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Treximet

"Sept. 30, 2011 (San Diego) -- A disturbing number of people with heart problems who shouldn't be prescribed standard migraine medications like Amerge, Axert, Frova, Imitrex, Maxalt, Relpax, Treximet, and Zomig are given the drugs anyway, research"...

Treximet

TREXIMET®
(sumatriptan and naproxen sodium) Tablets

WARNINGS

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 succinate - 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-a-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 looks like coffee grounds;
  • nausea, upper...

Read All Potential Side Effects and See Pictures of Treximet »

What are the precautions when taking sumatriptan and naproxen sodium tablets (Treximet)?

Before taking this product, tell your doctor or pharmacist if you are allergic to naproxen or to sumatriptan; or to aspirin or other NSAIDs (such as ibuprofen, celecoxib); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before taking this medication, tell your doctor or pharmacist your medical history, especially of: asthma (including a history of worsening breathing after taking aspirin or other NSAIDs), blood circulation problems (for example, in your legs, arms/hands, or stomach), blood disorders (such as anemia, bleeding/clotting problems), growths in the nose (nasal polyps), certain types of headaches (hemiplegic or basilar migraine), heart...

Read All Potential Precautions of Treximet »

Last reviewed on RxList: 5/30/2014
This monograph has been modified to include the generic and brand name in many instances.

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Treximet - User Reviews

Treximet User Reviews

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Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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