There were no statistically significant differences between the 50 mg and 100 mg dose groups in any trial. Keep a list of them to show your healthcare provider or pharmacist when you get a new medicine.Sumatriptan tablets can cause dizziness, weakness, or drowsiness. [see USP Controlled Room Temperature].Advise the patient to read the FDA-approved patient labeling (Patient Information).Inform patients that Sumatriptan tablets may cause serious cardiovascular side effects such as myocardial infarction or stroke. NDC 42043-222-09Store at 20° to 25°C (68° and 77°F). In patients who experience symptoms or signs suggestive of non-coronary vasospasm reaction following the use of any 5-HTReports of transient and permanent blindness and significant partial vision loss have been reported with the use of 5‑HTOveruse of acute migraine drugs (e.g., ergotamine, triptans, opioids, or combination of these drugs for 10 or more days per month) may lead to exacerbation of headache (medication overuse headache). NDC 42043-220-09Sumatriptan Tablets USP, 50 mg are pink colored, film coated, triangular biconvex debossed with “S” on one side and “103” on the other side, supplied in Unit dose packs -Carton of 9 Unit-dose tablets (1 x 9s) each with cross perforation and individually labeled. The components of opadry white used in the formulation of 100 mg tablets are hypromellose, titanium dioxide, and polyethylene glycol 400.The brands listed in this patient information leaflet are trademarks of their respective owners and are not trademarks of Orchid Healthcare. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function and of concomitant disease or other drug therapy.A cardiovascular evaluation is recommended for geriatric patients who have other cardiovascular risk factors (e.g., diabetes, hypertension, smoking, obesity, strong family history of CAD) prior to receiving Sumatriptan tablets The maximum single dose in patients with mild to moderate hepatic impairment should not exceed 50 mg. Sumatriptan tablets are contraindicated in patients with severe hepatic impairment [see Clinical Pharmacology (12.3)].Patients in clinical trials (N = 670) received single oral doses of 140 to 300 mg without significant adverse reactions.
The highest no-effect dose was 50 mg/kg/day, or approximately 2 times the MRHD on a mg/mThe developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Sumatriptan tablets and any potential adverse effects on the breastfed infant from Sumatriptan or from the underlying maternal condition.Safety and effectiveness in pediatric patients have not been established. Radiolabeled The pharmacokinetics of Sumatriptan in patients with severe hepatic impairment has not been studied. A second dose of Sumatriptan tablets or other medication was allowed 4 to 24 hours after the initial treatment for recurrent headache.
Such reactions can be life-threatening or fatal. Triptans work by vasoconstricting the meningeal blood vessels.
These reactions have been chosen for inclusion due to either their seriousness, frequency of reporting, or causal connection to Sumatriptan or a combination of these factors.Ergot-containing drugs have been reported to cause prolonged vasospastic reactions. If you have these symptoms, do not drive a car, use machinery, or do anything where you need to be alert.Call your healthcare provider right away if you have any of the following symptoms of serotonin syndrome:The most common side effects of Sumatriptan tablets include:Tell your healthcare provider if you have any side effect that bothers you or that does not go away.These are not all the possible side effects of Sumatriptan tablets. Apprise patients of the importance of this follow-up Inform patients that anaphylactic/anaphylactoid reactions have occurred in patients receiving Sumatriptan tablets. The use of Sumatriptan tablets is contraindicated in patients with CAD and those with Prinzmetal’s variant angina.Cerebral hemorrhage, subarachnoid hemorrhage, and stroke have occurred in patients treated with 5-HTBefore treating headaches in patients not previously diagnosed as migraineurs, and in migraineurs who present with atypical symptoms, exclude other potentially serious neurological conditions. Earlier examinations for these toxicities were not conducted and no‑effect doses were not established.
Sumatriptan tablets may cause coronary artery vasospasm (Prinzmetal’s angina), even in patients without a history of CAD.Perform a cardiovascular evaluation in triptan-naive patients who have multiple cardiovascular risk factors (e.g., increased age, diabetes, hypertension, smoking, obesity, strong family history of CAD) prior to receiving Sumatriptan tablets.
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