IMITREX Nasal Spray is indicated for the acute treatment of migraine attacks with or without aura in adults.

IMITREX Nasal Spray is 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 IMITREX Nasal Spray have not been established for cluster headache, which is present in an older, predominantly male population.

In controlled clinical trials, single doses of 5, 10, or 20 mg of IMITREX Nasal Spray administered into 1 nostril were effective for the acute treatment of migraine in adults. A greater proportion of patients had headache response following a 20-mg dose than following a 5- or 10-mg dose (see CLINICAL TRIALS). Individuals may vary in response to doses of IMITREX Nasal Spray. The choice of dose should therefore be made on an individual basis, weighing the possible benefit of the 20-mg dose with the potential for a greater risk of adverse events. A 10-mg dose may be achieved by the administration of a single 5-mg dose in each nostril. There is evidence that doses above 20 mg do not provide a greater effect than 20 mg.

If the headache returns, the dose may be repeated once after 2 hours, not to exceed a total daily dose of 40 mg. The safety of treating an average of more than 4 headaches in a 30-day period has not been established.

IMITREX Nasal Spray 5 mg (NDC 0173-0524-00) and 20 mg (NDC 0173-0523-00) are each supplied in boxes of 6 nasal spray devices. Each unit dose spray supplies 5 and 20 mg, respectively, of sumatriptan.

Store between 36° and 86°F (2° and 30°C). Protect from light.

GlaxoSmithKline, Research Triangle Park, NC 27709

FDA Rev. Date: 10/13/2004

Brand Name: Imitrex Nasal Spray
Generic Name: Sumatriptan

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