Nevirapine XR APOTEX nevirapine 400 mg modified release tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

nevirapine

Available from:

Apotex Pty Ltd

INN (International Name):

Nevirapine

Authorization status:

Registered

Patient Information leaflet

NEVIRAPINE XR APOTEX
_Contains the active ingredient Nevirapine anhydrous_
CONSUMER MEDICINE INFORMATION
_FOR A COPY OF A LARGE PRINT LEAFLET, PH: 1800 195 055_
WHAT IS IN THIS LEAFLET
READ THIS LEAFLET CAREFULLY BEFORE
TAKING YOUR MEDICINE.
This leaflet answers some common
questions about nevirapine. It does
not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
The information in this leaflet was
last updated on the date listed on the
last page. More recent information on
this medicine may be available.
ASK YOUR DOCTOR OR PHARMACIST:
•
if there is anything you do not
understand in this leaflet,
•
if you are worried about taking
your medicine, or
•
to obtain the most up-to-date
information.
You can also download the most up
to date leaflet from
www.apotex.com.au.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you using this medicine
against the benefits they expect it
will have for you.
Pharmaceutical companies cannot
give you medical advice or an
individual diagnosis.
Keep this leaflet with your medicine.
You may want to read it again.
WHAT THIS MEDICINE IS
USED FOR
The name of your medicine is
Nevirapine XR APOTEX modified
release tablets. It contains the active
ingredient nevirapine anhydrous.
It is used to treat infection by the
Human Immunodeficiency Virus
(HIV-1). HIV-1 is the main virus
responsible for the development of
Acquired Immunodeficiency
Syndrome (AIDS).
Ask your doctor if you have any
questions about why this medicine
has been prescribed for you. Your
doctor may have prescribed this
medicine for another reason.
This medicine is available only with
a doctor's prescription.
_HOW IT WORKS_
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

Summary of Product characteristics

Product Information – Australia
Nevirapine XR APOTEX Modified release Tablets
Page 1
NEVIRAPINE XR APOTEX MODIFIED RELEASE TABLETS
NAME OF THE MEDICINE
Nevirapine (as anhydrous form)
Chemical Name:
11-cyclopropyl-5,11-dihydro-4-methyl-6_H_-dipyrido[3,2-_b_:2',3'_e_][1,4]diazepin-6-
one.
Structural Formula:
Molecular Formula:
C
15
H
14
N
4
O
Molecular Weight:
266.3
CAS Registry Number:
129618-40-2
DESCRIPTION
DRUG SUBSTANCE
APPEARANCE: White or almost white powder
SOLUBILITY: Practically insoluble in water, sparingly soluble or
slightly soluble in methylene chloride,
slightly soluble in methanol.
PKA VALUES: 2.8
POLYMORPHISM STATEMENT: Nevirapine exhibits polymorphism. The
Crystalline form II is considered
for the purpose of development.
DRUG PRODUCT
Each modified release tablets contains 400mg nevirapine, as the active
ingredient.
In addition, each modified release tablet contains the following
inactive ingredients: Methycellulose,
Hypromellose, Iron Oxide Yellow, Magnesium Stearate.
PHARMACOLOGY
PHARMACOLOGICAL ACTIONS
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.
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
Product Information – Australia
Nevirapine XR APOTEX Modified release Tablets
Page 2
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 _HI