美国FDA近日已批准Treximet（舒马普坦85毫克+萘普生钠500毫克）用于紧急治疗有或无先兆的成人偏头痛发作。
Treximet是惟一将曲坦类药和抗炎止痛剂结合在同一片剂中的药物，具有靶向多种偏头痛机制的作用。这项批准是基于有2900多名偏头痛患者参加的两项相同的双盲、随机、安慰剂对照、平行分组的多中心研究，研究显示，与单用85毫克舒马普坦或500毫克萘普生钠或安慰剂相比，用Treximet治疗可使更多的患者在两小时和4小时时的偏头痛得到缓解。
在此研究中，Treximet可有效缓解偏头痛发作并可持续2~24小时，同时有效缓解其相关症状如恶心、畏光等。服用Treximet24小时内最常见的不良反应有眩晕、恶心、嗜睡、胸部不适及胸痛，颈、喉及下巴疼痛，紧张，反胃及口干等
Sumatriptan + naproxen combination tablet
Company:
GlaxoSmithKline
Antimigraine (Selective 5-HT1B/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, ?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? (blister card)
5/30/08
TREXIMET 