APO-Riluzole

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

Riluzole

Available from:

Apotex Pty Ltd

Class:

Medicine Registered

Patient Information leaflet

APO-RILUZOLE

_Contains the active ingredient riluzole_
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 riluzole. 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 APO-
Riluzole. It contains the active
ingredient Riluzole.
It is used to treat people with
amyotrophic lateral sclerosis, which
can cause muscle degeneration
leading to muscle weakness. It is a
form of Motor Neurone Disease.
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.
It is important to remember that you
may not feel any different when you
take riluzole. The benefits of using
riluzole may not be noticeable to
you.
You should not stop taking riluzole
without speaking to your doctor first
There is no evidence that this
medicine is addictive.
_USE IN CHILDREN_
This medicine should not be used in
children.
BEFORE YOU TAKE THIS
MEDICINE
_WHEN YOU MUST NOT TAKE IT_

Summary of Product characteristics

Product Information 
– Australia 
APO-Riluzole Tablets 
Page 1 
APO-RILUZOLE TABLETS  

NAME OF THE MEDICINE 
Riluzole  

Chemical Name: 
2-amino-6-trifluoromethoxybenzothiazole. 

Structural Formula: 

Molecular Formula: 
C
8
H
5
F
3
N
2
OS 

Molecular Weight: 
234.2 

CAS Registry Number:  1744-22-5 

DESCRIPTION 
Riluzole  is  a  white  to  slightly  yellow,  fine  crystalline,  non-hygroscopic  powder.  It  is  very  slightly 
soluble  in  water  and  0.1N  sodium  hydroxide,  sparingly  soluble  in  0.1N  hydrochloric  acid;  and 
very soluble in methanol, acetone, acetonitrile, dichloromethane and dimethyl sulfoxide. 

PHARMACOLOGY 
PHARMACODYNAMIC PROPERTIES 
The aetiology and pathogenesis of
amyotrophic lateral sclerosis (ALS) are not known, although a 
number  of  hypotheses  have  been  advanced.  One  hypothesis  is  that  motor  neurones  made 
vulnerable  through  either  genetic  predisposition  or  environmental  factors,  are  injured  by 
glutamate. In some cases of familial ALS, enzyme superoxide dismutase has been found to be 
defective. 
The  mechanism  of  action  of  riluzole  has  not  been  completely  elucidated  but  evidence  to  date 
suggests that it may involve inactivation of voltage dependent sodium channels and impairment 
of glutamatergic neurotransmission.  
There are no validated animal models of ALS in which to test riluzole. Riluzole has been shown 
to  cross  the  blood  brain  barrier  and  to  possess  neuroprotective  properties  in  various  in  vivo 
experimental  models  of  neuronal  injury  known  to  involve  excitotoxic  mechanisms,  such  as 
cerebral  ischemia.  In  vitro,  riluzole  protects  cultured  rat  motorneurones