naproxen/sumatriptan (Rx)

Brand and Other Names:Treximet
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

naproxen/sumatriptan

tablet

  • 60mg/10mg
  • 500mg/85mg

Migraine Headache

Indicated for the acute treatment of migraine attacks with or without aura

500mg/85mg PO, may repeat once after 2 hr, not to exceed 2 tablets/24 hr

Dosage Modifications

Hepatic impairment

  • Mild-to-moderate: Reduce dose to 60 mg/10 mg
  • Severe: Contraindicated

Renal impairment

  • Mild (CrCl 60-89 mL/min) or moderate (CrCl 30-59 mL/min): No dose adjustment required; monitor renal function in patients with renal impairment, pre-existing kidney disease, or dehydration
  • CrCl <30 mL/min: Not recommended

Dosage Forms & Strengths

naproxen/sumatriptan

tablet

  • 60mg/10mg
  • 500mg/85mg

Migraine Headache

Indicated for the acute treatment of migraine attacks with or without aura

<12 years: Safety and efficacy not established

≥12 years: Recommended dose is 1 tablet (60 mg/10 mg) PO per 24 hr prn; maximum dose is 1 tablet (500 mg/85 mg) per 24 hr

Dosing Considerations

Safety of treating an average of >2 migraine headaches in pediatric patients in a 30-day period has not been established

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Interactions

Interaction Checker

and naproxen/sumatriptan

No Results

     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            Warnings

            Black Box Warnings

            Cardiovascular Risk

            • NSAIDs may increase risk of serious cardiovascular thrombotic events, myocardial infarction (MI), & stroke, which can be fatal
            • Risk may increase with duration of use
            • Patients with risk factors for or existing cardiovascular disease may be at greater risk
            • NSAIDs are contraindicated for perioperative pain in the setting of coronary artery bypass graft (CABG) surgery (increased risk of MI & stroke)

            Gastrointestinal Risk

            • NSAIDs increase risk of serious GI adverse events including bleeding, ulceration, & perforation of the stomach or intestines, which can be fatal
            • GI adverse events may occur at any time during use & without warning symptoms
            • Elderly patients are at greater risk for serious GI events

            Contraindications

            Aspirin allergy or triad

            Hypotension with prior NSAID or aspirin use

            History or suspected ischemic heart disease, CVA/TIA, peripheral vascular disease

            Vasospastic CAD

            Uncontrolled hypertension

            Basilar or hemiplegic migraine

            Post CABG

            Hepatic impairment

            Within 24 hr of ergot-type drugs (eg, methysergide, dihydroergotamine) or other 5-HT1 agonists

            Concomitant or within 2 wk of using MAO-A inhibitors

            3rd trimester pregnancy

            Cautions

            Not recommmended for patients with likelihood of unrecognized CAD, severe renal impairment (CrCl <30 mL/min), or women who are breast feeding

            Use NSAIDs with caution with underlying cardiovascular disease, active/history of peptic ulcer, inflammatory bowel disease, GI disease, bleeding disorder, renal/hepatic impairment, anemia, asthma, heart failure, edema, dehydration, HTN, or seizure disorder

            Long-term administration of NSAIDs may result in renal papillary necrosis and other renal injury; patients at greatest risk include the elderly, or those with impaired renal function, hypovolemia, heart failure, liver dysfunction, salt depletion, and individuals taking diuretics, ACE inhibitors, or ARBs

            Overuse of acute migraine drugs (eg, ergotamine, triptans, opioids, or a combination of drugs for 10 or more days per month) may lead to exacerbation of headache (medication overuse headache); medication overuse headache may present as migraine-like daily headaches, or as a marked increase in frequency of migraine attacks

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            Pregnancy & Lactation

            Pregnancy Category: C; avoid NSAIDs during 3rd trimester, may cause premature closure of ductus arteriosus

            The Quebec Pregnancy Registry identified 4705 women who had spontaneous abortions by 20 weeks' gestation; each case was matched to 10 control subjects (n=47,050) who had not had spontaneous abortions; exposure to nonaspirin NSAIDs during pregnancy was documented in approximately 7.5% of cases of spontaneous abortions and in approximately 2.6% of controls. (CMAJ, September 6, 2011; DOI:10.1503/cmaj.110454)

            Lactation: Both components are excreted in breast milk, avoid if breast feeding

            Pregnancy Categories

            A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

            B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

            C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

            D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

            X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

            NA:Information not available.

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            Pharmacology

            Mechanism of Action

            Naproxen: Inhibits synthesis of prostaglandins in body tissues by inhibiting at least 2 cyclooxygenase (COX) isoenzymes, COX-1 and COX-2; may inhibit chemotaxis, alter lymphocyte activity, and decrease proinflammatory cytokine activity

            Sumatriptan: Selective 5-HT1B and 5-HT1D receptor agonist in cranial arteries; elicits vasoconstrictive and anti-inflammatory effects; associated with antidromic neuronal transmission and relief of migraine headache

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            Administration

            Instructions

            May take with or without food

            Swallow tablet whole; do not split, crush, or chew

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            Formulary

            FormularyPatient Discounts

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            The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
            QL Quantity Limits
            Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
            ST Step Therapy
            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
            OR Other Restrictions
            Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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