Naproxen / Sumatriptan Dosage

Medically reviewed by Drugs.com. Last updated on May 1, 2025.

Usual Adult Dose for Migraine

Initial dose: 1 tablet (sumatriptan-naproxen 85/500 mg) orally once
Maximum dose: 2 tablets (sumatriptan-naproxen 85/500 mg) in a 24-hour period taken at least 2 hours apart

Comments:

• Use only if a clear diagnosis of migraine has been established; if migraine does not respond to treatment, reconsider the diagnosis of migraine before treating any subsequent attacks.
• Use the lowest effective dosage for the shortest duration consistent with individual treatment goals.
• The safety of treating more than 5 migraines headaches (on average) in a 30-day period or cluster headaches has not been established.
• This drug is not indicated for the prevention of migraine attacks.

Use: For the acute treatment of migraine with or without aura

Usual Pediatric Dose for Migraine

12 YEARS OR OLDER:
Initial dose: 1 tablet (sumatriptan-naproxen 10/60 mg) orally once
Maximum dose: 1 tablet (sumatriptan-naproxen 85/500 mg) in a 24-hour period

Comments:

• Use only if a clear diagnosis of migraine has been established; if migraine does not respond to treatment, reconsider the diagnosis of migraine before treating any subsequent attacks.
• Use the lowest effective dosage for the shortest duration consistent with individual treatment goals.
• The safety of treating more than 2 migraines headaches (on average) in a 30-day period or cluster headaches has not been established for pediatric patients.
• This drug is not indicated for the prevention of migraine attacks.

Use: For the acute treatment of migraine with or without aura in patients 12 years of age or older

Renal Dose Adjustments

Mild to moderate renal dysfunction (CrCl 30 to 89 mL/min): Monitor renal function
Severe renal dysfunction (CrCl less than 30 mL/min): Not recommended

If clinical signs and symptoms consistent with renal disease develop or if systemic manifestations occur, therapy should be discontinued.

Liver Dose Adjustments

Mild to moderate hepatic dysfunction: Reduce dose to 1 tablet (sumatriptan-naproxen 10/60 mg) orally in a 24-hour period
Severe hepatic dysfunction: Contraindicated

If clinical signs and symptoms consistent with liver disease develop, if systemic manifestations occur, or if abnormal liver tests persist or worsen, therapy should be discontinued.

Precautions

US FDA requires a medication guide to assure safe use. For additional information visit:
www.fda.gov/drugs/drug-safety-and-availability/medication-guides

US BOXED WARNINGS: Risk of Serious Cardiovascular and Gastrointestinal Events

• Cardiovascular Thrombotic Events: Nonsteroidal anti-inflammatory drugs (NSAIDs) cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction, and stroke, which can be fatal. This risk may occur early in treatment and may increase with duration of use. This drug is contraindicated in the setting of coronary artery bypass graft (CABG) surgery.
• Gastrointestinal (GI) Bleeding, Ulceration, and Perforation: NSAIDs cause an increased risk of serious GI adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients and patients with a prior history of peptic ulcer disease and/or GI bleeding are at greater risk for serious GI events.

CONTRAINDICATIONS:

• Known hypersensitivity (e.g., anaphylactic reactions, angioedema, and serious skin reactions) to sumatriptan, naproxen, or any product excipients
• Ischemic coronary artery disease (angina pectoris, history of myocardial infarction, or documented silent ischemia) or coronary artery vasospasm, including Prinzmetal's angina
• In the setting of coronary artery bypass graft surgery
• Wolff-Parkinson-White syndrome or arrhythmias associated with other cardiac accessory conduction pathway disorders
• History of stroke or transient ischemic attack, or history of hemiplegic or basilar migraine because these patients are at a higher risk of stroke
• Peripheral vascular disease
• Ischemic bowel disease
• Uncontrolled hypertension
• Recent use (within 24 hours) of ergotamine-containing medication, ergot-type medication (such as dihydroergotamine or methysergide), or another 5-hydroxytryptamine 1 agonist
• Use concurrently, or within 2 weeks of a monoamine oxidase (MAO)-A inhibitor
• History of asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs; severe sometimes fatal, anaphylactic reactions to NSAIDs have been reported in such patients
• Severe hepatic impairment

Safety and efficacy have not been established in patients younger than 12 years.

Consult WARNINGS section for additional precautions.

Dialysis

Naproxen: Hemodialysis does not decrease plasma concentration due to a high level of protein binding.

Sumatriptan: The effect of hemodialysis or peritoneal dialysis on serum concentration is unknown.

Other Comments

Administration advice:

• Administer orally with or without food
• Tablets should not be split, crushed, or chewed
• For patients with multiple cardiovascular risk factors who have had a negative CV evaluation, consider administering the first under close medical supervision, follow with an ECG.

Storage requirements:

• Store at 25C (77F); excursions permitted to 15 to 30C (59 to 86F).
• Do not repackage; dispense and store in original container with desiccant

General:

• Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals.
• Use of acute migraine drugs for 10 or more days per month may lead to medication overuse headache.
• This drug should not be used within 24 hours of another triptan or an ergot-type medication.

Monitoring:

• Cardiovascular: For cardiac risk/disease and blood pressure (prior to and periodically during treatment); for the development of cardiovascular events (during therapy); for worsening heart failure (during therapy in patients with heart failure)
• General: For adverse events (during long term therapy); hydration status (prior to/during therapy)
• Hematologic: Bleeding time and platelet aggregation (during therapy in patients with coagulation disorders or bleeding risk); hemoglobin and hematocrit (during therapy if anemia is suspected)
• Hepatic: Liver function (during therapy, especially in patients with impairment)
• Neurological: For potentially serious neurological conditions (prior to therapy, especially for atypical migraine symptoms)
• Renal: Kidney function (during therapy, especially in at-risk patients such as those with renal impairment, preexisting disease, heart failure, or dehydration, and in older adults)

Patient advice:

• Read the US FDA-approved patient labeling (Medication Guide).
• Understand the risk of cardiovascular and cerebrovascular events and seek medical advice promptly in the event of chest pain, shortness of breath, irregular heartbeat, significant rise in blood pressure, weakness and slurring of speech.
• Be aware that this product contains a NSAID; watch for and report any unexplained weight gain or edema, signs or symptoms of hepatotoxicity, or gastrointestinal bleeding.
• Recognize the signs and symptoms of serious skin manifestations and contact a health care professional at first appearance of a skin rash or any other sign of hypersensitivity.
• Speak to your health care provider if you are pregnant, planning to become pregnant, or breastfeeding.

Frequently asked questions

• What are the brands of sumatriptan?

See also:

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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