Classes
DEA Class; Rx
Common Brand Names; Treximet
NSAIDs;
Serotonin 5-HT-Receptor Agonists
Description
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
Indications
Contraindications
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
Adverse Effects
>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%)
Warnings
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 and Lactation
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
Maximum Dosage
2 tablets of 85 mg sumatriptan/500 mg naproxen in 24 hours PO.
Safety and efficacy have not been established.
1 tablet of 85 mg sumatriptan/500 mg naproxen in 24 hours PO.
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.
How supplied
naproxen/sumatriptan
tablet
- 60mg/10mg
- 500mg/85mg