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Naproxen/Sumatriptan

    DEA Class;  Rx

    Common Brand Names; Treximet

    NSAIDs; 

    Serotonin 5-HT-Receptor Agonists

    Combination NSAID (naproxen) and serotonin-receptor agonist (sumatriptan)
    Used for acute treatment of migraine attacks with or without aura
    May reduce migraine recurrence as compared with monotherapy with either naproxen or sumatriptan

    For the acute treatment of migraine with or without aura.

    Aspirin allergy or triad

    Hypotension with prior NSAID or aspirin use

    History or suspected ischemic heart disease, CVA/TIA, peripheral vascular disease

    Vasospastic CAD

    Uncontrolled hypertension

    Basilar or hemiplegic migraine

    Post CABG

    Hepatic impairment

    Within 24 hr of ergot-type drugs (eg, methysergide, dihydroergotamine) or other 5-HT1 agonists

    Concomitant or within 2 wk of using MAO-A inhibitors

    3rd trimester pregnancy

    >10%

    Gastric erosion (19%); compared with 38% for equal naproxen dose without PPI

    Dyspepsia (18%); compared with 27% for equal naproxen dose without PPI

    Gastritis (17%)

    1-10%

    Diarrhea (6%)

    Abdominal pain (6%)

    Nausea (5%)

    Hiatal hernia (4%)

    Abdominal distension (4%)

    Flatulence (4%)

    Esophagitis (4%)

    Constipation (3%)

    Headache (3%)

    Dysgeusia (2%)

    Erosive duodenitis (2%)

    Hemorrhagic gastritis (1%)

    Not recommmended for patients with likelihood of unrecognized CAD, severe renal impairment (CrCl <30 mL/min), or women who are breast feeding

    Use NSAIDs with caution with underlying cardiovascular disease, active/history of peptic ulcer, inflammatory bowel disease, GI disease, bleeding disorder, renal/hepatic impairment, anemia, asthma, heart failure, edema, dehydration, HTN, or seizure disorder

    Long-term administration of NSAIDs may result in renal papillary necrosis and other renal injury; patients at greatest risk include the elderly, or those with impaired renal function, hypovolemia, heart failure, liver dysfunction, salt depletion, and individuals taking diuretics, ACE inhibitors, or ARBs

    Overuse of acute migraine drugs (eg, ergotamine, triptans, opioids, or a combination of drugs for 10 or more days per month) may lead to exacerbation of headache (medication overuse headache); medication overuse headache may present as migraine-like daily headaches, or as a marked increase in frequency of migraine attacks

    Pregnancy; Avoid use of NSAIDs in pregnant women at about 30 weeks gestation and later; NSAIDs increase risk of premature closure of fetal ductus arteriosus at approximately this gestational age

    Lactation:

    The naproxen anion has been found in milk of lactating women at a concentration equivalent to approximately 1% of maximum naproxen concentration in plasma

    Sumatriptan is excreted in human milk following subcutaneous administration; there is no information regarding sumatriptan concentrations in milk from lactating women following administration of sumatriptan tablets

    Adults

    2 tablets of 85 mg sumatriptan/500 mg naproxen in 24 hours PO.

    Geriatric

    Safety and efficacy have not been established.

    Adolescents

    1 tablet of 85 mg sumatriptan/500 mg naproxen in 24 hours PO.

    Children

    12 years: 1 tablet of 85 mg sumatriptan/500 mg naproxen in 24 hours PO.
    Less than 12 years: Safety and efficacy have not been established.

    naproxen/sumatriptan

    tablet

    • 60mg/10mg
    • 500mg/85mg