NEVIHOPE 200 mg Tablets (Nevirapine Tablets USP 200mg)

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

NEVIRAPINE

Boleh didapati daripada:

Paxten Sdn Bhd

INN (Nama Antarabangsa):

NEVIRAPINE

Unit dalam pakej:

60tablet Tablets

Dikeluarkan oleh:

Macleods Pharmaceuticals Ltd.

Risalah maklumat

_Consumer Medication Information Leaflet (RiMUP) _
NEVIHOPE 200MG TABLET
(NEVIRAPINE TABLETS USP 200 MG)
Nevirapine (200mg)
. 1
WHAT IS IN THIS LEAFLET
1.
What Nevihope is used for
2.
How Nevihope works
3.
Before you use Nevihope
4.
How to take Nevihope
5.
While
you
are
using
Nevihope
6.
Side Effects
7.
Storage
and
Disposal
of
Nevihope
8.
Product description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of Revision
WHAT NEVIHOPE IS USED FOR
Nevihope belongs to a group of
medicines called antiretrovirals,
used in the treatment of Human
Immunodeficiency Virus (HIV-
1) infection.
Nevihope
is
indicated
for
the
treatment
of
HIV-1
infected
adults and for larger children.
You
must
take
Nevihope
together
with
other
antiretroviral
medicines.
Your
doctor will recommend the best
medicines for you.
HOW NEVIHOPE WORKS
The
active
substance
of
your
medicine
is
called
nevirapine.
Nevirapine reduces the amount
of
viruses
in
the
blood
thus
improving
your
medical
condition.
Nevirapine belongs to a class of
anti-HIV medicines called non-
nucleoside reverse transcriptase
inhibitors
(NNRTIs).
Reverse
transcriptase is an enzyme that
HIV needs in order to multiply.
Nevirapine
stops
reverse
transcriptase from working. By
stopping
reverse
transcriptase
from working, Nevihope helps
control HIV-1 infection.
BEFORE YOU USE NEVIHOPE
_-When you must not take it _
Do not take Nevihope if:
- you are allergic to nevirapine
or any of the other ingredients
of this medicine
-
you
have
taken
Nevihope
before
and
had
to
stop
the
treatment because you suffered
from
severe
rashes,
allergy
reactions or liver problems
- you are taking St. John's wort
as this can affect the efficacy of
Nevihope
-
you
have
severe
liver
problems
_-Before you start to take it _
_Warnings and precautions _
Talk
to
your
doctor
or
pharmacist
before
taking
Nevihope. During the first 18
weeks
of
treatment
with
Nevihope it is very important
that you and your doctor watch
out for signs of liver or skin
reactions.
These
can
become
severe and even life threatening.
You are a

Ciri produk

SECTION D ARTWORKS
_ _
NEVIHOPE 200MG TABLET
NEVIRAPINE TABLETS USP 200 MG MACLEODS PHARMACEUTICALS LTD.
D3 PACKAGE INSERT
For the use only of a Registered Medical Practitioner or a Hospital or
a Laboratory
NEVIHOPE 200MG TABLET
NEVIRAPINE TABLETS USP 200 MG
COMPOSITION:
Each uncoated tablet contains:
Nevirapine USP……………….200 mg
DOSAGE FORM:
Uncoated Tablet
PRODUCT DESCRIPTION:
White to off white, oval , biconvex uncoated tablets having “M”
and “L” debossed on upper
punches separated by a deep score separating the “M” and “L”
and “1” and “1” debossed on
the other side with a breakline separating “1” and “1”.
PHARMACOLOGY:
THERAPEUTIC CODE: _ATC CODE:_
J05A G01
Mechanism of Action:
Nevirapine is a non-nucleoside reverse transcriptase inhibitor (NNRTI)
of HIV-1. Nevirapine
binds directly to reverse transcriptase (RT) and blocks the
RNA-dependent and DNA-
dependent DNA polymerase activities by causing a disruption of the
enzyme's catalytic site.
The activity of nevirapine does not compete with template or
nucleoside triphosphates. HIV-
2 RT and eukaryotic DNA polymerases (such as human DNA polymerases α,
β, γ, or δ) are
not inhibited by nevirapine.
Nevirapine in combination with efavirenz exhibited strong antagonistic
anti-HIV-1 activity in
cell culture and was additive to antagonistic with the protease
inhibitor ritonavir or the fusion
inhibitor enfuvirtide. Nevirapine exhibited additive to synergistic
anti-HIV-1 activity in
combination
with
the
protease
inhibitors
amprenavir,
atazanavir,
indinavir,
lopinavir,
SECTION D ARTWORKS
_ _
NEVIHOPE 200MG TABLET
NEVIRAPINE TABLETS USP 200 MG MACLEODS PHARMACEUTICALS LTD.
nelfinavir, saquinavir and tipranavir, and the NRTIs abacavir,
didanosine, emtricitabine,
lamivudine, stavudine, tenofovir and zidovudine.
PHARMACOKINETICS:
ABSORPTION
Nevirapine is readily absorbed (> 90%) after oral administration in
healthy volunteers and in
adults with HIV-1 infection. Peak plasma nevirapine concentrations of
2 ± 0.4 µg/ml (7.5
µM) wer