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Triptan + NSAID combination Pregnancy: UK SPC section 4.6: contraindicated during the third trimester of pregnancy. Should not be used during the first and second trimester unless absolutely necessary; if used, the dose should be kept as low as possible and the treatment as short as possible. Antenatal monitoring for oligohydramnios and ductus arteriosus constriction should be considered after exposure to naproxen for several days from gestational week 20 onward, and treatment discontinued if either is found. Both components are excreted in human breast milk.

Sumatriptan with naproxen

Used in: Headache & Migraine

This is a fixed-dose combination of the 5-HT1 agonist (triptan) sumatriptan with the NSAID naproxen, used for acute treatment of migraine attacks.

Auto-extracted from the source labelling — not yet independently clinician-verified. These values were distilled from the UK SPC (or the US label where noted) but have not had a clinician sign-off. Confirm against the current SmPC before prescribing.

Adult dose

Dose: One tablet of sumatriptan/naproxen 85 mg/457 mg
Route: Oral
Frequency: Single dose, given as early as possible after the onset of migraine headache. If the patient responded to the first dose but symptoms recur, a second dose may be given after a minimum interval of 2 hours
Max: 2 tablets in a 24-hour period, taken at least 2 hours apart
UK SPC (Suvexx 85 mg/457 mg film-coated tablets) section 4.2: 'The recommended dosage for adults is one tablet of sumatriptan/naproxen 85 mg/457 mg.' Indicated for the acute treatment of migraine only and must not be used prophylactically; the recommended dose should not be exceeded. If the patient does not respond to the first dose, a second dose should not be taken for the same attack. The safety of treating an average of more than 5 migraine attacks in a 30-day period has not been established, and section 4.4 warns that regular intake of acute migraine medication for more than 9 days a month for more than 3 months may predispose to medication overuse headache. Tablets should be swallowed whole with water and must not be split, crushed or chewed, as this affects the optimised rate of drug absorption; may be taken with or without food. Paediatrics: efficacy and safety in children aged less than 18 years have not been established — verify any paediatric use against a children's formulary. Elderly (over 65 years): not studied and use in this population is not recommended. Hepatic impairment: contraindicated in moderate and severe impairment (Child-Pugh B and C) and not recommended in mild impairment (Child-Pugh A); if use in mild impairment is necessary, only one dose should be given within a 24-hour period with monitoring. NOTE ON SOURCES: the openFDA fallback in this bundle was a sumatriptan-only subcutaneous injection label (Caplin Steriles) covering a different product, route and dose, and was NOT used for this fixed-combination page. The UK SPC section 4.5 was not captured in this bundle, so the interaction entries below are drawn from the contraindicated combinations in section 4.3 — verify against section 4.5 of the UK SPC.

Dose adjustments

Renal

UK SPC section 4.2: contraindicated in patients with GFR less than 30 mL/min/1.73 m2. In patients with mild or moderate renal impairment, only one dose should be administered within a 24-hour period and renal function should be monitored during treatment.

Dose auto-extracted from UK Summary of Product Characteristics (SPC) via the eMC; US FDA prescribing information (openFDA / DailyMed) — cross-check; US labelling may differ from UK — not yet clinician-verified. Always confirm against the product SmPC and your local formulary before prescribing.

Contraindications

  • Hypersensitivity to the active substances or to any of the excipients
  • Severe cardiac failure, history of myocardial infarction or ischaemic heart disease, coronary vasospasm (Prinzmetal's angina), peripheral vascular disease, or symptoms or signs consistent with ischaemic heart disease
  • History of ischaemic stroke or transient ischaemic attack
  • Previous hypersensitivity reactions (e.g. nasal polyps, asthma, rhinitis, angioedema or urticaria) in response to ibuprofen, aspirin or other NSAIDs
  • History of upper gastrointestinal bleeding or perforation related to previous NSAID therapy
  • Active acute peptic ulcer or gastrointestinal bleeding, or two or more distinct previous episodes of proven ulceration or bleeding
  • Moderate and severe hypertension, and mild uncontrolled hypertension
  • Severe renal impairment (GFR below 30 mL/min/1.73 m2)
  • Moderate and severe hepatic impairment
  • Concomitant use with ergotamine or its derivatives (including methysergide) or any triptan / 5-HT1 receptor agonist
  • Concomitant use with reversible (e.g. moclobemide) or irreversible (e.g. selegiline) MAOIs, or within 2 weeks of discontinuing MAOI therapy
  • The last trimester of pregnancy

Side effects

  • Dizziness (most commonly reported in adults in clinical trials, incidence at least 2%)
  • Somnolence and paraesthesia
  • Nausea
  • Dry mouth and dyspepsia
  • Chest discomfort — sumatriptan can cause pain, sensations of heat or cold, pressure or tightness that may be intense and affect any part of the body including the chest and throat
  • Class risks: coronary artery vasospasm, transient myocardial ischaemia, myocardial infarction and ventricular arrhythmias with 5-HT1 agonists; peptic ulcer with or without bleeding with NSAIDs

Interactions

  • Ergotamine and ergotamine derivatives, including methysergide — must not be used concomitantly (section 4.3)
  • Other triptans / 5-HT1 receptor agonists — must not be used concomitantly (section 4.3)
  • Reversible MAOIs (e.g. moclobemide) and irreversible MAOIs (e.g. selegiline) — must not be used concomitantly, nor within 2 weeks of discontinuing MAOI therapy (section 4.3)
  • Other NSAIDs and aspirin — cross-hypersensitivity is a contraindication; naproxen carries the class gastrointestinal and cardiovascular risks described in section 4.4

Clinical monograph

How it works

Sumatriptan causes cranial vasoconstriction and inhibits trigeminal neuropeptide release, while naproxen inhibits cyclo-oxygenase to reduce prostaglandin-mediated neurogenic inflammation, giving complementary actions.

Prescribing in practice

  • It is contraindicated in ischaemic heart disease, coronary vasospasm, uncontrolled hypertension and cerebrovascular disease because of the triptan, and the naproxen component adds gastrointestinal, renal and cardiovascular NSAID risks.
  • It must not be combined with ergot derivatives or other triptans, and caution is needed with serotonergic drugs because of serotonin syndrome risk.
  • Frequent use of acute migraine treatment can cause medication-overuse headache, so frequency of attacks and treatment days should be reviewed.

Monitoring

Monitor blood pressure, headache frequency and gastrointestinal and renal tolerance with regular use.

Counselling the patient

  • Take it as early as possible in an attack, but limit how many days per month you treat to avoid rebound headaches.
  • Report chest tightness, jaw or arm pain, or any indigestion, black stools or breathlessness.
  • Take with food and avoid other NSAIDs or other triptans.

Evidence & guidelines

Combined sumatriptan-naproxen provides greater and more sustained migraine relief than either component alone in randomised trials.

Reference: NICE CG150; Drug verified in RxNorm (NLM); confirm dosing against the manufacturer SPC (eMC). Verify against your local formulary and current prescribing references before prescribing. The structured dose values shown have been reviewed by a clinician. Monograph status: clinician-reviewed (2026-07-04).

Related

Curated clinical cross-links plus same-class fallbacks.