Patients may pay as little as $25*
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For adult patients with acute migraine

When your first
triptan falls short,
turn to TREXIMET

*This offer will reduce patient out-of-pocket cost, based on a maximum prescription
benefit of $45 paid by PERNIX®. Some limitations apply: link to Terms and Conditions.

Superior Pain Relief

2 to 24 hours vs sumatriptan alone1*

  • Study 1 sustained pain-free results: TREXIMET 25%,
    sumatriptan 16%, naproxen sodium 10%, placebo 8%
  • Study 2 sustained pain-free results: TREXIMET 23%,
    sumatriptan 14%, naproxen sodium 10%, placebo 7%

*P<0.01 TREXIMET vs sumatriptan, naproxen sodium, and placebo.1

Study design: Randomized, double-blind, single-attack, placebo-controlled, parallel-group studies conducted among
1441 (Study 1) and 1470 (Study 2) patients diagnosed with migraine, evaluating the safety and efficacy of TREXIMET
in the acute treatment of moderate-to-severe migraine. Patients were randomized to receive TREXIMET; sumatriptan
85 mg; naproxen sodium 500 mg; or placebo, to be used after onset of a migraine with moderate-to-severe pain.1

1 tablet that works in 2 different
ways on 3 physiologic aspects
of migraine

  • Sumatriptan is a 5-HT1 receptor
    agonist that binds with high affinity
    to 5-HT1B and 5-HT1D receptors
  • Naproxen is an NSAID with analgesic
    and antipyretic properties

The exact mechanism of action is unknown.

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IMPORTANT SAFETY INFORMATION

TREXIMET tablets are indicated for the acute treatment of migraine attacks, with or without aura, in adults. Carefully consider the potential benefits and risks of TREXIMET and other treatment options when deciding to use TREXIMET. TREXIMET is not intended for the prophylactic therapy of migraine or for use in the management of hemiplegic or basilar migraine. Safety and effectiveness of TREXIMET have not been established for cluster headache.

TREXIMET tablets contain 85 mg sumatriptan and 500 mg naproxen sodium.

WARNINGS

Cardiovascular Risk: TREXIMET may cause an increased risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke, which can be fatal. This risk may increase with duration of use. Patients with cardiovascular disease or risk factors for cardiovascular disease may be at greater risk (see WARNINGS in complete Prescribing Information).

Gastrointestinal Risk: TREXIMET contains a nonsteroidal anti-inflammatory drug (NSAID). NSAID-containing products cause an increased risk of serious gastrointestinal adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients are at greater risk for serious gastrointestinal (GI) events (see WARNINGS in complete Prescribing Information).

  • TREXIMET should only be used where a clear diagnosis of migraine headache has been established
  • TREXIMET is contraindicated in patients with history, symptoms, or signs of ischemic cardiac, cerebrovascular, or peripheral vascular syndromes and in patients with other significant underlying cardiovascular diseases; and in patients who have had coronary artery bypass graft (CABG) surgery
  • TREXIMET should not be given to patients with uncontrolled hypertension. Use with caution in patients with controlled hypertension because the components have been shown to increase blood pressure. Significant elevation in blood pressure, including hypertensive crisis, has been reported in patients receiving sumatriptan with and without a history of hypertension. NSAID-containing products can lead to onset of new hypertension. Blood pressure should be closely monitored
  • TREXIMET is contraindicated in patients receiving MAO-A inhibitors or ergotamine-containing or ergot-type medications. Do not use within 2 weeks of discontinuation of MAO-A inhibitor therapy. Do not use within 24 hours of any ergotamine-containing or ergot-type medication. TREXIMET should not be administered within 24 hours of another 5-HT1 agonist
  • TREXIMET should not be administered to patients with hemiplegic or basilar migraine
  • TREXIMET is contraindicated in patients with hepatic impairment
  • TREXIMET is contraindicated in patients who have had allergic reactions or hypersensitivity to products containing naproxen. It is also contraindicated in patients in whom aspirin or other NSAID/analgesic drugs induce the syndrome of asthma, rhinitis, and nasal polyps. Use with caution in patients with preexisting asthma. Assess patients for these medical conditions. Anaphylactic/anaphylactoid reactions to naproxen have the potential of being fatal
  • TREXIMET is contraindicated in patients with hypersensitivity to sumatriptan or any other component of the product. Anaphylactic/anaphylactoid reactions have occurred in patients receiving sumatriptan, which can be fatal
  • TREXIMET should not be given to patients with ischemic or vasospastic coronary artery disease (CAD)
  • It is strongly recommended that sumatriptan-containing products not be given to patients with risk factors for CAD unless a cardiovascular evaluation shows the patient is reasonably free of CAD, ischemic myocardial disease, or other significant underlying cardiovascular disease. It is strongly recommended that patients with risk factors predictive of CAD who have a satisfactory cardiovascular evaluation be monitored closely, including an ECG when administering the first dose because cardiac ischemia can occur in the absence of clinical symptoms. Intermittent long-term users of TREXIMET who have or acquire risk factors for CAD should undergo periodic cardiovascular evaluation
  • Serious adverse cardiac events, including acute myocardial infarction (MI), life-threatening disturbances of cardiac rhythm, and death have been reported within a few hours following administration of sumatriptan. The incidence of these events is extremely low. Some have occurred in patients with no cardiac disease history and with documented absence of CAD, and the proximity of the events to sumatriptan use supports the conclusion that some cases were caused by the drug. With known underlying CAD, the relationship is uncertain
  • Studies with NSAIDs have shown an increased risk of serious cardiovascular thrombotic events, MI, and stroke, which can be fatal. Use the lowest effective dose for the shortest duration possible. There is no consistent evidence that concurrent use of aspirin mitigates this increased risk; concurrent aspirin use increases the risk of serious GI events
  • Cerebrovascular hemorrhage, subarachnoid hemorrhage, stroke, and other cerebrovascular events, some fatal, have been reported in patients treated with sumatriptan. In a number of cases, it appears possible that these events were primary. It is important to advise patients not to administer TREXIMET if a headache is atypical. Migraineurs may be at increased risk of certain cerebrovascular events
  • Sumatriptan may cause other vasospastic reactions. Peripheral vascular ischemia and colonic ischemia with abdominal pain and bloody diarrhea have been reported. Transient and permanent blindness and significant partial vision loss have been reported with sumatriptan
  • TREXIMET should be used with caution in patients with fluid retention or heart failure
  • Cases of life-threatening serotonin syndrome have been reported during combined use of selective serotonin reuptake inhibitors (SSRIs) or serotonin norepinephrine reuptake inhibitors (SNRIs) and triptans. This syndrome may also occur with triptans alone
  • NSAID-containing products can cause serious GI adverse events including: inflammation, bleeding, ulceration, and perforation of the stomach, small intestine, or large intestine, which can be fatal. Risks may increase with longer duration of use. TREXIMET should be prescribed with extreme caution in those with a history of ulcer disease or GI bleeding; use with caution in patients with a history of inflammatory bowel disease
  • Long-term administration of NSAIDs has resulted in renal papillary necrosis and other renal injury. TREXIMET is not recommended in patients with advanced renal disease
  • NSAID-containing products can cause serious adverse events such as exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis, which can be fatal. These serious events may occur without warning. Inform patients about the signs and symptoms of serious skin manifestations, and to discontinue TREXIMET at the first appearance of skin rash or any other sign of hypersensitivity
  • TREXIMET should not be used in late pregnancy (third trimester) because NSAID-containing products have been shown to cause premature closure of the ductus arteriosus and delayed parturition. TREXIMET should not be used during early pregnancy unless the potential benefit justifies the potential risk to the fetus
  • Avoid use of TREXIMET in nursing mothers because the active components can pass into breast milk
  • TREXIMET and other naproxen-containing products should not be used concomitantly since they all circulate in the plasma as the naproxen anion
  • TREXIMET should be used with caution in patients with a history of epilepsy or conditions associated with a lowered seizure threshold. There have been reports of seizure following administration of sumatriptan
  • Overuse of acute migraine drugs (e.g., ergotamine, triptans, opioids, or a combination of drugs for 10 or more days per month) may lead to exacerbation of headache (medication overuse headache). Detoxification of patients, including withdrawal of the overused drugs, and treatment of withdrawal symptoms may be necessary. Inform patients about the risks of medication overuse, and encourage patients to track headache frequency and medication use
  • TREXIMET may reduce the effectiveness of antihypertensives, such as beta-blockers. TREXIMET may also potentiate renal disease in patients receiving ACE inhibitors, furosemide, or thiazide diuretics
  • TREXIMET may increase the plasma levels of methotrexate and lithium: patients should be monitored for signs of toxicity. Probenecid may increase plasma levels of naproxen
  • Use of TREXIMET with aspirin is not generally recommended because of the potential for increased adverse events. Concomitant use with warfarin has a higher risk of serious GI bleeding than taking either drug alone
  • In 2 well-controlled clinical trials, the most common adverse events reported with TREXIMET ≥2% and greater than placebo were dizziness (4%), somnolence (3%), nausea (3%), chest discomfort/chest pain (3%), neck/throat/jaw pain/tightness/pressure (3%), paresthesia (2%), dyspepsia (2%), dry mouth (2%)

Reference: 1. Brandes JL, Kudrow D, Stark SR, et al. Sumatriptan-naproxen for acute treatment of migraine: a randomized trial. JAMA. 2007;297(13):1443-1454.

Please consult the complete Prescribing Information, including Boxed Warnings, on this site.

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