Suvalan

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

Sumatriptan succinate

Patient Information leaflet

SUVALAN(R)
1
SUVALAN(R)
_contains the active ingredient sumatriptan succinate_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
Please read this leaflet carefully
before you start taking SUVALAN
tablets.
This leaflet answers some common
questions about SUVALAN tablets.
It does not contain all of the
available information.
It does not take the place of talking
to your doctor or pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the expected benefits of you taking
SUVALAN tablets 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 SUVALAN IS
USED FOR
SUVALAN tablets contain the active
ingredient sumatriptan succinate.
This medicine belongs to a group of
drugs called serotonin agonists.
SUVALAN tablets are used to
relieve a migraine attack.  They
should not be used to prevent
migraine attacks from occurring.
SUVALAN tablets may be used for
migraine headaches with or without
what is known as 'aura'.
It is thought that migraine headache
is due to widening of certain blood
vessels in the head.  SUVALAN
tablets work by making those vessels
normal again and ease the symptoms
of migraine.
Your SUVALAN tablets do not work
in other types of headache which are
not a migraine.
SUVALAN tablets are not addictive.
BEFORE YOU TAKE
SUVALAN
_WHEN YOU MUST NOT TAKE IT_
DO NOT TAKE SUVALAN IF YOU HAVE
EVER HAD AN ALLERGIC REACTION TO
SUMATRIPTAN SUCCINATE OR ANY OF
THE INGREDIENTS LISTED AT THE END OF
THIS LEAFLET.
DO NOT TAKE SUVALAN IF YOU HAVE
OR HAVE HAD:
*
heart disease or heart attack
*
shortness of breath, pain or
tightness in the chest, jaw or
upper arm
*
peripheral vascular disease (pain
in the back of the legs) or are
prone to cold, tingling or numb
hands and feet
*
Prinzmetal's angina (an
uncommon form of angina where
pain

Summary of Product characteristics

 
Suvalan
®

PRODUCT INFORMATION 

NAME OF THE MEDICINE 

Sumatriptan succinate is the therapeutically active ingredient
in Suvalan tablets. 

sumatriptan 
succinate

DESCRIPTION 

The chemical name of sumatriptan is
3-[2-(dimethylamino)ethyl]-N-methyl-1H-indole-5-
methane sulphonamide.  The molecular formula of sumatriptan is C
14
H
21
N
3
O
2
S, the 
relative molecular mass is 295.4.  It takes the form of a white
to pale yellow powder. 
Chemically, sumatriptan succinate is: 3-[2-(dimethylamino)
ethyl]-N-methyl-1H-indole-5-
methane sulphonamide, butane-1,4-dioate (1:1).  The molecular
formula of sumatriptan 
succinate is C
14
H
21
N
3
O
2
SC
4
H
6
O
4
, the relative molecular mass is 413.5.  It takes the form of 
a white to off-white powder.  CAS Registry number is 103628-46-2. 

PHARMACOLOGY 

Sumatriptan has been demonstrated to be a specific vascular
5-hydroxytryptamine-1 
(5HT
1
) receptor agonist with no effect at other 5HT receptor (5HT
2
-5HT
7
) subtypes.  The 
vascular 5HT
1
 receptor is found predominantly in cranial blood vessels and
mediates 
vasoconstriction.  In animals, sumatriptan selectively constricts
the carotid arterial 
circulation, but does not alter cerebral blood flow.  The carotid
arterial circulation 
supplies blood to the extracranial and intracranial tissues such as
the meninges, and 
dilatation and/or oedema formation in these vessels is thought to
be the underlying 
mechanism of migraine in man.  In addition, experimental evidence
suggests that 
sumatriptan inhibits trigeminal nerve activity.  Both these actions
may contribute to the 
anti-migraine action of sumatriptan in humans. 

PHARMACOKINETICS 

After oral administration, sumatriptan is rapidly absorbed, 70% of
maximum concentration 
occurring at 45 minutes.  After a 100 mg dose the mean maximum
plasma concentration is 
54 ng/mL.  Mean absolute oral bioavailability is 14% partly due to
presystemic metabolism 
and partly due