IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.
SUMATRIPTAN/NAPROXEN SODIUM - ORAL
COMMON BRAND NAME(S): Treximet
WARNING: See also Side Effects and Precautions sections. Naproxen may infrequently cause serious (rarely fatal) ulcers or bleeding in the stomach or intestines. This side effect can occur without warning at any time during treatment with naproxen. Seek emergency medical attention if you have symptoms such as sudden or severe stomach/abdominal pain, black/bloody stools or vomit that is bloody or looks like coffee grounds. Older adults are at increased risk for serious stomach/intestinal bleeding. This medication may rarely cause blood clots to form, resulting in serious (possibly fatal) heart attacks and strokes. The risk may be greater if you have heart disease or increased risk for heart disease (for example, due to smoking, family history of heart disease, or conditions such as high blood pressure or diabetes), or with longer use. Talk to your doctor or pharmacist about the benefits and risks of treatment, as well as other possible medication choices.
USES: This product contains naproxen and sumatriptan. It is used to treat migraines when they occur. It helps to relieve headache and other symptoms of migraines, including sensitivity to light/sound, nausea, and vomiting. This product does not prevent future migraines or reduce how often you may get a headache. Naproxen is known as a nonsteroidal anti-inflammatory drug (NSAID). It is used to relieve pain. Sumatriptan belongs to a group of drugs called triptans. It affects a certain natural chemical (serotonin) that narrows blood vessels in the brain. It may also block other pain signals in the brain.
HOW TO USE: Read the Medication Guide provided by your pharmacist before you start using this product and each time you get a refill. If you have any questions, consult your doctor or pharmacist. Take this medication by mouth as directed by your doctor, with a full glass of water (8 ounces or 240 milliliters). Do not lie down for at least 10 minutes after taking this drug. To prevent stomach upset, take this medication with food, milk, or an antacid. Do not break, crush, or chew the tablet. Take this medication at the first sign of a migraine. If there is no improvement in your symptoms, do not take any more doses of this medication before talking to your doctor. If your symptoms are only partly relieved, or if your headache comes back, you may take a second dose after 2 hours or as directed by your doctor. Do not take more than 2 doses in a 24-hour period. If you have never taken this medication before and you have risk factors for heart disease (see Precautions section), your doctor may need to monitor you for rare but serious side effects (such as chest pain) when you take the first dose. Your doctor may ask you to take the first dose in the office. Your dosage is based on your medical condition and response to treatment. This medication works best when taken at the first signs of the headache. If you wait until the headache has worsened, the medication may not work as well. To minimize side effect risks (such as stomach bleeding), use this medication at the lowest effective dose for the shortest possible length of time. Do not increase your dose or take it more often or for longer than prescribed. Overuse of this medication can also lead to worsening of headache (medication overuse headache) or rebound headache. Tell your doctor if you need to use the medication more often, if the medication is not working as well, or if you have more frequent or worse headaches. Your doctor may need to change your medication and/or add a separate medication to prevent the headaches. If the pain is not relieved or if it worsens after the first dose, tell your doctor immediately.
SIDE EFFECTS: See also Warning section. Dizziness, drowsiness, flushing, nausea, and heartburn may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly. Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects. Tell your doctor immediately if any of these unlikely but serious side effects occur: difficult/painful swallowing, feelings of tingling/numbness/prickling/heat, swelling hands/ankles/feet, sudden/unexplained weight gain, hearing changes (such as ringing in the ears), unusual tiredness. Tell your doctor immediately if any of these rare but very serious side effects occur: easy bleeding/bruising, change in the amount of urine, blue fingers/toes/nails, feeling of cold hands/feet, mental/mood changes (such as depression), seizures. Chest/jaw/neck tightness can commonly occur shortly after using sumatriptan. Only rarely are these signs of a serious condition. However, you may not be able to tell them apart from a serious reaction related to a lack of blood flow to the heart, brain, or other parts of the body. Stop taking this medication and seek immediate medical attention if you notice any of the following rare but very serious side effects: shortness of breath, chest/jaw/left arm pain, fainting, fast/irregular/pounding heartbeat, vision changes, weakness on one side of the body, confusion, slurred speech. This drug may rarely cause serious (possibly fatal) liver disease. If you notice any of the following rare but very serious side effects, stop taking this product and tell your doctor immediately: yellowing eyes/skin, dark urine, persistent nausea/vomiting. This medication may rarely cause a very serious condition called serotonin syndrome. The risk increases when this medication is taken with certain other drugs such as other triptans used to treat migraine headaches (such as rizatriptan, zolmitriptan), certain antidepressants including SSRIs (such as citalopram, fluoxetine, paroxetine) and SNRIs (such as duloxetine, venlafaxine), or a certain drug to treat obesity (sibutramine). Before taking this drug, tell your doctor if you take any of these medications. Serotonin syndrome may be more likely when you start or increase the dose of any of these medications. Seek immediate medical attention if you develop some of the following symptoms: mental/mood changes (such as hallucinations, restlessness), loss of coordination, fast heartbeat, high fever, sweating, severe nausea/vomiting/diarrhea, twitchy muscles. A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any of the following symptoms of a serious allergic reaction: rash/blisters, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing. This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist. In the US - Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
PRECAUTIONS: See also How to Use section. Before taking this product, tell your doctor or pharmacist if you are allergic to naproxen or to sumatriptan; or to aspirin or other NSAIDs (such as ibuprofen, celecoxib); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details. This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: aspirin-sensitive asthma (a history of worsening breathing with runny/stuffy nose after taking aspirin or other NSAIDs), heart disease (such as chest pain, previous heart attack), decreased blood flow in the brain (such as previous stroke, transient ischemic attack), blood circulation disease (such as ischemic bowel disease, Raynaud's disease), certain types of headaches (hemiplegic or basilar migraine), liver disease, previous or planned heart bypass surgery (CABG). Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease, seizures, stomach/intestine/esophagus problems (such as bleeding, ulcers), congestive heart failure, high blood pressure, swelling (edema, fluid retention), a severe loss of body water (dehydration), blood disorders (such as anemia), bleeding or clotting problems, asthma, growths in the nose (nasal polyps). Tell your doctor if you have the following risk factors for heart disease: diabetes, family history of heart disease, high cholesterol, overweight, smoker, female after menopause, male over age 40. This drug may make you dizzy or drowsy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. This product contains salt (sodium). Tell your doctor before using this drug if you are limiting your intake of salt. Before having surgery, tell your doctor or dentist that you are using this medication. This medicine may cause stomach bleeding. Daily use of alcohol and tobacco may increase your risk for stomach bleeding, especially when combined with this medicine. Limit alcohol and stop smoking. Consult your doctor or pharmacist for more information. This medication may make you more sensitive to the sun. Avoid prolonged sun exposure, tanning booths, and sunlamps. Use a sunscreen and wear protective clothing when outdoors. The risk of heart disease, liver disease, kidney disease, and high blood pressure increases with age. Therefore, older adults may be at greater risk for stomach/intestinal bleeding, high blood pressure, and kidney problems while using this product. Before using this medication, women of childbearing age should talk with their doctor(s) about the benefits and risks (such as miscarriage). Tell your doctor if you are pregnant or if you plan to become pregnant. During pregnancy, this medication should be used only when clearly needed. It is not recommended for use during the first and last trimesters of pregnancy due to possible harm to the unborn baby and interference with normal labor/delivery. These drugs pass into breast milk and may have undesirable effects on a nursing infant. Consult your doctor before breast-feeding. Avoid breastfeeding for at least 12 hours after any treatment with sumatriptan.
DRUG INTERACTIONS: See also Side Effects section. Your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor or pharmacist first. This drug should not be used with the following medications because very serious interactions may occur: cidofovir, a certain weight loss drug (sibutramine). If you are currently using any of these medications listed above, tell your doctor or pharmacist before starting this product. Do not take this medication if you are taking MAO inhibitors (isocarboxazid, linezolid, methylene blue, moclobemide, phenelzine, procarbazine, rasagiline, selegiline, tranylcypromine) or if you have used MAO inhibitors in the past 2 weeks. In some cases a serious (possibly fatal) drug interaction may occur. Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: aliskiren, ACE inhibitors (such as captopril, lisinopril), angiotensin II receptor blockers (such as losartan, valsartan), corticosteroids (such as prednisone), cyclosporine, desmopressin, digoxin, drospirenone, lithium, methotrexate, pemetrexed, probenecid, tenofovir. This medication may increase the risk of bleeding when taken with other drugs that also may cause bleeding. Examples include anti-platelet drugs such as clopidogrel, "blood thinners" such as dabigatran/enoxaparin/warfarin, among others. Check all prescription and nonprescription medicine labels carefully since many medications contain pain relievers/fever reducers (aspirin, NSAIDs such as celecoxib, ibuprofen, ketorolac). These drugs are similar to the naproxen in this medication and may increase your risk of side effects if taken together. However, if your doctor has directed you to take low-dose aspirin to prevent heart attack or stroke (usually at dosages of 81-325 milligrams a day), you should continue taking the aspirin unless your doctor instructs you otherwise. Ask your doctor or pharmacist for more details. If you also take any ergotamine medication (such as dihydroergotamine or methysergide) or any other triptan drugs (such as zolmitriptan, rizatriptan), you will need to separate your sumatriptan dose from your dose of these other medications in order to lessen the chance of serious side effects. Ask your doctor how long you should wait between your doses of these drugs. Also report the use of drugs which might increase seizure risk when combined with sumatriptan such as isoniazid (INH), phenothiazines (such as thioridazine), theophylline, or tricyclic antidepressants (such as amitriptyline) among others. Consult your doctor or pharmacist for details. This medication can affect the results of certain lab tests (such as bleeding times, adrenal function tests). Make sure laboratory personnel and all your doctors know you use this drug. This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.
OVERDOSE: If overdose is suspected, contact your local poison control center or emergency room immediately. US residents can call the US National Poison Hotline at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: extreme drowsiness, slow/shallow breathing, seizures, shakiness (tremor).
NOTES: Do not share this medication with others. Certain foods/beverages or food additives (such as red wine, cheese, chocolate, monosodium glutamate) as well as some lifestyle patterns (such as irregular eating/sleeping habits, stress) may cause a migraine headache. Avoiding these "triggers" may help decrease the frequency of migraine headaches. Consult your doctor for more details. Laboratory and/or medical tests (such as complete blood count, EKG, blood pressure, liver and kidney function tests) may be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.
MISSED DOSE: Take this medication only as needed when a migraine occurs, as directed by your doctor. This medication should not be taken on a regular schedule.
STORAGE: Store at room temperature at 77 degrees F (25 degrees C) away from light and moisture. Brief storage at 59-86 degrees F (15-30 degrees C) is permitted. Do not store in the bathroom. Keep all medications away from children and pets. Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.
Information last revised July 2012. Copyright(c) 2012 First Databank, Inc.