IMITREX tablets contain sumatriptan succinate, a selective 5‑HT 1B/1D receptor 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 14 H 21 N 3 O 2 S•C 4 H 6 O 4 , 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 IMITREX tablet for oral administration c...

Read more

IMITREX tablets are indicated for the acute treatment of migraine with or without aura in adults. Limitations of Use: • Use only if a clear diagnosis of migraine headache has been established. If a patient has no response to the first migraine attack treated with IMITREX, reconsider the diagnosis of migraine before IMITREX is administered to treat any subsequent attacks. • IMITREX is not indicated for the prevention of migraine attacks. • Safety and effectiveness of IMITREX tablets have not been est...

Read more

25-mg Tablets: White, triangular-shaped, film-coated, and debossed with “I” on one side and “25” on the other. Each tablet contains 35 mg of sumatriptan succinate equivalent to 25 mg of sumatriptan. 50-mg Tablets: White, triangular-shaped, film-coated, and debossed with “IMITREX 50” on one side and a chevron shape (^) on the other. Each tablet contains 70 mg of sumatriptan succinate equivalent to 50 mg of sumatriptan. 100-mg Tablets: Pink, triangular-shaped, film-coated, and debossed with “IMITREX 1...

Read more

• Single dose of 25-mg, 50-mg, or 100-mg tablet. • A second dose should only be considered if some response to the first dose was observed. Separate doses by at least 2 hours. • Maximum dose in a 24-hour period: 200 mg. • Maximum single dose should not exceed 50 mg in patients with mild to moderate hepatic impairment. 2.1 Dosing Information The recommended dose of IMITREX tablets is 25 mg, 50 mg, or 100 mg. Doses of 50 mg and 100 mg may provide a greater effect than the 25-mg dose, but doses of 100 mg...

Read more

IMITREX Tablets are contraindicated in patients with: • Ischemic coronary artery disease (CAD) (angina pectoris, history of myocardial infarction, or documented silent ischemia) or coronary artery vasospasm, including Prinzmetal’s angina • Wolff-Parkinson-White syndrome or arrhythmias associated with other cardiac accessory conduction pathway disorders • History of stroke or transient ischemic attack (TIA) or history of hemiplegic or basilar migraine because these patients are at a higher risk...

Read more

Patients in clinical trials (N = 670) received single oral doses of 140 to 300 mg without significant adverse reactions. Volunteers (N = 174) received single oral doses of 140 to 400 mg without serious adverse reactions. Overdose in animals has been fatal and has been heralded by convulsions, tremor, paralysis, inactivity, ptosis, erythema of the extremities, abnormal respiration, cyanosis, ataxia, mydriasis, salivation, and lacrimation. The elimination half-life of sumatriptan is approximately 2....

Read more

• Myocardial ischemia/infarction and Prinzmetal’s angina: Perform cardiac evaluation in patients with multiple cardiovascular risk factors. • Arrhythmias: Discontinue IMITREX if occurs. • Chest/throat/neck/jaw pain, tightness, pressure, or heaviness: Generally not associated with myocardial ischemia; evaluate for coronary artery disease in patients at high risk. • Cerebral hemorrhage, subarachnoid hemorrhage, and stroke: Discontinue IMITREX if occurs. • Gastrointestinal ischemic reactions and periph...

Read more

7.1 Ergot-Containing Drugs Ergot-containing drugs have been reported to cause prolonged vasospastic reactions. Because these effects may be additive, use of ergotamine-containing or ergot-type medications (like dihydroergotamine or methysergide) and IMITREX tablets within 24 hours of each other is contraindicated. 7.2 Monoamine Oxidase-A Inhibitors MAO‑A inhibitors increase systemic exposure by 7-fold. Therefore, the use of IMITREX tablets in patients receiving MAO‑A inhibitors is contraindicated ...

Read more

Data from a prospective pregnancy exposure registry and epidemiological studies of pregnant women have not detected an increased frequency of birth defects or a consistent pattern of birth defects among women exposed to sumatriptan compared with the general population . In developmental toxicity studies in rats and rabbits, oral administration of sumatriptan to pregnant animals was associated with embryolethality, fetal abnormalities, and pup mortality. When administered by the intravenous route ...

Read more