Finished product reference
Sumatriptan / Naproxen
Tablet · Oral · 85 mg/500 mg
- List code
- 15589
- Salt form
- Succinate
- Pharmacologic class
- Antimigraine combination: 5-HT1B/1D receptor agonist (triptan) plus NSAID
What it is and how it works
Sumatriptan constricts cranial blood vessels and inhibits release of pro-inflammatory neuropeptides from trigeminal nerve endings via 5-HT1B/1D receptors. Naproxen inhibits cyclo-oxygenase and prostaglandin synthesis, reducing neurogenic inflammation; the combination targets different mechanisms of migraine.
Indications
Acute treatment of migraine attacks with or without aura in adults.
Dosage and administration (summary)
Oral: one tablet (sumatriptan 85 mg/naproxen 500 mg) at the onset of the attack; a second tablet may be taken after at least 2 hours if migraine recurs, maximum two tablets in 24 hours.
Contraindications
Ischaemic heart disease, cerebrovascular disease, peripheral vascular disease, uncontrolled hypertension, severe hepatic or renal impairment, active peptic ulcer or GI bleeding, and use with ergotamine or MAOIs; recent CABG surgery.
Warnings and precautions
Triptans may cause coronary vasospasm; NSAIDs increase cardiovascular thrombotic and gastrointestinal bleeding risks. Serotonin syndrome may occur with SSRIs or SNRIs. Overuse may cause medication-overuse headache.
Pregnancy
Avoid, particularly in the third trimester when naproxen is contraindicated.
Storage and supply
Store below 25 °C.
Source: reference summary prepared from the EU SmPC/EPAR, BNF and WHO Model Formulary. The approved product information in Iran governs.
Reference information for professional sourcing and registration enquiries, not medical advice or a promotion. Drug information is condensed from US FDA prescribing information (public domain, via openFDA and DailyMed) and does not replace the product’s approved labelling in Iran. Availability, origin and documentation are confirmed per enquiry.
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