Adult Dosing
Acute migraine attacks (with or without aura)
- 1 tab (naproxen 500 mg/sumatriptan 85 mg) PO x 1; may repeat after at least 2 hrs if inadequate response
- Max: 2 tabs/24 hrs; 5 headaches/30 days
Notes:
- May be administered with or without food
- Do not split/crush/chew tablets
Pediatric Dosing
- Safety and effectiveness in pediatric patients have not been established
[Outline]
Renal Dose Adjustment (Based on CrCl)
- < 30 mL/min: Use not recommended
Hepatic Dose Adjustment
- Hepatic impairment: Contraindicated
- Naproxen/sumatriptan increases risk of serious and potentially fatal cardiovascular thrombotic events, MI, and stroke, therefore should not be given to patients with documented ischemic or vasospastic coronary artery disease (CAD) or to patients with a history of CABG surgery, or risk of CAD [US Black Box Warning]
- First dose of naproxen/sumatriptan should be administered in the setting with medically staffed and equipped facility, and ECG obtained immediately following first-time use. Patients who are intermittent long-term users of naproxen/sumatriptan should undergo periodic cardiovascular evaluation
- Long term use of NSAIDs is associated with increased risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke, which can be fatal. To minimize the risk for an adverse cardiovascular event use the lowest effective dose and for shortest duration possible
- Cerebral hemorrhage, subarachnoid hemorrhage, stroke, and other cerebrovascular events have been reported with sumatriptan. Care should be taken to exclude other potentially serious neurological conditions before treating headaches in patients not previously diagnosed as migraineurs, and in migraineurs who present with atypical symptoms
- Peripheral vascular ischemia and colonic ischemia with abdominal pain and bloody diarrhea have been reported with sumatriptan
- Transient and permanent blindness and significant partial vision loss have been observed with sumatriptan
- Significant elevation in blood pressure, including hypertensive crisis, has been reported in patients with and without a history of hypertension receiving sumatriptan. Use cautiously in patients with controlled hypertension and do not use in patients with uncontrolled hypertension
- NSAIDs can cause fluid retention and edema. Use cautiously in patients with fluid retention or heart failure
- Life-threatening serotonin syndrome including mental status changes, autonomic instability, neuromuscular aberrations and/or gastrointestinal symptoms, has been observed with triptans, particularly in combination with selective serotonin reuptake inhibitors (SSRIs) or serotonin norepinephrine reuptake inhibitors (SNRIs). Closely monitor patients particularly during treatment initiation and dose increase
- NSAIDs can cause serious gastrointestinal adverse events including inflammation, bleeding, ulceration, and perforation of the stomach, small intestine, or large intestine [US Black Box Warnings]
- Renal papillary necrosis and other renal injury has been reported with long term use of NSAIDs. Patients with impaired renal function, heart failure, liver dysfunction, those taking diuretics and angiotensin-converting enzyme (ACE) inhibitors, and the elderly are at greater risk
- Naproxen/sumatriptan is not recommended in patients with advanced renal disease. If initiated, closely monitor renal function
- Anaphylactic/anaphylactoid reactions have been observed with both sumatriptan and naproxen. This is more likely to occur in individuals with a history of sensitivity to multiple allergens. Emergency medicine should be readily available in case of anaphylaxis
- NSAID-containing products can cause serious adverse events such as exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis, which can be fatal. Discontinue treatment at the first sign of skin rash
- NSAID-containing products have been shown to cause premature closure of the ductus arteriosus, hence should not be used in late pregnancy and also during early pregnancy unless the potential benefit justifies the potential risk to the fetus
- Chest discomfort and jaw or neck tightness rarely associated with ischemic ECG changes have been reported following use of sumatriptan
- Seizure has been reported following administration of sumatriptan. Use cautiously in patients with a history of epilepsy or conditions associated with a lowered seizure threshold
- Severe hepatic reactions, including jaundice and fatal fulminant hepatitis, liver necrosis, and hepatic failure, some with fatal outcomes, have been reported with NSAIDs.
- Overuse of acute migraine treatments has been associated with the exacerbation of headache in susceptible patients. Withdrawal of the treatment can be considered
- NSAID-containing products inhibit platelet aggregation and have been shown to prolong bleeding time in some patients. Closely monitor patients with coagulation disorders or patients receiving anticoagulants
- Cross reactivity between aspirin and other NSAIDs has been reported in aspirin-sensitive patients. Do not administer naproxen/sumatriptan in patients with aspirin sensitivity and use cautiously in patients with preexisting asthma
Cautions: Use cautiously in
- Renal impairment
- Controlled hypertension
- Fluid retention
- Heart failure
- History of ulcer disease
- History of gastrointestinal bleeding
- Preexisting asthma
- History of epilepsy
- Dehydration
- Cardiac risk factors
- Geriatric population
- Substance abuse (alcohol/cigarettes)
Pregnancy Category:C
Breastfeeding: Sumatriptan is excreted in breastmilk in low levels, therefore it would not be expected to cause adverse effects in most breastfed infants. Limited information indicates that levels of naproxen in breastmilk are low, and adverse effects in breastfed infants are apparently uncommon. However, other agents may be preferred while nursing a newborn or preterm infant because of naproxen's long half-life and reported serious adverse reaction in a breastfed neonate. This information is based upon LactMed database (available at http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT last accessed 15 February 2011). According to the manufacturer's data, naproxen & sumatriptan are excreted in human breast milk. Due to the possible adverse effects on nursing infants, use of this drug in nursing mothers should be avoided.
US Trade Name(s)
US Availability
Treximet (naproxen/sumatriptan)
Canadian Trade Name(s)
Canadian Availability
UK Trade Name(s)
UK Availability
Australian Trade Name(s)
Australian Availability
[Outline]
Pricing data from www.DrugStore.com in U.S.A.
- Treximet 85-500 MG TABS [Bottle] (GLAXO SMITH KLINE)
9 mg = $219.98
27 mg = $629.97
Warning: This pricing information is subject to change at the sole discretion of DS Pharmacy. For the most current and up-to-date pricing information, please visit drugstore.com.
Drug Name: Treximet 85/500 (sumitriptan / naproxen) Oral Tablet
Ingredient(s): Naproxen mixture with Sumatriptan
Imprint: TREXIMET
Color(s): Blue
Shape: Capsule
Size (mm): 19.00
Score: 1
Inactive Ingredient(s): croscarmellose sodium / dextrose monohydrate / anhydrous dibasic calcium phosphate / fd&c blue no. 2 / lecithin, soybean / magnesium stearate / maltodextrin / cellulose, microcrystalline / povidone / sodium bicarbonate / carboxymethylcellulose sodium / talc / titanium dioxide
Drug Label Author:
GlaxoSmithKline LLC
DEA Schedule:
Non-Scheduled