Treximet 500 mg/1
Sumatriptan Succinate and Naproxen Sodium · TABLET, FILM COATED · Currax Pharmaceuticals LLC
Treximet is a tablet, film coated containing sumatriptan succinate and naproxen sodium at 500 mg/1, taken oral. Manufactured by Currax Pharmaceuticals LLC.
Key Facts
- Brand Name
- Treximet
- Generic Name
- Sumatriptan Succinate and Naproxen Sodium
- NDC Code (Product)
42847-850- Manufacturer
- Currax Pharmaceuticals LLC
- Strength
- 500 mg/1
- Dosage Form
- TABLET, FILM COATED
- Route
- ORAL
- Marketing Status
- Application #
- NDA021926
- Marketing Start
- 04/25/2008
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE TREXIMET is indicated for the acute treatment of migraine with or without aura in adults and pediatric patients 12 years of age and older. TREXIMET is a combination of sumatriptan, a serotonin (5-HT) 1b/1d receptor agonist (triptan), and naproxen sodium, a non-steroidal anti-inflammatory drug, indicated for the acute treatment of migraine with or without aura in adults and pediatric patients 12 years of age and older. ( 1 ) Limitations of Use: Use only if a clear diagnosis of migraine headache has been established. ( 1 ) Not indicated for the prophylactic therapy of migraine attacks. ( 1 ) Not indicated for the treatment of cluster headache. ( 1 ) Limitations of Use: Use only if a clear diagnosis of migraine headache has been established. If a patient has no response to the first migraine attack treated with TREXIMET, reconsider the diagnosis of migraine before TREXIMET is administered to treat any subsequent attacks. TREXIMET is not indicated for the prevention of migraine attacks. Safety and effectiveness of TREXIMET have not been established for cluster headache.
Dosage & Administration
2 DOSAGE AND ADMINISTRATION Adults Recommended dosage: 1 tablet of 85/500 mg. ( 2.1 ) Maximum dosage in a 24-hour period: 2 tablets of 85/500 mg; separate doses by at least 2 hours. ( 2.1 ) Pediatric Patients 12 to 17 years of Age Recommended dosage: 1 tablet of 10/60 mg. ( 2.2 ) Maximum dosage in a 24-hour period: 1 tablet of 85/500 mg. Mild to Moderate Hepatic Impairment Recommended dosage: 1 tablet of 10/60 mg. ( 2.3 , 8.7 ) 2.1 Dosage in Adults The recommended dosage for adults is 1 tablet of TREXIMET 85/500 mg. TREXIMET 85/500 mg contains a dose of sumatriptan higher than the lowest effective dose. The choice of the dose of sumatriptan, and of the use of a fixed combination such as in TREXIMET 85/500 mg should be made on an individual basis, weighing the possible benefit of a higher dose of sumatriptan with the potential for a greater 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 an average of 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 consistent with individual patient treatment …
Contraindications
4 CONTRAINDICATIONS TREXIMET is contraindicated in the following patients: Ischemic coronary artery disease (CAD) (angina pectoris, history of myocardial infarction, or documented silent ischemia) or coronary artery vasospasm, including Prinzmetal's angina [see Warnings and Precautions (5.1) ]. In the setting of coronary artery bypass graft (CABG) surgery [see Warnings and Precautions (5.1) ] . Wolff-Parkinson-White syndrome or arrhythmias associated with other cardiac accessory conduction pathway disorders [see Warnings and Precautions (5.3) ] . History of stroke or transient ischemic attack (TIA) or history of hemiplegic or basilar migraine because these patients are at a higher risk of stroke [s ee Warnings and Precautions (5.5) ]. Peripheral vascular disease [see Warnings and Precautions (5.6) ]. Ischemic bowel disease [see Warnings and Precautions (5.6) ]. Uncontrolled hypertension [see Warnings and Precautions (5.8) ]. Recent use (i.e., within 24 hours) of ergotamine-containing medication, ergot-type medication (such as dihydroergotamine or methysergide), or another 5-hydroxytryptamine 1 (5-HT 1 ) agonist [see Drug Interactions (7) ]. Concurrent administration of a monoamine …
Drug Interactions
7 DRUG INTERACTIONS Drugs that Interfere with Hemostasis (e.g. warfarin, aspirin, SSRIs/SNRIs): Monitor patients for bleeding who are concomitantly taking TREXIMET with drugs that interfere with hemostasis. Concomitant use of TREXIMET and analgesic doses of aspirin is not generally recommended. ( 7.1 ) ACE Inhibitors and ARBs: Concomitant use with TREXIMET in elderly, volume depleted, or those with renal impairment may result in deterioration of renal function. In such high risk patients, monitor for signs of worsening renal function. ( 7.1 ) Diuretics: NSAIDs can reduce natriuretic effect of loop and thiazide diuretics. Monitor patients to assure diuretic efficacy including antihypertensive effects. ( 7.1 ) Digoxin: Concomitant use with TREXIMET can increase serum concentration and prolong half-life of digoxin. Monitor serum digoxin levels. ( 7.1 ) Lithium: Increases lithium plasma levels. ( 7.1 ) Methotrexate: Increases methotrexate plasma levels. ( 7.1 ) 7.1 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 Ergot…
Adverse Reactions
6 ADVERSE REACTIONS The following serious adverse reactions are described below and elsewhere in labeling: Cardiovascular Thrombotic Events [see Warnings and Precautions (5.1) ] GI Bleeding, Ulceration and Perforation [see Warnings and Precautions (5.2) ] Arrhythmias [see Warnings and Precautions (5.3) ] Chest, Throat, Neck, and/or Jaw Pain/Tightness/Pressure [see Warnings and Precautions (5.4) ] Cerebrovascular Events [see Warnings and Precautions (5.5) ] Other Vasospasm Reactions [see Warnings and Precautions (5.6) ] Hepatotoxicity [see Warnings and Precautions (5.7) ] Hypertension [see Warnings and Precautions (5.8) ] Heart Failure and Edema [see Warnings and Precautions (5.9) ] Medication Overuse Headache [see Warnings and Precautions (5.10) ] Serotonin Syndrome [see Warnings and Precautions (5.11) ] Renal Toxicity and Hyperkalemia [see Warnings and Precautions (5.12) ] Anaphylactic Reactions [see Warnings and Precautions (5.13) ] Serious Skin Reactions [see Warnings and Precautions (5.14) ] Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) [see Warnings and Precautions (5.15) ] Hematological Toxicity [see Warnings and Precautions (5.17) ] Exacerbation Asthma Relate…
Frequently Asked Questions
What is Treximet used for?
Treximet contains Sumatriptan Succinate and Naproxen Sodium. It is a tablet, film coated taken oral. Consult your doctor for specific uses.
Is Treximet a controlled substance?
Treximet is not classified as a controlled substance by the DEA.
What is the generic name for Treximet?
The generic name for Treximet is Sumatriptan Succinate and Naproxen Sodium. There are 1 other brand versions of Sumatriptan Succinate and Naproxen Sodium.
What is the NDC code for Treximet 500 mg/1?
The NDC (National Drug Code) for Treximet 500 mg/1 is 42847-850, listed by Currax Pharmaceuticals LLC.