Prescribing Information (see boxed WARNINGS) and Medication Guide
TREXIMET may increase the risk of heart attack, stroke, serious stomach and intestinal problems such as bleeding and ulcers, and serious rash that may be fatal and occur without warning. Risk of stomach and intestinal problems increases in the elderly (see boxed WARNINGS). Continued Below
This section includes information that will help you better understand migraine pain and TREXIMET.
You should always be informed about the medicines you take or are considering taking. The more you know, the easier it will be for you and your doctor to find the appropriate migraine treatment.
What is TREXIMET?
Prescription TREXIMET is an FDA-approved treatment for acute migraine attacks in adults. It contains 85 mg of sumatriptan and 500 mg of naproxen sodium. Only TREXIMET combines these two medicines in one tablet:
| 1 | IMITREX® (sumatriptan) | ![]() |
2 | Prescription-strength naproxen sodium (an NSAID) |
TREXIMET is superior to the ingredient in IMITREX Tablets at relieving migraine pain. Results may vary.
What should I know about the Important Safety Information for TREXIMET?
TREXIMET may increase the risk of heart attack, stroke, serious stomach and intestinal problems such as bleeding and ulcers, and serious rash that may be fatal and occur without warning. Risk of stomach and intestinal problems increases in the elderly.
Please see additional Important Safety Information below, and Risks and Possible Side Effects
What if I do not have TREXIMET with me when I have my first migraine symptoms?
Headache experts recommend treating at the first sign of migraine pain; however, TREXIMET may provide migraine pain relief even if migraine pain is already moderate or severe. Results may vary. Always take your migraine treatment as instructed by your doctor.
How should I take TREXIMET?
Take 1 TREXIMET tablet to treat your migraine headache. Do not take more than 2 TREXIMET tablets in 24 hours; the efficacy of taking a second dose has not been established. Doses should be separated by at least 2 hours. TREXIMET can be taken with or without food. The safety of treating more than 5 migraines in a 30-day period has not been established.
Can I split my TREXIMET tablet?
Do not split, crush, or chew TREXIMET tablets.
What if my health insurer limits the amount of TREXIMET it will cover each month?
If you need more than what your insurance normally covers, talk to your doctor, who may be able to help.
Prescription TREXIMET is for the acute treatment of migraine attacks in adults.
TREXIMET may increase the risk of heart attack, stroke, serious stomach and intestinal problems such as bleeding and ulcers, and serious rash that may be fatal and occur without warning. Risk of stomach and intestinal problems increases in the elderly.
Do not take TREXIMET if you have a history of heart or liver disease, stroke, TIAs, problems with blood circulation, uncontrolled blood pressure, or allergic reaction to aspirin, NSAIDs, or sumatriptan (Imitrex®); or right before or after heart surgery called coronary artery bypass graft (CABG).
Talk to your doctor before taking TREXIMET if you have risk factors for heart disease like high blood pressure, high cholesterol, smoking, obesity, diabetes, family history of heart disease, are a post-menopausal female, or male over age 40.
Talk to your doctor before taking TREXIMET if you have stomach ulcers or bleeding; chest pain, shortness of breath, irregular heartbeats; kidney problems; asthma; Crohn's disease or ulcerative colitis; are pregnant, nursing, or thinking about becoming pregnant; or taking medications, especially pain relievers or antidepressants. TREXIMET should not be used in late pregnancy (third trimester) because TREXIMET can harm your unborn baby. TREXIMET should not be used if you are breastfeeding or plan to breastfeed because TREXIMET passes into your breast milk and may harm your baby. Serotonin syndrome, a life-threatening problem, may occur with TREXIMET, especially if used with antidepressants called SSRIs or SNRIs. Do not take TREXIMET if you have taken an MAOI antidepressant within the last 2 weeks. Do not take TREXIMET if you have taken ergotamine-containing medicines or other triptans within the last 24 hours. TREXIMET should only be used exactly as prescribed, at the lowest dose and for the shortest time possible.
Some people who take TREXIMET too often may have worse headaches. If your headaches get worse, your doctor may stop treatment with TREXIMET. Your doctor may encourage you to track your headache frequency and medication use.