Indications 

Treximet is a prescribed medication for the immediate relief of migraines, with or without aura, in adult and adolescent patients aged 12 and above. 

Treximet comprises two components: naproxen, a nonsteroidal anti-inflammatory drug (NSAID) used for pain relief, and sumatriptan, a member of the triptan class that acts on serotonin to constrict brain blood vessels and potentially alleviates pain by affecting specific brain nerves. 

Uses and Dosage 

Before taking Treximet and with every prescription refill, carefully review its medication guide and patient information leaflet. If you have any inquiries, seek guidance from your healthcare provider or pharmacist. 

The dosage of Treximet may vary per individual based on their medical condition, age, and response to the treatment. 

Typically, Treximet is taken at the first sign of a migraine as directed by the doctor, without regard to food intake. The tablet must be ingested whole with a full glass of water and should not be cut, crushed, or chewed. 

If the headache persists or if partial relief is attained: 

• Adults can consider a second dose 2 hours after the initial one, not exceeding 2 doses within 24 hours. 
• For individuals aged 12 to 17: The safety and effectiveness of taking more than 1 dose of Treximet within 24 hours are uncertain. Consult your doctor for guidance if your headache persists or recurs. 

If the initial dose does not provide relief, consult your doctor before taking a second dose. 

Some individuals may need to have their initial Treximet dose administered in a healthcare provider’s office or another medical facility. Consult your doctor to determine if this applies to you. 

Do not exceed treating more than 5 headaches in 30 days with Treximet (or more than 2 headaches in 30 days if you are aged 12 to 17). Inform your doctor if you require more frequent use, experience reduced effectiveness, or if your headaches worsen. 

Side Effects 

Listed below are the potential adverse effects of Treximet. Tell your doctor promptly should any of these effects last or worsen. 

Common Side Effects 

• Dizziness, drowsiness, weakness, or fatigue 
• Irregular heartbeats 
• Numbness or tingling in fingers or toes 
• Dry mouth, heartburn, nausea 
• Sensation of heat 
• Tight muscles, chest, or throat discomfort 

Serious Side Effects 

• Numbness, tingling, or fingers/toes appearing pale or blue 
• Leg cramps, burning, coldness, or a heavy sensation in feet or legs 
• Severe headache, blurred vision, pulsing sensations in neck or ears 
• Seizure 
• Heart-related issues: 
  • Swelling 
  • Rapid weight gain 
  • Breathlessness 
• Elevated serotonin levels: 
  • Agitation 
  • Hallucinations 
  • Fever 
  • Sweating 
  • Shivering 
  • Rapid heart rate 
  • Muscle stiffness 
  • Twitching 
  • Coordination loss 
  • Nausea 
  • Vomiting 
  • Diarrhea 
• Kidney problems: 
  • Minimal urination 
  • Ankle/foot swelling 
  • Fatigue 
• Breathlessness 
  • Liver issues:  
  • Appetite loss 
  • Upper right stomach pain 
  • Fatigue 
  • Itching 
  • Dark urine 
  • Clay-colored stools 
  • Jaundice (yellowing of skin/eyes) 
• Low red blood cells (anemia):  
  • Pale skin 
  • Unusual fatigue 
  • Light-headedness 
  • Breathlessness 
• Signs of stomach bleeding:  
  • Bloody or tar-like stools 
  • Coughing up blood, or vomit resembling coffee grounds 
• Stomach problems: 
  • Sudden, severe stomach pain (particularly after eating) 
  • Vomiting 
  • Constipation 
  • Bloody diarrhea 
  • Weight loss 

Stop taking Treximet and contact your doctor promptly if you experience any of the serious side effects listed above. 

Discontinue Treximet use and promptly seek emergency medical assistance if you experience: 

• Indications of a heart attack or stroke, such as: 
  • Chest pain radiating to the jaw or shoulder 
  • Sudden numbness or weakness on one side of the body 
  • Slurred speech 
  • Breathlessness 
• Indications of a severe drug reaction, potentially impacting multiple body systems, such as: 
  • Skin rash 
  • Fever 
  • Swollen glands 
  • Muscle discomfort 
  • Pronounced weakness 
  • Atypical bruising 
  • Yellowing of the skin or eyes

Seek immediate medical help if you have signs of a severe skin reaction such as: 

• Fever 
• Sore throat 
• Burning eyes 
• Skin pain 
• Red or purple skin rash with blistering and peeling 

Allergic Reactions 

Although rare, a severe allergic reaction to Treximet may occur. Prompt medical attention is necessary upon observing any indications of an allergic response, including: 

• Hives 
• Trouble breathing 
• Face, lips, tongue, or throat swelling 

Not all side effects of Treximet are included in this list. Inform your doctor if any unlisted effects arise. 

Cautions 

Before starting treatment with Treximet, inform your doctor if you have any known allergies, particularly to sumatriptan, naproxen, aspirin, or other NSAIDs (like ibuprofen and celecoxib). 

Consult your pharmacist for additional details about Treximet, as it may contain inactive ingredients that may lead to allergic reactions or other complications. 

To ensure Treximet is safe for you, disclose to your physician your medical background, especially if you have a history of: 

• Asthma, including past worsening of breathing after taking aspirin or other NSAIDs 
• Blood circulation problems (e.g., in legs, arms/hands, or stomach) 
• Blood disorders (e.g., anemia, bleeding/clotting problems) 
• Nasal polyps 
• Certain types of headaches (hemiplegic or basilar migraine) 
• Heart problems (e.g., chest pain, irregular heartbeat, previous heart attack) 
• Liver disease 
• Seizure 
• Transient ischemic attack 
• Throat/stomach/intestinal problems (e.g., bleeding, heartburn, ulcers) 
• Swelling (edema, fluid retention) 

Inform all your healthcare providers of any current or recently started or stopped medications, including prescription and over-the-counter drugs, vitamins, and herbal supplements to reduce the risk of drug interactions with Treximet. 

Some of the products that may interact with Treximet include:  

• Aliskiren 
• Angiotensin-converting enzyme (ACE) inhibitors (e.g., captopril, lisinopril) 
• Angiotensin II receptor blockers (ARBs) (e.g., losartan, valsartan),  
• Cidofovir  
• Corticosteroids (e.g., prednisone) 
• Diuretics (e.g., furosemide) 

Refrain from utilizing Treximet if you have taken an MAO inhibitor within the previous 14 days, as this could lead to a potentially harmful drug interaction. MAO inhibitors encompass: 

• Isocarboxazid  
• Linezolid 
• Methylene blue injection 
• Phenelzine 
• Rasagiline 
• Selegiline 
• Tranylcypromine  

Treximet can elevate the risk of bleeding when used alongside other medications that may also induce bleeding. These medications include: 

• Anti-platelet drugs (e.g., clopidogrel) 
• Blood thinners (e.g., dabigatran, enoxaparin, and warfarin) 

If taking ergotamine medication (e.g., dihydroergotamine) or other “triptan” drugs (e.g., zolmitriptan, rizatriptan) along with Treximet, ensure you space your doses apart to reduce the risk of severe side effects. Consult your doctor to determine the recommended time interval between these medication doses. 

Treximet contains sodium. Before using this medication, inform your doctor if you are restricting your salt intake. 

Carefully review the labels of all your prescription and non-prescription medications, as many contain pain relievers/fever reducers like aspirin or NSAIDs such as celecoxib, ibuprofen, or ketorolac. These drugs are similar to naproxen and may heighten the risk of side effects if used concurrently.  

However, if your doctor has prescribed low-dose aspirin (typically 81-162 milligrams daily) for heart attack or stroke prevention, continue taking it unless advised otherwise. Regular use of naproxen may reduce aspirin’s effectiveness in preventing heart issues. Discuss these risks and benefits with your doctor and inquire about alternative pain and fever relief options. 

Naproxen elevates the risk of severe heart attack or stroke. Avoid using Treximet just before or after heart bypass surgery (coronary artery bypass graft or CABG). Naproxen can also potentially lead to life-threatening stomach or intestinal bleeding. 

Treximet can potentially affect specific laboratory tests, like bleeding times and adrenal function tests, leading to inaccurate results. Inform laboratory staff and your healthcare providers about your use of this medication to ensure the accuracy of test results. 

The use of Treximet can heighten sun sensitivity. Minimize sun exposure, avoid tanning equipment, and use sunscreen with protective clothing. Notify your doctor right away if you experience sunburn or skin irritation. 

During pregnancy, refrain from using Treximet unless specifically advised by your healthcare provider. The use of NSAIDs during the final 20 weeks of pregnancy can result in significant heart or kidney issues for the developing baby and potential pregnancy complications. 

Sumatriptan and naproxen can be transferred into breast milk and may have adverse effects on a nursing baby. Before breastfeeding, seek advice from your healthcare provider.