Treximet® (sumatriptan and naproxen sodium)

Treximet® (sumatriptan and naproxen sodium) is a selective 5-HT1B/1D receptor agonist (triptan) and antiinflammatory indicated for the acute treatment of migraine, with or without aura, in adults and pediatric patients 12 years of age and older who have a clear migraine diagnosis. It comes in tablet form and is administered by mouth.

Treximet generally begins to work within 2 hours. It is intended to reduce acute migraine symptoms of migraine attacks that have already begun. It should not to be used as a prophylactic therapy to prevent the onset of migraine or to treat hemiplegic or basilar migraine.

Overuse of acute migraine drugs can cause medication overuse headaches. Overuse is considered dosing more than 10 or more days per month for 3 months or longer. Symptoms may need to be treated, and detoxification from migraine medications may be required.

What are the ingredients in Treximet?

The active ingredients in Treximet are sumatriptan and naproxen sodium.

How does Treximet work?

Treximet contains sumatriptan which works by binding with 5-HT1B/1D receptors on blood vessels in the brain. It narrows the blood vessels (constriction) surrounding the brain, which is correlated with the relief of migraine. It also reduces the inflammatory substances in the body that can trigger head pain, nausea, sensitivity to light and sound, and other migraine symptoms.

Treximet contains a nonsteroidal anti-inflammatory drug (NSAID), naproxen. NSAIDs inhibit the synthesis of inflammatory mediators. Treximet works best if it is taken as soon as migraine symptoms appear.

What are the possible side effects of Treximet?

Many clinical trials evaluated the safety and efficacy of Treximet. The most common side effects experienced by those taking Treximet include:

• Dizziness
• Nausea or dry mouth
• Pain or tight feeling in your chest, throat, jaw, or neck
• Fatigue- feeling weak, drowsy, or tired
• Flushing in pediatric patients (warm, red skin)

Treximet can also cause an increased risk of serious gastrointestinal problems including bleeding, ulceration, and perforation of the stomach or intestines.

This is not an exhaustive list of all potential side effects of Treximet. For more information, consult your doctor or healthcare provider. If you notice any new or worsening side effects when taking Treximet, contact your doctor or healthcare provider immediately.

Things to note about Treximet

Treximet tablets are a fixed combination of sumatriptan and naproxen sodium. Before starting Treximet talk with your doctor if you:

• Have a history of hypersensitivity to sumatriptan and naproxen sodium
• Have a history of coronary artery disease (CAD), angina or heart attacks
• Have a history of high blood pressure or high cholesterol
• Have a history of hemiplegic or basilar migraine
• Have a history of stroke, transient ischemic attacks (TIAs)
• Have a history of Wolff-Parkinson-White syndrome
• Have a history of peripheral vascular disease (circulation problems)
• Have a history of ischemic bowel disease
• Have taken a ergot-containing medication within the 24 hours prior to migraine
• Have taken an MAO-A inhibitor within 2 weeks prior to migraine onset
• Take methotrexate, aspirin, furosemide, probenecid, lithium, warfarin, propanolol or other beta blockers
• Take anti-depressant medicines including selective serotonin reuptake inhibitors (SSRIs), serotonin norepinephrine reuptake inhibitors (SNRIs), or tricyclic antidepressants (TCAs)
• Have severe hepatic (liver) impairment
• Have severe renal (kidney) problems
• Are pregnant or planning to get pregnant, Treximet should not be used during pregnancy unless the potential benefit justifies the potential risk to the fetus.

Before taking Treximet make sure to tell your doctor about all the medicines you take, including prescription and nonprescription, vitamins, and herbal supplements. Treximet and other medicines may affect each other, causing side effects.

Individuals with the above conditions should be monitored closely while taking Treximet.

If there is no response to the first migraine attack treated with Treximet, a physician should reconsider the migraine diagnosis prior to using the medication in any subsequent attacks.

A cardiovascular evaluation should be performed on patients who have never taken a triptan medication but who have multiple cardiovascular risk factors (e.g., increased age, diabetes, hypertension, smoking, obesity, strong family history of CAD) before starting Treximet. For those with a cardiac history, the first dose of Treximet should be administered in a medically supervised setting and an electrocardiogram (ECG) should be performed immediately following the dose.

Before taking Treximet make sure to tell your doctor about all the medicines you take, including prescription and nonprescription, vitamins, and herbal supplements. Treximet and other medicines may affect each other, causing side effects. Because Treximet can cause dizziness, weakness, or drowsiness, you should not not drive a car, use machinery, or do anything requiring you to be fully alert when taking this medication.

Keep track of when you have migraine attacks and when you take Treximet so you can monitor its effectiveness and communicate with your doctor about how the medication is working for you.

You should begin no medication or supplement without first checking with your health care provider and should let them know of any other prescriptions, OTCs, and herbals you are taking to ensure there are no interactions.

For additional details, read the full prescribing information of Treximet.