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Treximet(TM) (Sumatriptan and Naproxen Sodium) Tablets Approved by FDA for Acute Treatment of Migraine
Date:4/15/2008

f which are undiagnosed. According to the International Headache Society's diagnostic criteria, migraine is characterized by recurrent headaches which, if untreated, typically last four to 72 hours, with symptoms including moderate to severe headache pain, throbbing head pain, head pain located on one side of the head, head pain aggravated by routine activity, nausea, vomiting, and sensitivity to light and sound.

In the past, many clinicians believed that migraine was a vascular condition, induced by blood vessel dilation alone. Today, new insight suggests that migraine is much more complex, involving a chain of events that are both neurovascular and inflammatory. Treximet contains sumatriptan that mediates vasoconstriction, which correlates with the relief of migraine headache. It also contains naproxen, an anti-inflammatory agent. Therefore, sumatriptan and naproxen sodium contribute to the relief of migraine through pharmacologically different mechanisms of action.

Important Safety Information About Treximet

Prescription Treximet is indicated for the acute treatment of migraine attacks, with or without aura, in adults. Treximet should only be used where a clear diagnosis of migraine headache has been established. Treximet may cause an increased risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke, which can be fatal. This risk may increase with duration of use. Patients with cardiovascular disease or risk factors for cardiovascular disease may be at greater risk. Treximet contains a non- steroidal anti-inflammatory drug (NSAID). NSAID-containing products cause an increased risk of serious gastrointestinal adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients are at greater risk for serious gastrointestinal events. Treximet is contraindicated in patients with hist
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SOURCE GlaxoSmithKline
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