Treximet

(Sumatriptan Succinate/Naproxen Sodium)

Treximet is a combination of sumatriptan succinate, a serotonin (5-HT) 1b/1d receptor agonist (triptan), and naproxen sodium, a non-steroidal anti-inflammatory drug.

The mechanism of action for sumatriptan is that it narrows widened blood vessels in the brain and blocks pain signals linked to migraines, while naproxen is an anti-inflammatory drug that reduces inflammation and pain. Together, they relieve migraine pain and associated symptoms like nausea and sensitivity to light, and help reduce the chance of the headache returning.

Follow all directions given to you by your doctor and read all documents provided, including the full Prescribing Information, FDA-Approved Product Labeling, Instructions for Use, and Medication Guide before using Treximet. However, the following is a synopsis of the general guidelines for the use of Treximet:

• Treximet is taken by mouth at the first sign of a migraine headache.
• Swallow the tablet whole with water. Do not crush, split, or chew it.
• Do not take more than one dose within 24 hours unless directed by your healthcare provider.
• Do not use Treximet to treat more than the recommended number of migraine attacks per month.
• Treximet should not be used for hemiplegic or basilar migraine.
• If the first dose does not relieve your migraine, do not take another dose without medical advice.

Your healthcare provider may review your response over time and adjust your treatment plan if migraines continue or worsen.

Some mild or common side effects of Treximet seen in clinical trials as compared to placebo include:

• Dizziness.
• Dry mouth.
• Nausea.
• Weight gain.
• Constipation.
• Tingling sensations.
• Drowsiness.
• Stomach discomfort or indigestion.
• Chest pain (angina), pressure, or tightness.

Some individuals may experience serious side effects while using Treximet. These side effects may require immediate medical attention. If you experience any of the following, contact your healthcare provider or seek emergency medical help:

• Signs of a heart attack or stroke, including sudden weakness, slurred speech, or vision changes. This has been observed most consistently at higher doses.
• Severe stomach pain, black stools, or vomiting blood may indicate gastrointestinal bleeding.
• Allergic reactions such as rash, blisters, swelling of the face, or shortness of breath.
• Serotonin syndrome, especially when used with antidepressants, with symptoms such as agitation, fever, sweating, fast heart rate, or confusion.
• Severe skin reactions, including toxic epidermal necrolysis.
• Symptoms of congestive heart failure, including shortness of breath, unexplained weight gain, or edema.

These are not all of the possible side effects of Treximet. You should always seek medical advice from your healthcare provider for any questions or concerns about your medical condition or treatment. Read all patient information, medication guides, or drug information sheets that come with this medication. You can also report adverse effects to the Food and Drug Administration at www.fda.gov/medwatch or 1-800-FDA-1088.

Before starting Treximet, it is crucial to discuss any existing health conditions with your healthcare provider. You should be sure that your healthcare provider is aware of all your medical conditions, including if you have:

• High blood pressure or uncontrolled hypertension.
• Heart disease, heart failure, or a history of heart attack.
• Peripheral vascular disease or Raynaud’s syndrome.
• Liver disease or hepatic impairment.
• Kidney disease or reduced renal function.
• A history of stomach ulcers or gastrointestinal bleeding.
• Blood disorders such as anemia.
• Risk factors for cardiovascular disease, including diabetes, smoking, and high cholesterol.
• Patients with migraine may be at increased risk of certain cerebrovascular events (e.g., stroke, hemorrhage, TIA).
• Do not use Treximet just before or after heart bypass surgery (coronary artery bypass graft, or CABG).
• Ischemic bowel disease.
• Treximet should be used with caution and under medical supervision in patients with higher cardiovascular or gastrointestinal risk.

Boxed Warning

Treximet contains naproxen sodium, a nonsteroidal anti-inflammatory drug. NSAIDs increase the risk of serious cardiovascular thrombotic events, including heart attack and stroke, which can be life-threatening. This risk may occur early in treatment and may increase with duration of use.

NSAIDs also increase the risk of serious gastrointestinal adverse events, including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. Elderly patients and those with a prior history of ulcer disease or gastrointestinal bleeding are at greater risk.

Treximet is contraindicated in the setting of coronary artery bypass graft surgery.

Treximet should not be used in patients with:

• Uncontrolled hypertension.
• Previous stroke or transient ischemic attack.
• Peripheral vascular disease.
• Hemiplegic or basilar migraine.
• Recent use of ergotamine, dihydroergotamine, or other triptans.
• Use of monoamine oxidase inhibitors within the past 14 days.
• Known hypersensitivity to sumatriptan, naproxen sodium, or NSAIDs.

Your healthcare provider will review contraindications carefully before prescribing Treximet. Hepatic abnormalities may be the result of hypersensitivity rather than direct toxicity.

Treximet is designed for the acute treatment of migraine attacks. Some patients may experience relief within 1 to 2 hours after taking a dose. Response time varies depending on the severity of the migraine and individual factors. Treximet does not prevent future migraine attacks.

When Treximet is taken with other prescription drugs, over-the-counter medications, vitamins, and supplements, it may change how they work or increase the frequency or severity of side effects. Make sure that you tell your healthcare professional about anything that you are taking to avoid any negative drug interactions, including:

• Ergotamine or dihydroergotamine increases the risk of vasospasm.
• Monoamine oxidase (MAO) inhibitors may increase sumatriptan levels.
• SSRIs or SNRIs, which increase the risk of serotonin syndrome.
• Anticoagulants such as warfarin increase the bleeding risk.
• Corticosteroids or other NSAIDs, which increase gastrointestinal bleeding risk.
• Diuretics or ACE inhibitors may reduce kidney function when combined with NSAIDs.
• Lithium, which may have increased blood levels when used with NSAIDs.
• ACE Inhibitors, Angiotensin Receptor Blockers, and Beta-blockers.
• Methotrexate is known for its toxicity.
• Probenecid, given concurrently, increases naproxen anion plasma levels and extends its plasma half-life significantly, which could have adverse reactions.

Treximet tablets contain a fixed combination of sumatriptan and naproxen sodium in a single dose. The specific strength prescribed depends on age and clinical judgment.

Treximet should be stored at room temperature, away from the reach of children or pets.

Treximet is manufactured by GlaxoSmithKline.

Yes. Generic versions containing the combination of sumatriptan and naproxen sodium are available.

Treximet is taken as needed for migraine attacks and does not require tapering. If you find you are needing Treximet frequently or migraines are worsening, speak with your healthcare provider. Do not increase doses or frequency without medical advice.

Treximet, particularly the naproxen component, may cause harm to an unborn baby, especially when used later in pregnancy. Talk to your doctor if you are already pregnant or if you have any plans to become pregnant.

Both sumatriptan and naproxen can pass into breast milk. Your healthcare provider will advise whether to avoid breastfeeding for a period after dosing or choose an alternative treatment.