Sumatriptan is a serotonin receptor agonist that works in the brain to relieve migraine headaches. Naproxen is a NSAID.
This medicine is available only with your doctor's prescription. This product is available in the following dosage forms:
2 What to Know Before Using
Before using Treximet, you must know all about the risks and complications associated with it. This is a decision you and your doctor will make.
For this medicine, the following should be considered:
Allergies: Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Pediatric Population: Appropriate studies have not been performed on the relationship of age to the effects of sumatriptan and naproxen combination in children younger than 12 years of age. Safety and efficacy have not been established.
Geriatric Population: Use of sumatriptan and naproxen combination is not recommended in elderly patients with kidney problems, heart and blood vessel disease, or high blood pressure.
Pregnancy: 1st Trimester: Category C: Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.
2nd Trimester: Category C: Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.
3rd Trimester: Category X: Studies in animals or pregnant women have demonstrated positive evidence of fetal abnormalities. This drug should not be used in women who are or may become pregnant because the risk clearly outweighs any possible benefit.
Breastfeeding: There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Drug Interactions: Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose or other precautions may be necessary.
When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine or give you special instructions about the use of food, alcohol, or tobacco.
Other Medical Problems
The presence of other medical problems may affect the use of this medicine.
Make sure you tell your doctor if you have any other medical problems, especially:
Proper usage of Treximet requires strict adherence to your doctor’s orders. Do not use more of it and do not use it more often than directed. Using too much of this medicine may increase the chance of side effects.
For adults: If your headache does not improve after taking this medicine, wait at least 2 hours before taking the second dose. Do not take more than 2 tablets in 24 hours.
For children 12 years of age or older: If your headache does not improve after the first dose of medicine, do not take the second dose. Call your doctor.
Do not use this medicine for a regular headache that is different from your usual migraine. Talk to your doctor about what to do for regular headaches.
This medicine comes with a Medication Guide. Read and follow the instructions carefully. Ask your doctor if you have any questions.
Swallow the tablet whole. Do not crush, break, or chew it. You may take the tablet with or without food.
Dosing: The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
For oral dosage form (tablets):
For migraine headaches:
Adults—One tablet once a day. The dose may be repeated once after waiting 2 hours. Do not take more than 2 tablets in 24 hours.
Children 12 to 17 years of age—One tablet once a day. Do not take more than 1 tablet in 24 hours.
Children younger than 12 years of age—Use and dose must be determined by your doctor.
Storage: Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing. Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed. Ask your healthcare professional how you should dispose of any medicine you do not use.
4 Precautions to Take
Before using Treximet, there are some precautions you must take. It is very important that your doctor checks your progress at regular visits.
This will allow your doctor to see if the medicine is working properly and to decide if you should continue to take it. Blood and urine tests will be needed to check for unwanted effects.
Check with your doctor if you have used this medicine and have not had good relief. Also, check with your doctor if your migraineheadaches are worse, or if they are occurring more often, than before you started using this medicine.
Make sure your doctor knows if you are pregnant. You should not use this medicine during the later part of pregnancy unless your doctor says it is okay.
You should not take this medicine if you have used a MAO inhibitor (MAOI) such as isocarboxazid (Marplan®), phenelzine (Nardil®), selegiline (Eldepryl®), or tranylcypromine (Parnate®) within the past 2 weeks.
Do not use this medicine if you have taken other migraine medicines (eg, almotriptan, frovatriptan, naratriptan, rizatriptan, zolmitriptan, Axert™, Frova®, Amerge®, Maxalt®, or Zomig®) or an ergotamine medicine (eg, dihydroergotamine, methysergide, Cafergot®, D.H.E. 45®, Ergomar®, or Migranal®) within the past 24 hours.
This medicine may cause problems if you have heart disease. If your doctor thinks you might have a problem with this medicine, he or she may want you to take your first dose in the doctor’s office or clinic. This medicine may increase your risk of having a blood clot, heart attack, or stroke.
This is more likely to occur if you or a family member already has a heart disease, if you have diabetes, high blood pressure, high cholesterol, if you smoke, if you are male and over 40 years of age, or if you are female and have gone through menopause.
People who use this medicine for a long time might also have a higher risk. Check with your doctor if you have chest pain, faintness, nausea, unusual sweating, trouble breathing, trouble seeing, or trouble speaking while using this medicine.
Check with your doctor right away if you have chest discomfort, jaw or neck tightness after using this medicine. Also, tell your doctor if you have sudden or severe abdominal or stomach pain after taking this medicine.
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).
Do not use this medicine if you are also using other medicines containing naproxen. Using these medicines together may cause serious unwanted effects. Make sure your doctor knows about all the medicines you are using.
Sumatriptan and naproxen combination may cause a serious condition called serotonin syndrome when taken with some medicines. This especially includes medicines used to treat depression, such as:
Using too much of this medicine or any other migraine medicines (eg, ergotamine, triptans, opioids, or a combination treatment for 10 or more days per month) may worsen your headache. Talk to your doctor about this risk. It may also be helpful to note of how often your migraine attacks occur and how much medicines you use.
Check with your doctor immediately if blurred vision, difficulty in reading, or any other change in vision occurs during or after your treatment. Your eyes may need to be checked by an ophthalmologist (eye doctor).
Drinking alcoholic beverages can make headaches worse or cause new headaches to occur. People who suffer from severe headaches should probably avoid alcoholic beverages, especially during a headache.
This medicine may cause some people to become dizzy, drowsy, or less alert than normal. If any of these side effects occur, do not drive, use machines, or do anything else that could be dangerous while you are dizzy or less alert.
Before you have any medical tests, tell the medical doctor in charge that you are taking this medicine. The results of some tests may be affected by this medicine.
Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.
5 Potential Side Effects
As with many medications, there are several potential side effects associated with Treximet. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur:
burning, crawling, itching, numbness, prickling, "pins and needles" or tingling feelings
chest discomfort or pain
fast, irregular, pounding or racing heartbeat or pulse
jaw, neck, or throat pain
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.
Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
redness of the face, neck, arms, and occasionally, upper chest
sleepiness or unusual drowsiness
stomach discomfort, upset or pain
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
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