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

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    Contraindicated

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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

            Drug reaction with eosinophilia and systemic symptoms (DRESS)

            • Drug Reaction reported in patients taking NSAIDs; some of these events have been fatal or life-threatening; DRESS typically, although not exclusively, presents with fever, rash, lymphadenopathy, and/or facial swelling
            • Other clinical manifestations may include hepatitis, nephritis, hematological abnormalities, myocarditis, or myositis; sometimes symptoms of DRESS may resemble an acute viral infection
            • Eosinophilia is often present; because this disorder is variable in its presentation, other organ systems not noted here may be involved
            • Early manifestations of hypersensitivity, such as fever or lymphadenopathy, may be present even though rash is not evident; if such signs or symptoms are present, discontinue therapy and evaluate the patient immediately
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            Pregnancy & Lactation

            Pregnancy

            Use of NSAIDs can cause premature closure of fetal ductus arteriosus and fetal renal dysfunction leading to oligohydramnios and, in some cases, neonatal renal impairment

            Because of these risks, limit dose and duration of use between about 20 and 30 weeks of gestation, and avoid use at about 30 weeks of gestation and later in pregnancy

            Use of NSAIDs at about 30 weeks gestation or later in pregnancy increases risk of premature closure of fetal ductus arteriosus

            Use of NSAIDs at about 20 weeks gestation or later in pregnancy has been associated with cases of fetal renal dysfunction leading to oligohydramnios, and in some cases, neonatal renal impairment

            If an NSAID is necessary at about 20 weeks gestation or later in pregnancy, limit use to lowest effective dose and shortest duration possible; if treatment extends beyond 48 hours, consider monitoring with ultrasound for oligohydramnios; if oligohydramnios occurs, discontinue drug and follow up according to clinical practice

            Data from observational studies regarding other potential embryofetal risks of NSAID use in women in the first or second trimesters of pregnancy are inconclusive

            Data from a prospective pregnancy exposure registry and epidemiological studies of pregnant women have not detected an increased frequency of birth defects or a consistent pattern of birth defects among women exposed to sumatriptan compared with the general population

            In animal studies, administration of sumatriptan and naproxen, alone or in combination, during pregnancy resulted in developmental toxicity (increased incidences of fetal malformations, embryofetal and pup mortality, decreased embryofetal growth) at clinically relevant doses

            Based on animal data, prostaglandins have been shown to have an important role in endometrial vascular permeability, blastocyst implantation, and decidualization

            In animal studies, administration of prostaglandin synthesis inhibitors such as naproxen sodium resulted in increased pre-and post-implantation loss

            Prostaglandins also have been shown to have an important role in fetal kidney development; in published animal studies, prostaglandin synthesis inhibitors have been reported to impair kidney development when administered at clinically relevant doses

            Several studies have suggested that women with migraine may be at increased risk of preeclampsia and gestational hypertension during pregnancy

            Labor or Delivery

            • There are no studies on effects of naproxen tablets during labor or delivery; in animal studies, NSAIDS, including naproxen, inhibit prostaglandin synthesis, cause delayed parturition, and increase incidence of stillbirth

            Infertility

            • Based on mechanism of action, the use of prostaglandin-mediated NSAIDs may delay or prevent rupture of ovarian follicles, which has been associated with reversible infertility in some women
            • Published animal studies have shown that administration of prostaglandin synthesis inhibitors has the potential to disrupt prostaglandin-mediated follicular rupture required for ovulation
            • Small studies in women treated with NSAIDs have also shown a reversible delay in ovulation; consider withdrawal of NSAIDs, including naproxen tablets, in women who have difficulties conceiving or who are undergoing investigation of infertility

            Lactation

            The naproxen anion has been found in milk of lactating women at a concentration equivalent to approximately 1% of maximum naproxen concentration in plasma

            Sumatriptan is excreted in human milk following subcutaneous administration; there is no information regarding sumatriptan concentrations in milk from lactating women following administration of sumatriptan tablets

            There are no data on effects of naproxen or sumatriptan on breastfed infant or effects of naproxen or sumatriptan on milk production; the developmental and health benefits of breastfeeding should be considered along with mother’s clinical need for therapy and any potential adverse effects on breastfed infant from drug or from underlying maternal condition

            Infant exposure to sumatriptan can be minimized by avoiding breastfeeding for 12 hr after treatment with sumatriptan tablets

            Following subcutaneous administration of a 6-mg dose of sumatriptan injection in 5 lactating volunteers, sumatriptan was present in milk

            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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            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.
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            Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.