Dosing and uses of Treximet (naproxen/sumatriptan)
Adult dosage forms and strengths
naproxen/sumatriptan
tablet
- 60mg/10mg
- 500mg/85mg
Migraine Headache
Indicated for the acute treatment of migraine attacks with or without aura
500mg/85mg PO, may repeat once after 2 hr, not to exceed 2 tablets/24 hr
Dosage modifications
Hepatic impairment
- Mild-to-moderate: Reduce dose to 60 mg/10 mg
- Severe: Contraindicated
Renal impairment
- Mild (CrCl 60-89 mL/min) or moderate (CrCl 30-59 mL/min): No dose adjustment required; monitor renal function in patients with renal impairment, pre-existing kidney disease, or dehydration
- CrCl <30 mL/min: Not recommended
Pediatric dosage forms and strengths
naproxen/sumatriptan
tablet
- 60mg/10mg
- 500mg/85mg
Migraine Headache
Indicated for the acute treatment of migraine attacks with or without aura
<12 years: Safety and efficacy not established
≥12 years: Recommended dose is 1 tablet (60 mg/10 mg) PO per 24 hr prn; maximum dose is 1 tablet (500 mg/85 mg) per 24 hr
Dosing Considerations
Safety of treating an average of >2 migraine headaches in pediatric patients in a 30-day period has not been established
Warnings
Black box warnings
Cardiovascular Risk
- NSAIDs may increase risk of serious cardiovascular thrombotic events, myocardial infarction (MI), & stroke, which can be fatal
- Risk may increase with duration of use
- Patients with risk factors for or existing cardiovascular disease may be at greater risk
- NSAIDs are contraindicated for perioperative pain in the setting of coronary artery bypass graft (CABG) surgery (increased risk of MI & stroke)
Gastrointestinal Risk
- NSAIDs increase risk of serious GI adverse events including bleeding, ulceration, & perforation of the stomach or intestines, which can be fatal
- GI adverse events may occur at any time during use & without warning symptoms
- Elderly patients are at greater risk for serious GI events
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
Cautions
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 category: C; avoid NSAIDs during 3rd trimester, may cause premature closure of ductus arteriosus
The Quebec Pregnancy Registry identified 4705 women who had spontaneous abortions by 20 weeks' gestation; each case was matched to 10 control subjects (n=47,050) who had not had spontaneous abortions; exposure to nonaspirin NSAIDs during pregnancy was documented in approximately 7.5% of cases of spontaneous abortions and in approximately 2.6% of controls. (CMAJ, September 6, 2011; DOI:10.1503/cmaj.110454)
Lactation: Both components are excreted in breast milk, avoid if breast feeding
Pregnancy categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.
C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.
D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.
X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.
NA: Information not available.
Pharmacology of Treximet (naproxen/sumatriptan)
Mechanism of action
Naproxen: Inhibits synthesis of prostaglandins in body tissues by inhibiting at least 2 cyclooxygenase (COX) isoenzymes, COX-1 and COX-2; may inhibit chemotaxis, alter lymphocyte activity, and decrease proinflammatory cytokine activity
Sumatriptan: Selective 5-HT1B and 5-HT1D receptor agonist in cranial arteries; elicits vasoconstrictive and anti-inflammatory effects; associated with antidromic neuronal transmission and relief of migraine headache
Administration
Instructions
May take with or without food
Swallow tablet whole; do not split, crush, or chew
