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Details with Side Effects
Because strategies for the management of overdose are continually evolving, it is advisable to contact a Poison Control Center to determine the latest recommendations for the management of an overdose of any drug.
There have been no reports of overdosage with TREXIMET. Since sumatriptan and naproxen have pharmacologically different actions, it is difficult to predict how an individual will respond to an overdosage with TREXIMET.
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.
Significant naproxen overdosage may be characterized by lethargy, dizziness, drowsiness, epigastric pain, abdominal discomfort, heartburn, indigestion, nausea, transient alterations in liver function, hypoprothrombinemia, renal dysfunction, metabolic acidosis, apnea, disorientation, or vomiting. Gastrointestinal bleeding can occur. Hypertension, acute renal failure, respiratory depression, and coma may occur, but are rare. Anaphylactoid reactions have been reported with therapeutic ingestion of NSAIDs, and may occur following an overdose. Because naproxen sodium may be rapidly absorbed, high and early blood levels should be anticipated. A few patients have experienced seizures, but it is not clear whether or not these were drug related. It is not known what dose of the drug would be life threatening.
In animals 0.5 g/kg of activated charcoal was effective in reducing plasma levels of naproxen. 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. Emesis and/or activated charcoal (60 to 100 g in adults, 1 to 2 g/kg in children) and/or osmotic cathartic may be indicated in patients seen within 4 hours of ingestion with symptoms or following a large overdose. Forced diuresis, alkalinization of urine, or hemoperfusion may not be useful due to high protein binding.
TREXIMET should not be given to patients with history, symptoms, or signs of ischemic cardiac, cerebrovascular, or peripheral vascular syndromes. In addition, patients with other significant underlying cardiovascular diseases should not receive TREXIMET, nor should patients who have had coronary artery bypass graft (CABG) surgery. Ischemic cardiac syndromes include, but are not limited to, angina pectoris of any type (e.g., stable angina of effort and vasospastic forms of angina, such as the Prinzmetal variant), all forms of myocardial infarction, and silent myocardial ischemia. Cerebrovascular syndromes include, but are not limited to, strokes of any type as well as transient ischemic attacks. Peripheral vascular disease includes, but is not limited to, ischemic bowel disease (see WARNINGS: Cardiovascular Effects).
TREXIMET should not be given to patients with uncontrolled hypertension because the components have been shown to increase blood pressure.
Monoamine Oxidase-A Inhibitors
Concurrent administration of MAO-A inhibitors or use of TREXIMET within 2 weeks of discontinuation of MAO-A inhibitor therapy is contraindicated (see CLINICAL PHARMACOLOGY: Drug Interactions and PRECAUTIONS: DRUG INTERACTIONS).
Ergotamine-Containing or Ergot-Type Medications
TREXIMET and any ergotamine-containing or ergot-type medication (like dihydroergotamine or methysergide) should not be used within 24 hours of each other (see PRECAUTIONS: DRUG INTERACTIONS). Other 5-HT1 Agonists: Since TREXIMET contains sumatriptan, it should not be administered within 24 hours of another 5-HT1 agonist.
TREXIMET should not be administered to patients with hemiplegic or basilar migraine.
Allergy to Naproxen/Asthma, Nasal Polyps, Urticaria, and Hypotension Associated With Nonsteroidal Anti-inflammatory Drugs
TREXIMET is contraindicated in patients who have had allergic reactions to prescription as well as to over-the-counter products containing naproxen. It is also contraindicated in patients in whom aspirin or other nonsteroidal anti-inflammatory/analgesic drugs induce the syndrome of asthma, rhinitis, and nasal polyps. Anaphylactic/anaphylactoid reactions to naproxen, whether of the true allergic type or the pharmacologic idiosyncratic type (e.g., aspirin hypersensitivity syndrome), usually but not always occur in patients with a known history of such reactions. Both types of reactions have the potential of being fatal. Therefore, careful questioning of patients for medical conditions such as asthma, nasal polyps, urticaria, and hypotension associated with NSAIDs before starting therapy is important. In addition, if such symptoms occur during therapy, treatment should be discontinued (see WARNINGS: Anaphylactic/Anaphylactoid Reactions and PRECAUTIONS: Preexisting Asthma).
Hypersensitivity to Sumatriptan or Naproxen
TREXIMET is contraindicated in patients with hypersensitivity to sumatriptan, naproxen, or any other component of the product.
Last reviewed on RxList: 12/2/2011
This monograph has been modified to include the generic and brand name in many instances.
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