Treximet

DRUG DESCRIPTION

TREXIMET contains sumatriptan (as the succinate), a selective 5-hydroxytryptamine1 (5-HT1) receptor subtype agonist, and naproxen sodium, a member of the arylacetic acid group of nonsteroidal anti-inflammatory drugs (NSAIDs).

Sumatriptan succinate is chemically designated as 3-[2-(dimethylamino)ethyl]-N-methyl?­indole-5-methanesulfonamide succinate (1:1), and it has the following structure:

Sumatriptan Structural Formula Illustration

The empirical formula is C14H21N3O2S •C4H6O4, representing a molecular weight of 413.5. Sumatriptan succinate is a white to off-white powder that is readily soluble in water and in saline.

Naproxen sodium is chemically designated as (S)-6-methoxy-?-methyl-2-naphthaleneacetic acid, sodium salt, and it has the following structure:

The empirical formula is C14H13NaO3, representing a molecular weight of 252.23. Naproxen sodium is a white-to-creamy white crystalline solid, freely soluble in water at neutral pH.

Each TREXIMET Tablet for oral administration contains 119 mg of sumatriptan succinate equivalent to 85 mg of sumatriptan and 500 mg of naproxen sodium. Each tablet also contains the inactive ingredients croscarmellose sodium, dextrose monohydrate, dibasic calcium phosphate, FD&C Blue No. 2, lecithin, magnesium stearate, maltodextrin, microcrystalline cellulose, povidone, sodium bicarbonate, sodium carboxymethylcellulose, talc, and titanium dioxide.

What are the possible side effects of sumatriptan and naproxen (Treximet)?

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

Call your doctor at once if you a serious side effect such as:

  • chest pain or pressure, tight feeling in your neck or jaw, pain spreading to your arm or shoulder;
  • sudden numbness or weakness, confusion, problems with vision, speech, or balance;
  • bloody, or tarry stools, coughing up blood or vomit that...

Read All Potential Side Effects and See Pictures of Treximet »

What are the precautions when taking sumatriptan and naproxen sodium tablets (Treximet)?

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...

Read All Potential Precautions of Treximet »


Treximet Consumer (continued)

SIDE EFFECTS: See also Warning section.

Dizziness, drowsiness, flushing, tiredness, 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).

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, unusual/extreme tiredness, 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 NSRIs (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.

During the first 6 months of pregnancy, this medication should be used only when clearly needed. Naproxen is not recommended for use during the last 3 months of pregnancy due to possible harm to the unborn baby and interference with normal labor/delivery. Discuss the risks and benefits with your doctor.

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.


Treximet Patient Information Including Side Effects

Brand Names: Treximet

Generic Name: sumatriptan and naproxen (Pronunciation: soo ma TRIP tan and na PROX en)

  • What is sumatriptan and naproxen (Treximet)?
  • What are the possible side effects of sumatriptan and naproxen (Treximet)?
  • What is the most important information I should know about sumatriptan and naproxen
  • What should I discuss with my health care provider before taking sumatriptan and naproxen (Treximet)?
  • How should I take sumatriptan and naproxen (Treximet)?
  • What happens if I miss a dose (Treximet)?
  • What happens if I overdose (Treximet)?
  • What should I avoid while taking sumatriptan and naproxen (Treximet)?
  • What other drugs will affect sumatriptan and naproxen (Treximet)?
  • Where can I get more information?

What is sumatriptan and naproxen (Treximet)?

Sumatriptan is a headache medicine. It is believed to work by narrowing the blood vessels around the brain. Sumatriptan also reduces substances in the body that can trigger headache pain, nausea, sensitivity to light and sound, and other migraine symptoms.

Naproxen is in a group of drugs called nonsteroidal anti-inflammatory drugs (NSAIDs). Naproxen works by reducing hormones that cause inflammation and pain in the body.

The combination of sumatriptan and naproxen is used to treat migraine headaches.

Sumatriptan and naproxen will only treat a headache that has already begun. It will not prevent headaches or reduce the number of attacks. This medication should not be used to treat a migraine that causes visual aura (such as flickering lights) with weakness on one side of the body, speech problems, ringing in your ears.

Sumatriptan and naproxen may also be used for other purposes not listed in this medication guide.

What are the possible side effects of sumatriptan and naproxen (Treximet)?

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

Call your doctor at once if you a serious side effect such as:

  • chest pain or pressure, tight feeling in your neck or jaw, pain spreading to your arm or shoulder;
  • sudden numbness or weakness, confusion, problems with vision, speech, or balance;
  • bloody, or tarry stools, coughing up blood or vomit that looks like coffee grounds;
  • nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
  • urinating less than usual or not at all;
  • pale skin, weakness, easy bruising, flu symptoms;
  • swelling or rapid weight gain;
  • numbness, tingling, pale or blue-colored appearance in your fingers or toes;
  • severe blistering, peeling, and red skin rash;
  • seizure (convulsions); or
  • anxiety, restlessness, high fever, sweating, memory problems, trouble concentrating, loss of coordination, vomiting, diarrhea, fast heart rate, hallucinations, or fainting.

Less serious side effects may include:

  • dizziness, drowsiness;
  • constipation, dizziness, indigestion, dry mouth;
  • warmth, numbness, or tingly feeling;
  • redness in your face;
  • tight muscles; or
  • mild pressure or heavy feeling in any part of your body.

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.

What is the most important information I should know about sumatriptan and naproxen

Do not take more than 2 sumatriptan and naproxen tablets in 24 hours.

You should not use this medication if you are allergic to sumatriptan (Imitrex) or naproxen (Aleve, Anaprox, Naprosyn), or if you have a history of asthma or allergic reaction caused by aspirin or other NSAIDs (non-steroidal anti-inflammatory drugs).

Do not take sumatriptan and naproxen if you have liver disease, uncontrolled high blood pressure, or a history of heart disease, angina (chest pain), blood circulation problems, heart attack, stroke, or heart bypass surgery.

Do not take sumatriptan and naproxen if you have taken a monoamine oxidase inhibitor (MAOI) such as isocarboxazid (Marplan), tranylcypromine (Parnate), selegiline (Eldepryl, Emsam), or phenelzine (Nardil) in the past 14 days.

Do not take sumatriptan and naproxen within 24 hours before or after taking any of the following medications: almotriptan (Axert), eletriptan (Relpax), frovatriptan (Frova), naratriptan (Amerge), rizatriptan (Maxalt, Maxalt-MLT), sumatriptan (Imitrex), or zolmitriptan (Zomig), or ergot medicine such as methysergide (Sansert), ergotamine (Ergomar, Ergostat, Cafergot, Ercaf, Wigraine), dihydroergotamine (D.H.E. 45, Migranal Nasal Spray), ergonovine (Ergotrate), methylergonovine (Methergine).

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