Company:

GlaxoSmithKline

Antimigraine (Selective 5-HT_1B/1D receptor agonist + NSAID)

Sumatriptan (as succinate) 85mg, naproxen sodium 500mg; tabs.

Acute treatment of migraine.

Treximet is a combination product that treats migraine headaches via multiple mechanisms: sumatriptan selectively vasoconstricts intracranial/extracerebral blood vessels and inhibits trigeminal sensory nerve activation and the release of vasoactive neuropeptides, while naproxen inhibits the production of prostaglandin mediators of inflammation.

The efficacy of Treximet was established in two randomized, double-blind, multicenter, parallel-group studies which used placebo, sumatriptan, and naproxen sodium as comparison treatments.

Swallow whole. 1 tab once; may repeat once after 2 hours; max 2 tabs/day. The safety of treating an average of more than 5 migraines in a 30-day period has not been established.

Not recommended.

Aspirin allergy or triad syndrome (asthma, rhinitis, nasal polyps), hypotension with prior NSAID or aspirin use. History, symptoms, or signs of ischemic cardiac (eg, MI, angina pectoris, silent myocardial ischemia), cerebrovascular (eg, stroke, TIA), or peripheral vascular (eg, ischemic bowel disease, Raynaud) syndromes. Vasospastic coronary artery disease (CAD). Uncontrolled hypertension (HTN). Significant underlying cardiovascular disease. Basilar or hemiplegic migraine. Coronary artery bypass surgery. Hepatic impairment (esp. elderly). Within 24hrs of ergot-type drugs (eg, methysergide, dihydroergotamine) or other 5-HT₁ agonists. During or within 2 weeks after discontinuing MAO-type A inhibitors. 3rd trimester pregnancy.

Confirm diagnosis. Avoid excessive use. Likelihood of unrecognized coronary artery disease (HTN, hypercholesterolemia, men over age 40, postmenopausal women, obese, smokers, diabetes, strong family history); not recommended; exclude underlying cardiovascular disease, supervise 1st dose, consider monitoring ECG. Active peptic ulcer. History of GI disease or bleeding disorders. Monitor for GI bleed. Severe renal dysfunction (CrCl<30mL/min): not recommended. Impaired renal or hepatic function. Anemia. Asthma. Heart failure. Edema. Dehydration. HTN. Seizure disorders. Elderly. Debilitated. Pregnancy (Cat.C; see Contraindications). Labor & delivery, nursing mothers: not recommended.

Ergotamines, other 5-HT1 agonists, MAOIs: see Contraindications. Avoid aspirin, other NSAIDs. Serotonin syndrome with SSRIs (eg, citalopram, fluoxetine), SNRIs (eg, duloxetine, venlafaxine). May potentiate methotrexate, lithium. May antagonize diuretics, antihypertensives (eg, ß-blockers). Increased risk of renal toxicity with ACEIs, diuretics. Increased risk of GI bleed with oral corticosteroids, anticoagulants (monitor), alcohol. Probenecid increases naproxen levels and delays elimination. May interfere with tests for 17-ketogenic steroids, 5-HIAA.

Dizziness, somnolence, paresthesia, nausea, dyspepsia, dry mouth, GI ulcers/bleed, abdominal pain, chest or neck/throat/jaw discomfort/pain, fatigue.

Register pregnant patients exposed to Treximet by calling (800) 336-2176.

Tabs—9 (blister card)

5/30/08