Treximet is a tablet containing a combination of sumatriptan and naproxen. Naproxen is a nonsteroidal anti-inflammatory drug (NSAID). Sumatriptan is a migraine headache medicine.

Treximet is used to treat migraine headaches. This medicine will only treat a headache that has already begun. It will not prevent headaches or reduce the number of attacks.

Treximet should not be used to treat cluster headaches or any headache that causes loss of movement on one side of your body.

You should not use Treximet if you have heart problems, uncontrolled high blood pressure, blood circulation problems, Wolff-Parkinson-White Syndrome, a history of heart attack or stroke, severe liver disease, a history of severe allergic reaction to aspirin or an NSAID, or if you are in late pregnancy.

Naproxen can increase your risk of fatal heart attack or stroke. Do not use Treximet just before or after heart bypass surgery (coronary artery bypass graft, or CABG). Naproxen may also cause stomach or intestinal bleeding, which can be fatal.

Get emergency medical help if you have signs of a heart attack or stroke: chest pain spreading to your jaw or shoulder, sudden numbness or weakness on one side of the body, slurred speech, feeling short of breath.

Do not take Treximet within 24 hours before or after using another migraine headache medicine.

Take Treximet exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides. Use the lowest dose that is effective in treating your condition. Overuse of migraine headache medicine can actually make your headaches worse.

Take 1 tablet as soon as you notice headache symptoms, or after an attack has already begun. You may take the medicine with or without food.

Swallow the Treximet tablet whole and do not crush, chew, or break it.

If your headache does not go away, call your doctor before taking a second tablet. If your headache does not completely go away, or goes away and comes back, take a second tablet 2 hours after the first.

If you are 12 to 17 years old: Do not take a second tablet without first asking your doctor.

You must wait at least 2 hours before you take a second tablet. Do not take more than 2 Treximet tablets in 24 hours. If your symptoms have not improved, call your doctor before taking any more tablets.

You should not use Treximet to treat more than 5 headaches in 30 days (or more than 2 headaches in 30 days if you are 12 to 17 years old).

Store at room temperature away from moisture and heat.

Usual Adult Dose of Treximet for Migraine:

Initial dose: 1 tablet (sumatriptan-naproxen 85/500 mg) orally once
Maximum dose: 2 tablets (sumatriptan-naproxen 85/500 mg) in a 24-hour period taken at least 2 hours apart

Comments:
-Use only if a clear diagnosis of migraine has been established; if migraine does not respond to treatment, reconsider the diagnosis of migraine before treating any subsequent attacks.
-The safety of treating more than 5 migraines headaches (on average) in a 30-day period has not been established.

Use: For the acute treatment of migraine with or without aura.

Usual Pediatric Dose of Treximet for Migraine:

Age: 12 years or older
Initial dose: 1 tablet (sumatriptan-naproxen 10/60 mg) orally once
Maximum dose: 1 tablet (sumatriptan-naproxen 85/500 mg) in a 24-hour period

Comments:
-Use only if a clear diagnosis of migraine has been established; if migraine does not respond to treatment, reconsider the diagnosis of migraine before treating any subsequent attacks.
-The safety of treating more than 2 migraines headaches (on average) in a 30-day period has not been established.

Use: For the acute treatment of migraine with or without aura in patients 12 years of age or older.

You should not use Treximet if you are allergic to naproxen (Aleve, Anaprox, Naprosyn) or sumatriptan (Imitrex), or if you have:

• heart problems, uncontrolled high blood pressure;

• a history of heart attack or stroke (including TIA or "mini-stroke");

• Wolff-Parkinson-White Syndrome (sudden fast heartbeats) or other heart rhythm disorder;

• blood circulation problems (including poor blood flow to your arms and legs, stomach, intestines, or kidneys);

• a history of asthma or severe allergic reaction after taking aspirin or an NSAID; or

• severe liver disease.

Naproxen can increase your risk of fatal heart attack or stroke, even if you don't have any risk factors. Do not use Treximet just before or after heart bypass surgery (coronary artery bypass graft, or CABG).

Naproxen may also cause stomach or intestinal bleeding, which can be fatal. These conditions can occur without warning while you are using Treximet, especially in older adults.

Do not use Treximet if you have used an MAO inhibitor in the past 14 days. A dangerous drug interaction could occur. MAO inhibitors include isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, selegiline, tranylcypromine, and others.

Do not take Treximet within 24 hours before or after using another migraine headache medicine, including:

• sumatriptan tablets, injection, or nasal spray;

• almotriptan, eletriptan, frovatriptan, naratriptan, rizatriptan, or zolmitriptan; or

• ergot medicine such as ergotamine, dihydroergotamine, or methylergonovine.

To make sure Treximet is safe for you, tell your doctor if you have ever had:

• heart problems or a stroke (in you or a family member);

• high blood pressure, high cholesterol, diabetes, or if you smoke;

• asthma;

• epilepsy or other seizure disorder; or

• liver or kidney disease.

If you are pregnant, you should not take Treximet unless your doctor tells you to. Taking a NSAID during the last 20 weeks of pregnancy can cause serious heart or kidney problems in the unborn baby and possible complications with your pregnancy.

You should not breastfeed while you are taking this medicine.

Treximet is not approved for use by anyone younger than 12 years old.

Since Treximet is taken only when needed, it does not have a daily dosing schedule. Do not take more than 2 tablets in 24 hours.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Avoid drinking alcohol. It may increase your risk of stomach bleeding.

Avoid taking aspirin or other salicylates such as Nuprin Backache Caplet, Kaopectate, KneeRelief, Pamprin Cramp Formula, Pepto-Bismol, Tricosal, Trilisate, and others.

Avoid driving or hazardous activity until you know how this medicine will affect you. Your reactions could be impaired.

Ask a doctor or pharmacist before using other medicines for pain, fever, swelling, or cold/flu symptoms. They may contain ingredients similar to naproxen (such as aspirin, ibuprofen, or ketoprofen).

Get emergency medical help if you have signs of an allergic reaction to Treximet (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).

Stop using Treximet seek medical treatment if you have a serious drug reaction that can affect many parts of your body. Symptoms may include skin rash, fever, swollen glands, muscle aches, severe weakness, unusual bruising, or yellowing of your skin or eyes.

Stop taking this medicine and seek emergency medical help if you have signs of a heart attack or stroke: chest pain spreading to your jaw or shoulder, sudden numbness or weakness on one side of the body, slurred speech, feeling short of breath.

Stop using Treximet and call your doctor at once if you have:

• numbness, tingling, pale or blue-colored appearance in your fingers or toes;

• leg cramps, burning, coldness, or heavy feeling in your feet or legs;

• severe headache, blurred vision, pounding in your neck or ears;

• a seizure;

• heart problems - swelling, rapid weight gain, feeling short of breath;

• high levels of serotonin in the body - agitation, hallucinations, fever, sweating, shivering, fast heart rate, muscle stiffness, twitching, loss of coordination, nausea, vomiting, diarrhea;

• kidney problems - little or no urination, swelling in your feet or ankles, feeling tired or short of breath;

• liver problems - loss of appetite, stomach pain (upper right side), tiredness, itching, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);

• low red blood cells (anemia) - pale skin, unusual tiredness, feeling light-headed or short of breath;

• signs of stomach bleeding - bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds; or

• stomach problems - sudden severe stomach pain (especially after eating), vomiting, constipation, bloody diarrhea, weight loss.

Common Treximet side effects may include:

• dizziness, drowsiness, feeling weak or tired;

• irregular heartbeats;

• numbness or tingling in your fingers or toes;

• dry mouth, heartburn, nausea;

• feeling hot; or

• tight muscles, pain or pressure in your chest or throat.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Ask your doctor before using Treximet if you take an antidepressant. Taking certain antidepressants with an NSAID may cause you to bruise or bleed easily.

Tell your doctor about all your other medicines, especially:

• cyclosporine;

• lithium;

• methotrexate;

• heart or blood pressure medication, including a diuretic or "water pill";

• a blood thinner - warfarin, Coumadin, Jantoven; or

• steroid medicine - prednisone, dexamethasone, and others.

This list is not complete. Other drugs may interact with naproxen and sumatriptan, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.