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Treximet

Pronunciation

Generic Name: sumatriptan and naproxen (SOO ma TRIP tan and na PROX en)
Brand Names: Treximet

What is Treximet?

Treximet is a tablet containing a combination of sumatriptan and naproxen. Sumatriptan is a headache medicine that narrows blood vessels around the brain. Sumatriptan also reduces substances in the body that can trigger certain migraine symptoms.

Naproxen is a nonsteroidal anti-inflammatory drug (NSAID). Naproxen works by reducing hormones that cause inflammation and pain in the body.

Treximet is used to treat migraine headaches. It will only treat a headache that has already begun. Treximet will not prevent headaches or reduce the number of attacks.

Treximet should not be used to treat cluster headaches or any headache that causes loss of movement on one side of your body.

Important information

You should not use Treximet if you have uncontrolled high blood pressure, blood circulation problems, a history of heart disease or heart bypass surgery, a history of heart attack or stroke, a heart rhythm disorder, severe liver disease, a history of severe allergic reaction to aspirin or an NSAID, or if you are in late pregnancy.

Do not take Treximet within 24 hours before or after using another migraine headache medicine.

Naproxen can increase your risk of fatal heart attack or stroke, especially if you have heart disease. Do not use Treximet just before or after heart bypass surgery (coronary artery bypass graft, or CABG).

Get emergency medical help if you have signs of a heart attack or stroke: chest pain spreading to your jaw or shoulder, sudden numbness or weakness on one side of the body, slurred speech, feeling short of breath.

Naproxen may also cause stomach or intestinal bleeding, which can be fatal. These conditions can occur without warning, especially in older adults.

Before taking this medicine

You should not use Treximet if you are allergic to sumatriptan (Imitrex) or naproxen (Aleve, Anaprox, Naprosyn), or if you have:

  • uncontrolled high blood pressure;

  • blood circulation problems (including poor blood flow to your arms and legs, stomach, intestines, or kidneys);

  • a history of heart disease, angina (chest pain), recent or upcoming heart bypass surgery (CABG), heart attack, or stroke (including TIA or "mini-stroke");

  • Wolff-Parkinson-White Syndrome (sudden fast heartbeats) or other heart rhythm disorder;

  • severe liver disease;

  • a history of asthma or severe allergic reaction after taking aspirin or an NSAID; or

  • if you are in late pregnancy.

Naproxen can increase your risk of fatal heart attack or stroke, especially if you use it long term or take high doses, or if you have heart disease. Naproxen may also cause stomach or intestinal bleeding, which can be fatal. These conditions can occur without warning while you are using this medicine, especially in older adults.

Do not use Treximet if you have used an MAO inhibitor in the past 14 days. A dangerous drug interaction could occur. MAO inhibitors include isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, selegiline, tranylcypromine, and others.

Do not take Treximet within 24 hours before or after using another migraine headache medicine, including:

  • sumatriptan tablets or nasal spray, almotriptan, eletriptan, frovatriptan, naratriptan, rizatriptan, or zolmitriptan; or

  • ergot medicine such as ergotamine, dihydroergotamine, or methylergonovine.

To make sure Treximet is safe for you, tell your doctor if you have:

  • heart problems, high blood pressure, high cholesterol, fluid retention, diabetes, or if you smoke;

  • a history of stomach ulcers or bleeding;

  • epilepsy or other seizure disorder; or

  • liver or kidney disease.

Taking Treximet during the last 3 months of pregnancy may harm the unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

Sumatriptan and naproxen can pass into breast milk and may harm a nursing baby. You should not breast-feed while you are taking this medication.

Treximet is not approved for use by anyone younger than 12 years old.

How should I take Treximet?

Take Treximet exactly as prescribed by your doctor. Follow all directions on your prescription label. Do not take this medicine in larger amounts or for longer than recommended. Use the lowest dose that is effective in treating your condition. Overuse of migraine headache medicine can actually make your headaches worse.

Take one (1) Treximet tablet as soon as you notice headache symptoms, or after an attack has already begun. You may take the medicine with or without food.

Do not crush, chew, or break the tablet. Swallow the pill whole.

If your headache does not go away, call your doctor before taking a second tablet. If your headache does not completely go away, or goes away and comes back, take a second Treximet tablet two (2) hours after the first.

If you are 12 to 17 years old: Do not take a second tablet without first asking your doctor.

You must wait at least 2 hours before you take a second tablet. Do not take more than 2 Treximet tablets in 24 hours. If your symptoms have not improved, call your doctor before taking any more tablets.

Call your doctor if you have more than five headaches in one month (30 days).

Store Treximet at room temperature away from moisture and heat.

Treximet dosing information

Usual Adult Dose of Treximet for Migraine:

Initial dose: 1 tablet (sumatriptan-naproxen 85/500 mg) orally once
Maximum dose: 2 tablets (sumatriptan-naproxen 85/500 mg) in a 24-hour period taken at least 2 hours apart

Comments:
-Use only if a clear diagnosis of migraine has been established; if migraine does not respond to treatment, reconsider the diagnosis of migraine before treating any subsequent attacks.
-The safety of treating more than 5 migraines headaches (on average) in a 30-day period has not been established.

Use: For the acute treatment of migraine with or without aura.

Usual Pediatric Dose of Treximet for Migraine:

Age: 12 years or older
Initial dose: 1 tablet (sumatriptan-naproxen 10/60 mg) orally once
Maximum dose: 1 tablet (sumatriptan-naproxen 85/500 mg) in a 24-hour period

Comments:
-Use only if a clear diagnosis of migraine has been established; if migraine does not respond to treatment, reconsider the diagnosis of migraine before treating any subsequent attacks.
-The safety of treating more than 2 migraines headaches (on average) in a 30-day period has not been established.

Use: For the acute treatment of migraine with or without aura in patients 12 years of age or older.

What happens if I miss a dose?

Since Treximet is taken only when needed, it does not have a daily dosing schedule. Do not take more than 2 tablets in 24 hours.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while taking Treximet?

Treximet may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

Avoid taking aspirin while you are taking Treximet.

Ask a doctor or pharmacist before using any cold, allergy, or pain medication. Many medicines available over the counter contain aspirin or other medicines similar to naproxen. Taking certain products together can cause you to get too much of this type of medication. Check the label to see if a medicine contains aspirin, ibuprofen, ketoprofen, or naproxen.

Avoid drinking alcohol. It may increase your risk of stomach bleeding.

Treximet side effects

Get emergency medical help if you have signs of an allergic reaction to Treximet: sneezing, runny or stuffy nose; wheezing or trouble breathing; hives; swelling of your face, lips, tongue, or throat.

Get emergency medical help if you have signs of a heart attack or stroke: chest pain spreading to your jaw or shoulder, sudden numbness or weakness on one side of the body, slurred speech, feeling short of breath.

Stop using Treximet and call your doctor at once if you have:

  • numbness, tingling, pale or blue-colored appearance in your fingers or toes;

  • leg cramps, burning or heavy feeling in your feet or legs;

  • a seizure (convulsions);

  • swelling, rapid weight gain, shortness of breath;

  • stomach problems - sudden severe stomach pain (especially after eating), vomiting, bloody diarrhea, weight loss;

  • signs of stomach bleeding - bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds;

  • liver problems - nausea, upper stomach pain, itching, tired feeling, flu-like symptoms, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);

  • kidney problems - little or no urinating, painful or difficult urination, swelling in your feet or ankles;

  • low red blood cells (anemia) - pale skin, feeling light-headed or short of breath; or

  • severe skin reaction - fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.

Common Treximet side effects may include:

  • dizziness, drowsiness, weakness;

  • irregular heartbeats;

  • numbness or tingling;

  • dry mouth, heartburn, nausea; or

  • tight muscles, pain or pressure in your chest or throat.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

See also: Side effects (in more detail)

What other drugs will affect Treximet?

Ask your doctor before using Treximet if you take an antidepressant such as citalopram, escitalopram, fluoxetine (Prozac), fluvoxamine, paroxetine, sertraline (Zoloft), trazodone, or vilazodone. Taking any of these medicines with naproxen may cause you to bruise or bleed easily.

Tell your doctor about all your current medicines and any you start or stop using, especially:

  • lithium;

  • methotrexate;

  • heparin or warfarin (Coumadin, Jantoven);

  • heart or blood pressure medication, including a diuretic or "water pill"; or

  • steroid medicine (such as prednisone).

This list is not complete. Other drugs may interact with sumatriptan and naproxen, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

Where can I get more information?

  • Your pharmacist can provide more information about Treximet.
  • Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use Treximet only for the indication prescribed.
  • Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2016 Cerner Multum, Inc. Version: 4.01. Revision Date: 2015-09-09, 3:11:21 PM.

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