Naproxen-sumatriptan

Mechanism of Action

Naproxen: Inhibits synthesis of prostaglandins in body tissues by inhibiting at least 2 cyclooxygenase (COX) isoenzymes, COX-1 and COX-2; may inhibit chemotaxis, alter lymphocyte activity, and decrease proinflammatory cytokine activity

Sumatriptan: Selective 5-HT1B and 5-HT1D receptor agonist in cranial arteries; elicits vasoconstrictive and anti-inflammatory effects; associated with antidromic neuronal transmission and relief of migraine headache

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

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, feeling short of breath.

Stop using this medicine and call your doctor at once if you have:

• numbness, tingling, pale or blue-colored appearance in your fingers or toes;
• leg cramps, burning or heavy feeling in your feet or legs;
• a seizure (convulsions);
• swelling, rapid weight gain, shortness of breath;
• stomach problems--sudden severe stomach pain (especially after eating), vomiting, bloody diarrhea, weight loss;
• signs of stomach bleeding--bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds;
• liver problems--nausea, upper stomach pain, itching, tired feeling, flu-like symptoms, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
• kidney problems--little or no urinating, painful or difficult urination, swelling in your feet or ankles;
• low red blood cells (anemia)--pale skin, feeling light-headed or short of breath; or
• severe skin reaction--fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.

Common side effects may include:

• dizziness, drowsiness, weakness;
• irregular heartbeats;
• numbness or tingling;
• dry mouth, heartburn, nausea; or
• tight muscles, pain or pressure in your chest or throat.

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.