País: Estados Unidos
Língua: inglês
Origem: NLM (National Library of Medicine)
sumatriptan succinate (UNII: J8BDZ68989) (SUMATRIPTAN - UNII:8R78F6L9VO)
Preferred Pharmaceuticals, Inc
sumatriptan succinate
SUMATRIPTAN 25 mg
PRESCRIPTION DRUG
Abbreviated New Drug Application
SUMATRIPTAN SUCCINATE- SUMATRIPTAN SUCCINATE TABLET PREFERRED PHARMACEUTICALS, INC ---------- SUMATRIPTAN SUCCINATE DESCRIPTION Sumatriptan tablets USP contain sumatriptan (as the succinate), a selective 5-hydroxytryptamine receptor subtype agonist. Sumatriptan succinate USP is chemically designated as 3-[2- (dimethylamino) ethyl]-N-methyl-indole-5-methanesulfonamide succinate (1:1), and it has the following structure: The molecular formula is C H N O S•C H O , representing a molecular weight of 413.5. Sumatriptan succinate USP is a white to off-white powder that is readily soluble in water and in saline. Each sumatriptan tablet USP for oral administration contains 35, 70, or 140 mg of sumatriptan succinate USP equivalent to 25, 50, or 100 mg of sumatriptan, respectively. Each tablet also contains the inactive ingredients croscarmellose sodium, lactose anhydrous, lactose monohydrate, magnesium stearate, mannitol, microcrystalline cellulose, talc, titanium dioxide and triacetin. 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 alpha , alpha , or beta-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 from animal studies show that sumatriptan also activates 5- HT receptors on peripheral terminals of the trigeminal nerve innervating cranial blood vessels. Such an action may also contribute to the antimigrainous effec Leia o documento completo