Država: Avstralija
Jezik: angleščina
Source: Department of Health (Therapeutic Goods Administration)
sumatriptan succinate, Quantity: 140 mg
Lupin Australia Pty Limited
sumatriptan succinate
Tablet
Excipient Ingredients: croscarmellose sodium; microcrystalline cellulose; lactose; magnesium stearate; colloidal anhydrous silica; crospovidone; titanium dioxide; hypromellose; macrogol 400
Oral
2 tablets
(S4) Prescription Only Medicine
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.
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
Registered
2010-06-18
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 Preberite celoten dokument
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 Preberite celoten dokument