Naproxen-Sumatriptan

Naproxen and Sumatriptan are combination prescription medications used to treat migraine headaches. 

• Naproxen and Sumatriptan are available under various brand names: Treximet

Common side effects of Naproxen and Sumatriptan include:

• dizziness, drowsiness, feeling weak or tired.
• irregular heartbeats.
• numbness or tingling in your fingers or toes.
• dry mouth, heartburn, nausea.
• feeling hot; or
• tight muscles, pain, or pressure in your chest or throat.

Serious side effects of Naproxen and Sumatriptan include:

• hives, 
• difficult breathing, 
• swelling in the face or throat.
• severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).
• numbness, tingling, pale or blue-colored appearance in the fingers or toes.
• leg cramps, burning, coldness, or heavy feeling in the feet or legs.
• severe headache, blurred vision, pounding in the neck or ears.
• a seizure.
• heart problems--swelling, rapid weight gain, feeling short of breath.
• high levels of serotonin in the body--agitation, hallucinations, fever, sweating, shivering, fast heart rate, muscle stiffness, twitching, loss of coordination, nausea, vomiting, diarrhea.
• kidney problems--little or no urination, swelling in the feet or ankles, feeling tired or short of breath.
• liver problems--loss of appetite, stomach pain (upper right side), tiredness, itching, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).
• low red blood cells (anemia)--pale skin, unusual tiredness, feeling light-headed or short of breath.
• signs of stomach bleeding--bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds; or
• stomach problems--sudden severe stomach pain (especially after eating), vomiting, constipation, bloody diarrhea, weight loss.

Rare side effects of Naproxen and Sumatriptan include:

• none

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors.
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
• Serious heart symptoms such as fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheartedness, or passing out.

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult and pediatric dosage

Tablet

• 60 mg/10 mg
• 500 mg/85 mg

Migraine, moderate to severe, acute treatment

Adult dosage

• Take 1 tablet as soon as you notice headache symptoms, or after an attack has already begun. You may take the medicine with or without food.
• Swallow the tablet whole and do not crush, chew, or break it.

Pediatric dosage

• Children and Adolescents above 12 to 17 years:
• 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 tablets in 24 hours. If your symptoms have not improved, call your doctor before taking any more tablets.
• You should not use this medicine to treat more than 5 headaches in 30 days

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Naproxen and Sumatriptan have severe interactions with the following drugs:
  • almotriptan
  • bromocriptine
  • cabergoline
  • dihydroergotamine
  • dihydroergotamine intranasal
  • eletriptan
  • ergoloid mesylates
  • ergotamine
  • frovatriptan
  • methylergonovine
  • naratriptan
  • procarbazine
  • rizatriptan
  • zolmitriptan
• Naproxen and Sumatriptan have serious interactions with at least 39 other drugs.
• Naproxen and Sumatriptan have moderate interactions with at least 303 other drugs.
• Naproxen and Sumatriptan have minor interactions with at least 82 other drugs.

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all your products. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your health care professional or doctor for additional medical advice, or if you have health questions or concerns.

Contraindications

• Hypersensitivity to Naproxen and Sumatriptan
• heart problems, uncontrolled high blood pressure.
• a history of heart attack or stroke (including TIA or "mini-stroke").
• Wolff-Parkinson-White Syndrome (sudden fast heartbeats) or other heart rhythm disorder.
• blood circulation problems (including poor blood flow to your arms and legs, stomach, intestines, or kidneys);
• a history of asthma or severe allergic reaction after taking aspirin or an NSAID.
• severe liver disease
• if you are in late pregnancy.

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Naproxen and Sumatriptan?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Naproxen and Sumatriptan?”

Cautions

• You should not use this medicine if you have heart problems, uncontrolled high blood pressure, blood circulation problems, Wolff-Parkinson-White Syndrome, a history of heart attack or stroke, severe liver disease, a history of severe allergic reaction to aspirin or an NSAID, or if you are in late pregnancy.
• Naproxen can increase your risk of fatal heart attack or stroke. Do not use this medicine just before or after heart bypass surgery (coronary artery bypass graft, or CABG). Naproxen may also cause stomach or intestinal bleeding, which can be fatal.
• 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, or feeling short of breath.
• Naproxen may also cause stomach or intestinal bleeding, which can be fatal. These conditions can occur without warning while you are using naproxen and sumatriptan, especially in older adults.
• Do not use naproxen and sumatriptan 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 naproxen and sumatriptan within 24 hours before or after using another migraine headache medicine, including:
• sumatriptan tablets, injection, or nasal spray;
• almotriptan, eletriptan, frovatriptan, naratriptan, rizatriptan, or zolmitriptan; or
• ergot medicine such as ergotamine, dihydroergotamine, or methylergonovine.
• Avoid drinking alcohol. It may increase your risk of stomach bleeding.
• Avoid taking aspirin or other salicylates such as Nuprin Backache Caplet, Kaopectate, KneeRelief, Pamprin Cramp Formula, Pepto-Bismol, Tricosal, Trilisate, and others.
• Avoid driving or hazardous activity until you know how this medicine will affect you. Your reactions could be impaired.
• Ask a doctor or pharmacist before using other medicines for pain, fever, swelling, or cold/flu symptoms. They may contain ingredients similar to naproxen (such as aspirin, ibuprofen, or ketoprofen).

Pregnancy and Lactation

• Taking this Naproxen and Sumatriptan during the last 3 months of pregnancy may harm the unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.
• Lactation
  • You should not breastfeed while you are taking this medicine.