Trustiva Tablet

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

EFAVIRENZ; TENOFOVIR DISOPROXIL FUMARATE; EMTRICITABINE

Boleh didapati daripada:

CAMBER LABORATORIES SDN. BHD.

INN (Nama Antarabangsa):

EFAVIRENZ; TENOFOVIR DISOPROXIL FUMARATE; EMTRICITABINE

Unit dalam pakej:

30tablet Tablets

Dikeluarkan oleh:

Hetero Labs Limited

Risalah maklumat

TRUSTIVA TABLET
®
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
Efavirenz, Emtricitabine and Tenofovir Disoproxil Fumarate
(600mg/200mg/300mg)
WHAT IS IN THIS LEAFLET
1.
What
_TRUSTIVA _
_(Efavirenz, _
_Emtricitabine _
_and _
_Tenofovir _
_Disoproxil Fumarate) _
is used for
2.
How
_TRUSTIVA _
_(Efavirenz, _
_Emtricitabine _
_and _
_Tenofovir _
_DF) _
works
3.
Before
you
use
_TRUSTIVA _
_(Efavirenz, _
_Emtricitabine _
_and _
_Tenofovir DF) _
4.
How to use
_TRUSTIVA (Efavirenz, _
_Emtricitabine and Tenofovir DF) _
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of
_TRUSTIVA _
_(Efavirenz, _
_Emtricitabine _
_and _
_Tenofovir DF) _
8.
Product Description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of revision
WHAT
_TRUSTIVA _
_(EFAVIRENZ, _
_EMTRICITABINE _
_AND _
_TENOFOVIR _
_DF) _
IS
USED FOR
TRUSTIVA
can
be
used
alone
as
a
complete
regimen,
or
in
combination
with other anti-HIV-1 medicines to treat
people with HIV-1 infection.
HOW
_TRUSTIVA _
_(EFAVIRENZ, _
_EMTRICITABINE AND TENOFOVIR DF) _WORKS
TRUSTIVA helps block HIV-1 reverse
transcriptase,
a
viral
chemical
in
your
body (enzyme) that is needed for HIV-1
to multiply, lowers the amount of HIV- 1
in the blood (viral load) and may also
help to increase the number of T cells
(CD4
+
cells),
allowing
your
immune
system to improve.
BEFORE YOU USE _TRUSTIVA (EFAVIRENZ, _
_EMTRICITABINE AND TENOFOVIR DF) _
-
_When you must not use it _
_Pregnancy and lactation _
Do not take
_TRUSTIVA (EFAVIRENZ, _
_EMTRICITABINE AND TENOFOVIR DF) _
if
you
are
pregnant,
trying
to
get
pregnant
or
think
you
may
be
pregnant.
Do not take
_TRUSTIVA (EFAVIRENZ, _
_EMTRICITABINE AND TENOFOVIR DF) _
if
you
are
breast-feeding.
Ask
your
doctor or pharmacist for advice before
taking any medicine.
If
you
are
allergic
to
efavirenz,
emtricitabine,
tenofovir
disoproxil
fumarate
or
any
of
the
other
ingredients of this medicine.
-
_Before you start to use it _
Tell your doctor if you have any heart
disorder.
Tell your healthcare provider if you:
•
Have
kidney
pro

Ciri produk

TRUSTIVA
Efavirenz, Emtricitabine and Tenofovir Disoproxil Fumarate Tablets
600 mg / 200 mg / 300 mg
NAME OF PRODUCT
Trustiva Tablet
NAME AND STRENGTH OF ACTIVE INGREDIENT
Each film-coated tablet contains:
600 mg of Efavirenz, 200 mg of Emtricitabine and 300 mg of Tenofovir
Disoproxil Fumarate is
equivalent to 245 mg of Tenofovir Disoproxil.
DOSAGE FORM
Oral, fixed-dose tablet
PRODUCT DESCRIPTION
Pink colored, capsule shaped, film coated tablets debossed with 'H'
on one side and '128' on the other
side.
PHARMACODYNAMICS/PHARMACOKINETICS
PHARMACODYNAMICS
_CARDIAC ELECTROPHYSIOLOGY: _
The effect of TRUSTIVA on the QTc interval was evaluated in an
open-label, positive and placebo
controlled, fixed single sequence 3-period, 3-treatment crossover QT
study in 58 healthy subjects
enriched for CYP2B6 polymorphisms. The mean Cmax of efavirenz in
subjects with CYP2B6 *6/*6
genotype following the administration of 600 mg daily dose for 14 days
was 2.25-fold the mean Cmax
observed in subjects with CYP2B6 *1/*1 genotype. A positive
relationship between efavirenz
concentration and QTc prolongation was observed. Based on the
concentration-QTc relationship, the
mean QTc prolongation and its upper bound 90% confidence interval are
8.7 ms and 11.3 ms in
subjects with CYP2B6*6/*6 genotype following the administration of 600
mg daily dose for 14 days.
(see Section Warnings and Precautions & Section Interaction with Other
Medicaments).
_EFAVIRENZ_
Efavirenz is a non-nucleoside reverse transcriptase (RT) inhibitor of
HIV-1. Efavirenz activity is
mediated predominantly by the noncompetitive inhibition of HIV-1
reverse transcriptase (RT). HIV-2
RT and human cellular DNA polymerases, α, β, γ and δ are not
inhibited by efavirenz.
_EMTRICITABINE_
Emtricitabine, a synthetic nucleoside analog of cytidine, is
phosphorylated by cellular enzymes to form
emtricitabine 5'-triphosphate. Emtricitabine 5'-triphosphate inhibits
the activity of the HIV-1 RT by
competing with the natural substrate deoxycytidine 5'-triphosphate,
and by being in