"March 11, 2014 - The U.S. Food and Drug Administration allowed marketing of the first device as a preventative treatment for migraine headaches. This is also the first transcutaneous electrical nerve stimulation (TENS) device specifically "...
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.
Additional Treximet Information
Treximet - User Reviews
Treximet User Reviews
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Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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