Hirapine Tablet 200mg

Quốc gia: Malaysia

Ngôn ngữ: Tiếng Anh

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

Thành phần hoạt chất:

Nevirapine (Anhydrous)

Sẵn có từ:

DUOPHARMA (M) SDN. BHD.

INN (Tên quốc tế):

Nevirapine (Anhydrous)

Các đơn vị trong gói:

60 Tablet Tablets

Sản xuất bởi:

DUOPHARMA (M) SDN. BHD.

Tờ rơi thông tin

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
1
HIRAPINE TABLET
Nevirapine (200mg)
WHAT IS IN THIS LEAFLET
1.
What HIRAPINE TABLET
is used for
2.
How HIRAPINE TABLET
works
3.
Before you use HIRAPINE
TABLET
4.
How to use HIRAPINE
TABLET
5.
While
you
are
using
HIRAPINE TABLET
6.
Side effects
7.
Storage and disposal of
HIRAPINE TABLET
8.
Product description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
WHAT HIRAPINE TABLET
IS USED FOR
HIRAPINE TABLET is used
for
the
treatment
of
Human
Immunodeficiency
Virus
(HIV-1) infection in adults and
children
over
the
age
of
12
months.
HOW HIRAPINE TABLET
WORKS
HIRAPINE TABLET contains
Nevirapine which belongs to a
class
of
anti-HIV
medicines.
Nevirapine
decrease
HIV-1
activities and production.
BEFORE
YOU
USE
HIRAPINE
TABLET
_-_
_ _
_When you must not use it _
You must not use HIRAPINE
TABLET
if
you
are
hypersensitive
to
the
Nevirapine or to any of the
excipients.
You must not use HIRAPINE
TABLET
if
you
have
liver
impairment.
_-_
_ _
_Before you start to use it _
Before
taking
HIRAPINE
TABLET, you must tell your
doctor or pharmacist if you
have, or have had, any of the
following conditions:

Liver disease

Post-exposure
prophylaxis
(taking antiviral medicines
after
being
potentially
exposed to HIV to prevent
becoming infected)

Kidney dysfunction
If you are not sure if you have,
or
have
had,
any
of
these
conditions,
you
should
raise
those
concerns
with
your
doctor or pharmacist.
_Pregnancy _
Ask for your doctor’s advice if
you are pregnant, or likely to
become pregnant during your
course of medication.
_Breast-feeding _
HIRAPINE TABLET was
excreted
in
the
breast
milk.
Women who are infected HIV-
1
is
generally
recommended
not
to
breastfeed
infants
regardless
of
the
use
of
medicine,
to
avoid
post-natal
transmission of HIV-1.
_-_
_ _
_Taking other medicines _
Inform
your
doctor
or
pharmacist
before
taking
HIRAPINE TABLET.
Before
using
HIRAPINE
TABLET, it is important to tell
your
doctor
or
pharmacist
if
you are taking or about to take
any o

Đặc tính sản phẩm

Page 1 of 4
[REVISION DATE: 12.06.2019]
[DUOPHARMA (M) SDN BHD]
HIRAPINE TABLET 200MG
DESCRIPTION:
A round 9mm, scored tablet white to off-white in colour with markings
‘DUO 3’ on the scored side and ‘DUO 4’ on the other side.
COMPOSITION:
Each tablet contains Nevirapine 200mg.
PHARMACODYNAMICS:
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 a, b, gamma or delta) are
not inhibited by nevirapine.
PHARMACOKINETICS:
Nevirapine is readily absorbed following oral administration and
absorption is not affected by food. Peak plasma concentration occurs
up to 4 hours after a single dose. Nevirapine is about 60% bound to
plasma proteins. Concentrations in the CNS are about 45% of those in
plasma. Nevirapine crosses the placenta and is distributed into breast
milk. It is extensively metabolised by hepatic microsomal
enzymes, principally by cytochrome P450 isoenzymes of the CYP3A
family. Autoinduction of these enzymes results in a 1.5- to 2-fold
increase in apparent oral clearance after 2 to 4 weeks administration
of
usual doses, and a decrease in terminal half-life from 45 hours to 25
to 30 hours over the same period. Nevirapine is mainly excreted in the
urine as glucoronide conjugates of the hydroxylated metabolites.
INDICATION:
Nevirapine in combination with antiretroviral agents is indicated for
the treatment of HIV-1 infection in adults and children over the age
of 2 months. Resistant virus emerges rapidly when Nevirapine is
administered as monotherapy or in dual combination therapy with an
antiretroviral agent. Therefore, Nevirapine should always be
administered in combination with at least two additional
antiretroviral
agents. Avoid usage o