A fixed-dose combination (FDC) medication containing Sumatriptan, a selective serotonin (5-HT1B/1D) receptor agonist (triptan), and Naproxen, a non-steroidal anti-inflammatory drug (NSAID) of the propionic acid class. This combination is specifically designed for the acute treatment of migraine attacks with or without aura in adults. The rationale is to target multiple migraine pain pathways simultaneously: Sumatriptan causes cranial vasoconstriction and inhibits neurogenic inflammation, while Naproxen provides peripheral anti-inflammatory and analgesic effects, potentially offering superior and more sustained pain relief compared to monotherapy.
Adult: One tablet (Sumatriptan 85mg + Naproxen 500mg) at the onset of migraine pain. A second dose may be taken if headache returns, but no sooner than 2 hours after the first dose.
Note: Swallow the tablet whole with a full glass of water. Can be taken with or without food, but taking with food may reduce GI upset from naproxen. Do not crush or chew. Should not be used for more than 10 days per month.
The combination exerts a synergistic effect on migraine pathophysiology. Sumatriptan binds with high affinity to vascular 5-HT1B receptors, causing vasoconstriction of painfully dilated cerebral and meningeal blood vessels. It also activates pre-synaptic 5-HT1D receptors on trigeminal nerve terminals, inhibiting the release of vasoactive neuropeptides (CGRP, substance P) and neurogenic inflammation. Naproxen inhibits the cyclooxygenase (COX-1 and COX-2) enzymes, reducing the synthesis of prostaglandins (PGs), which are key mediators of pain, inflammation, and sensitization of peripheral nociceptors in the trigeminovascular system.
Pregnancy: Pregnancy Category C (US FDA). Avoid in first and second trimesters unless potential benefit justifies risk. Contraindicated in third trimester (risk of premature closure of ductus arteriosus, oligohydramnios, inhibition of labor, and potential maternal and neonatal bleeding).
Driving: May cause dizziness, drowsiness, or visual disturbances. Patients should be cautioned about operating machinery or driving until they are certain the medication does not adversely affect their performance.
| MAO-A Inhibitors (e.g., Phenelzine, Tranylcypromine, Moclobemide) | Markedly increased sumatriptan plasma levels and risk of serotonin syndrome. Contraindicated. | High |
| Other 5-HT1 Agonists (Triptans: Rizatriptan, Zolmitriptan) | Increased risk of vasospastic reactions. Avoid within 24 hours of each other. | High |
| Ergot derivatives (Ergotamine, Dihydroergotamine) | Prolonged vasospastic reactions. Contraindicated within 24 hours. | High |
| SSRIs/SNRIs (e.g., Fluoxetine, Sertraline, Venlafaxine) | Increased risk of serotonin syndrome (weakness, hyperreflexia, incoordination). | Moderate |
| Anticoagulants (Warfarin), Antiplatelets (Clopidogrel) | Naproxen increases risk of bleeding by inhibiting platelet function and potential GI ulceration. | High |
| Other NSAIDs (including low-dose Aspirin) | Increased risk of GI toxicity (ulcers, bleeding) with no added therapeutic benefit. | High |
| ACE Inhibitors (e.g., Ramipril), ARBs (e.g., Losartan), Diuretics | Naproxen may reduce antihypertensive efficacy and worsen renal function. | Moderate |
| Lithium | Naproxen decreases renal clearance of lithium, leading to toxicity. | High |
| Methotrexate | Naproxen may decrease methotrexate clearance, increasing toxicity risk. | High |
| Cyclosporine, Tacrolimus | Increased risk of nephrotoxicity. | High |
| Probenecid | Increases naproxen plasma levels by reducing its clearance. | Moderate |
| CYP2C9 Inhibitors (e.g., Fluconazole, Amiodarone) | May increase naproxen levels. | Low |
Same composition (Sumatriptan (85mg) + Naproxen (500mg)), different brands: