"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"...
The following serious adverse reactions are described below and elsewhere in labeling:
- Myocardial Ischemia/Infarction, Stroke, Prinzmetal's Angina [see WARNINGS AND PRECAUTIONS]
- Gastrointestinal effects [see WARNINGS AND PRECAUTIONS]
- Arrhythmias [see WARNINGS AND PRECAUTIONS]
- Chest, throat, neck, and/or jaw pain/tightness/pressure [see WARNINGS AND PRECAUTIONS]
- Cerebrovascular events [see WARNINGS AND PRECAUTIONS]
- Other vasospasm reactions [see WARNINGS AND PRECAUTIONS]
- Increase in blood pressure [see WARNINGS AND PRECAUTIONS]
- Congestive heart failure and edema [see WARNINGS AND PRECAUTIONS]
- Medication overuse headache [see WARNINGS AND PRECAUTIONS]
- Serotonin syndrome [see WARNINGS AND PRECAUTIONS]
- Renal Toxicity [see WARNINGS AND PRECAUTIONS]
- Anaphylactic reactions [see CONTRAINDICATIONS, WARNINGS AND PRECAUTIONS]
- Serious skin reactions [see WARNINGS AND PRECAUTIONS]
- Hepatotoxicity [see WARNINGS AND PRECAUTIONS]
- Hematological toxicity [see WARNINGS AND PRECAUTIONS]
- Exacerbation Asthma Related to Aspirin Sensitivity [see WARNINGS AND PRECAUTIONS]
- Seizures [see WARNINGS AND PRECAUTIONS]
Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The adverse reactions reported below are specific to the clinical trials with TREXIMET 85/500 mg. See also the full prescribing information for naproxen and sumatriptan products.
Table 1 lists adverse reactions that occurred in 2 placebo-controlled clinical trials (Study 1 and 2) in adult patients who received 1 dose of study drug. Only adverse reactions that occurred at a frequency of 2% or more in any group treated with TREXIMET 85/500 mg and that occurred at a frequency greater than the placebo group are included in Table 1.
Table 1: Adverse Reactions in Pooled
Placebo-Controlled Trials in Adult Patients with Migraine
|Adverse Reactions||TREXIMET 85/500 mg %
(n = 737)
(n = 752)
|Sumatriptan 85 mg %
(n = 735)
|Naproxen Sodium 500 mg %
(n = 732)
|Nervous system disorders|
|Paresthesia||2||< 1||2||< 1|
|Dry mouth||2||1||2||< 1|
|Pain and other pressure sensations|
|Chest discomfort/ chest pain||3||< 1||2||1|
|Neck/throat/ jaw pain/tightness/ pressure||3||1||3||1|
The incidence of adverse reactions in controlled clinical trials was not affected by gender or age of the patients. There were insufficient data to assess the impact of race on the incidence of adverse reactions.
Pediatric Patients 12 to 17 Years of Age
In a placebo-controlled clinical trial that evaluated pediatric patients 12 to 17 years of age who received 1 dose of TREXIMET 10/60 mg, 30/180 mg, or 85/500 mg, adverse reactions occurred in 13% of patients who received 10/60 mg, 9% of patients who received 30/180 mg, 13% who received 85/500 mg, and 8% who received placebo. No patients who received TREXIMET experienced adverse reactions leading to withdrawal from the trial. The incidence of adverse reactions in pediatric patients 12 to 17 years of age was comparable across all 3 doses compared with placebo. Table 2 lists adverse reactions that occurred in a placebo-controlled trial in pediatric patients 12 to 17 years of age at a frequency of 2% or more with TREXIMET and were more frequent than the placebo group.
Table 2: Adverse Reactions
in a Placebo-Controlled Trial in Pediatric Patients 12 to 17 Years of Age with
|Adverse Reactions||TREXIMET 10/60 mg %
(n = 96)
|TREXIMET 30/180 mg %
(n = 97)
|TREXIMET 85/500 mg %
(n = 152)
(n = 145)
|Hot flush (i.e., hot flash[es])||0||2||< 1||0|
Read the Treximet (sumatriptan and naproxen sodium tablets) Side Effects Center for a complete guide to possible side effects
Ergot-containing drugs have been reported to cause prolonged vasospastic reactions. Because these effects may be additive, use of ergotamine-containing or ergot-type medications (like dihydroergotamine or methysergide) and TREXIMET within 24 hours of each other is contraindicated.
Monoamine Oxidase-A Inhibitors
MAO-A inhibitors increase systemic exposure of orally administered sumatriptan by 7-fold. Therefore, the use of TREXIMET in patients receiving MAO-A inhibitors is contraindicated.
Other 5-HT1 Agonists
Because their vasospastic effects may be additive, coadministration of TREXIMET and other 5-HT1 agonists (e.g., triptans) within 24 hours of each other is contraindicated.
Naproxen sodium and other NSAIDs have been reported to reduce the tubular secretion of methotrexate in an animal model, possibly increasing the toxicity of methotrexate. Concomitant administration of some NSAIDs with high-dose methotrexate therapy has been reported to elevate and prolong serum methotrexate levels, resulting in deaths from severe hematologic and gastrointestinal toxicity. During concomitant use of TREXIMET and methotrexate, monitor patients for methotrexate toxicity.
When naproxen is administered with aspirin ( > 1 gram/day), its protein binding is reduced, although the clearance of free naproxen is not altered. Concomitant administration of TREXIMET and aspirin is not generally recommended because of the increased risk of bleeding [see WARNINGS AND PRECAUTIONS].
Selective Serotonin Reuptake Inhibitors/Serotonin Norepinephrine Reuptake Inhibitors And Serotonin Syndrome
Cases of serotonin syndrome have been reported during coadministration of triptans and SSRIs, SNRIs, TCAs, and MAO inhibitors [see WARNINGS AND PRECAUTIONS].
Angiotensin-Converting Enzyme Inhibitors
NSAIDs may diminish the antihypertensive effect of angiotensin converting enzyme (ACE) inhibitors. The use of TREXIMET in patients who are receiving ACE inhibitors may potentiate renal disease states [see WARNINGS AND PRECAUTIONS]. Monitor for signs of worsening renal function during concomitant use of TREXIMET and ACE-inhibitors in patients who are elderly, volume-depleted, or have impaired renal function.
Clinical trials, as well as postmarketing observations, have shown that NSAIDs can reduce the natriuretic effect of furosemide and thiazides in some patients. This response has been attributed to inhibition of renal prostaglandin synthesis. During concomitant use of TREXIMET, observe patients for signs of renal failure, in addition to assuring diuretic efficacy [see WARNINGS AND PRECAUTIONS].
NSAIDs elevated plasma lithium levels and a reduced renal lithium clearance. The mean minimum lithium concentration increased 15%, and the renal clearance was decreased by approximately 20%. These effects have been attributed to NSAID inhibition of renal prostaglandin synthesis. During concomitant use of TREXIMET and lithium, monitor patients for signs of lithium toxicity.
Probenecid given concurrently increases naproxen anion plasma levels and extends its plasma half-life significantly.
Propranolol And Other Beta-Blockers
Propranolol 80 mg given twice daily had no significant effect on sumatriptan pharmacokinetics. Naproxen and other NSAIDs can reduce the antihypertensive effect of propranolol and other beta-blockers.
The effects of warfarin and NSAIDs on gastrointestinal bleeding are synergistic, such that patients taking both drugs have a higher risk of serious gastrointestinal bleeding than patients taking either drug alone.
Drug/Laboratory Test Interactions
Naproxen may decrease platelet aggregation and prolong bleeding time. This effect should be kept in mind when bleeding times are determined.
The administration of naproxen sodium may result in increased urinary values for 17-ketogenic steroids because of an interaction between the drug and/or its metabolites with m-di-nitrobenzene used in this assay. Although 17-hydroxy-corticosteroid measurements (Porter-Silber test) do not appear to be artificially altered, it is suggested that therapy with naproxen be temporarily discontinued 72 hours before adrenal function tests are performed if the Porter-Silber test is to be used.
Naproxen may interfere with some urinary assays of 5-hydroxy indoleacetic acid (5HIAA).
Read the Treximet Drug Interactions Center for a complete guide to possible interactions
Last reviewed on RxList: 9/10/2015
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