Migraine and headache:

Indications for: TREXIMET

Acute treatment of migraine with or without aura in adults and children ≥12yrs old.

Limitations of Use:

Use only if clear diagnosis of migraine. Not indicated for prevention of migraine attacks. Safety and effectiveness not established for cluster headache.

Adult Dosage:

Use lowest effective dose for shortest duration. Swallow whole. 1 tab (85/500mg) once; may repeat once after 2 hours; max 2 tabs/day. Mild to moderate hepatic impairment: 1 tab (10/60mg)/day. The safety of treating an average of more than 5 migraines in a 30-day period has not been established.

Children Dosage:

<12yrs: not established. Use lowest effective dose for shortest duration. 12–17yrs: 1 tab (10/60mg) once; max 1 tab (85/500mg)/day. The safety of treating an average of more than 2 migraines in a 30-day period has not been established.

TREXIMET Contraindications:

Ischemic coronary artery disease (CAD) (eg, angina pectoris, MI, silent ischemia). Coronary artery vasospasm (including Prinzmetal's angina). Coronary artery bypass graft surgery. Wolff-Parkinson-White syndrome or arrhythmias associated with other cardiac accessory conduction pathway disorders. History of stroke or TIA. History of hemiplegic or basilar migraine. Peripheral vascular disease. Ischemic bowel disease. Uncontrolled hypertension (HTN). 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. Aspirin allergy. Severe hepatic impairment.

Boxed Warning:

Risk of serious cardiovascular and gastrointestinal events.

TREXIMET Warnings/Precautions:

Increased risk of serious cardiovascular events (including MI, stroke). Exclude cardiovascular disease in patients with multiple risk factors (eg, increased age, diabetes, hypertension, smoking, obesity, strong family history of CAD) before initiating; if negative, supervise 1st dose, consider monitoring ECG. Avoid in severe heart failure; if necessary, monitor. Increased risk of serious GI adverse events (including inflammation, bleeding, ulceration, perforation). History of ulcer disease and/or GI bleeding. Discontinue if serious arrhythmias or cerebrovascular events occur or if serotonin syndrome is suspected. Peripheral or GI vascular ischemia and infarction following other 5-HT1 agonists. Hypertension; monitor BP closely. Hepatic impairment. Discontinue if signs/symptoms of liver or renal disease develop, or if abnormal LFTs persist or worsen. Severe renal impairment (CrCl<30mL/min): not recommended; monitor in mild or moderate impairment, pre-existing kidney disease, dehydration. Hypovolemia. Hyperkalemia. Coagulation disorders. Monitor CBCs, blood chemistry, hepatic, and renal function in long-term therapy. Pre-existing asthma. Seizure disorders. May mask signs of infection or fever. Discontinue at 1st sign of rash or any other hypersensitivity. Elderly. Debilitated. Labor & delivery. May be associated with a reversible delay in ovulation in females of reproductive potential. Pregnancy (avoid during ≥30 weeks gestation): increased risk of premature closure of the fetal ductus arteriosus; (20–30 weeks gestation): may cause fetal renal dysfunction/oligohydramnios; if treatment needed, limit dose and duration of use. Nursing mothers: minimize infant exposure by avoiding breastfeeding for 12hrs after dose.

TREXIMET Classification:

Selective 5-HT1B/1D receptor agonist + NSAID.

TREXIMET Interactions:

See Contraindications. Concomitant aspirin, salicylates (eg, diflunisal, salsalate) or other NSAIDs: not recommended. Increased risk of GI bleed with anticoagulants, antiplatelets, oral corticosteroids, SSRIs, SNRIs, smoking, alcohol, or prolonged NSAID therapy; monitor. May antagonize, or increase risk of renal failure with diuretics (eg, loop or thiazides), ACE inhibitors, ARBs, or β-blockers; monitor closely. Potentiates digoxin; monitor levels. May potentiate lithium, methotrexate, cyclosporine; monitor for toxicity. Concomitant with pemetrexed may increase risk of pemetrexed-associated myelosuppression, renal, and GI toxicity. Serum levels increased by probenecid. Risk of serotonin syndrome with concomitant SSRIs, SNRIs, TCAs, MAOIs. May interfere with 5HIAA urinary assays or Porter-Silber tests.

Adverse Reactions:

Dizziness, somnolence, nausea, chest or neck/throat/jaw discomfort/pain, paresthesia, dyspepsia, dry mouth; cardiovascular thrombotic events, GI ulcer/bleed, hepatotoxicity, renal toxicity, hypersensitivity reactions, serious skin reactions (eg, exfoliative dermatitis, Stevens-Johnson Syndrome, toxic epidermal necrolysis), Drug Reaction with Eosinophilia and Systemic Symptoms (discontinue if occurs), anemia. Children: hot flush, muscle tightness.

Generic Drug Availability:


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