Ülke: Singapur
Dil: İngilizce
Kaynak: HSA (Health Sciences Authority)
Selexipag
JOHNSON & JOHNSON INTERNATIONAL (SINGAPORE) PTE LTD
B01AC27
TABLET, FILM COATED
Selexipag 1.2 mg
ORAL
Prescription Only
ALLPACK GROUP AG (Primary and Secondary Packager)
ACTIVE
2017-07-06
1/23 PRODUCT INFORMATION UPTRAVI ® (SELEXIPAG) 200, 400, 600, 800, 1000, 1200, 1400 AND 1600 MICROGRAMS FILM COATED TABLETS NAME OF THE MEDICINE Active: selexipag UPTRAVI ® (selexipag) is a selective non-prostanoid prostacyclin IP receptor agonist. The chemical name of selexipag is 2-{4-[(5,6-diphenylpyrazin-2- yl)(isopropyl)amino]butoxy}- _N_ -(methylsulfonyl) acetamide. _ _ _Structural formula: _ _ _ The molecular formula: C 26 H 32 N 4 O 4 S The molecular weight: 496.62 mg/mol CAS: 475086-01-2 Pharmacotherapeutic group: Platelet aggregation inhibitors excl. heparin ATC code: B01AC27. DESCRIPTION Selexipag is a pale yellow crystalline powder that is practically insoluble in water. In the solid state selexipag is very stable, is not hygroscopic, and is not light sensitive. Each round film-coated tablet contains 200 micrograms or multiples thereof (respectively 400, 600, 800, 1000, 1200, 1400, or 1600 micrograms) selexipag. The tablets include the following inactive ingredients: mannitol, maize starch, hyprolose, and magnesium stearate. The tablets are film coated with a coating material containing hypromellose, propylene glycol, titanium dioxide, and carnauba wax. In addition, tablets may contain iron oxide red, iron oxide yellow, or iron oxide black. The film- coated tablets are not light sensitive. PHARMACOLOGY MECHANISM OF ACTION The vasculo-protective effects of prostacyclin (PGI 2 ) are mediated by the prostacyclin receptor (IP receptor). Decreased expression of IP receptors and decreased synthesis of prostacyclin contribute to the pathophysiology of pulmonary arterial hypertension (PAH). 2/23 Selexipag is an oral, selective, IP prostacyclin receptor agonist, and is structurally and pharmacologically distinct from prostacyclin and its analogues. Selexipag is hydrolysed by carboxylesterase to yield its active metabolite, which is approximately 37-fold more potent than selexipag. Selexipag and the active metabolite are high affinity IP receptor agonists with a high selectivity for the IP receptor versus oth Belgenin tamamını okuyun