Avandia

Kraj: Australia

Język: angielski

Źródło: Department of Health (Therapeutic Goods Administration)

Składnik aktywny:

Rosiglitazone maleate

Dostępny od:

GlaxoSmithKline Australia Pty Ltd

Klasa:

Medicine Registered

Ulotka dla pacjenta

AVANDIA
®
 TABLETS

_Rosiglitazone_
CONSUMER MEDICINE INFORMATION

WHAT IS IN THIS LEAFLET?
Please read this leaflet carefully
before you take AVANDIA.
This leaflet answers some common
questions about AVANDIA. It does
not contain all of the available
information.
It does not take the place of talking to
your doctor or pharmacist.
Please read this leaflet before you
start taking AVANDIA. If you are
helping someone else take
AVANDIA, please read this leaflet
before you give the first dose.
All medicines have risks and
benefits. Sometimes new risks are
found even when a medicine has
been used for many years. Your
doctor has weighed the expected
benefits of you taking AVANDIA
against the risks this medicine could
have for you.
If you have any concerns about
taking this medicine, ask your doctor
or pharmacist.
Keep this leaflet with the medicine.
You may need to read it again.
WHAT IS AVANDIA
USED FOR?
The name of your medicine is
AVANDIA. It is also known as
rosiglitazone.
AVANDIA belongs to a group of
medicines called glitazones.
AVANDIA is used to treat patients
with type 2 diabetes mellitus. This is
also called non-insulin dependent
diabetes (NIDDM) or maturity onset
diabetes.
Type 2 diabetes mellitus is a
condition in which your body does
not make enough insulin or where the
insulin that your body produces does
not work as well as it should. Insulin
is a natural body chemical that helps
the body's cells use the sugar from
the blood and so stops your blood
sugar levels from rising too high.
High blood sugar levels can cause
damage to the body's cells.
AVANDIA acts by making your
body more sensitive to insulin. It
therefore helps your body make
better use of the insulin it produces
and thus helps to restore your blood
sugar towards a normal level.
Your doctor may have prescribed
AVANDIA for another reason.
AVANDIA can be used alone (when
diet and exercise is not enough to
treat your diabetes) or together with
other anti-diabetic medicines.
There is no evidence that AVANDIA
is addictive.
BEFORE YOU T

Charakterystyka produktu

_ _

1                 
PRODUCT INFORMATION 

AVANDIA
®
 (ROSIGLITAZONE) 

NAME OF THE MEDICINE 

AVANDIA (rosiglitazone maleate) is an oral antidiabetic
agent, chemically designated as ( )-5-[[4-
[2-(methyl-2-pyridinylamino) ethoxy]phenyl]methyl]-2,4-thiazolidinedione, (_Z_)-2-butenedioate (1:1).   
The structural formula is: 
CO
2
H
CO
2
H
N
CH
3
N
O
S
NH
O
O
.

Molecular weight: 473.52 (357.44 free base) 
CAS number : 0155141-29-0 

DESCRIPTION 

Rosiglitazone maleate is a white to off-white solid with
a melting range of 122  to 123 C. It is 
readily soluble in ethanol and a buffered aqueous solution with
pH of 2.3; solubility decreases with 
increasing pH in the physiological range.   

AVANDIA tablets contain sodium starch glycollate, hypromellose, microcrystalline cellulose, 
lactose and magnesium stearate
as excipients.  The film coat contains hypromellose, lactose, 
macrogol 3000, titanium dioxide, glycerol triacetate
and the following colouring agents: 2mg tablet: 
iron oxide red (CI77491); 4mg
tablet: purified talc, iron oxide yellow (CI77492) and iron oxide red 
(CI77491); 8mg tablet: iron oxide red (CI77491). 

PHARMACOLOGY 

AVANDIA is a selective and
potent agonist at the PPAR  (peroxisomal proliferator activated 
gamma) nuclear receptor and is a member of the thiazolidinedione
class of antidiabetic agents. 

AVANDIA improves glycaemic control by improving insulin
sensitivity at key sites of insulin 
resistance namely adipose tissue, skeletal muscle and
liver.  Insulin resistance is known to play a 
major role in the pathophysiology of type 2
diabetes. Thus, AVANDIA improves metabolic control 
by lowering blood glucose, circulating insulin
and free fatty acids. 
The use of A