disoproxil.
Both
of
these
active
substances
are
antiretroviral
medicines
which are used to treat HIV infection.
Emtricitabine
is
a
nucleoside
reverse
transcriptase inhibitor and tenofovir is a
nucleotide reverse transcriptase inhibitor.
However, both are generally known as
NRTIs and they work by interfering with
the
normal
working
of
an
enzyme
(reverse transcriptase) that is essential for
the virus to reproduce itself.
BEFORE
YOU
USE
TENOF-EM
(EMTRICITABINE AND TENOFOVIR DF)_ _
-
_When you must not use it _
_Pregnancy and lactation _
Do
not
take
TENOF-EM
(EMTRICITABINE AND TENOFOVIR DF)
if
you
are
pregnant,
trying
to
get
pregnant
or
think
you
may
be
pregnant.
Do
not
take
TENOF-EM
(EMTRICITABINE AND TENOFOVIR DF)
if
you
are
breast-feeding.
Ask
your
doctor or pharmacist for advice before
taking any medicine.
-
_Before you start to use it _
Tell your doctor if you
•
have
liver
problems
including
hepatitis B virus infection
•
have
kidney
problems
or
re

Ficha técnica

TENOF-EM
EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE TABLETS 200 MG/300 MG
COMPOSITION
Each film coated tablet contains 200 mg of emtricitabine and 300 mg
of tenofovir disoproxil fumarate,
which is equivalent to 245 mg of tenofovir disoproxil.
DOSAGE FORM
Oral, film-coated tablets
DESCRIPTION
Blue, capsule shaped, film coated tablets debossed with 'H' on one
side and '124' on other side.
PHARMACOLOGY
PHARMACODYNAMICS
Emtricitabine is an NRTI that is converted intracellularly to its
active metabolite, emtricitabine 5'-
triphosphate. Tenofovir DF is an ester prodrug of the NRTI, tenofovir.
The prodrug is hydrolysed
intracellularly to tenofovir, which is then converted to the active
metabolite, tenofovir diphosphate.
The active metabolites of the drugs compete with deoxycytidine
5'-triphosphate (emtricitabine 5'-
triphosphate) or deoxyadenosine 5'- triphosphate (tenofovir
diphosphate) for incorporation into HIV
DNA, thereby terminating viral DNA chain growth and inhibiting the
activity of the viral reverse
transcriptase.
PHARMACOKINETICS
ABSORPTION
The median bioavailability of emtricitabine in fasted patients
following a single oral dose is 92%. The
median bioavailability of tenofovir in fasted patients following a
single oral dose is 25%.
DISTRIBUTION
Protein binding of emtricitabine is less than 4%; and of tenofovir, is
less than 0.7% (plasma) and 7.2%
(serum).
METABOLISM AND ELIMINATION
Emtricitabine undergoes limited metabolism and is primarily excreted
by the kidneys. The median
terminal elimination half-lives of emtricitabine and tenofovir were
15.5 and 17.6 hours when healthy
volunteers received a single dose of co-formulated
emtricitabine/tenofovir DF 200mg/300mg on two
separate occasions.
INDICATIONS
TREATMENT OF HIV-1 INFECTION:
Emtricitabine and Tenofovir disoproxil fumarate is indicated in
combination with other antiretroviral
agents
(such
as
non-nucleoside reverse transcriptase inhibitors or protease
inhibitors) for the
treatment of HIV-1 infection in adults.
The following points should be consi