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This safety and warning information is vital for anyone considering or currently taking medications containing naproxen or sumatriptan, such as Treximet. Understanding the potential risks and precautions can help in making informed decisions about its use. Below are the key safety details:

• Cardiovascular Risks: There is an increased risk of heart attack, stroke, and chest pain (angina) with naproxen, especially with long-term use or in higher doses. This risk is heightened in individuals with pre-existing heart conditions or those who have undergone heart surgery. Do not use this medication right before or after heart surgery such as coronary artery bypass graft (CABG).

• Gastrointestinal Concerns: Naproxen can lead to serious stomach issues, including ulcers and bleeding. These complications can occur at any time and are more likely in older adults or those with a history of stomach problems. Immediate medical attention is necessary if you experience symptoms such as persistent stomach pain, black or tarry stools, or vomit that resembles coffee grounds.

• Blood Pressure and Heart Failure: This medication can cause fluid retention, potentially leading to increased blood pressure and swelling, which may contribute to heart failure. Patients with a history of high blood pressure or heart failure should use caution.

• Irregular Heart Rhythms: Sumatriptan in the medication may cause irregular heart rhythms (arrhythmia), which can be serious. Avoid use if you have a condition that predisposes you to arrhythmias. Be vigilant for symptoms such as chest pain, dizziness, or trouble breathing.

• Vascular Narrowing: Sumatriptan may cause extreme narrowing of blood vessels, which can reduce blood flow to certain parts of the body, leading to complications.

• Serotonin Syndrome: There's a risk of serotonin syndrome when Treximet is combined with other medications that increase serotonin levels, such as certain antidepressants. Symptoms include confusion, rapid heart rate, and high blood pressure.

• Liver and Kidney Damage: Long-term use of naproxen can harm liver and kidneys, especially in older adults or those with pre-existing liver or kidney issues. Watch for symptoms like changes in urination, fatigue, or muscle cramps.

• Allergic Reactions: Severe allergic reactions, including anaphylaxis, can occur. Those with known allergies to NSAIDs or aspirin should avoid this medication. Seek immediate medical help if you experience symptoms like hives, facial swelling, or difficulty breathing.

• Pregnancy Warning: Naproxen poses risks to an unborn baby, particularly in the latter half of pregnancy. It can lead to serious fetal complications.

Contraindications: Treximet should not be used by individuals with:

• Previous allergic reactions to sumatriptan or naproxen.
• History of asthma or allergic reactions after taking NSAIDs.
• Recent heart surgery (CABG).
• Uncontrolled high blood pressure or coronary artery disease.
• Certain irregular heart rhythms, such as Wolff-Parkinson-White syndrome.
• History of stroke or "mini-stroke."
• Peripheral vascular or ischemic bowel disease.
• Severe liver problems.
• Recent use of ergot-containing medications or other triptans.
• Recent or current use of monoamine oxidase inhibitors (MAOIs).

Always discuss your full medical history and current medications with your healthcare provider to determine if this medication is safe for you. Seek immediate medical attention in case of overdose or serious side effects.

Common side effects:

• Flushing
• Dizziness
• Drowsiness
• Nausea
• Upset stomach
• Tingling or 'pins and needles' sensation
• Tiredness
• Weakness
• Dry mouth

• Indigestion

  Less common but important to monitor:

• Chest pain or discomfort
• Tightness or pressure in the neck, throat, or jaw
• Shortness of breath

• Unusual sweating

  Serious side effects:

• Blue fingers or toes
• Cold extremities
• Difficulty swallowing
• Signs of kidney problems
• Heart failure
• Liver damage
• Persistent nausea
• Dark urine
• Yellowing of the skin or eyes
• Serotonin syndrome
• Rapid heartbeat
• Hallucinations
• Severe dizziness
• Unexplained fever
• Serious allergic reaction (rash, itching, swelling, severe dizziness, or trouble breathing)

Certain medications can interact with this drug, potentially leading to serious effects. Notable interactions include:

1. Blood Pressure Medications: Aliskiren, ACE inhibitors (e.g., Captopril, Lisinopril), and angiotensin II receptor blockers (e.g., Losartan, Valsartan) may interact with this medication.

2. Corticosteroids and Diuretics: Drugs like Prednisone and diuretics such as Furosemide ("water pills") can also interact.

3. MAO Inhibitors: Avoid MAO inhibitors like isocarboxazid, linezolid, and others during treatment, as combining them can lead to a severe, possibly life-threatening reaction. Consult your doctor about when to start or stop this medication if you are using MAO inhibitors.

4. Serotonin-Enhancing Drugs: Taking drugs that increase serotonin, including MDMA, St. John's wort, and certain antidepressants (SSRIs like Fluoxetine/paroxetine and SNRIs like Duloxetine/Venlafaxine), may raise the risk of serotonin syndrome, especially when starting or increasing the dosage.

5. Bleeding Risk: This medication may heighten bleeding risks if taken with drugs like Clopidogrel, and anticoagulants such as Dabigatran, Enoxaparin, and Warfarin.

6. Pain Relievers/Fever Reducers: Many over-the-counter medicines contain NSAIDs, similar to Naproxen, and taking them together can amplify side effects. However, continue taking low-dose Aspirin for heart attack or stroke prevention as advised by your doctor, as naproxen might reduce aspirin's effectiveness in this regard. Discuss with your doctor alternative medications for pain or fever.

7. Ergotamine and Triptans: If you take ergotamine medications or triptan drugs like Zolmitriptan and Rizatriptan, you'll need to space out the doses to avoid serious side effects. Your doctor can advise on appropriate timing.

8. Lab Tests: This drug might affect certain lab tests, such as bleeding times and adrenal function tests, leading to inaccurate results. Inform all healthcare providers and lab personnel that you are using this medication.

Always discuss potential interactions with your healthcare provider to ensure safe and effective use of your medications.