Generic Name: sumatriptan/naproxen (SOO-ma-TRIP-tan/na-PROX-en)
Brand Name: Treximet
Sumatriptan/naproxen contains a nonsteroidal anti-inflammatory drug (NSAID). It may cause an increased risk of serious and sometimes fatal heart and blood vessel problems (eg, a heart attack, stroke). The risk may be greater if you already have heart problems or if you take sumatriptan/naproxen for a long time. Do not take sumatriptan/naproxen right before or after bypass heart surgery.
Sumatriptan/naproxen may cause an increased risk of serious and sometimes fatal stomach or bowel ulcers and bleeding. Elderly patients may be at greater risk. This may occur without warning signs.
Sumatriptan/naproxen is used for:
Treating migraine attacks in adults.
Sumatriptan/naproxen is a serotonin 5-HT1 receptor agonist ("triptan") and NSAID combination. The "triptan" works by narrowing blood vessels in the brain, which helps to relieve migraines. The NSAID may work to relieve pain by blocking certain substances in the body.
Do NOT use sumatriptan/naproxen if:
- you are allergic to any ingredient in sumatriptan/naproxen
- you have had a severe allergic reaction (eg, severe rash, hives, trouble breathing, growths in the nose, dizziness) to aspirin or another NSAID (eg, ibuprofen, celecoxib)
- you have liver problems, severe kidney problems, uncontrolled high blood pressure, or certain types of migraines (eg, hemiplegic, basilar)
- you are in the last 3 months of pregnancy
- you have recently had or will be having bypass heart surgery
- you have a history of ischemic heart disease (eg, angina, a heart attack), coronary artery disease (CAD), other moderate to severe heart problems, brain blood vessel disease (eg, a stroke, transient ischemic attack), or other blood vessel disease (eg, Raynaud syndrome, ischemic bowel disease)
- you are taking sibutramine or another medicine that contains naproxen
- you are taking a monoamine oxidase inhibitor (MAOI) (eg, phenelzine), or have taken an MAOI within the past 14 days
- you have used certain other migraine medicines (eg, an ergot derivative [eg, dihydroergotamine, methysergide], another serotonin 5-HT1 receptor agonist [eg, eletriptan, rizatriptan]) within the past 24 hours
Contact your doctor or health care provider right away if any of these apply to you.
Before using sumatriptan/naproxen:
Some medical conditions may interact with sumatriptan/naproxen. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
- if you are pregnant, planning to become pregnant, or are breast-feeding
- if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
- if you have allergies to medicines, foods, or other substances
- if you have a history of lung or breathing problems (eg, asthma), runny nose, growths in the nose (nasal polyps), or severe dizziness due to previous NSAID use
- if you have a history of liver or kidney problems, diabetes, other types of headaches (eg, cluster headaches), stomach or bowel problems (eg, bleeding, perforation, ulcers, ulcerative colitis, Crohn disease), mouth inflammation, or seizures (eg epilepsy)
- if you have a history of high blood pressure, blood disorders, bleeding or clotting problems, diabetes, heart problems (eg, heart failure, irregular heartbeat), heart bypass surgery, a stroke, blood vessel disease, or high cholesterol, or if you are at risk of any of these diseases
- if you have shortness of breath, chest pain, poor health, fluid retention, dehydration or low fluid volume, or low blood sodium levels
- if you are on a low-salt (sodium) diet, are very overweight, smoke, drink alcohol, or have a history of alcohol abuse
- if you have a family member who has had heart disease or a stroke
- if you are a woman who is past menopause or who has had your ovaries removed (oophorectomy)
- if you are a man who is older than 40 years old
- if your headache feels different than usual or you have not previously been diagnosed with a migraine headache
Some MEDICINES MAY INTERACT with sumatriptan/naproxen. Tell your health care provider if you are taking any other medicines, especially any of the following:
- Anticoagulants (eg, warfarin), antiplatelet medicines (eg, clopidogrel), aspirin, corticosteroids (eg, prednisone), heparin, rivaroxaban, or other NSAIDs (eg, ibuprofen) because the risk of stomach or bowel bleeding may be increased
- Selective serotonin reuptake inhibitors (SSRIs) (eg, fluoxetine), serotonin-norepinephrine reuptake inhibitors (SNRIs) (eg, duloxetine), or sibutramine because the risk of a serious side effect called serotonin syndrome may be increased. Symptoms of serotonin syndrome may include mental or mood changes, hallucinations, fast heartbeat, fever, loss of coordination, muscle spasms, increased sweating, nausea, vomiting, or diarrhea
- MAOIs (eg, phenelzine) or probenecid because they may increase the risk of sumatriptan/naproxen's side effects
- Bisphosphonates (eg, alendronate), cyclosporine, ergot derivatives (eg, dihydroergotamine, methysergide), lithium, methotrexate, quinolones (eg, ciprofloxacin), or other serotonin 5-HT1 receptor agonists (eg, eletriptan, rizatriptan) because the risk of their side effects may be increased by sumatriptan/naproxen
- Beta-blockers (eg, propranolol) because their effectiveness may be decreased by sumatriptan/naproxen
- Angiotensin-converting enzyme (ACE) inhibitors (eg, enalapril) or diuretics (eg, furosemide, hydrochlorothiazide) because their effectiveness may be decreased by sumatriptan/naproxen and the risk of kidney problems may be increased
This may not be a complete list of all interactions that may occur. Ask your health care provider if sumatriptan/naproxen may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.
How to use sumatriptan/naproxen:
Use sumatriptan/naproxen as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- Sumatriptan/naproxen comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get sumatriptan/naproxen refilled.
- It is best to take a dose of sumatriptan/naproxen as soon as you notice symptoms of a migraine attack.
- Take sumatriptan/naproxen by mouth with or without food. It may be taken with food if it upsets your stomach. Taking it with food may not lower the risk of stomach of bowel problems (eg, bleeding, ulcers). Talk with your doctor or pharmacist if you have persistent stomach upset.
- Swallow sumatriptan/naproxen whole. Do not break, crush, or chew before swallowing.
- If your symptoms do not improve after the first dose, do not take a second dose for the same attack. Contact your doctor.
- If your doctor has instructed you to take a second dose, do not take the second dose for at least 2 hours after the previous dose. Do not take more than 2 tablets in 24 hours.
- Do not treat more than 5 headaches within 30 days without checking with your doctor.
- If you miss a dose of sumatriptan/naproxen and you still have a headache, follow your doctor's dosing instructions. Contact your doctor right away if you are unsure of what to do if you miss a dose. Do not take sumatriptan/naproxen more often than prescribed. Do not take 2 doses at once.
Ask your health care provider any questions you may have about how to use sumatriptan/naproxen.
Important safety information:
- Sumatriptan/naproxen may cause dizziness or drowsiness. These effects may be worse if you take it with alcohol or certain medicines. Use sumatriptan/naproxen with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
- Overuse of sumatriptan/naproxen can cause your headache to become worse. Do NOT take more than the recommended dose or take more often than prescribed without checking with your doctor. Tell your doctor if your headaches become worse or if they occur more often.
- Sumatriptan/naproxen should not be used to prevent or reduce the number of migraine headaches you have. If you have a headache that is different than your usual migraine headaches, check with your doctor before taking sumatriptan/naproxen.
- Serious stomach or bowel ulcers or bleeding can occur with the use of sumatriptan/naproxen. Taking it in high doses or for a long time, smoking, or drinking alcohol increases the risk of these side effects. Taking sumatriptan/naproxen with food will NOT reduce the risk of these effects. Contact your doctor or emergency room at once if you develop severe stomach or back pain; black, tarry stools; vomit that looks like blood or coffee grounds; or unusual weight gain or swelling.
- Rarely, serious heart problems (eg, a heart attack, irregular heartbeat) have been reported within a few hours of taking sumatriptan/naproxen. Contact your doctor at once if fast or irregular heartbeat; chest, jaw, or neck pain or numbness; numbness of an arm or leg; severe stomach pain, dizziness, or vomiting; fainting; or vision changes occur. Discuss any questions or concerns with your doctor.
- Serotonin syndrome is a possibly fatal syndrome that can be caused by sumatriptan/naproxen. Your risk may be greater if you take sumatriptan/naproxen with certain other medicines (eg, SSRIs, SNRIs). Symptoms may include agitation; confusion; hallucinations; coma; fever; fast or irregular heartbeat; tremor; excessive sweating; and nausea, vomiting, or diarrhea. Contact your doctor at once if you have any of these symptoms.
- Sumatriptan/naproxen has naproxen in it. Before you start any new medicine, check the label to see if it has naproxen or any other NSAID (eg, ibuprofen) in it too. If it does or if you are not sure, check with your doctor or pharmacist.
- Check with your doctor before you take aspirin while you are taking sumatriptan/naproxen.
- Sumatriptan/naproxen may interfere with certain lab tests. Be sure your doctor and lab personnel know you are taking sumatriptan/naproxen.
- Lab tests, including blood pressure, complete blood cell counts, heart function, kidney function, or liver function, may be performed while you use sumatriptan/naproxen. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
- Use sumatriptan/naproxen with caution in the ELDERLY; they may be more sensitive to its effects, especially stomach or bowel bleeding and kidney problems.
- Sumatriptan/naproxen should not be used in CHILDREN; safety and effectiveness in children have not been confirmed.
- PREGNANCY and BREAST-FEEDING: Sumatriptan/naproxen may harm the fetus. Do not take it during the last 3 months of pregnancy. If you think you may be pregnant, contact your doctor. You will need to discuss the benefits and risks of taking sumatriptan/naproxen while you are pregnant. Sumatriptan/naproxen is found in breast milk. Do not breast-feed while taking sumatriptan/naproxen.
Possible side effects of sumatriptan/naproxen:
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:
Seek medical attention right away if any of these SEVERE side effects occur:
Constipation; diarrhea; dizziness; drowsiness; gas; heartburn; mild feeling of heaviness or pressure; mild numbness or tingling of the skin; nausea; stomach upset; tiredness; warm/hot sensation.
Severe allergic reactions (rash; hives; itching; trouble breathing; tightness in the chest; swelling of the mouth, face, lips, throat, or tongue); bloody diarrhea; bloody or black, tarry stools; change in the amount of urine produced; chest, neck, or jaw pain, tightness, or pressure; confusion; dark urine; fainting; fast or irregular heartbeat; fever, chills, or persistent sore throat; loss of appetite; loss of vision or other vision changes; mental or mood changes (eg, depression); numbness or tingling of an arm or leg; one-sided weakness; pale stools; red, swollen, blistered, or peeling skin; ringing in the ears or hearing change; seizures; severe headache or dizziness; severe or persistent stomach pain or nausea; severe or prolonged flushing; severe vomiting; shortness of breath; slurred speech or other speech changes; sudden or unexplained weight gain; swelling of hands, legs, or feet; unusual bruising or bleeding; unusual joint or muscle pain; unusual tiredness or weakness; very cold or blue fingers or toes; vomit that looks like coffee grounds; wheezing; yellowing of the skin or eyes.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
If OVERDOSE is suspected:
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include decreased urination; heartburn; loss of consciousness; seizures; severe dizziness or drowsiness; severe nausea or stomach pain; slow or shallow breathing; sluggishness; unusual bleeding or bruising; vomit that looks like coffee grounds.Proper storage of sumatriptan/naproxen:
Store sumatriptan/naproxen at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store in original packaging until just before use. Store away from heat, moisture, and light. Do not store in the bathroom. Keep sumatriptan/naproxen out of the reach of children and away from pets.
- If you have any questions about sumatriptan/naproxen, please talk with your doctor, pharmacist, or other health care provider.
- Sumatriptan/naproxen is to be used only by the patient for whom it is prescribed. Do not share it with other people.
- If your symptoms do not improve or if they become worse, check with your doctor.
- Check with your pharmacist about how to dispose of unused medicine.
This information should not be used to decide whether or not to take sumatriptan/naproxen or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about sumatriptan/naproxen. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to sumatriptan/naproxen. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using sumatriptan/naproxen.
Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.