NEVIRAPINE RBX nevirapine 200 mg tablets bottle pack

Maa: Australia

Kieli: englanti

Lähde: Department of Health (Therapeutic Goods Administration)

Aktiivinen ainesosa:

Nevirapine

Saatavilla:

Sun Pharma ANZ Pty Ltd

INN (Kansainvälinen yleisnimi):

Nevirapine

Pakkausseloste

Nevirapine CMI V5 August 2012
Page 1
_NEVIRAPINE RBX _
_NEVIRAPINE TABLETS _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS
LEAFLET
This leaflet answers some
common questions about
NEVIRAPINE RBX. It does not
contain all the available
information. It does not take
the place of talking to your
doctor or pharmacist.
This leaflet was last updated
on the date at the end of this
leaflet. More recent information
may be available. The latest
Consumer Medicine
Information is available from
https://www.ebs.tga.gov.au/
and may contain important
information about the medicine
and its use of which you should
be aware.
All medicines have benefits
and risks. Your doctor has
weighed the risks of you using
NEVIRAPINE RBX against the
benefits they expect it will have
for you.
ASK YOUR DOCTOR OR
PHARMACIST IF YOU HAVE ANY
QUESTIONS ABOUT YOUR
MEDICINE OR IF YOU HAVE ANY
TROUBLE BEFORE, DURING OR
AFTER USING NEVIRAPINE
RBX.
KEEP THIS LEAFLET WITH YOUR
NEVIRAPINE RBX.
You may need to read it again
later.
WHAT NEVIRAPINE
RBX IS USED FOR
NEVIRAPINE RBX is used in
the treatment of the infection
caused by the Human
Immunodeficiency Virus (HIV-
1). HIV-1 is the main virus
responsible for the
development of Acquired
Immunodeficiency Syndrome
(AIDS).
NEVIRAPINE RBX contains
the active ingredient
nevirapine. Nevirapine belongs
to a group of antiretroviral
medicines called non-
nucleoside reverse
transcriptase inhibitors
(NNRTIs). It works by inhibiting
or interrupting the enzyme
_reverse transcriptase _that the
HIV virus needs to multiply.
Nevirapine does not cure or
prevent HIV-1 infection or
AIDS, but it does hinder the
growth of HIV-1.
NEVIRAPINE RBX is
prescribed in combination with
other antiretroviral medicines
which hinder the growth of
HIV-1 in other ways. When
these medicines are taken with
NEVIRAPINE RBX, the growth
of HIV-1 is hindered more
effectively.
NEVIRAPINE RBX HAS NOT
BEEN SHOWN TO REDUCE THE
INCIDENCE OR FREQUENCY OF
THE ILLNESSES CAUSED BY
AIDS. IT IS IMPORTANT FOR YOU
TO CONTINUE SEEING YOUR
DOCTOR REGULARLY.
NEVIRAPINE

Valmisteyhteenveto

NEVIRAPINE RBX PI V9 Sep 2013
Page 1 of 33
PRODUCT INFORMATION
NEVIRAPINE RBX
Nevirapine 200 mg Tablets
NAME OF THE MEDICINE
Nevirapine
Structural formula:
Molecular Formula:
C
15
H
14
N
4
O
Chemical Name:
11-Cyclopropyl-4-methyl-5,11-dihydro-6H-dipyrido[3,2-b:2’,3’-
e][1,4]diazepin-6-one
Molecular Weight: 266.3
CAS Number: 129618-40-2
DESCRIPTION
Nevirapine is a non-nucleoside reverse transcriptase inhibitor with
activity against Human
Immunodeficiency Virus Type 1 (HIV-1). Nevirapine is a white to almost
white powder with
a pKa of 2.8. It is practically insoluble in water, sparingly soluble
or slightly soluble in
methylene chloride, and slightly soluble in methanol.
NEVIRAPINE RBX immediate-release tablets contain 200 mg of nevirapine
and the inactive
ingredients lactose, microcrystalline cellulose, povidone, sodium
starch glycollate type A,
colloidal anhydrous silica and magnesium stearate.
PHARMACOLOGY
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-
NEVIRAPINE RBX PI V9 Sep 2013
Page 2 of 33
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

or

) are
not inhibited by nevirapine.
In clinical studies, nevirapine has been associated with an increase
in HDL-cholesterol and an
overall improvement in the total to HDL-cholesterol ratio. However, in
the absence of
specific studies with nevirapine on modifying the cardiovascular risk
in HIV infected
patients, the clinical impact of these findings is not known. The
selection of antiretroviral
drugs must be guided primarily by their antiviral efficacy.
MICROBIOLOGY
_IN VITRO _HIV SUSCEPTIBILITY
The _in vitro _antiviral activity of nevirapine has been measured in a
variety of cell lines
includin