Combination drug treats migraines

Company:

GlaxoSmithKline

Pharmacologic class:

Antimigraine (selective 5-HT1B/1D receptor agonist + nonsteroidal anti-inflammatory drug [NSAID])

Active ingredients:

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

Indication:

Acute treatment of migraine.

Pharmacology:

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.

Clinical trials:

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

Adults:

Swallow whole. One tablet once; may repeat once after two hours; maximum two tablets per day. The safety of treating an average of more than five migraines in a 30-day period has not been established.

Children:

Not recommended.

Contraindications:

Aspirin allergy or triad syndrome (asthma, rhinitis, nasal polyps), hypotension with prior NSAID or aspirin use.

History, symptoms, or signs of ischemic cardiac (e.g., MI, angina pectoris, silent myocardial ischemia), cerebrovascular (e.g., stroke, transient ischemic attack), or peripheral vascular (e.g., ischemic bowel disease, Raynaud) syndromes. Vasospastic coronary artery disease. Uncontrolled hypertension (HTN). Significant underlying cardiovascular disease. Basilar or hemiplegic migraine. Coronary artery bypass surgery. Hepatic impairment (especially elderly). Within 24 hours of ergot-type drugs (e.g., methysergide, dihydroergotamine) or other 5-HT1 agonists. During or within two weeks after discontinuing monoamine oxidase-type A inhibitors. Third-trimester pregnancy.

Precautions:

Confirm diagnosis. Avoid excessive use. Likelihood of unrecognized coronary artery disease (HTN, hypercholesterolemia, men older than age 40, postmenopausal women, obese, smokers, diabetes, strong family history): not recommended; exclude underlying cardiovascular disease, supervise first dose, consider monitoring ECG. Active peptic ulcer. History of GI disease or bleeding disorders. Monitor for GI bleed. Severe renal dysfunction (creatinine clearance <30 mL/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 and delivery, nursing mothers: not recommended.

Interactions:

Ergotamines, other 5-HT1 agonists, monoamine oxidase inhibitors: see Contraindications. Avoid aspirin, other NSAIDs. Serotonin syndrome with selective serotonin reuptake inhibitors (e.g., citalopram, fluoxetine), serotonin norepinephrine reuptake inhibitors (e.g., duloxetine, venlafaxine). May potentiate methotrexate, lithium. May antagonize diuretics, antihypertensives (e.g., beta blockers). Increased risk of renal toxicity with ACE inhibitors, diuretics. Increased risk of GI bleed with oral corticosteroids, anticoagulants (monitor), alcohol. Probenecid increases naproxen levels and delays elimination. May interfere with tests for 5-hydroxyindoleacetic acid, 17-ketogenic steroids.

Adverse reactions:

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

Note:

Register pregnant patients exposed to Treximet by calling 800.336.2176.

How supplied:

Tabs—9 (blister card)

For more information, call 888.825.5249 or visit www.Treximet.com.

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