TREXIMET is a capsule containing a combination of sumatriptan and naproxen.

Sumatriptan is a headache medicine. It is believed to work by narrowing the blood vessels around the brain.

Naproxen is in a group of drugs called nonsteroidal anti-inflammatory drugs (NSAIDs). Naproxen works by reducing hormones that cause inflammation and pain in the body.

TREXIMET is used to treat migraine headaches.

TREXIMET will only treat a headache that has already begun. It will not prevent headaches or reduce the number of attacks.

TREXIMET may also be used for other purposes not listed in this medication guide.

 

You should not use TREXIMET if you are allergic to sumatriptan (Imitrex), naproxen (Aleve, Anaprox, Naprosyn), or if you have a history of asthma or allergic reaction caused by aspirin or other NSAIDs such as ibuprofen (Motrin, Advil), diclofenac (Cataflam, Voltaren), etodolac (Lodine), indomethacin (Indocin), ketoprofen (Orudis), and others.

Do not take TREXIMET if you have:

- liver disease;
- untreated or uncontrolled high blood pressure; or
- a history of heart disease, angina (chest pain), blood circulation problems, heart attack, stroke, or heart bypass surgery (also called coronary artery bypass graft, or CABG).

Do not take TREXIMET if you have taken a monoamine oxidase inhibitor (MAOI) such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate) in the past 14 days.

Do not take TREXIMET within 24 hours before or after taking any of the following medicines:

- almotriptan (Axert), eletriptan (Relpax), frovatriptan (Frova), naratriptan (Amerge), rizatriptan (Maxalt, Maxalt-MLT), sumatriptan (Imitrex), or zolmitriptan (Zomig); or
- ergot medicine such as ergotamine (Ergomar, Cafergot, Migergot), dihydroergotamine (D.H.E. 45, Migranal), or methylergonovine (Methergine).

 

If you any of these other conditions, you may need a dose adjustment or special tests to safely use TREXIMET:

- epilepsy or other seizure disorder;
- kidney disease;
- high blood pressure, congestive heart failure; or
- coronary artery disease (or risk factors that include diabetes, menopause, smoking, being overweight, having high blood pressure or high cholesterol, having a family history of coronary artery disease, being older than 40 and a man, or being a woman who has had a hysterectomy).

FDA pregnancy category C. Taking naproxen during the last 3 months of pregnancy may harm the unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication. Sumatriptan and naproxen can pass into breast milk and may harm a nursing baby. You should not breast-feed while you are taking TREXIMET.

 

Take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the medicine at the next regularly scheduled time. Do not take extra medicine to make up the missed dose.

 

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

 

Stop using TREXIMET and call your doctor at once if you have any of these serious side effects:

 

- seizure (convulsions);
- a red, blistering, peeling skin rash; or
- shallow breathing, weak pulse.

 

Less serious side effects may include:

 

- dizziness, drowsiness, weakness;
- nausea, vomiting, constipation, loss of appetite;
- blurred vision;
- flushing (redness, warmth, or tingly feeling); or sleep problems (insomnia).

 

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect.

 

Use TREXIMET exactly as prescribed by your doctor. Follow the directions on your prescription label. Never use more than the recommended dose. Overuse of migraine headache medicine can actually make your headaches worse. Tell your doctor if the medicine seems to stop working as well.

Take one (1) TREXIMET capsule as soon as you notice headache symptoms, or after an attack has already begun. You may take TREXIMET with or without food.

Do not crush, chew, or break the capsule. Swallow the pill whole.

After taking a capsule: If your headache does not completely go away, or goes away and comes back, you may take a second capsule two (2) hours after the first.

You must wait at least 2 hours before taking a second capsule. Do not take more than 2 TREXIMET capsules in 24 hours. If your symptoms have not improved, contact your doctor before taking any more capsules.

Contact your doctor if you have more than five headaches in one month (30 days).

Naproxen can cause you to have unusual results with certain medical tests. Tell any doctor who treats you if you have taken TREXIMET within the past 72 hours.

 

Keep TREXIMET in the original container and keep the container closed. Store it in a dry place at room temperature.

 

Do not give your TREXIMET capsules to anyone else. It has been prescribed only for you. Keep TREXIMET and all medications out of the reach of children.