sumatriptan and naproxen

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Pronunciation: SOO ma TRIP tan and na PROX en

Brand: Treximet

What is the most important information I should know about sumatriptan and naproxen

You should not use this medicine if you have uncontrolled high blood pressure, blood circulation problems, a history of heart disease or heart bypass surgery, a history of heart attack or stroke, a heart rhythm disorder, severe liver disease, a history of severe allergic reaction to aspirin or an NSAID, or if you are in late pregnancy.

Do not take sumatriptan and naproxen within 24 hours before or after using another migraine headache medicine.

Naproxen can increase your risk of fatal heart attack or stroke, especially if you have heart disease. Do not use this medicine just before or after heart bypass surgery (coronary artery bypass graft, or CABG).

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.

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

What is sumatriptan and naproxen?

Sumatriptan is a headache medicine that narrows blood vessels around the brain. Sumatriptan also reduces substances in the body that can trigger certain migraine symptoms.

Naproxen is a nonsteroidal anti-inflammatory drug (NSAID). Naproxen works by reducing hormones that cause inflammation and pain in the body.

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

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

Sumatriptan and naproxen may also be used for purposes not listed in this medication guide.

What should I discuss with my health care provider before taking sumatriptan and naproxen?

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

  • uncontrolled high blood pressure;
  • blood circulation problems (including poor blood flow to your arms and legs, stomach, intestines, or kidneys);
  • a history of heart disease, angina (chest pain), recent or upcoming heart bypass surgery (CABG), heart attack, or stroke (including TIA or "mini-stroke");
  • Wolff-Parkinson-White Syndrome (sudden fast heartbeats) or other heart rhythm disorder;
  • severe liver disease;
  • a history of asthma or severe allergic reaction after taking aspirin or an NSAID; or
  • if you are in late pregnancy.

Naproxen can increase your risk of fatal heart attack or stroke, especially if you use it long term or take high doses, or if you have heart disease. Naproxen may also cause stomach or intestinal bleeding, which can be fatal. These conditions can occur without warning while you are using this medicine, especially in older adults.

Do not use sumatriptan and naproxen 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 sumatriptan and naproxen within 24 hours before or after using another migraine headache medicine, including:

  • sumatriptan tablets or nasal spray, almotriptan, eletriptan, frovatriptan, naratriptan, rizatriptan, or zolmitriptan; or
  • ergot medicine such as ergotamine, dihydroergotamine, or methylergonovine.

To make sure sumatriptan and naproxen is safe for you, tell your doctor if you have:

  • heart problems, high blood pressure, high cholesterol, fluid retention, diabetes, or if you smoke;
  • a history of stomach ulcers or bleeding;
  • epilepsy or other seizure disorder; or
  • liver or kidney disease.

Taking this medicine during the last 3 months of pregnancy may harm the unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

Sumatriptan and naproxen can pass into breast milk and may harm a nursing baby. You should not breast-feed while you are taking this medication.

Sumatriptan and naproxen is not approved for use by anyone younger than 12 years old.

How should I take sumatriptan and naproxen?

Follow all directions on your prescription label. Do not take this medicine in larger amounts or for longer than recommended. Use the lowest dose that is effective in treating your condition. Overuse of migraine headache medicine can actually make your headaches worse.

Take one (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.

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

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 two (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 tablets in 24 hours. If your symptoms have not improved, call your doctor before taking any more tablets.

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

Store at room temperature away from moisture and heat.

What happens if I miss a dose?

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

What happens if I overdose?

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

What should I avoid while taking sumatriptan and naproxen?

This medicine may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

Avoid taking aspirin while you are taking sumatriptan and naproxen.

Ask a doctor or pharmacist before using any cold, allergy, or pain medication. Many medicines available over the counter contain aspirin or other medicines similar to naproxen. Taking certain products together can cause you to get too much of this type of medication. Check the label to see if a medicine contains aspirin, ibuprofen, ketoprofen, or naproxen.

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

What are the possible side effects of sumatriptan and naproxen?

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

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.

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

  • numbness, tingling, pale or blue-colored appearance in your fingers or toes;
  • leg cramps, burning or heavy feeling in your feet or legs;
  • a seizure (convulsions);
  • swelling, rapid weight gain, shortness of breath;
  • stomach problems --sudden severe stomach pain (especially after eating), vomiting, bloody diarrhea, weight loss;
  • signs of stomach bleeding --bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds;
  • liver problems --nausea, upper stomach pain, itching, tired feeling, flu-like symptoms, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
  • kidney problems --little or no urinating, painful or difficult urination, swelling in your feet or ankles;
  • low red blood cells (anemia) --pale skin, feeling light-headed or short of breath; or
  • severe skin reaction --fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.

Common side effects may include:

  • dizziness, drowsiness, weakness;
  • irregular heartbeats;
  • numbness or tingling;
  • dry mouth, heartburn, nausea; 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.

What other drugs will affect sumatriptan and naproxen?

Ask your doctor before using this medicine if you take an antidepressant such as citalopram, escitalopram, fluoxetine (Prozac), fluvoxamine, paroxetine, sertraline (Zoloft), trazodone, or vilazodone. Taking any of these medicines with naproxen may cause you to bruise or bleed easily.

Tell your doctor about all your current medicines and any you start or stop using, especially:

  • lithium;
  • methotrexate;
  • heparin or warfarin (Coumadin, Jantoven);
  • heart or blood pressure medication, including a diuretic or "water pill"; or
  • steroid medicine (such as prednisone).

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

Where can I get more information?

Your pharmacist can provide more information about sumatriptan and naproxen.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

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