The originating document has been archived. We cannot confirm the completeness, accuracy and currency of the content.
Pronunciation: SOO-ma-TRIP-tan/na-PROX-en SOE-dee-um
Class: Migraine combination
- Tablets sumatriptan 85 mg/naproxen sodium 500 mg
Selective agonist for vascular serotonin (5-HT) receptor subtype, causing vasoconstriction of cranial arteries.Naproxen
Decreases inflammation and pain, probably through inhibition of cyclooxygenase activity and prostaglandin synthesis.
Indications and Usage
For the acute treatment of migraine attacks with or without aura in adults.
History, symptoms, or signs of ischemic cardiac, cerebrovascular, or peripheral vascular syndromes; other significant underlying CV diseases; patients who have had coronary artery bypass graft (CABG) surgery; uncontrolled hypertension; coadministration of MAO-A inhibitors or use within 2 weeks of discontinuation of MAO-A inhibitor; hemiplegic or basilar migraine; hepatic impairment; allergy to naproxen; asthma, nasal polyps, urticaria, and hypotension associated with NSAIDs; hypersensitivity to sumatriptan, naproxen, or any other component of the product; coadministration with any ergotamine-containing or ergot-type medication (eg, dihydroergotamine, methysergide) within 24 hours of sumatriptan/naproxen; coadministration within 24 hours of another 5-HT 1 agonist.
Dosage and AdministrationAdults
PO 1 tablet at first sign of attack; may follow with 1 tablet 2 hours later if needed (max, 2 tablets in 24 h).Concomitant therapy
The combined use with MAO-A inhibitors or use within 2 weeks of the discontinuation of MAO-A inhibitor therapy is contraindicated; any ergotamine-containing or ergot-type medication or other 5-HT 1 agonists should not be used within 24 h of sumatriptan/naproxen.
- May administer with or without food.
- Tablets should not be split, crushed, or chewed.
- Dosing of tablets should be at least 2 h apart.
- The safety of treating an average of more than 5 migraine headaches in a 30-day period has not been established.
Store between 59° and 86°F. Do not repackage; dispense and store in the original container.
Drug InteractionsACE inhibitors (eg, captopril)
Naproxen may reduce the antihypertensive effect of ACE inhibitors and may potentiate renal disease states.Alcohol
May contribute to the increased risk of GI bleeding.Aminoglycosides (eg, gentamicin)
Plasma aminoglycoside levels may be elevated by naproxen.Anticoagulants (eg, warfarin)
Risk of hemorrhagic adverse reactions may be increased.Azole antifungals (eg, fluconazole)
Naproxen plasma concentration may be elevated, increasing the pharmacologic effects and the risk of adverse reactions.Beta-blockers (eg, propranolol)
Naproxen may inhibit renal prostaglandin synthesis, impairing the antihypertensive effect of beta-blockers.Bisphosphonates (eg, alendronate)
Biphosphates and naproxen may both synergistically increase the risk of GI adverse reactions, especially gastric ulcers.Corticosteroids
Concomitant use may contribute to the increased risk of GI bleeding.Cyclosporine
The nephrotoxicity of cyclosporine and naproxen may both be increased.Diuretics (eg, furosemide, hydrochlorothiazide)
Naproxen may reduce the natriuretic effect of furosemide and thiazides.Ergot alkaloids (eg, dihydroergotamine)
Use within 24 hours of treatment with an ergot-containing medication is contraindicated.Lithium
Naproxen may reduce renal lithium Cl by up to 20%. When an NSAID is started or stopped, monitor lithium levels every 4 to 5 days until stable and observe patients for clinical changes.MAOIs
Coadministration is contraindicated within 2 weeks of discontinuation of MAO-A inhibitor therapy.Methotrexate
Naproxen may contribute to reduced renal Cl and increased methotrexate toxicity. Coadministration of some NSAIDs with high-dose methotrexate therapy has resulted in death from severe hematologic and GI toxicity.NSAIDs (eg, ibuprofen)
Do not use with other naproxen-containing products; coadministration may increase the risk of GI bleeding.Probenecid
Plasma levels and half-life of naproxen may be increased.Salicylates (eg, aspirin)
Risk of GI irritation may be increased.Sibutramine
The serotonergic effects of sumatriptan and sibutramine may be additive, resulting in a serotonin syndrome.Serotonin 5-HT 1 receptor agonists (eg, rizatriptan)
Coadministration of two 5-HT 1 agonists within 24 h of each other is contraindicated.SSRIs/SNRIs (eg, duloxetine, sertraline, venlafaxine)
Life-threatening serotonin syndrome may occur with combined use.
Laboratory Test Interactions
Naproxen may decrease platelet aggregation, prolong bleeding time, increase urinary values for 17-ketogenic, and interfere with some urinary assays of 5-hydroxy indoleacetic acid.
Dizziness (4%); somnolence (3%); paresthesia (2%); asthenia (more than 1%); fatigue (at least 1%).
Nausea (3%); dry mouth, dyspepsia (2%); abdominal pain (at least 1%).
Chest discomfort/chest pain, neck/throat/jaw pain/tightness/pressure (3%); feeling hot, muscle tightness, palpitations (more than 1%).
Sumatriptan/naproxen may cause an increased risk of serious CV thrombotic reactions, MI, and stroke, which can be fatal. This risk may increase with duration of use. Patients with CV disease or risk factors for CV disease may be at greater risk.GI risk
Sumatriptan/naproxen contains an NSAID. NSAID-containing products cause an increased risk of serious GI adverse reactions, including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These reactions can occur at any time during use and without warning symptoms. Elderly patients are at greater risk for serious GI reactions.
Monitor for signs or symptoms of GI bleeding. Closely monitor BP during the initiation and throughout the course of therapy. Monitor renal function, serum creatinine, and/or CrCl in patients with renal impairment. Monitor platelet function in patients with coagulation disorders or patients receiving anticoagulants or in patients on long-term therapy. Obtain an ECG immediately following first-time use of sumatriptan/naproxen in patients with risk factors for coronary artery disease (CAD). Evaluate patients with signs and/or symptoms suggesting liver impairment or patients in whom an abnormal liver test has occurred for the development of more severe hepatic reactions while on therapy. Evaluate patients who experience signs or symptoms suggestive of angina following sumatriptan/naproxen for the presence of CAD or a predisposition to Prinzmetal variant angina before administering additional doses, and monitor patients via ECG if dosing is resumed and similar symptoms recur. Similarly, evaluate patients who experience other symptoms or signs suggestive of decreased arterial flow, such as ischemic bowel syndrome or Raynaud syndrome, following sumatriptan/naproxen for atherosclerosis or predisposition to vasospasm.
Category C . Do not use in late pregnancy.
Excreted. Avoid use.
Safety and efficacy not established.
Contraindicated for use in elderly patients who have hepatic impairment. It is not recommended for use in elderly patients who have renal impairment, higher risk for unrecognized CAD, and increases in BP that may be more pronounced in elderly patients.
Anaphylactic/anaphylactoid reactions, which may be life-threatening or fatal, may occur. Do not give to patients with the aspirin triad.
Not recommended for use in patients with CrCl less than 30 mL/min. Treatment is not recommended in patients with advanced renal disease. Use caution in patients with preexisting kidney disease or dehydration.
Contraindicated in patients with hepatic impairment.
Special Risk Patients
Use with caution in debilitated patients, patients who are dehydrated, patients with fluid retention or heart failure, patients with diseases that may alter the absorption, metabolism, or excretion of drugs, patients with a history of epilepsy or conditions associated with a lowered seizure threshold.
Do not administer to patients with aspirin-sensitive asthma and use cautiously in patients with preexisting asthma.
It is strongly recommended that sumatriptan-containing products not be given to patients in whom unrecognized CAD is predicted by the presence of risk factors (eg, hypertension, hypercholesterolemia, smoking, obesity, diabetes, strong family history of CAD, women with surgical or physiological menopause, men older than 40 years of age).
Patients treated with sumatriptan have reported cerebral hemorrhage, subarachnoid hemorrhage, stroke, and other cerebrovascular reactions, some resulting in fatalities.
Chest, jaw, or neck pain/discomfort
Serious adverse reactions such as exfoliative dermatitis, Stevens-Johnson syndrome, and TEN, which can be fatal, may occur.
Use with extreme caution in patients with a history of ulcer disease or GI bleeding. Other factors that increase the risk for GI bleeding in patients treated with NSAIDs include concomitant use of oral corticosteroids or anticoagulants, longer duration of NSAID therapy, smoking, use of alcohol, older age, and poor general health status.
Anemia may occur in patients receiving NSAIDs.
Borderline elevations of 1 or more liver tests may occur. Discontinue sumatriptan/naproxen if clinical signs and symptoms consistent with liver disease develop or if systemic manifestations (eg, eosinophilia, rash) occur.
Significant elevation in BP may occur. Use is contraindicated in uncontrolled hypertension; use with caution in controlled hypertension.
Take care to exclude other potentially serious neurologic conditions before treating headache in patients not previously diagnosed with migraine headache or who experience a headache that is atypical for them.
Sumatriptan and/or its metabolites bind to the melanin of the eye. Because there could be an accumulation in melanin-rich tissues over time, sumatriptan could possibly cause toxicity in these tissues after extended use. Sumatriptan also causes corneal opacities and defects in the corneal epithelium in dogs.
Not intended for the prophylactic therapy of migraine or for use in the management of hemiplegic or basilar migraine. Safety and effectiveness have not been established for cluster headache.
Other vasospasm-related reactions
Both peripheral vascular ischemia and colonic ischemia with abdominal pain and bloody diarrhea have been reported. Transient and permanent blindness and significant partial vision loss have also been reported.
Long-term NSAID use has resulted in renal papillary necrosis and other renal injury. Renal toxicity has also been seen in patients in whom renal prostaglandins have a compensatory role in the maintenance of renal perfusion. Patients at greatest risk are those with renal impairment, heart failure, or liver dysfunction, those taking diuretics and ACE inhibitors, and elderly patients. Discontinuation of NSAID therapy is usually followed by recovery to the pretreatment state.
The development of a potentially life-threatening serotonin syndrome (eg, agitation, coma, diarrhea, hallucinations, hyperreflexia, hyperthermia, incoordination, labile blood pressure, nausea, tachycardia, vomiting) may occur, particularly during combined use with SSRIs or SNRIs.
Abdominal discomfort, abnormal respiration, acute renal failure, anaphylactoid reactions, apnea, ataxia, coma, convulsions, disorientation, dizziness, drowsiness, epigastric pain, erythema of the extremities, GI bleeding, heartburn, hypertension, hypoprothrombinemia, inactivity, indigestion, lacrimation, lethargy, metabolic acidosis, mydriasis, nausea, paralysis, ptosis cyanosis, renal dysfunction, respiratory depression, salivation, transient alterations in liver function, tremor, vomiting.
- Encourage patients to read the Medication Guide that accompanies each prescription dispensed.
- Advise patients to be alert for the signs and symptoms of chest pain, shortness of breath, weakness, and slurring of speech, and to ask for medical advice when observing any indicative sign or symptoms.
- Advise patients to be alert for the signs and symptoms of ulcerations and bleeding and to ask for medical advice when observing any indicative sign or symptoms, including epigastric pain, dyspepsia, melena, and hematemesis.
- Advise patients to be alert for the signs and symptoms of skin rash and blisters, fever, or other signs of hypersensitivity, such as itching, and to ask for medical advice when observing any indicative signs or symptoms. Advise patients to stop the drug immediately if they develop any type of rash and contact their health care provider as soon as possible.
- Tell patients to promptly report signs or symptoms of unexplained weight gain or edema to their health care provider.
- Inform patients of the warning signs and symptoms of hepatotoxicity (eg, nausea, fatigue, lethargy, pruritus, jaundice, right upper quadrant tenderness, flu-type symptoms). If these occur, instruct patients to stop therapy and seek immediate medical therapy.
- Inform patients of the signs of an anaphylactic/anaphylactoid reaction (eg, difficulty breathing, swelling of the face or throat). If these occur, instruct patients to seek immediate emergency help.
- Inform patients that sumatriptan/naproxen should not be used in late pregnancy because NSAID-containing products have been shown to cause premature closure of the ductus arteriosus.
- Caution patients about the risk of serotonin syndrome, particularly during concomitant use with SSRIs or SNRIs.
- Advise patients whose activities require alertness to exercise caution if they experience drowsiness, dizziness, vertigo, or depression during therapy with sumatriptan/naproxen.
- Inform patients whose overall intake of sodium must be severely restricted, that each tablet contains sodium 61.2 mg.
Copyright © 2009 Wolters Kluwer Health.