FORSTAVIR-LE ( Efavirenz 600 mg Lamivudine 300 mg and Tenofovir Disoproxil Fumarate 300 mg ) Film-coated Tablets

Land: Malasía

Tungumál: enska

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

Virkt innihaldsefni:

EFAVIRENZ; LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE

Fáanlegur frá:

UNIMED SDN BHD

INN (Alþjóðlegt nafn):

EFAVIRENZ; LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE

Einingar í pakka:

30tablet Tablets; 90 Tablets; 100 Tablets

Framleitt af:

Aurobindo Pharma Limited, Unit-VII (SEZ)

Upplýsingar fylgiseðill

_Consumer Medication Information Leaflet (RiMUP) _
1
EFAVIRENZ
600
MG,
LAMIVUDINE
300
MG AND
TENOFOVIR DISOPROXIL FUMARATE 300 MG TABLETS
(EFAVIRENZ 600 MG, LAMIVUDINE 300 MG AND TENOFOVIR DISOPROXIL FUMARATE
300 MG)
WHAT IS IN THIS LEAFLET
1.
What Efavirenz, Lamivudine
and
Tenofovir
Disoproxil
Fumarate Tablets is used for
2.
How it works
3.
Before
you
use
Efavirenz,
Lamivudine
and
Tenofovir
Disoproxil Fumarate Tablets
4.
How
to
use
Efavirenz,
Lamivudine
and
Tenofovir
Disoproxil Fumarate Tablets
5.
While you are using it
6.
Side effects
7.
Storage
and
Disposal
of
Efavirenz,
Lamivudine
and
Tenofovir
Disoproxil
Fumarate Tablets
8.
Product Description
9.
Manufacturer
10.
Product Registration Holder
11.
Date of revision
WHAT
EFAVIRENZ,
LAMIVUDINE
AND
TENOFOVIR
DISOPROXIL
FUMARATE TABLETS IS USED FOR
Efavirenz,
Lamivudine
and
Tenofovir
Disoproxil
Fumarate
Tablets is used as a treatment for
Human Immunodeficiency Virus
(HIV)
infection
in
adults
and
adolescents over 12 years of age.
HOW
EFAVIRENZ,
LAMIVUDINE
AND
TENOFOVIR
DISOPROXIL
FUMARATE TABLETS WORKS
All
active
substances
interfere
with enzymes used by HIV for
making copies of itself and, by
doing so, block the reproduction
of the virus. Antiviral medicines
used for HIV infection are known
as antiretrovirals.
BEFORE
YOU
USE
EFAVIRENZ,
LAMIVUDINE
AND
TENOFOVIR
DISOPROXIL FUMARATE TABLETS
-
When you must not use it
•
if
you
are
allergic
(hypersensitive) to Efavirenz,
Lamivudine,
Tenofovir
Disoproxil Fumarate or any
of
the
other
ingredients
of
Efavirenz,
Lamivudine
and
Tenofovir
Disoproxil
Fumarate Tablets.
•
if you are currently taking St.
John´s
wort
(Hypericum
perforatum) (a herbal remedy
used
for
depression
and
anxiety)
or
voriconazole
(a
drug
used
against
fungal
infections).
-
Before you start to use it
Tell your doctor if you have had
kidney
disease
or
if
tests
have
shown
problems
with
your
kidneys.
Efavirenz,
Lamivudine
and
Tenofovir
Disoproxil
Fumarate Tablets may affect your
kidneys.
Efavirenz,
Lamivudine
and
Tenofovir
Disoproxil
Fumarate
Tablets is not

Vara einkenni

FORSTAVIR-LE
(EFAVIRENZ 600 MG, LAMIVUDINE 300 MG AND TENOFOVIR DISOPROXIL FUMARATE
300 MG)
FILM-COATED TABLETS
DESCRIPTION
White colored, oval shaped, beveled edge, biconvex, film coated
tablets, debossed with ‘I’ on one side and ‘91’ on the other
side.
PHARMACODYNAMICS
Pharmacotherapeutic group: Antivirals for treatment of HIV infections,
combinations, ATC code: J05AR11.
Mechanism of action and Pharmacodynamics effects:
Efavirenz is a non-nucleoside reverse transcriptase inhibitor (NNRTI)
of HIV-1. Efavirenz binds directly to reverse transcriptase and blocks
the RNA-dependent and DNA-dependent DNA polymerase activities by
inducing a conformational change that causes a disruption of the
enzyme’s catalytic site. The activity of Efavirenz does not compete
with template or nucleoside triphosphates. HIV-2 reverse transcriptase
and eukaryotic DNA polymerases (such as human DNA polymerases
α
,
β
,
γ
, or
δ
) are not inhibited by Efavirenz.
Lamivudine, the negative enantiomer of 2’-deoxy-3’-thiacytidine,
is a dideoxynucleoside analogue. Tenofovir Disoproxil Fumarate is
converted in vivo to Tenofovir, a nucleoside monophosphate
(nucleotide) analogue of adenosine monophosphate
Lamivudine and Tenofovir are phosphorylated by cellular enzymes to
form Lamivudine triphosphate and Tenofovir diphosphate,
respectively. Lamivudine triphosphate and Tenofovir diphosphate
competitively inhibit HIV-1 reverse transcriptase (RT), resulting in
DNA
chain termination. Both substances are active against HIV-1 and HIV-2,
as well as against hepatitis B virus.
Resistance:
A large proportion of patients experiencing virological failure while
receiving Efavirenz will develop resistance to Efavirenz. The main
mutations occurring are K103N, G190S/A/E and Y188L; a single one of
these mutations is sufficient to cause high-grade resistance. The
cross resistance between Efavirenz and Nevirapine or Delavirdine is
extensive; therefore patients who have experienced virological failure
with either of these drugs, are likely to harbour v