Arrow - Sumatriptan

Ülke: Yeni Zelanda

Dil: İngilizce

Kaynak: Medsafe (Medicines Safety Authority)

Aktif bileşen:

Sumatriptan succinate 100mg (140 mg as the succinate)

Mevcut itibaren:

Teva Pharma (New Zealand) Limited

INN (International Adı):

Sumatriptan succinate 100 mg (140 mg as the succinate)

Doz:

100 mg

Farmasötik formu:

Tablet

Kompozisyon:

Active: Sumatriptan succinate 100mg (140 mg as the succinate) Excipient: Croscarmellose sodium   Iron oxide red Lactose Magnesium stearate   Microcrystalline cellulose   Purified water

Paketteki üniteler:

Aluminium foil, polyamide/PVC/Aluminium foil cold form, 2 tablets

Sınıf:

Prescription

Reçete türü:

Prescription

Tarafından üretildi:

Natco Pharma Limited

Terapötik endikasyonlar:

Sumatriptan is indicated for acute relief of migraine attacks with or without aura.

Ürün özeti:

Package - Contents - Shelf Life: Aluminium foil, polyamide/PVC/Aluminium foil cold form - 2 tablets - 48 months from date of manufacture stored at or below 25°C - Bottle, plastic, White HDPE bottles 125mL with 35mm white PP induction cap - 100 tablets - 48 months from date of manufacture stored at or below 25°C - Bottle, plastic, White HDPE bottles 115ml with white pp screw cap 38mm with LDPE liner with AL induction foil - 100 tablets - 48 months from date of manufacture stored at or below 25°C

Yetkilendirme tarihi:

2006-01-09

Bilgilendirme broşürü

CONSUMER MEDICINE INFORMATION
ARROW - SUMATRIPTAN
SUMATRIPTAN (AS SUCCINATE) 50 MG AND 100 MG TABLETS
WHAT IS IN THIS LEAFLET
This leaflet answers some common questions about ARROW - SUMATRIPTAN.
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 benefits and risks. Your doctor has weighed the
risks of you taking
ARROW - SUMATRIPTAN against the benefits they expect it will have for
you.
IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, TALK TO YOUR
DOCTOR OR PHARMACIST.
Keep this leaflet with your medicine. You may need to read it again.
WHAT ARROW - SUMATRIPTAN IS USED FOR
ARROW - SUMATRIPTAN contains the active ingredient sumatriptan
succinate. This
medicine belongs to a group of medicines called serotonin agonists.
ARROW - SUMATRIPTAN is used to relieve migraine headache, with or
without what is
known as 'aura' (eg seeing dots or flickering lights, weakness or
numbness of limbs). It also
relieves other symptoms of a migraine attack like nausea, vomiting or
sensitivity to light and
sound.
ARROW - SUMATRIPTAN SHOULD NOT BE USED TO PREVENT MIGRAINE ATTACKS
FROM
OCCURRING. THERE IS NO INFORMATION ON THE USE OF ARROW - SUMATRIPTAN
IN SPECIAL
KINDS OF MIGRAINE KNOWN AS 'BASILAR MIGRAINE' OR 'HEMIPLEGIC
MIGRAINE'.
It is thought that migraine headache is due to widening of certain
blood vessels in the head.
ARROW - SUMATRIPTAN works by making those vessels normal again and
ease the
symptoms of migraine.
ARROW - SUMATRIPTAN does not work in other types of headache that are
not a migraine.
ARROW - SUMATRIPTAN is not recommended for use in children and
adolescents under 18
years of age.
Your doctor may have prescribed ARROW - SUMATRIPTAN for another
reason. Ask your
doctor if you have any questions about why ARROW - SUMATRIPTAN has
been prescribed
for you.
There is no evidence that ARROW - SUMATRIPTAN is addictive.
ARROW - SUMATRIPTAN is available only with a doctor's prescription.
BEFORE YOU TAKE ARROW - SUMATRIPTAN
_WHEN YOU NO

Ürün özellikleri

NEW ZEALAND DATA SHEET
ARROW - SUMATRIPTAN
Sumatriptan Tablets 50mg and 100mg
PRESENTATION
Arrow - Sumatriptan 50 mg Tablets: White to off white, triangular
shaped, biconvex
tablet, embossed with 'SA' over '50' on one side and '
' on the other side.
Arrow - Sumatriptan 100 mg Tablets: Pink, triangular shaped, biconvex
tablet,
embossed with "SA' over '100'; on one side and '
' on the other side.
USES
_ACTIONS _
PHARMACODYNAMICS
Sumatriptan has been demonstrated to be a specific vascular
5-hydroxytryptamine-1
(5HT
1
D
) receptor agonist with no effect at other 5HT receptor (5HT
2
to 5HT
7
)
subtypes. The vascular 5HT
1
D
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. Dilatation
and/or oedema
formation in these vessels is thought to be the underlying mechanism
of migraine in
humans. 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.
Clinical response begins in 30 minutes following a 100 mg oral dose of
sumatriptan.
Although the recommended dose of sumatriptan is 50 mg, migraine
attacks vary in
severity both within and between patients. Doses of 25 to 100 mg have
shown
greater efficacy than placebo in clinical trials, but 25 mg is
statistically significantly
less effective than 50 and 100 mg.
PHARMACOKINETICS
After oral administration, sumatriptan is rapidly absorbed with 70% of
maximum
concentration occurring at 45 minutes. After a 100 mg dose, mean
maximum plasma
concentration is 54 ng/mL.
Mean absolute oral bioavailability is 14%, partly due to pre-systemic
metabolism and
partly due to incomplete absorption.
Plasma protein binding is low (14 to 21%); the mean volume of
distribution is 170 L.
The major metabolit