Treximet (Sumatriptan and Naproxen Sodium Tablets) Drug Information: Description, User Reviews, Drug Side Effects, Interactions

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February 10, 2012

Treximet

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What is a migraine headache?

A migraine headache is a form of vascular headache. Migraine headache is caused by vasodilatation (enlargement of blood vessels) that causes the release of chemicals from nerve fibers that coil around the large arteries of the brain. Enlargement of these blood vessels stretches the nerves that coil around them and causes the nerves to release chemicals. The chemicals cause inflammation, pain, and further enlargement of the artery. The increasing enlargement of the arteries magnifies the pain.

Migraine attacks commonly activate the sympathetic nervous system in the body. The sympathetic nervous system is often thought of as the part of the nervous system that controls primitive responses to stress and pain, the so-called "fight or flight" response, and this activation causes many of the symptoms associated with migraine attacks; for example, the increased sympathetic n...

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Treximet

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TREXIMET™
(sumatriptan and naproxen sodium) Tablets

WARNING

Cardiovascular Risk: 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 (see WARNINGS: Cardiovascular Effects).

Gastrointestinal Risk: TREXIMET contains a nonsteroidal 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 (see WARNINGS: Risk of Gastrointestinal Ulceration, Bleeding, and Perforation With Nonsteroidal Anti-inflammatory Drug Therapy).

DRUG DESCRIPTION

TREXIMET contains sumatriptan (as the succinate), a selective 5-hydroxytryptamine1 (5-HT₁) receptor subtype agonist, and naproxen sodium, a member of the arylacetic acid group of nonsteroidal anti-inflammatory drugs (NSAIDs).

Sumatriptan succinate is chemically designated as 3-[2-(dimethylamino)ethyl]-N-methylindole-5-methanesulfonamide succinate (1:1), and it has the following structure:

Sumatriptan Structural Formula Illustration

The empirical formula is C₁₄H₂₁N₃O₂S •C₄H₆O₄, 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.

Naproxen sodium is chemically designated as (S)-6-methoxy-α-methyl-2-naphthaleneacetic acid, sodium salt, and it has the following structure:

Naproxen sodium Structural Formula Illustration

The empirical formula is C₁₄H₁₃NaO₃, representing a molecular weight of 252.23. Naproxen sodium is a white-to-creamy white crystalline solid, freely soluble in water at neutral pH.

Each TREXIMET Tablet for oral administration contains 119 mg of sumatriptan succinate equivalent to 85 mg of sumatriptan and 500 mg of naproxen sodium. Each tablet also contains the inactive ingredients croscarmellose sodium, dextrose monohydrate, dibasic calcium phosphate, FD&C Blue No. 2, lecithin, magnesium stearate, maltodextrin, microcrystalline cellulose, povidone, sodium bicarbonate, sodium carboxymethylcellulose, talc, and titanium dioxide.

What are the possible side effects of sumatriptan and naproxen (Treximet)?

Get emergency medical help if you have any of these signs of an allergic reaction: runny or stuffy nose; hives; wheezing or trouble breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you a serious side effect such as:

chest pain or pressure, tight feeling in your neck or jaw, pain spreading to your arm or shoulder;
sudden numbness or weakness, confusion, problems with vision, speech, or balance;
bloody, or tarry stools, coughing up blood or vomit that...

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