IMIGRAN™ FDT Tablets 50 mg / 100 mg ࣔຒᄫᙍ 50 ශ
IMIGRAN™ FDT Tablets 50 mg / 100 mg ࣔຒᄫᙍ 50 ශ
IMIGRAN™ FDT Tablets 50 mg / 100 mg ࣔຒᄫᙍ 50 ශ
You also want an ePaper? Increase the reach of your titles
YUMPU automatically turns print PDFs into web optimized ePapers that Google loves.
IMIGRAN <strong>FDT</strong> <strong>Tablets</strong><strong>50</strong><strong>mg</strong>/ <strong>100</strong><strong>mg</strong><br />
<strong>50</strong> 024380 <br />
<strong>100</strong> 024365 <br />
<br />
sumatriptan <strong>50</strong> <strong>100</strong> succinate <br />
<br />
<br />
<strong>50</strong> <strong>mg</strong> sumatriptan GS 1YM <strong>50</strong><br />
<strong>100</strong> <strong>mg</strong> sumatriptan GS YE7 <strong>100</strong><br />
<br />
<br />
<br />
<br />
<br />
<br />
<br />
<br />
<br />
• <br />
<strong>50</strong> <strong>100</strong> <br />
<br />
<br />
24 <br />
24 300 <br />
<br />
• 18 <br />
<br />
• 65 <br />
65 <br />
65
(IHD)Prinzmetal /<br />
IHD <br />
(CVA)(TIA)<br />
<br />
<br />
(ergotamine)(methylsergide)<br />
()<br />
(MAOI)<br />
<br />
<br />
<br />
<br />
<br />
<br />
()<br />
<br />
sumatriptan <br />
()<br />
<br />
<br />
40 <br />
<br />
<br />
<br />
<br />
(SSRI) <br />
sumatriptan (<br />
) triptans (SNRIs)<br />
<br />
sumatriptan SSRI/SNRI<br />
()<br />
triptan/5-HT1 sumatriptan <br />
<br />
<br />
Sumatriptan <br />
<br />
sulphonamide
(<br />
-MOH)<br />
<br />
propanololflunarizinepizotifen <br />
ergotamine <br />
ergotamine 24 <br />
sumatriptan sumatriptan 6 <br />
ergotamine <br />
(MAOIs)<br />
<br />
SSRIs sumatriptan (<br />
)<br />
triptans SNRIs ()<br />
<br />
<br />
<br />
<br />
1,000 <br />
<br />
<br />
<br />
<br />
12 <br />
<br />
<br />
<br />
<br />
<br />
<br />
( 1/10) ( 1/<strong>100</strong> 1/10) ( 1/<strong>100</strong>0<br />
1/<strong>100</strong>) ( 1/<strong>100</strong>00 1/<strong>100</strong>0) ( 1/<strong>100</strong>00)
sumatriptan <br />
<br />
<br />
<br />
<br />
<br />
<br />
<br />
<br />
<br />
<br />
<br />
<br />
<br />
<br />
<br />
<br />
<br />
<br />
<br />
<br />
()<br />
<br />
<br />
<br />
()
12 400<br />
16 <br />
<br />
<br />
10 <br />
sumatriptan <br />
<br />
<br />
ATC N02CC01<br />
<br />
5-HT1 <br />
Sumatriptan 5-hydroxytrytamine-1-(5-HT 1 D)<br />
5-HT (5-HT 2-7 ) 5-HT 1 D <br />
<br />
sumatriptan <br />
<br />
<br />
sumatriptan sumatriptan <br />
<br />
<br />
6 10-15 20 15 <br />
<strong>100</strong> 25 30 <br />
<strong>50</strong> <strong>100</strong> 30 20 <br />
67%<br />
72% 42%<br />
33 26 <br />
40% 47%<br />
15%()<br />
<strong>50</strong> <br />
25-<strong>100</strong> 25 <strong>50</strong> <strong>100</strong><br />
<br />
<br />
sumatriptan <br />
<br />
<strong>100</strong> 54 ng/ml<br />
14%<br />
sumatriptan Cmax 15%
(14 21%) 170 <br />
<br />
sumatriptan indole acetic acid <br />
(glucuronide conjugate) 5-HT 1 <br />
5-HT 2 <br />
<br />
2 1160 ml/min<br />
260 ml/min<br />
80%Sumatriptan <br />
<br />
<br />
• <br />
sumatriptan <br />
<br />
<br />
<strong>50</strong> <strong>100</strong><br />
sumatriptan (<strong>FDT</strong>)<br />
2,696 <br />
<strong>50</strong> <strong>100</strong> sumatriptan <br />
(<br />
)<br />
<br />
<br />
()<br />
()<br />
( 1)( 2)<br />
sumatriptan (<strong>50</strong> <strong>100</strong> <strong>FDT</strong>)(p
1*<br />
80<br />
16<br />
70<br />
12<br />
72<br />
67<br />
60<br />
8<br />
Percent of Subjects<br />
<strong>50</strong><br />
40<br />
4<br />
0<br />
10 15 20 25<br />
42<br />
30<br />
20<br />
10<br />
Placebo n=892<br />
<strong>50</strong><strong>mg</strong> n=902<br />
<strong>100</strong><strong>mg</strong> n=902<br />
0<br />
0 10 20 30 40 <strong>50</strong> 60 70 80 90 <strong>100</strong> 110 120<br />
Minutes<br />
* Kaplan-Meier <br />
1 10-25 <br />
<strong>50</strong> <strong>100</strong> sumatriptan <strong>FDT</strong> <br />
30 20 <br />
<strong>50</strong> <strong>100</strong> 67% 72%<br />
42% ( 1)<br />
2*<br />
70<br />
60<br />
10<br />
8<br />
6<br />
Placebo n=892<br />
<strong>50</strong> <strong>mg</strong> n=902<br />
<strong>100</strong><strong>mg</strong> n=902<br />
Percent of Subjects<br />
<strong>50</strong><br />
40<br />
30<br />
20<br />
4<br />
2<br />
0<br />
20 25 30 35 40<br />
47<br />
40<br />
15<br />
10<br />
0<br />
0 10 20 30 40 <strong>50</strong> 60 70 80 90 <strong>100</strong> 110 120<br />
Minutes
Kaplan-Meier <br />
2 20-40 <br />
<strong>50</strong> <strong>100</strong> sumatriptan <strong>FDT</strong> <br />
33 26 <br />
<strong>50</strong> <strong>100</strong> 40% 47%<br />
15% ( 2)<br />
Sumatriptan <strong>FDT</strong> <br />
600 12 17 sumatriptan<br />
sumatriptan <br />
2 <br />
(12 17 sumatriptan)<br />
<br />
<br />
<br />
<br />
<br />
sumatriptan <br />
<br />
sumatriptan <br />
<br />
<br />
<br />
Calcium hydrogen phosphate anhydrous<br />
Microcrystalline cellulose<br />
Sodium hydrogen carbonate<br />
Croscarmellose sodium<br />
Magnesium Stearate<br />
Purified Water<br />
Hypromellose<br />
Titanium dioxide<br />
Glycerol Triacetate<br />
Iron oxide red.
30<br />
<br />
2 - <strong>100</strong>0 <br />
: GDS 21 / IPI 06<br />
: 02 April 2007<br />
Glaxo Operations UK Limited<br />
Priory Street, Ware, Hertfordshire, SG12 ODJ, UK
Change language