Sumatriptan/naproxen (By mouth)

Introduction

Naproxen Sodium (na-PROX-en SOE-dee-um), Sumatriptan Succinate (soo-ma-TRIP-tan SUX-i-nate)

Treats migraine headaches. This medicine does not prevent migraines. This medicine contains a triptan and a nonsteroidal anti-inflammatory drug (NSAID).

Brand Name(s)

Treximet

There may be other brand names for this medicine.

When This Medicine Should Not Be Used

Do not use this medicine if you have had an allergic reaction to sumatriptan, naproxen, aspirin, or other NSAID medicines (such as diclofenac, ibuprofen, Advil®, Celebrex®). Do not use this medicine if you have liver, heart, or blood vessel disease. Tell your doctor if you have uncontrolled high blood pressure, a history of heart disease, heart attack, angina, stroke, transient ischemic attack (TIA), ischemic bowel disease, peripheral vascular disease, or coronary artery bypass graft (CABG) surgery. You should not use this medicine to prevent migraine attacks or for hemiplegic or basilar migraines. Do not use this medicine if you have used an MAO inhibitor (MAOI) in the past 2 weeks (selegiline (Eldepryl®), isocarboxazid (Marplan®), phenelzine (Nardil®), or tranylcypromine (Parnate®). Do not use this medicine if you have taken another migraine headache medicine in the past 24 hours, such as another triptan or an ergot medicine.

How to Use This Medicine

Tablet

• Your doctor will tell you how much of this medicine to use and how often. Do not use more medicine or use it more often than your doctor tells you to.
• If your headache comes back or does not go away after taking this medicine, wait at least 2 hours before taking another dose. Do not take more than 2 doses in 24 hours.
• Swallow the tablet whole. Do not crush, break, or chew it.
• Use this medicine for the shortest time possible and in the smallest dose possible. This will help lower the risk of side effects.
• This medicine should come with a Medication Guide. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions. Ask your pharmacist for the Medication Guide if you do not have one.

How to Store and Dispose of This Medicine

• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.
• Ask your pharmacist, doctor, or health caregiver about the best way to dispose of any outdated medicine or medicine no longer needed.
• Keep all medicine away from children and never share your medicine with anyone.

Drugs and Foods to Avoid

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Make sure your doctor knows if you are also using aspirin, lithium (Eskalith®, Lithobid®), methotrexate (Rheumatrex®), probenecid (Benemid®), or a blood thinner (such as warfarin, Coumadin®). Tell your doctor if you are also using certain blood pressure medicines (such as captopril, enalapril, lisinopril, metoprolol, propranolol, Accupril®, Altace®, Inderal®, Lotrel®, or Toprol®) or a diuretic (water pill, such as furosemide, hydrochlorothiazide [HCTZ], torsemide, Demadex®, or Lasix®).
• Tell your doctor if you are also using medicine to treat depression (such as citalopram, duloxetine, escitalopram, fluoxetine, fluvoxamine, olanzapine, paroxetine, sertraline, venlafaxine, Celexa®, Cymbalta®, Effexor®, Lexapro®, Paxil®, Prozac®, or Zoloft®).
• Do not take any other medicine that contains naproxen or other NSAID medicines, such as ibuprofen (Advil®).

Warnings While Using This Medicine

• Make sure your doctor knows if you are pregnant or breastfeeding. Do not use this medicine during the later part of pregnancy unless your doctor tells you to.
• Make sure your doctor knows if you have kidney disease, heart failure, asthma, bleeding problems, or a history of seizures or stomach or bowel bleeding. Tell your doctor if you are on a low-salt diet or if you have edema (retaining water).
• This medicine can cause heart problems, including heart attack. This is more likely to happen if you already have heart disease. Tell your doctor if you have any risk factors for heart disease, such as high blood pressure, high cholesterol, smoking, diabetes, or a family history of heart disease. Men over 40 years old and women who are past menopause are also more likely to have heart disease.
• Get emergency help right away if you have any symptoms of a heart attack or stroke. Some possible symptoms are chest pain or discomfort, uneven heartbeat, pain that spreads to you arm or jaw, unusual sweating, feeling faint, trouble breathing, slurred speech, or weakness on one side of your body.
• You should not use this medicine if your headache symptoms are different from your usual migraine headache. Call your doctor if you have an unusual or severe headache. Check with your doctor if you used this medicine and your migraine did not go away. If your symptoms do not improve or if they get worse, call your doctor.
• This medicine might cause bleeding or ulcers in your stomach or intestines. This problem can happen without warning signs. This is more likely if you have had a stomach ulcer in the past, if you smoke or drink alcohol regularly, if you are over 60 years of age, are in poor health, or are using certain other medicines (such as a steroid or a blood thinner).
• Stop using this medicine and check with your doctor right away if you have any symptoms of liver problems, such as dark-colored urine or pale stools, nausea, vomiting, loss of appetite, pain in your upper stomach, or yellow skin or eyes.
• You could make your migraine headaches worse if you take migraine medicine too often (more than 10 days every month). Keep track of how often you have migraines and how much medicine you use.
• This medicine may make you dizzy or drowsy. Do not drive, use machines, or do anything else that could be dangerous if you are not alert until you know how this medicine affects you.

Possible Side Effects While Using This Medicine

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Anxiety, restlessness, fast heartbeat, fever, sweating, muscle spasms, twitching, nausea, vomiting, diarrhea, seeing or hearing things that are not there
• Blistering, peeling, or red skin rash
• Change in how much or how often you urinate
• Chest pain that may spread to your arms, jaw, back, or neck, trouble breathing, nausea, unusual sweating, faintness
• Coughing up blood, pain in your lower leg (calf)
• Dark-colored urine or pale stools, nausea, vomiting, loss of appetite, pain in your upper stomach
• Fast, pounding, or uneven heartbeat
• Numbness or weakness in your arm or leg, or on one side of your body
• Severe stomach pain, bloody or black, tarry stools
• Swelling in your hands, ankles, or feet
• Tightness or discomfort in your chest, neck, or jaw
• Tingling, numbness, or cold feeling in your hands or feet
• Unusual bleeding, bruising, or weakness
• Unusual headache, problems with vision, speech, or walking
• Unusual weight gain
• Vomiting of blood or something that looks like coffee grounds
• Yellowing of your skin or the whites of your eyes

If you notice these less serious side effects, talk with your doctor:

• Dizziness or drowsiness
• Vision changes that are not part of a usual migraine

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088