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Sumatriptan / naproxen

Class
Antimigraine agents
Subclass
Triptan / nonsteroidal anti-inflammatory drug combination
Substance name
Sumatriptan / naproxen
Brand names
Treximet®
Contains
Naproxen sodium
Sumatriptan
Common formulations
Film-coated tablet
See also
Naproxen DR (EC-Naprosyn®)
Naproxen sodium ER (Naprelan®)
Naproxen (Naprosyn®)
Dosage and administration
Adults patients
Symptomatic relief of migraine attacks
•
Maintenance: 85/500 mg PO q2h PRN
•
Maximum: 170/1,000 mg per day
Do not exceed sumatriptan/naproxen use for more than 5 migraine attacks in a 30-day period.
Indications for use
Labeled indications
Adults
•
Symptomatic relief of migraine attacks
Safety risks
Boxed warnings
Cardiovascular thrombotic events
•
Maintain a high level of suspicion, as NSAIDs have been associated with an increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke. Avoid using in patients with a recent myocardial infarction.
•
Do not use in patients undergoing CABG.
Serious gastrointestinal adverse events
•
Maintain a high level of suspicion, as NSAIDs have been associated with an increased risk of serious gastrointestinal adverse events, including bleeding, ulceration, and perforation, especially in elderly patients and patients with a prior history of peptic ulcer disease and/or gastrointestinal bleeding. Monitor for signs of bleeding.
Contraindications
Hypersensitivity to sumatriptan/naproxen or its components
Coronary artery disease
•
Do not use sumatriptan in patients with coronary artery disease, coronary artery vasospasm, including vasospastic angina, or other significant CVDs.
Hemiplegic or basilar migraine
History of hypersensitivity reactions to NSAIDs
•
Do not use in patients with a history of asthma, urticaria, or other allergic-type reactions after aspirin or other NSAIDs. Use caution in patients with asthma.
History of stroke or TIA
Ischemic bowel disease
PAD
Uncontrolled hypertension
•
Monitor BP in all patients.
WPW syndrome
•
Do not use sumatriptan in patients with WPW syndrome or other accessory conduction pathway disorders.
Concomitant use of MAOIs
•
Do not use sumatriptan with or within 14 days of stopping MAOIs.
Concomitant use of other 5-HT1 agonists or ergots
•
Do not use sumatriptan within 24 hours of taking other 5-HT1 agonists or ergotamine-containing or ergot-type medications, such as dihydroergotamine or methysergide.
Warnings and precautions
Anemia
•
Maintain a high level of suspicion, as NSAIDs have been associated with an increased risk of anemia. Monitor hemoglobin levels and for signs of bleeding.
Chest tightness, chest pain, neck pain, jaw pain
•
Maintain a high level of suspicion, as 5-HT1 agonists have been associated with an increased risk of non-cardiac chest pain and related symptoms.
Edema
•
Use caution in patients taking diuretics, ACEis, or ARBs, as naproxen may blunt the cardiovascular effects of these agents. Avoid using in patients with severe HF unless the benefits are expected to outweigh the risk of worsening HF.
Hepatotoxicity
•
Maintain a high level of suspicion, as naproxen has been associated with an increased risk of elevations of serum transaminases and, rarely, severe hepatic injury, including fulminant hepatitis, liver necrosis, and hepatic failure. Monitor liver enzymes periodically in patients on long-term treatment.
HF
•
Maintain a high level of suspicion, as NSAIDs have been associated with an increased risk of myocardial infarction, hospitalization for HF, and death.
Hypersensitivity reactions
•
Maintain a high level of suspicion, as sumatriptan has been associated with an increased risk of serious hypersensitivity reactions, including angioedema and anaphylaxis.
Increased serum potassium
•
Maintain a high level of suspicion, as NSAIDs have been associated with an increased risk of hyperkalemia.
Mask symptoms of infection
•
Maintain a high level of suspicion, as NSAIDs reduce inflammation and fever, potentially diminishing the utility of diagnostic signs in detecting infections.
Medication overuse headache
•
Use caution in patients taking the drug for a prolonged period.
Renal toxicity
•
Maintain a high level of suspicion, as long-term use of NSAIDs has been associated with an increased risk of renal papillary necrosis, renal insufficiency, AKI, and other renal injury, especially in patients with renal or hepatic impairment, HF, dehydration or hypovolemia, taking diuretics, ACEis, or ARBs, and in the elderly. Monitor renal function in patients with renal or hepatic impairment, HF, dehydration, or hypovolemia.
Seizure
•
Use caution in patients with a seizure disorder.
Serotonin syndrome
•
Use caution in patients taking SSRIs, SNRIs, or TCAs.
Severe cutaneous adverse reactions
•
Maintain a high level of suspicion, as NSAIDs have been associated with an increased risk of severe cutaneous adverse reactions, including exfoliative dermatitis, Stevens-Johnson Syndrome, and toxic epidermal necrolysis.
Specific populations
Renal impairment
CrCl ≥ 30 mL/min
•
Monitor renal function.
CrCl < 30 mL/min
•
Do not use.
Renal replacement therapy
Any modality
•
Do not use.
Hepatic impairment
Child-Pugh A (mild)
•
Reduce dose.
Child-Pugh B (moderate)
•
Reduce dose.
Child-Pugh C (severe)
•
Do not use.
Pregnancy and breastfeeding
Pregnancy
< 20 weeks of gestation
•
Use only if benefits outweigh potential risks.
> 30 weeks of gestation
•
Avoid use. Monitor for oligohydramnios. NSAIDs may cause premature closure of fetal ductus arteriosus.
20-30 weeks of gestation
•
Use only if benefits outweigh potential risks. Limit use to the lowest effective dose and shortest duration possible. Consider obtaining ultrasound monitoring of amniotic fluid if treatment extends beyond 48 hours. Discontinue if oligohydramnios develops.
Breastfeeding
Use only if benefits outweigh potential risks.
Unknown amount excreted in breastmilk.
Unknown drug levels in breastfed infants.
Some adverse effects on lactation reported.
Adverse reactions
Common 1-10%
•
Dizziness, paresthesia, dyspepsia, dry mouth, somnolence, nausea, chest discomfort, chest pain, neck pain, jaw pain, throat tightness
Unknown frequency
•
Exfoliative dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis, fixed drug eruption, gastrointestinal perforation, cardiac arrhythmias, stroke, myocardial infarction, vasospastic reactions, heart failure, medication overuse headache, serotonin syndrome, renal papillary necrosis, acute kidney injury, anaphylaxis, DRESS syndrome, gastrointestinal bleeding, raynaud's phenomenon, hepatotoxicity, ↑ liver enzymes, edema, ↑ serum potassium, anemia, seizure
Interactions
Drug(s)
Check Interactions
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