Sandomigran

البلد: أستراليا

اللغة: الإنجليزية

المصدر: Department of Health (Therapeutic Goods Administration)

العنصر النشط:

Pizotifen malate

متاح من:

Novartis Pharmaceuticals Australia Pty Ltd

الفئة:

Medicine Registered

نشرة المعلومات

SANDOMIGRAN
®

_Pizotifen malate_
CONSUMER MEDICINE INFORMATION

WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Sandomigran.
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. Some 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 Sandomigran
against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT THIS
MEDICINE, ASK YOUR DOCTOR OR
PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT SANDOMIGRAN IS
USED FOR
Sandomigran is used to prevent
"vascular" headaches, including
migraine, cluster headaches and
vasomotor headaches.
Vascular headaches are thought to be
caused by temporary changes in the
size of small blood vessels in the
brain. These changes cause the pain
and problems with vision that often
happen during a severe headache.
Sandomigran prevents an attack by
stopping the blood vessels from
changing in size.
Sandomigran is only used to prevent
severe headaches from happening. It
will not stop an attack once it has
started.
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.
Sandomigran is only available with a
doctor's prescription. It is not
addictive.
There is not enough information to
recommend this medicine for
children.
BEFORE YOU TAKE
SANDOMIGRAN
_WHEN YOU MUST NOT TAKE IT_
DO NOT TAKE SANDOMIGRAN IF YOU
HAVE AN ALLERGY TO PIZOTIFEN (THE
ACTIVE INGREDIENT) OR TO

خصائص المنتج

1
SANDOMIGRAN
®

(PIZOTIFEN MALATE) 

DESCRIPTION 

Pizotifen is a cycloheptathiophene derivative structurally related to
cyproheptadine and the 
tricyclic antidepressants.  The malate salt is a white to
yellow-tinged crystalline powder.  MW = 
429.54, pKa 6.95 in water. 

EXCIPIENTS: silica colloidal anhydrous, lactose, magnesium stearate,
starch-maize, talc-
purified, povidone, acacia, sucrose, titanium dioxide, cetyl
palmitate. 

PHARMACOLOGY 

PHARMACODYNAMICS 
Sandomigran (pizotifen) is a competitive serotonin antagonist.  It
also possesses antihistamine, 
antibradykinin and weak anticholinergic properties.  It is suitable
for the prophylactic treatment 
of migraine, reducing the frequency of attacks, but is without effect
in the migraine attack. 

The migraine attack is thought to consist of a prodromal phase of
constriction followed by 
dilatation of the extracranial vessels.  The mode of action of
pizotifen in preventing migraine is 
not fully understood but it is known to inhibit the reuptake of
serotonin by blood platelets, 
preventing loss of tone of extracranial vessels.  It also possesses
appetite-stimulating and 
antidepressant properties. 

PHARMACOKINETICS 
The absorption of pizotifen is rapid (absorption half-life 0.5 - 0.8
hours) and nearly complete 
(estimated 80%).  Peak plasma levels are achieved  4 - 6 hours
following a single oral dose.  
Metabolism is extensive and the drug is widely distributed.
 Volume of distribution is at least  7 
litres/kg.  Protein binding amounts to 91%.  The main metabolite
(N-glucuronide) is eliminated 
N
S
CH
3
Pizotifen
COOH
COOH
CH
CH
2
OH
.
MALATE

2
with a half-life of about 23 hours.  Less than 1% of the drug is
excreted in the urine unchanged 
although as much as 55% of a dose has been detected in the urine as
metabolites.  In patients 
with kidney insufficiency dosage adjustment may therefore be
necessary. 

INDICATIONS 

  Prophylactic (in