Monograph Details
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Pain & Pyrexia
> Migraine and headache
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TREXIMET |
| Manufacturer |
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GlaxoSmithKline Pharmaceuticals |
| Legal Classification |
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Rx
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| Pharmacological Class |
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Selective 5-HT1B/1D receptor agonist + NSAID. |
| Generic Name |
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Sumatriptan (as succinate) 85mg, naproxen sodium 500mg; tabs. |
| Indications |
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Acute treatment of migraine. |
| Children |
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Not recommended. |
| Adults |
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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. |
| Contraindications |
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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. |
| Precautions |
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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; avoid in 3rd trimester). Labor & delivery, nursing mothers: not recommended. |
| Interactions |
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Ergotamines, other 5-HT1 agonists, MAOIs: see Contraindications. Avoid aspirin, other NSAIDs. Serotonin syndrome with SSRIs (eg, citalopram, escitalopram, fluoxetine, fluvoxamine), SNRIs (eg, duloxetine, venlafaxine). May potentiate methotrexate, lithium. May antagonize diuretics, antihypertensives (eg, β-blockers). Increased risk of renal toxicity with ACEIs, diuretics. Increased risk of GI bleed with oral corticosteroids, anticoagulants (monitor), smoking, alcohol. Probenecid increases naproxen levels and delays elimination. May interfere with tests for 17-ketogenic steroids, 5-HIAA. |
| Adverse Reactions |
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Dizziness, somnolence, paresthesia, nausea, dyspepsia, dry mouth, GI ulcers/bleed, abdominal pain, chest or neck/throat/jaw discomfort/pain, fatigue, rash (discontinue if occurs). See literature re: risk of cardiovascular events. |
| Extra Text |
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Note: Register pregnant patients exposed to Treximet by calling (800) 336-2176. |
| How Supplied |
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Tabs—9 (blister card) |
| Additional Resources |
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• Related Prescribing Note |
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