SUMATRIPTAN-LAPL sumatriptan 100 mg (as succinate) tablet blister pack

Quốc gia: Úc

Ngôn ngữ: Tiếng Anh

Nguồn: Department of Health (Therapeutic Goods Administration)

Thành phần hoạt chất:

sumatriptan succinate, Quantity: 140 mg

Sẵn có từ:

Lupin Australia Pty Limited

INN (Tên quốc tế):

sumatriptan succinate

Dạng dược phẩm:

Tablet

Thành phần:

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

Tuyến hành chính:

Oral

Các đơn vị trong gói:

2 tablets

Loại thuốc theo toa:

(S4) Prescription Only Medicine

Chỉ dẫn điều trị:

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.

Tóm tắt sản phẩm:

Visual Identification: White coloured, capsule shaped, biconvex film-coated tablets debossed with"100" one side and plain on the other side which contain Sumatriptan (as succinate) 100 mg.; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 2 Years; Container Temperature: Store below 30 degrees Celsius

Tình trạng ủy quyền:

Registered

Ngày ủy quyền:

2010-06-18

Tờ rơi thông tin

AUSTRALIAN PRODUCT INFORMATION – SUMATRIPTAN-LAPL
(SUMATRIPTAN SUCCINATE) TABLET
1
NAME OF THE MEDICINE
Sumatriptan succinate.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 50 mg or 100 mg sumatriptan (as succinate).
List of excipients with known effects: lactose.
For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
Sumatriptan-LAPL tablets are available in two strengths, 50 mg and 100
mg.
•
Sumatriptan-LAPL 50 mg tablets are pink coloured, capsule shaped,
biconvex film-coated tablets,
debossed with “50” on one side and plain on the other side which
contain sumatriptan (as
succinate) 50 mg.
•
Sumatriptan-LAPL
100
mg
tablets
are
white
coloured,
capsule
shaped,
biconvex
film-coated tablets debossed with “100” on one side and plain on
the other side which contain
sumatriptan (as succinate) 100 mg.
4
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Sumatriptan-LAPL tablets are indicated for the acute relief of
migraine attacks with or without aura.
There is no information available on the use of Sumatriptan-LAPL
tablets in the treatment of basilar or
hemiplegic migraine.
4.2 DOSE AND METHOD OF ADMINISTRATION
Sumatriptan is indicated for the acute intermittent relief of both
migraine and cluster headache. It
should not be used prophylactically.
Ergotamine or ergotamine derivatives and sumatriptan should not be
administered concurrently (see
SECTION 4.3 CONTRAINDICATIONS).
MIGRAINE
It is recommended to start the treatment at the first sign of a
migraine headache or associated
symptoms such as nausea, vomiting or photophobia. The efficacy of
sumatriptan is independent of the
Sumatriptan-LAPL v3.0
Page 2 of 13
(sumatriptan succinate) tablet
duration of the attack when starting treatment. Administration during
a migraine aura prior to other
symptoms occurring may not prevent the development of a headache.
If a patient does not respond to the first dose of sumatriptan, a
second dose should not be taken for the
same attack. Sumatriptan may be used for sub

Đặc tính sản phẩm

Sumatriptan-LAPL tablets
________________________________________________________________________________
_______________________________________________________________________________
Page 1 of 12
PRODUCT INFORMATION
SUMATRIPTAN-LAPL TABLETS (LUPIN AUSTRALIA PTY. LTD)
NAME OF THE MEDICINE:
Sumatriptan succinate
Sumatriptan is the therapeutically active ingredient in
Sumatriptan-LAPL 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 103628-48-4.
Sumatriptan-LAPL
tablets contain sumatriptan succinate, the inactive ingredients
lactose, croscarmellose sodium,
microcrystalline cellulose, crospovidone, silica - colloidal anhydrous
,
magnesium stearate, and the relative colourants
Opadry 03B84755 White and Opadry 03B28796 Pink contain hypromellose,
titanium dioxide, polyethylene glycol, iron
oxide red, iron oxide black, depending on the colour..
Sumatriptan-LAPL tablets
________________________________________________________________________________
_______________________________________________________________________________
Page 2 of 12
PHARMACOLOGY:
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 bl