SUMATRIPTAN-WT sumatriptan 50 mg (as succinate) tablet blister pack

Страна: Австралия

Език: английски

Източник: Department of Health (Therapeutic Goods Administration)

Активна съставка:

sumatriptan succinate, Quantity: 70 mg

Предлага се от:

Medis Pharma Pty Ltd

INN (Международно Name):

sumatriptan succinate

Лекарствена форма:

Tablet

Композиция:

Excipient Ingredients: lactose; croscarmellose sodium; colloidal anhydrous silica; microcrystalline cellulose; crospovidone; magnesium stearate; titanium dioxide; hypromellose; iron oxide red; iron oxide black; macrogol 400

Начин на приложение:

Oral

Броя в опаковка:

2 tablets, 4 tablets

Вид предписание :

(S4) Prescription Only Medicine

Терапевтични показания:

Sumatriptan tablets are indicated for the acute relief of migraine attacks with or without aura. There is no information available on the use of sumatriptan tablets in the treatment of basilar or hemiplegic migraine.

Каталог на резюме:

Visual Identification: Pink coloured, capsule shaped, biconvex film-coated tablets debossed with"50" one side and plain on the other side which contain Sumatriptan (as succinate) 50 mg.; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 2 Years; Container Temperature: Store below 30 degrees Celsius

Статус Оторизация:

Registered

Дата Оторизация:

2010-06-18

Листовка

SUMATRIPTAN-GA
Sumatriptan succinate
_CONSUMER MEDICINE INFORMATION _
110113 Sumatriptan-GA CMI v1
Page 1 of 4
WHAT IS IN THIS LEAFLET
Please read this leaflet carefully
before
you
start
taking
Sumatriptan-GA tablets.
This
leaflet
answers
some
common
questions
about
Sumatriptan-GA 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
Sumatriptan-GA
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 SUMATRIPTAN-GA IS
USED FOR
Sumatriptan-GA tablets contain
the
active
ingredient
sumatriptan
succinate.
This
medicine belongs to a group of
drugs called serotonin agonists.
Sumatriptan-GA
tablets
are
used
to
relieve
a
migraine
attack. They should not be used
to prevent migraine attacks from
occurring.
Sumatriptan-GA
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.
Sumatriptan-GA
tablets
work by making those vessels
normal
again
and
ease
the
symptoms of migraine.
Your Sumatriptan-GA tablets do
not
work
in
other
types
of
headache
which
are
not
a
migraine.
Sumatriptan-GA tablets are not
addictive.
BEFORE YOU TAKE
SUMATRIPTAN-GA
_WHEN YOU MUST NOT TAKE IT _
_ _
DO NOT TAKE SUMATRIPTAN-GA
TABLETS IF:
• YOU
HAVE
EVER
HAD
AN
ALLERGIC
REACTION
TO
SUMATRIPTAN SUCCINATE (SEE
"SIDE-EFFECTS") OR ANY OF THE
INGREDIENTS
LISTED
TOWARD
THE END OF THIS LEAFLET. (SEE
"INGREDIENTS").
• 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
w

Данни за продукта

SUMATRIPTAN-WT _PRODUCT INFORMATION _
Sumatriptan-WT PI v1.doc
Page 1 of 11
NAME OF THE MEDICINE
PROPRIETARY NAME:
SUMATRIPTAN-WT TABLETS
NON-PROPRIETARY NAME:
Sumatriptan succinate
CHEMICAL NAME:
3-[2-(dimethylamino) ethyl]-N-methyl-1H-indole-5-methane
sulphonamide, butane-1,4-dioate (1:1).
MOLECULAR FORMULA:
C
14
H
21
N
3
O
2
SC
4
H
6
O
4
MOLECULAR WEIGHT:
413.5
CAS NUMBER:
103628-48-4
STRUCTURE:
Sumatriptan succinate
DESCRIPTION
Sumatriptan succinate takes the form of a white to off-white powder.
Sumatriptan-WT tablets contain the active sumatriptan succinate. The
inactive ingredients are
lactose, croscarmellose sodium, cellulose-microcrystalline,
crospovidone, colloidal silicon dioxide,
magnesium stearate, and Opadry White or Pink (depending on the colour
contain - hypromellose,
titanium dioxide, macrogol 400 , Iron oxide red CI77491, Iron oxide
black CI77499).
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:
Population pharmacokinetic modelling indicated that clearance and
volume of distribution both
increase
with
body
size
in
the
adolescent
population
resulting
in higher
exposure
in
lower
bodyweight adolescents. The model predicted that a subject with a body
weight of 40 kg would
have
an
apparent
clearance
of
222
L/h
and
a