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.
• The safety of treating more than 5 migraines headaches (on average) in a 30-day period has not been established.
• This drug is not indicated for the prevention of migraine attacks.

Usual Pediatric Dose for Migraine

Age: 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.
• The safety of treating more than 2 migraines headaches (on average) in a 30-day period has not been established.
• This drug is not indicated for the prevention of migraine attacks.

Renal Dose Adjustments

Severe renal impairment (CrCl less than 30 mL/min): Use is not recommended
Mild to moderate renal impairment (CrCl 30 to 89 mL/min): Monitor renal function

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

Liver Dose Adjustments

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

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 BOXED WARNINGS: Risk of Serious Cardiovascular and Gastrointestinal Events

• Cardiovascular Thrombotic Events: 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.

• Hypersensitivity 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
• 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

Dialysis

No data available

Other Comments

Administration advice:

• Take 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.

• Do not repackage; dispense and store in original container with desiccant

• Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals.
• Use of acute migraine drugs for 10 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.

• Monitor renal function in patients with mild to moderate renal impairment, dehydration, or preexisting kidney disease.
• Monitor blood pressure; periodically evaluate patients for cardiovascular risks.
• Closely monitor patients with coagulation disorders or those patients receiving anticoagulants for potential effects on platelet function.

• Patients should be instructed to read the US FDA-approved patient labeling (Medication Guide).
• Patients should 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.
• Patients should be aware that this product contains a NSAID; they should be instructed to watch for and report any unexplained weight gain or edema, signs or symptoms of hepatotoxicity, or gastrointestinal toxicity.
• Inform patients about the signs and symptoms of serious skin manifestations and instruct patients to contact their health care professional at first appearance of a skin rash or any other sign of hypersensitivity.
• Patients should talk to their health care provider if they are pregnant, planning to become pregnant, or breastfeeding.

Frequently asked questions

• What are the brands of sumatriptan?