"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:
- Cardiovascular Thrombotic Events [see WARNINGS AND PRECAUTIONS]
- GI Bleeding, Ulceration and Perforation [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]
- Hepatotoxicity [see WARNINGS AND PRECAUTIONS]
- Hypertension [see WARNINGS AND PRECAUTIONS]
- Heart Failure and Edema [see WARNINGS AND PRECAUTIONS]
- Medication Overuse Headache [see WARNINGS AND PRECAUTIONS]
- Serotonin Syndrome [see WARNINGS AND PRECAUTIONS]
- Renal Toxicity and Hyperkalemia [see WARNINGS AND PRECAUTIONS]
- Anaphylactic Reactions [see WARNINGS AND PRECAUTIONS]
- Serious Skin Reactions [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|
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 Migraine
|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
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
|Clinical Impact:||Ergot-containing drugs have been reported to cause prolonged vasospastic reactions.|
|Intervention:||Because these effects may be additive, coadministration of TREXIMET and ergotamine-containing or ergot-type medications (like dihydroergotamine or methysergide) within 24 hours of each other is contraindicated.|
|Monoamine Oxidase-A Inhibitors|
|Clinical Impact:||MAO-A inhibitors increase systemic exposure of orally administered sumatriptan by 7-fold.|
|Intervention:||The use of TREXIMET in patients receiving MAO-A inhibitors is contraindicated.|
|Other 5-HT1 Agonists|
|Clinical Impact:||5-HT1 agonist drugs can cause vasospastic effects.|
|Intervention:||Because these effects may be additive, coadministration of TREXIMET and other 5 HT1 agonists (e.g., triptans) within 24 hours of each other is contraindicated.|
|Drugs That Interfere with Hemostasis|
|Intervention:||Monitor patients with concomitant use of TREXIMET with anticoagulants (e.g., warfarin), antiplatelet agents (e.g., aspirin), selective serotonin reuptake inhibitors (SSRIs), and serotonin norepinephrine reuptake inhibitors (SNRIs) for signs of bleeding [see WARNINGS AND PRECAUTIONS].|
|Clinical Impact:||Controlled clinical studies showed that the concomitant use of NSAIDs and analgesic doses of aspirin does not produce any greater therapeutic effect than the use of NSAIDs alone. In a clinical study, the concomitant use of an NSAID and aspirin was associated with a significantly increased incidence of GI adverse reactions as compared to use of the NSAID alone [see WARNINGS AND PRECAUTIONS and CLINICAL PHARMACOLOGY].|
|Intervention:||Concomitant use of TREXIMET and analgesic doses of 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|
|Clinical Impact:||Cases of serotonin syndrome have been reported during coadministration of triptans and SSRIs, SNRIs, TCAs, and MAO inhibitors [see WARNINGS AND PRECAUTIONS].|
|Intervention:||Discontinue TREXIMET if serotonin syndrome is suspected.|
|ACE Inhibitors, Angiotensin Receptor Blockers, and Beta-blockers|
|Clinical Impact:||Clinical studies, as well as post-marketing observations, showed that NSAIDs reduced the natriuretic effect of loop diuretics (e.g., furosemide) and thiazide diuretics in some patients. This effect has been attributed to the NSAID inhibition of renal prostaglandin synthesis.|
|Intervention:||During concomitant use of TREXIMET with diuretics, observe patients for signs of worsening renal function, in addition to assuring diuretic efficacy including antihypertensive effects [see WARNINGS AND PRECAUTIONS].|
|Clinical Impact:||The concomitant use of naproxen with digoxin has been reported to increase the serum concentration and prolong the half-life of digoxin.|
|Intervention:||During concomitant use of TREXIMET and digoxin, monitor serum digoxin levels.|
|Clinical Impact:||NSAIDs have produced elevations in plasma lithium levels and reductions in renal lithium clearance. The mean minimum lithium concentration increased 15%, and the renal clearance decreased by approximately 20%. This effect has been attributed to NSAID inhibition of renal prostaglandin synthesis.|
|Intervention:||During concomitant use of TREXIMET and lithium, monitor patients for signs of lithium toxicity.|
|Clinical Impact:||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. Concomitant use of NSAIDs and methotrexate may increase the risk for methotrexate toxicity (e.g., neutropenia, thrombocytopenia, renal dysfunction).|
|Intervention:||During concomitant use of TREXIMET and methotrexate, monitor patients for methotrexate toxicity.|
|Clinical Impact:||Concomitant use of NSAIDs and cyclosporine may increase cyclosporine’s nephrotoxicity.|
|Intervention:||During concomitant use of TREXIMET and cyclosporine, monitor patients for signs of worsening renal function.|
|NSAIDs and Salicylates|
|Clinical Impact:||Concomitant use of naproxen with other NSAIDs or salicylates (e.g., diflunisal, salsalate) increases the risk of GI toxicity, with little or no increase in efficacy [see WARNINGS AND PRECAUTIONS].|
|Intervention:||The concomitant use of naproxen with other NSAIDs or salicylates is not recommended.|
|Clinical Impact:||Concomitant use of NSAIDs and pemetrexed may increase the risk of pemetrexed-associated myelosuppression, renal, and GI toxicity (see the pemetrexed prescribing information).|
|Intervention:||During concomitant use of TREXIMET and pemetrexed, in patients with renal impairment whose creatinine clearance ranges from 45 to 79 mL/min, monitor for myelosuppression, renal and GI toxicity. NSAIDs with short elimination halflives (e.g., diclofenac, indomethacin) should be avoided for a period of two days before, the day of, and two days following administration of pemetrexed.
In the absence of data regarding potential interaction between pemetrexed and NSAIDs with longer half-lives (e.g., meloxicam, nabumetone), patients taking these NSAIDs should interrupt dosing for at least five days before, the day of, and two days following pemetrexed administration.
|Clinical Impact:||Probenecid given concurrently increases naproxen anion plasma levels and extends its plasma half-life significantly. The clinical significance of this is unknown.|
|Intervention:||Reduce the frequency of administration of Treximet when given concurrently with probenecid.|
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: 5/25/2016
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