"Today, the U.S. Food and Drug Administration approved Topamax (topiramate) for prevention (prophylaxis) of migraine headaches in adolescents ages 12 to 17. This is the first FDA approval of a drug for migraine prevention in this age group. The me"...
Patients (N = 670) have received single oral doses of 140 to 300 mg of sumatriptan without significant adverse effects. Volunteers (N = 174) have received single oral doses of 140 to 400 mg without serious adverse events.
Overdose of sumatriptan in animals has been fatal and has been heralded by convulsions, tremor, paralysis, inactivity, ptosis, erythema of the extremities, abnormal respiration, cyanosis, ataxia, mydriasis, salivation, and lacrimation.
In addition to the adverse events already described, significant naproxen overdosage may be characterized by lethargy, epigastric pain, abdominal discomfort, transient alterations in liver function, hypoprothrombinemia, metabolic acidosis, apnea, disorientation, or vomiting. Acute renal failure, respiratory depression, and coma may occur, but are rare.
Patients should be managed by symptomatic and supportive care. There are no specific antidotes. Hemodialysis does not decrease the plasma concentration of naproxen because of the high degree of its protein binding. It is unknown what effect hemodialysis or peritoneal dialysis has on the serum concentrations of sumatriptan. Forced diuresis, alkalinization of urine, or hemoperfusion may not be useful due to high protein binding.
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].
- History of coronary artery bypass graft (CABG) surgery [see WARNINGS AND PRECAUTIONS].
- Wolff-Parkinson-White syndrome or arrhythmias associated with other cardiac accessory conduction pathway disorders [see WARNINGS AND PRECAUTIONS].
- 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 [see WARNINGS AND PRECAUTIONS].
- Peripheral vascular disease [see WARNINGS AND PRECAUTIONS].
- Ischemic bowel disease [see WARNINGS AND PRECAUTIONS].
- Uncontrolled hypertension [see WARNINGS AND PRECAUTIONS].
- Recent use (i.e., within 24 hours) of ergotamine-containing medication, ergot-type medication (such as dihydroergotamine or methysergide), or another 5-hydroxytryptamine1 (5-HT1) agonist [see DRUG INTERACTIONS].
- Concurrent administration of a monoamine oxidase (MAO)-A inhibitor or recent (within 2 weeks) use of an MAO-A inhibitor [see DRUG INTERACTIONS, CLINICAL PHARMACOLOGY].
- Asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs [see WARNINGS AND PRECAUTIONS].
- Hypersensitivity to sumatriptan, naproxen, or any other component of TREXIMET. Reactions have included angioedema and anaphylaxis [see WARNINGS AND PRECAUTIONS].
- Third trimester of pregnancy [see WARNINGS AND PRECAUTIONS, Use In Specific Populations].
- Severe hepatic impairment [see WARNINGS AND PRECAUTIONS, Use In Specific Populations, CLINICAL PHARMACOLOGY].
Last reviewed on RxList: 9/10/2015
Additional Treximet Information
Treximet - User Reviews
Treximet User Reviews
Now you can gain knowledge and insight about a drug treatment with Patient Discussions.
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
Find the secrets to longer life.