Țară: Statele Unite ale Americii
Limbă: engleză
Sursă: NLM (National Library of Medicine)
SUMATRIPTAN SUCCINATE (UNII: J8BDZ68989) (SUMATRIPTAN - UNII:8R78F6L9VO)
STAT Rx USA LLC
SUMATRIPTAN SUCCINATE
SUMATRIPTAN 25 mg
ORAL
PRESCRIPTION DRUG
Sumatriptan tablets are indicated for the acute treatment of migraine attacks with or without aura in adults. Sumatriptan tablets are not intended for the prophylactic therapy of migraine or for use in the management of hemiplegic or basilar migraine (see CONTRAINDICATIONS ). Safety and effectiveness of sumatriptan tablets have not been established for cluster headache, which is present in an older, predominantly male population. Sumatriptan tablets should not be given to patients with history, symptoms, or signs of ischemic cardiac, cerebrovascular, or peripheral vascular syndromes. In addition, patients with other significant underlying cardiovascular diseases should not receive sumatriptane tablets. Ischemic cardiac syndromes include, but are not limited to, angina pectoris of any type (e.g., stable angina of effort, vasospastic forms of angina such as the Prinzmetal variant), all forms of myocardial infarction, and silent myocardial ischemia. Cerebrovascular syndromes include, but are not limited to,
Sumatriptan tablets USP, 25, 50 mg of sumatriptan (base) as the succinate. Sumatriptan tablets USP, 25 mg are white, round, biconvex film-coated tablets debossed with “RDY” on one side and “291” on the other side. The tablets are supplied in bottles of 30, 36, 90 100, 500, unit of use blister pack of 9's and unit dose package of 100's. Sumatriptan tablets USP, 50 mg are white, round, biconvex film-coated tablets debossed with “RDY” on one side and “292” on the other side. The tablets are supplied in bottles of 30, 36, 90 100, 500, unit of use blister pack of 9's and unit dose package of 100's. Store at 20 to 25°C (68 – 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). Relabeling and Repackaging by: STAT Rx USA LLC Gainesville, GA 30501
Abbreviated New Drug Application
SUMATRIPTAN SUCCINATE- SUMATRIPTAN SUCCINATE TABLET STAT RX USA LLC ---------- 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 effect of sumatripta Citiți documentul complet