Pajjiż: Stati Uniti
Lingwa: Ingliż
Sors: NLM (National Library of Medicine)
SUMATRIPTAN SUCCINATE (UNII: J8BDZ68989) (SUMATRIPTAN - UNII:8R78F6L9VO)
Hikma Pharmaceutical
SUMATRIPTAN SUCCINATE
SUMATRIPTAN SUCCINATE 25 mg
PRESCRIPTION DRUG
Abbreviated New Drug Application
SUMATRIPTAN SUCCINATE- SUMATRIPTAN SUCCINATE TABLET, FILM COATED HIKMA PHARMACEUTICAL ---------- SUMATRIPTAN SUCCINATE TABLETS DESCRIPTION Sumatriptan succinate tablets contain sumatriptan (as the succinate), a selective 5-hydroxytryptamine receptor subtype agonist. Sumatriptan succinate is chemically designated as 3-[2-(dimethylamino)ethyl]- N-methyl-indole-5-methanesulfonamide succinate (1:1), and it has the following structure: The empirical formula is C H N O S•C H O , representing a molecular weight of 413.5. Sumatriptan succinate is a white to off-white powder that is readily soluble in water and in saline. Each sumatriptan succinate tablet for oral administration contains 35, 70, or 140 mg of sumatriptan succinate equivalent to 25, 50, or 100 mg of sumatriptan, respectively. Each tablet also contains the inactive ingredients colloidal silicon dioxide, croscarmellose sodium, magnesium stearate , microcrystalline cellulose, Povidone K-30, sodium bicarbonate, talc. Each 100 mg tablet also contains polyvinyl alcohol, titanium dioxide, polyethylene glycol 3350, talc, iron oxide red, and each 50 mg and 25 mg tablet contains: polyvinyl alcohol, titanium dioxide, polyethylene glycol 3350 and talc. CLINICAL PHARMACOLOGY MECHANISM OF ACTION Sumatriptan is an agonist for a vascular 5-hydroxytryptamine receptor subtype (probably a member of the 5-HT family) having only a weak affinity for 5-HT , 5-HT , and 5-HT receptors and no significant affinity (as measured using standard radioligand binding assays) or pharmacological activity at 5-HT , 5-HT , or 5-HT receptor subtypes or at α -, α -, or β-adrenergic; dopamine ; dopamine ; muscarinic; or benzodiazepine receptors. The vascular 5-HT receptor subtype that sumatriptan activates is present on cranial arteries in both dog and primate, on the human basilar artery, and in the vasculature of human dura mater and mediates vasoconstriction. This action in humans correlates with the relief of migraine headache. In addition to causing vasoconstriction, experimental data f Aqra d-dokument sħiħ