IMITREX-25 (Sumatriptan succinate -25)
Sumatriptan succinate tablets are indicated for the acute treatment of migraine attacks with or without aura in adults. Sumatriptan succinate tablets are not intended for the prophylactic therapy of migraine or for use in the management of hemiplegic or basilar migraine. Safety and effectiveness of sumatriptan succinate tablets have not been established for cluster headache, which is present in an older, predominantly male population.
DOSAGE AND ADMINISTRATION In controlled clinical trials, single doses of 25, 50, or 100 mg of sumatriptan succinate tablets were effective for the acute treatment of migraine in adults. There is evidence that doses of 50 and 100 mg may provide a greater effect than 25 mg. There is also evidence that doses of 100 mg do not provide a greater effect than 50 mg. Individuals may vary in response to doses of sumatriptan succinate tablets. The choice of dose should therefore be made on an individual basis, weighing the possible benefit of a higher dose with the potential for a greater risk of adverse events. If the headache returns or the patient has a partial response to the initial dose, the dose may be repeated after 2 hours, not to exceed a total daily dose of 200 mg. If a headache returns following an initial treatment with sumatriptan succinate injection, additional single sumatriptan succinate tablets (up to 100 mg/day) may be given with an interval of at least 2 hours between tablet doses.
The safety of treating an average of more than 4 headaches in a 30-day period has not been established. Because of the potential of MAO-A inhibitors to cause unpredictable elevations in the bioavailability of oral sumatriptan, their combined use is contraindicated. Hepatic disease/functional impairment may also cause unpredictable elevations in the bioavailability of orally administered sumatriptan. Consequently, if treatment is deemed advisable in the presence of liver disease, the maximum single dose should in general not exceed 50 mg. HOW SUPPLIED Imitrex tablets, 25 and 50 mg of sumatriptan (base) as the succinate. Imitrex tablets, 25 mg are white, round, film-coated tablets embossed with “”I”” on one side and “”25″” on the other. Imitrex tablets, 50 mg are white, capsule-shaped, film-coated tablets embossed with “”Imitrex”” on one side and “”50″” on the other. Store between 2-30°C (36-86°F).