A fixed-dose combination (FDC) medication for the acute treatment of migraine attacks with or without aura in adults. Sumatriptan is a selective serotonin (5-HT1B/1D) receptor agonist (triptan) that causes cranial vasoconstriction and inhibits neurogenic inflammation. Naproxen is a non-steroidal anti-inflammatory drug (NSAID) that inhibits cyclooxygenase (COX) enzymes, reducing prostaglandin synthesis and inflammation. This combination provides synergistic action, targeting both the vascular and inflammatory components of migraine, offering superior pain relief and reduced recurrence compared to monotherapy.
Adult: One tablet (Sumatriptan 50mg + Naproxen 550mg) taken at the onset of migraine pain. A second dose may be taken after at least 2 hours if headache recurs. Do not exceed 2 tablets in 24 hours.
Note: Take with a full glass of water. Can be taken with or without food, but taking with food or milk may reduce GI upset from naproxen. Swallow whole; do not crush or chew. Should be used for acute attacks only, not on a daily scheduled basis.
The combination exerts a dual mechanism. 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 non-selectively inhibits both COX-1 and COX-2 enzymes, blocking the conversion of arachidonic acid to prostaglandins (PGs) and thromboxanes. In migraine, this reduces the inflammatory cascade and sensitization of perivascular nociceptors, potentiating the effect of sumatriptan.
Pregnancy: US FDA Pregnancy Category C (sumatriptan) and Category C (naproxen in 1st/2nd trimester) / Category D (naproxen in 3rd trimester). Avoid in 1st trimester if possible due to NSAID-associated risk of miscarriage and congenital defects. Absolutely contraindicated in 3rd trimester due to risk of premature closure of ductus arteriosus, oligohydramnios, and prolonged labor. Use only if potential benefit justifies potential fetal risk.
Driving: May cause dizziness, drowsiness, somnolence, or visual disturbances. Patients should not drive or operate machinery until they know how the medication affects them.
| SSRIs/SNRIs (e.g., Sertraline, Venlafaxine) | Increased risk of serotonin syndrome. | Major |
| Other NSAIDs (e.g., Ibuprofen, Aspirin) | Increased risk of GI toxicity, bleeding, and reduced antiplatelet effect of aspirin. | Major |
| Anticoagulants (Warfarin, NOACs) | Increased risk of bleeding due to antiplatelet effect of naproxen and potential displacement from protein binding. | Major |
| Lithium | Naproxen decreases renal clearance of lithium, leading to toxicity. | Major |
| Methotrexate | Naproxen may decrease renal excretion of methotrexate, increasing toxicity risk. | Major |
| Diuretics (Furosemide, Thiazides) | Naproxen reduces diuretic and antihypertensive efficacy; risk of renal impairment. | Moderate |
| ACE Inhibitors/ARBs (e.g., Ramipril, Losartan) | Naproxen reduces antihypertensive effect; risk of renal impairment, especially in volume-depleted patients. | Moderate |
| Corticosteroids (e.g., Prednisolone) | Markedly increased risk of GI ulceration and bleeding. | Major |
| Selective Serotonin Reuptake Inhibitors (SSRIs) | Increased bleeding risk. | Moderate |
| Ergot Alkaloids (Ergotamine) | Prolonged vasospastic reactions; contraindicated within 24 hours. | Major |
| MAO-A Inhibitors (Moclobemide) | Reduced sumatriptan metabolism, increasing toxicity risk; contraindicated. | Major |
| 5-HT1 Agonists (other Triptans) | Additive vasoconstrictive effects; avoid within 24 hours. | Major |
Same composition (Sumatriptan (50mg) + Naproxen (550mg)), different brands: