Treximet

Treximet is a prescription medicine used to treat migraine headaches. It may be used alone or with other medications.

Treximet belongs to a class of drugs called NSAIDs and serotonin 5-HT-receptor agonists.

Treximet’s safety and effectiveness in children younger than 12 years of age is unknown.

Side Effects of Treximet

RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS

Cardiovascular Thrombotic Events

• NSAIDs cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, which can be fatal. This risk may occur early in treatment and may increase with duration of use.
• Treximet is contraindicated in the setting of coronary artery bypass graft (CABG) surgery.

Gastrointestinal Bleeding, Ulceration, and Perforation

• NSAIDs cause an increased risk of serious gastrointestinal (GI) 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 and patients with a prior history of peptic ulcer disease and/or GI bleeding are at greater risk for serious GI events.

Treximet may cause serious side effects including:

• hives,
• difficulty breathing,
• swelling of your face, lips, tongue, or throat,
• severe skin reaction,
• fever,
• sore throat,
• burning eyes,
• skin pain,
• red or purple skin rash with blistering and peeling,
• pain spreading to your jaw or shoulder,
• sudden numbness or weakness on one side of the body,
• slurred speech,
• shortness of breath,
• numbness, tingling, pale or blue-colored appearance in your fingers or toes,
• leg cramps,
• burning, coldness, or heavy feeling in your legs,
• severe headache,
• blurred vision,
• pounding in your neck or ears,
• seizure,
• swelling,
• rapid weight gain,
• little or no urination,
• swelling of your feet or ankles,
• tiredness,
• loss of appetite,
• stomach pain (upper right side),
• tiredness,
• itching,
• dark urine,
• clay-colored stools,
• yellowing of the skin or eyes (jaundice),
• pale skin,
• bloody or tarry stools,
• coughing up blood,
• vomit that looks like coffee grounds,
• sudden severe stomach pain (especially after eating),
• vomiting,
• constipation,
• bloody diarrhea,
• weight loss,
• agitation,
• hallucinations,
• fever,
• sweating,
• shivering,
• fast heart rate,
• muscle stiffness,
• twitching,
• loss of coordination,
• nausea,
• vomiting, and
• diarrhea

If you experience any of the symptoms listed above, seek medical help right away.

The most common side effects of Treximet include:

• dizziness,
• drowsiness,
• weakness,
• tiredness,
• irregular heartbeats,
• numbness or tingling in your fingers or toes,
• dry mouth,
• heartburn,
• nausea,
• feeling hot,
• tight muscles, and
• pain or pressure in your chest or throat

If you have any side effect that bothers you or does not go away, inform your doctor.

These are not all the possible side effects of Treximet. For more information, consult your doctor or pharmacist.

Contact your doctor for medical advice about side effects. You may also report side effects to the FDA at 1-800-FDA-1088.

Dosage for Treximet

Dosage in Adults

The recommended dosage for adults is 1 tablet of Treximet 85/500 mg. Treximet 85/500 mg contains a higher dose of sumatriptan. The choice of the dose and use of a fixed combination like Treximet 85/500 mg should be made based on individual needs, considering the potential benefit and risk of adverse reactions.

• The maximum recommended dosage in a 24-hour period is 2 tablets, taken at least 2 hours apart.
• The safety of treating more than 5 migraine headaches in adults in a 30-day period has not been established.
• Use the lowest effective dosage for the shortest duration according to individual treatment goals.

Dosage in Pediatric Patients 12 to 17 Years Of Age

• The recommended dosage for pediatric patients 12 to 17 years of age is 1 tablet of Treximet 10/60 mg.
• The maximum recommended dosage in a 24-hour period is 1 tablet of Treximet 85/500 mg.
• The safety of treating more than 2 migraine headaches in pediatric patients in a 30-day period has not been established.
• Use the lowest effective dosage for the shortest duration according to individual treatment goals.

Dosing in Patients with Hepatic Impairment

• Treximet is contraindicated in patients with severe hepatic impairment.
• In patients with mild to moderate hepatic impairment, the recommended dosage in a 24-hour period is 1 tablet of Treximet 10/60 mg.
• Use the lowest effective dosage for the shortest duration according to individual treatment goals.

Administration Information

• Treximet may be taken with or without food. Do not split, crush, or chew the tablets.

QUESTION

Drug Interactions with Treximet

Clinically Significant Drug Interactions with Treximet

See Table 3 for clinically significant drug interactions with NSAIDs or Sumatriptan

Table 3. Clinically Significant Drug Interactions with naproxen or sumatriptan

• Naproxen and anticoagulants like warfarin have a synergistic effect on bleeding. The concomitant use of naproxen and anticoagulants increases the risk of serious bleeding compared to using either drug alone.
• Platelet serotonin release plays a role in hemostasis. Case-control and cohort epidemiological studies have shown that using drugs that interfere with serotonin reuptake along with an NSAID may increase the risk of bleeding more than using an NSAID alone.
• NSAIDs may diminish the antihypertensive effect of angiotensin converting enzyme (ACE) inhibitors, angiotensin receptor blockers (ARBs), or beta-blockers (including propranolol).
• In elderly patients, those who are volume-depleted (including those on diuretic therapy), or have renal impairment, co-administration of an NSAID with ACE inhibitors or ARBs may result in deterioration of renal function, including possible acute renal failure. These effects are usually reversible.
• During concomitant use of Treximet and ACE-inhibitors, ARBs, or beta-blockers, monitor blood pressure to ensure that the desired blood pressure is obtained.
• During concomitant use of Treximet and ACE-inhibitors or ARBs in elderly patients, those who are volume-depleted, or have impaired renal function, monitor for signs of worsening renal function.

During concomitant use of Treximet and pemetrexed, monitor for myelosuppression, renal and GI toxicity in patients with renal impairment (creatinine clearance 45 to 79 mL/min). Avoid using NSAIDs with short elimination half-lives (e.g., diclofenac, indomethacin) for two days before, the day of, and two days after administering pemetrexed. If using NSAIDs with longer half-lives like meloxicam or nabumetone, interrupt dosing for at least five days before, the day of, and two days after pemetrexed administration.

Drug/Laboratory Test Interactions

Blood Tests

• Naproxen may decrease platelet aggregation and prolong bleeding time. Consider this effect when determining bleeding times.

Urine Tests

• The administration of naproxen sodium may lead to increased urinary values for 17-ketogenic steroids due to an interaction between the drug and/or its metabolites with m-di-nitrobenzene used in this assay.
• For the Porter-Silber test, therapy with naproxen should be temporarily discontinued 72 hours before adrenal function tests to avoid artificial alteration.

Naproxen may interfere with some urinary assays of 5-hydroxy indoleacetic acid (5HIAA).

Naproxen may interfere with some urinary assays of 5-hydroxy indoleacetic acid (5HIAA).