Neoral

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

Cyclosporin

Available from:

Novartis Pharmaceuticals Australia Pty Ltd

Class:

Medicine Registered

Patient Information leaflet

NEORAL
®

_cyclosporin_
CONSUMER MEDICINE INFORMATION

WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Neoral.
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
final page. More recent information
on the medicine may be available.
YOU SHOULD ENSURE THAT YOU SPEAK
TO YOUR PHARMACIST OR DOCTOR TO
OBTAIN THE MOST UP TO DATE
INFORMATION ON THE MEDICINE. YOU
CAN ALSO DOWNLOAD THE MOST UP TO
DATE LEAFLET FROM
WWW.NOVARTIS.COM.AU.
Those updates may contain important
information about the medicine and
its use of which you should be aware.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking Neoral against
the benefits they expect it will 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 NEORAL IS USED
FOR
Neoral is used for people who have
had a kidney, heart or liver
transplant, to prevent the body from
rejecting the new organ. It does this
by blocking the development of
special cells which would normally
attack the transplanted tissue.
Neoral is also used to treat several
other conditions which are thought to
be caused by a problem with the
immune system:
•
a kidney disease called nephrotic
syndrome
•
severe cases of rheumatoid
arthritis (a disease, affecting the
joints with pain and swelling)
•
severe cases of:
-
psoriasis (a skin disease with
thickened patches of red skin,
often with silvery scales)
-
atopic dermatitis (skin allergies)
Neoral contains the active ingredient,
cyclosporin. It belongs to a group of
medicines called immuno-
suppressive agents. These medicines
help to control your body's immune
system.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed it
for another reason.
Neoral is only ava

Summary of Product characteristics

PAGE 1 OF 26 

NEORAL
Ò

(CYCLOSPORIN) 
Immunosuppressive agent 
DESCRIPTION 
Cyclosporin (BAN, AAN), ciclosporin (prop. INN),
cyclosporine (USAN), also known as 
Cyclosporin A.
 A cyclic polypeptide consisting of 11 amino acids.  It is produced
as a 
metabolite
by the fungus species _Beauveria nivea_ (formerly _Tolypocladium inflatum Gams_). 
Chemical Name: 
Cyclo[[(2_S_,3_R_,4_R_,6_E_)-3-hydroxy-4-methyl-2-(methylamino)oct-6- 

enoyl]-_L_-2-aminobutanoyl-_N_-methylglycyl-_N_-methyl-_L_-leucyl-_L_-valyl- 

_N_-methyl-l-leucyl-_L_-alanyl-_D_-alanyl-_N_-methyl-_L_-leucyl-_N_-methyl-_L_- 

leucyl-_N_-methyl-_L_-valyl] 
Chemical formula:        C
62
H
111
N
11
O
12

Chemical structure: 
N
CH
CO N
CH
C
N
CH
CO
N
CH
C
N
CH
2
CH
CH
N
CO
CH
OC
N
CO
CO
CH
N
O
H
N
C
CH
N
O
H
O
H
CO
CH
CO
N
CH
2
CH
CH
3
CH
3
CH
3
CH
CH
3
CH
3
CH
3
CH
CH
CH
3
HO
CH
2
C
H
C
H
CH
3
CH
2
CH
3
CH
3
CH
2
CH
CH
3
CH
3
CH
CH
3
CH
3
CH
3
CH
2
CH
CH
3
CH
3
CH
3
H
CH
3
CH
2
CH
CH
3
CH
3
CH
3
CH
3
CH
3
L
L
L
L
L
L
L
L
L
D
(R)
(R)

Molecular Weight:      1202.635 
CAS Number:  
59865-13-3 
Cyclosporin  is poorly soluble in water (0.004% w/w) and
n-hexane, but is very soluble in 
other organic solvents and in lipids. 
Neoral is a microemulsion pre-concentrate formulation
of cyclosporin. When mixed with 
water (either in the form of gastric fluid or a beverage),
Neoral immediately forms a 
microemulsion which facilitates the gastrointestinal
absorption of cyclosporin. 

Pharmacokinetic studies have demonstrated
that Neoral provides more consistent cyclosporin 
absorption than the conventional oral forms of Sandimmun
®
  (see  PHARMACOLOGY  - 
Pharmacokinetics).  Also, in a small number of patients,
conversion from Sandimmun to 
PAGE 2 OF 26 

Neoral will result in a marked increase in cyclosporin
exposure. It is therefore important 
when conve