VIRAMUNE XR nevirapine 100 mg extended-release tablet bottle

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

Nevirapine

Available from:

Boehringer Ingelheim Pty Ltd

INN (International Name):

Nevirapine

Patient Information leaflet

1
VIRAMUNE XR CMI0135-05
VIRAMUNE
 XR
EXTENDED-RELEASE
TABLETS
_Nevirapine_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Viramune XR.
It does not contain all the available
information.
It does not take the place of talking
to your doctor or pharmacist.
All medicines have benefits and
risks. Your doctor has weighed the
risks of you using Viramune XR
against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
USING THIS MEDICINE, ASK 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 your pharmacist, doctor, or
from www.medicines.org.au and
may contain important information
about the medicine and its use of
which you should be aware.
KEEP THIS LEAFLET WITH YOUR
MEDICINE.
You may need to read it again.
WHAT VIRAMUNE XR IS
USED FOR
Viramune XR 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).
Viramune XR 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.
Viramune XR does not cure or
prevent HIV-1 infection or AIDS,
but it does hinder the growth of
HIV-1.
Viramune XR is prescribed in
combination with other
antiretroviral medicines which
hinder the growth of HIV-1 in other
ways. When these medicines are
taken with Viramune XR, the
growth of HIV-1 is hindered more
effectively.
VIRAMUNE XR HAS NOT BEEN SHOWN
TO REDUCE THE LIKELIHOOD THAT YOU
WILL DEVELOP THE ILLNESSES
ASSOCIATED WITH ADVANCED HIV-1
INFECTION. IT IS IMPORTANT FOR YOU
TO CONTINUE SEEING YOUR DOCTOR
REGULARLY.
VIRAMUNE XR DOES NOT REDUCE OR
PREVENT TRANSMISSION OF

Summary of Product characteristics

VIRAMUNE PI0097-13
1
VIRAMUNE

TABLETS
VIRAMUNE
 XR EXTENDED-RELEASE TABLETS
VIRAMUNE
 ORAL SUSPENSION
(NEVIRAPINE)
NAME OF THE MEDICINE
VIRAMUNE contains the active ingredient nevirapine. In the solid
state, nevirapine can exist in
either an anhydrous form (the actual active moiety, used for
production of VIRAMUNE tablets), or
a hemihydrate pseudopolymorph (used in VIRAMUNE oral suspension).
Nevirapine has the following structural formula:
N
N
N
O
CH
3
H
N
N
N
N
O
CH
3
H
N
.½H
2
O
_Nevirapine _
_ _
_ _
_ _
_ _
_ Nevirapine hemihydrate _
DESCRIPTION
Nevirapine
is
a
non-nucleoside
reverse
transcriptase
inhibitor
with
activity
against
Human
Immunodeficiency Virus Type 1 (HIV-1).
The chemical name of nevirapine
is 11-cyclopropyl-5,11-dihydro-4-methyl-6H-dipyrido[3,2-b:2',3'-
e][1,4]diazepin-6-one. Nevirapine is a white to off-white crystalline
powder with the molecular
weight
of
266.3
and
the
molecular
formula
C
15
H
14
N
4
O.
The
Chemical
Abstracts
Service
Registration number is 129618-40-2.
The
chemical
name
of
nevirapine
hemihydrate
is
11-cyclopropyl-5,11-dihydro-4-methyl-6H-
dipyrido[3,2-b:2',3'-e][1,4]diazepin-6-one hemihydrate. Nevirapine
hemihydrate is a white to off-
white
crystalline
powder
with
a
molecular
weight
of
275.3
and
molecular
formula
of
C
15
H
14
N
4
O.½H
2
O.
VIRAMUNE is available as immediate-release VIRAMUNE tablets,
extended-release VIRAMUNE
XR tablets or as a suspension for oral administration.
Each VIRAMUNE immediate-release tablet contains 200 mg of nevirapine
and the inactive
ingredients microcrystalline cellulose, lactose monohydrate, povidone,
sodium starch glycollate,
colloidal anhydrous silica and magnesium stearate.
Each VIRAMUNE XR extended-release tablet contains either 400 mg, 100
mg or 50 mg of
nevirapine and the inactive ingredients lactose monohydrate,
hypromellose, iron oxide yellow
CI77492 and magnesium stearate.
Each 5 mL of the oral suspension contains 50 mg of nevirapine (as
nevirapine hemihydrate) and
the
inactive
ingredients
carbomer
934P,
methyl
hydroxybenzoa