What is the most important information I should know about TREXIMET® (sumatriptan/naproxen sodium)?
TREXIMET® may increase your chance of a heart attack or stroke that can lead to death.
TREXIMET® contains 2 medicines: sumatriptan and naproxen sodium (a nonsteroidal anti-inflammatory
drug [NSAID]).
- This risk may happen early in treatment and may increase:
- with increasing doses of NSAIDs
- with longer use of NSAIDs.
Do not take TREXIMET® right before or after a heart surgery called a “coronary artery bypass
graft (CABG)."
Avoid taking TREXIMET® after a recent heart attack, unless your healthcare provider tells you
to. You may have an increased risk of another heart attack if you take NSAIDs after a recent heart
attack.
Stop taking TREXIMET® and get emergency help right away if you have any of the following
symptoms of a heart attack or stroke:
- discomfort in the center of your chest that lasts for more than a few minutes, or that goes away and comes back
- severe tightness, pain, pressure, or heaviness in your chest, throat, neck, or jaw
- pain or discomfort in your arms, back, neck, jaw, or stomach
- shortness of breath with or without chest discomfort
- breaking out in a cold sweat
- nausea or vomiting
- feeling lightheaded
- weakness in one part or on one side of your body
- slurred speech
TREXIMET® is not for people with risk factors for heart disease unless a heart exam is done and shows
no problem. You have a higher risk for heart disease if you:
- have high blood pressure
- smoke
- have diabetes
- have high cholesterol levels
- are overweight
- have a family history of heart disease
TREXIMET® can cause ulcers and bleeding in the stomach and intestines at any time during your
treatment.
Ulcers and bleeding can happen without warning symptoms and may cause death.
Your chance of getting an ulcer or bleeding increases with:
- past history of stomach ulcers, or stomach or intestinal bleeding with use of NSAIDs
- the use of medicines called “corticosteroids,” “anticoagulants,” and antidepressant medicines called “SSRIs” or
“SNRIs”
- more frequent use
- drinking alcohol
- having poor health
- advanced liver disease
- bleeding problems
- longer use
- smoking
- older age
TREXIMET® may cause serious allergic reactions or serious skin reactions that can be
life-threatening. Stop taking TREXIMET® and get emergency help right away if you
develop:
- sudden wheezing
- rash
- problems breathing or swallowing
- blisters or bleeding of your lips, eye lids, mouth, nose, or genitals
- swelling of your lips, tongue, throat or body
- fainting
- reddening of your skin with blisters or peeling
TREXIMET® should only be used exactly as prescribed, at the lowest dose possible for
your treatment, and for the shortest time needed.
TREXIMET® already contains an NSAID (naproxen). Do not use TREXIMET®
with other medicines to lessen pain or fever or with other medicines for colds or sleeping problems without talking
to your healthcare provider first, because they may contain an NSAID also.
Who should not take TREXIMET®?
Do not take TREXIMET® if you have:
- heart problems, history of heart problems, or right before or after heart bypass surgery
- had a stroke, transient ischemic attack (TIAs), or problems with your blood circulation
- hemiplegic migraines or basilar migraines. If you are not sure if you have these types of migraines, ask your
healthcare provider.
- narrowing of blood vessels to your legs and arms (peripheral vascular disease), stomach (ischemic bowel
disease), or kidneys
- uncontrolled high blood pressure
- taken any medicines in the last 24 hours that are called 5-HT1 agonists that are triptans or contain ergotamine.
Ask your healthcare provider for a list of these medicines if you are not sure.
- taken an antidepressant medicine called a monoamine oxidase (MAO) inhibitor within the last 2 weeks. Ask your
healthcare provider for a list if you are not sure.
- had an asthma attack, hives, or other allergic reaction with aspirin or any other NSAID medicine
- an allergy to sumatriptan, naproxen, or any of the ingredients in TREXIMET®.
- third trimester of pregnancy
- liver problems
What should I tell my healthcare provider before taking TREXIMET®?
Before you take TREXIMET®, tell your healthcare provider about all of your medical conditions,
including if you:
- have high blood pressure
- have asthma
- have high cholesterol
- have diabetes
- smoke
- are overweight
- have heart problems or a family history of heart problems or stroke
- have kidney problems
- have liver problems
- have had epilepsy or seizures
- are not using effective birth control
- are pregnant, think you might be pregnant, or are trying to become pregnant. Taking NSAIDs, including
TREXIMET®, at about 20 weeks of pregnancy or later may harm your unborn baby. If you need to take
NSAIDs for more than 2 days when you are between 20 and 30 weeks of pregnancy, your healthcare provider may need
to monitor the amount of fluid in your womb around your baby. You should not take NSAIDs after about 30
weeks of pregnancy.
- are breastfeeding or plan to breastfeed. The components of TREXIMET® pass into your breast milk
and may harm your baby. Talk with your healthcare provider about the best way to feed your baby if you take
TREXIMET®.
Tell your healthcare provider about all the medicines you take, including prescription and
over-the-counter medicines, vitamins, and herbal supplements.
TREXIMET® and certain other medicines can affect each other, causing serious side effects.
What should I avoid while taking TREXIMET®?®?
TREXIMET® can cause dizziness, weakness, or drowsiness. If you have these symptoms, do not drive a
car, use machinery, or do anything where you need to be alert.
What are the possible side effects of TREXIMET®?
TREXIMET® may cause serious side effects. See “What is the most important information
I should know about TREXIMET®?”
These serious side effects include:
- changes in color or sensation in your fingers and toes (Raynaud’s syndrome)
- new or worse high blood pressure
- heart failure from body swelling (fluid retention)
- kidney problems including kidney failure
- low red blood cells (anemia)
- liver problems including liver failure
- asthma attacks in people who have asthma
- stomach and intestinal problems (gastrointestinal and colonic ischemic events). Symptoms of gastrointestinal and
colonic ischemic events include:
- sudden or severe stomach pain
- weight loss
- constipation or diarrhea
- fever
- stomach pain after meals
- nausea or vomiting
- bloody diarrhea
- problems with blood circulation to your legs and feet (peripheral vascular ischemia). Symptoms of peripheral
vascular ischemia include:
- cramping and pain in your legs or hips
- feeling of heaviness or tightness in your leg muscles
- burning or aching pain in your feet or toes while resting
- numbness, tingling, or weakness in your legs
- cold feeling or color changes in 1 or both legs or feet
- medication overuse headaches. Some people who use too many TREXIMET® tablets may have worse
headaches (medication overuse headache). If your headaches get worse, your healthcare provider may decide to
stop your treatment with TREXIMET®.
- serotonin syndrome. Serotonin syndrome is a rare but serious problem that can happen in people using
TREXIMET®, especially if TREXIMET® is used with antidepressant medicines called
SSRIs or SNRIs.
- Stop taking TREXIMET® and call your healthcare provider right away if you have any of the
following symptoms of serotonin syndrome:
- changes in blood pressure
- tight muscles
- mental changes such as seeing things that are not there (hallucinations), agitation, or coma
- fast heartbeat
- high body temperature
- trouble walking
- seizures. Seizures have happened in people taking sumatriptan, one of the ingredients in
TREXIMET®, who have never had seizures before. Talk with your healthcare provider about your
chance of having seizures while you take TREXIMET®.
The most common side effects of TREXIMET® include:
- dizziness
- pain, discomfort, or stiffness in your neck, throat, jaw, or chest
- tingling or numbness in your fingers or toes
- dry mouth
- heartbeat problems
- feeling weak, drowsy, or tired
- nausea
- heartburn
- feeling hot
- muscle tightness
Stop TREXIMET® and call your healthcare provider right away if you have any of the
following symptoms:
- nausea that seems out of proportion to your migraine
- vomit blood
- yellow skin or eyes
- more tired or weaker than usual
- itching
- swelling of the arms, legs, hands, and feet
- sudden or severe stomach pain
- blood in your bowel movement or it is black and sticky like tar
- unusual weight gain
- flu-like symptoms
- diarrhea
- tenderness in your upper right side
These are not all of the possible side effects of TREXIMET®. For more information, ask your
healthcare provider or pharmacist.
To report adverse events, a product complaint, or for additional information about
TREXIMET®, call Currax Pharmaceuticals LLC at 1-800-793-2145.
TREXIMET® is used to treat acute migraine headaches with or without aura in patients 12 years of
age and older.
LIMITATIONS OF USE
TREXIMET® is not used to treat other types of headaches such as hemiplegic (that make you unable
to move on one side of your body) or basilar (rare form of migraine with aura) migraines.
TREXIMET® is not used to prevent or decrease the number of migraine headaches you have.
It is not known if TREXIMET® is safe and effective to treat cluster headaches.
You are encouraged to report negative side effects of taking
TREXIMET® to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.
Please see Full Prescribing Information, including Boxed WARNINGS, and Medication Guide before
prescribing TREXIMET®.
TREXIMET is a registered trademark of Currax Pharmaceuticals LLC. All
other trademarks are property of their respective owners.
This web site is intended only for residents of the United States.
What is the most important information I should know about TREXIMET® (sumatriptan/naproxen sodium)?
TREXIMET® may increase your chance of a heart attack or stroke that can lead to death.
TREXIMET® contains 2 medicines: sumatriptan and naproxen sodium (a nonsteroidal anti-inflammatory
drug [NSAID]).
- This risk may happen early in treatment and may increase:
- with increasing doses of NSAIDs
- with longer use of NSAIDs.
Do not take TREXIMET® right before or after a heart surgery called a “coronary artery bypass
graft (CABG)."
Avoid taking TREXIMET® after a recent heart attack, unless your healthcare provider tells you
to. You may have an increased risk of another heart attack if you take NSAIDs after a recent heart
attack.
Stop taking TREXIMET® and get emergency help right away if you have any of the following
symptoms of a heart attack or stroke:
- discomfort in the center of your chest that lasts for more than a few minutes, or that goes away and comes back
- severe tightness, pain, pressure, or heaviness in your chest, throat, neck, or jaw
- pain or discomfort in your arms, back, neck, jaw, or stomach
- shortness of breath with or without chest discomfort
- breaking out in a cold sweat
- nausea or vomiting
- feeling lightheaded
- weakness in one part or on one side of your body
- slurred speech
TREXIMET® is not for people with risk factors for heart disease unless a heart exam is done and shows
no problem. You have a higher risk for heart disease if you:
- have high blood pressure
- smoke
- have diabetes
- have high cholesterol levels
- are overweight
- have a family history of heart disease
TREXIMET® can cause ulcers and bleeding in the stomach and intestines at any time during your
treatment.
Ulcers and bleeding can happen without warning symptoms and may cause death.
Your chance of getting an ulcer or bleeding increases with:
- past history of stomach ulcers, or stomach or intestinal bleeding with use of NSAIDs
- the use of medicines called “corticosteroids,” “anticoagulants,” and antidepressant medicines called “SSRIs” or
“SNRIs”
- more frequent use
- drinking alcohol
- having poor health
- advanced liver disease
- bleeding problems
- longer use
- smoking
- older age
TREXIMET® may cause serious allergic reactions or serious skin reactions that can be
life-threatening. Stop taking TREXIMET® and get emergency help right away if you
develop:
- sudden wheezing
- rash
- problems breathing or swallowing
- blisters or bleeding of your lips, eye lids, mouth, nose, or genitals
- swelling of your lips, tongue, throat or body
- fainting
- reddening of your skin with blisters or peeling
TREXIMET® should only be used exactly as prescribed, at the lowest dose possible for
your treatment, and for the shortest time needed.
TREXIMET® already contains an NSAID (naproxen). Do not use TREXIMET®
with other medicines to lessen pain or fever or with other medicines for colds or sleeping problems without talking
to your healthcare provider first, because they may contain an NSAID also.
Who should not take TREXIMET®?
Do not take TREXIMET® if you have:
- heart problems, history of heart problems, or right before or after heart bypass surgery
- had a stroke, transient ischemic attack (TIAs), or problems with your blood circulation
- hemiplegic migraines or basilar migraines. If you are not sure if you have these types of migraines, ask your
healthcare provider.
- narrowing of blood vessels to your legs and arms (peripheral vascular disease), stomach (ischemic bowel
disease), or kidneys
- uncontrolled high blood pressure
- taken any medicines in the last 24 hours that are called 5-HT1 agonists that are triptans or contain ergotamine.
Ask your healthcare provider for a list of these medicines if you are not sure.
- taken an antidepressant medicine called a monoamine oxidase (MAO) inhibitor within the last 2 weeks. Ask your
healthcare provider for a list if you are not sure.
- had an asthma attack, hives, or other allergic reaction with aspirin or any other NSAID medicine
- an allergy to sumatriptan, naproxen, or any of the ingredients in TREXIMET®.
- third trimester of pregnancy
- liver problems
What should I tell my healthcare provider before taking TREXIMET®?
Before you take TREXIMET®, tell your healthcare provider about all of your medical conditions,
including if you:
- have high blood pressure
- have asthma
- have high cholesterol
- have diabetes
- smoke
- are overweight
- have heart problems or a family history of heart problems or stroke
- have kidney problems
- have liver problems
- have had epilepsy or seizures
- are not using effective birth control
- are pregnant, think you might be pregnant, or are trying to become pregnant. Taking NSAIDs, including
TREXIMET®, at about 20 weeks of pregnancy or later may harm your unborn baby. If you need to take
NSAIDs for more than 2 days when you are between 20 and 30 weeks of pregnancy, your healthcare provider may need
to monitor the amount of fluid in your womb around your baby. You should not take NSAIDs after about 30
weeks of pregnancy.
- are breastfeeding or plan to breastfeed. The components of TREXIMET® pass into your breast milk
and may harm your baby. Talk with your healthcare provider about the best way to feed your baby if you take
TREXIMET®.
Tell your healthcare provider about all the medicines you take, including prescription and
over-the-counter medicines, vitamins, and herbal supplements.
TREXIMET® and certain other medicines can affect each other, causing serious side effects.
What should I avoid while taking TREXIMET®?®?
TREXIMET® can cause dizziness, weakness, or drowsiness. If you have these symptoms, do not drive a
car, use machinery, or do anything where you need to be alert.
What are the possible side effects of TREXIMET®?
TREXIMET® may cause serious side effects. See “What is the most important information
I should know about TREXIMET®?”
These serious side effects include:
- changes in color or sensation in your fingers and toes (Raynaud’s syndrome)
- new or worse high blood pressure
- heart failure from body swelling (fluid retention)
- kidney problems including kidney failure
- low red blood cells (anemia)
- liver problems including liver failure
- asthma attacks in people who have asthma
- stomach and intestinal problems (gastrointestinal and colonic ischemic events). Symptoms of gastrointestinal and
colonic ischemic events include:
- sudden or severe stomach pain
- weight loss
- constipation or diarrhea
- fever
- stomach pain after meals
- nausea or vomiting
- bloody diarrhea
- problems with blood circulation to your legs and feet (peripheral vascular ischemia). Symptoms of peripheral
vascular ischemia include:
- cramping and pain in your legs or hips
- feeling of heaviness or tightness in your leg muscles
- burning or aching pain in your feet or toes while resting
- numbness, tingling, or weakness in your legs
- cold feeling or color changes in 1 or both legs or feet
- medication overuse headaches. Some people who use too many TREXIMET® tablets may have worse
headaches (medication overuse headache). If your headaches get worse, your healthcare provider may decide to
stop your treatment with TREXIMET®.
- serotonin syndrome. Serotonin syndrome is a rare but serious problem that can happen in people using
TREXIMET®, especially if TREXIMET® is used with antidepressant medicines called
SSRIs or SNRIs.
- Stop taking TREXIMET® and call your healthcare provider right away if you have any of the
following symptoms of serotonin syndrome:
- changes in blood pressure
- tight muscles
- mental changes such as seeing things that are not there (hallucinations), agitation, or coma
- fast heartbeat
- high body temperature
- trouble walking
- seizures. Seizures have happened in people taking sumatriptan, one of the ingredients in
TREXIMET®, who have never had seizures before. Talk with your healthcare provider about your
chance of having seizures while you take TREXIMET®.
The most common side effects of TREXIMET® include:
- dizziness
- pain, discomfort, or stiffness in your neck, throat, jaw, or chest
- tingling or numbness in your fingers or toes
- dry mouth
- heartbeat problems
- feeling weak, drowsy, or tired
- nausea
- heartburn
- feeling hot
- muscle tightness
Stop TREXIMET® and call your healthcare provider right away if you have any of the
following symptoms:
- nausea that seems out of proportion to your migraine
- vomit blood
- yellow skin or eyes
- more tired or weaker than usual
- itching
- swelling of the arms, legs, hands, and feet
- sudden or severe stomach pain
- blood in your bowel movement or it is black and sticky like tar
- unusual weight gain
- flu-like symptoms
- diarrhea
- tenderness in your upper right side
These are not all of the possible side effects of TREXIMET®. For more information, ask your
healthcare provider or pharmacist.
To report adverse events, a product complaint, or for additional information about
TREXIMET®, call Currax Pharmaceuticals LLC at 1-800-793-2145.
TREXIMET® is used to treat acute migraine headaches with or without aura in patients 12 years of
age and older.
LIMITATIONS OF USE
TREXIMET® is not used to treat other types of headaches such as hemiplegic (that make you unable
to move on one side of your body) or basilar (rare form of migraine with aura) migraines.
TREXIMET® is not used to prevent or decrease the number of migraine headaches you have.
It is not known if TREXIMET® is safe and effective to treat cluster headaches.
You are encouraged to report negative side effects of taking
TREXIMET® to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.
Please see Full Prescribing Information, including Boxed WARNINGS, and Medication Guide before
prescribing TREXIMET®.
TREXIMET is a registered trademark of Currax Pharmaceuticals LLC. All
other trademarks are property of their respective owners.
This web site is intended only for residents of the United States.
