Sumatriptan and Naproxen Sodium

Warning

Risk of serious cardiovascular and gastrointestinal events

Contraindications

• Ischemic coronary artery disease
• History of stroke or transient ischemic attack
• Peripheral vascular disease
• Uncontrolled hypertension
• Recent use of ergotamine-containing medication or other 5-HT1 agonists
• Concurrent administration of monoamine oxidase-A inhibitors
• Severe hepatic impairment

Adverse Reactions

• Cardiovascular thrombotic events
• Gastrointestinal bleeding, ulceration, and perforation
• Arrhythmias
• Chest, throat, neck, and/or jaw pain/tightness/pressure
• Cerebrovascular events
• Other vasospasm reactions
• Hepatotoxicity
• Hypertension
• Heart failure and edema
• Medication overuse headache
• Serotonin syndrome
• Renal toxicity and hyperkalemia
• Anaphylactic reactions
• Serious skin reactions
• Drug reaction with eosinophilia and systemic symptoms (DRESS)
• Hematological toxicity

General Guidance

Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals

Pregnancy

• Use of NSAIDs, including sumatriptan and naproxen sodium, can cause premature closure of the fetal ductus arteriosus and fetal renal dysfunction
• Limit dose and duration of use between 20 and 30 weeks of gestation

Nursing Mothers

• Sumatriptan and naproxen sodium is excreted in human milk
• Caution should be exercised when administering sumatriptan and naproxen sodium to nursing mothers

Pediatric Use

• Safety and effectiveness in pediatric patients under 12 years of age have not been established
• The safety and efficacy of sumatriptan and naproxen sodium for the acute treatment of migraine in pediatric patients 12 to 17 years of age was established in a double-blind, placebo-controlled trial

Geriatric Use

• Elderly patients, compared to younger patients, are at greater risk for NSAID-associated serious cardiovascular, gastrointestinal, and/or renal adverse reactions
• A cardiovascular evaluation is recommended for geriatric patients who have other cardiovascular risk factors prior to receiving sumatriptan and naproxen sodium