naproxen (Rx, OTC)

Brand and Other Names:Aleve, EC Naprosyn, more...Anaprox, Anaprox DS, Naprosyn, Naprox Sodium, Naproxen EC, Naproxen SR, Naprelan, Menstridol
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

tablet

  • 220mg (OTC)
  • 250mg
  • 275mg
  • 375mg
  • 500mg
  • 550mg

tablet delayed release

  • 375mg
  • 500mg

tablet extended release

  • 375mg
  • 500mg
  • 750mg

capsule

  • 220mg

oral suspension

  • 25mg/mL
more...

Pain

500 mg PO initially, then 250 mg PO q6-8hr or 500 mg PO q12hr PRN; not to exceed 1250 mg/day naproxen base on day 1; subsequent daily doses should not exceed 1000 mg naproxen base

Extended release: 750-1000 mg PO qDay; may temporarily increase to 1500 mg/day if tolerated well and clinically indicated

Rheumatoid Arthritis, Osteoarthritis, Ankylosing Spondylitis

500-1000 mg/day PO divided q12hr; may increase to 1500 mg/day if tolerated well for limited time

Extended release: 750-1000 mg PO qDay; may temporarily increase to 1500 mg/day if tolerated well and clinically indicated

Dysmenorrhea

500 mg PO initially, then 250 mg PO q6-8hr or 500 mg PO q12hr (long-acting formula); not to exceed 1250 mg/day on first day; subsequent doses should not exceed 1000 mg/day naproxen base

Gout, Acute

750 mg PO initially, followed by 250 mg q8hr until attack subsides

Extended release: 1000-1500 mg qDay, followed by 1000 mg qDay until attack subsides

Migraine (Off-label)

750 mg PO initially, may give additional 250-500 mg if necessary; not to exceed 1250 mg in 24 hr

Dosing Considerations

220 mg of naproxen sodium contains 200 mg of naproxen

Delayed-release formulation not recommended for acute pain

Take with food or 8-12 oz of water to avoid gastrointestinal (GI) effects

Dosing Modifications

CrCl <30 mL/min: Use not recommended

Dosage Forms & Strengths

tablet

  • 220mg (OTC)
  • 250mg
  • 275mg
  • 375mg
  • 500mg
  • 550mg

tablet delayed release

  • 375mg
  • 500mg

tablet extended release

  • 375mg
  • 500mg
  • 750mg

capsule

  • 220mg

oral suspension

  • 25mg/mL
more...

Pain

>2 years

  • Cancer pain (off-label): 5-7 mg/kg PO q8-12hr; not to exceed 1000 mg/day 

>12 years

  • 500 mg PO initially, then 250 mg PO q6-8hr or 500 mg PO q12hr PRN; not to exceed 1250 mg/day naproxen base on day 1; subsequent daily doses should not exceed 1000 mg naproxen base
  • Extended release: 750-1000 mg PO qDay; may temporarily increase to 1500 mg/day if tolerated well and clinically indicated

Juvenile Idiopathic Arthritis

>2 years: 10 mg/kg/day oral suspension PO divided q12hr; not to exceed 15 mg/kg/day 

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Interactions

Interaction Checker

and naproxen

No Results

     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            Adverse Effects

            1-10%

            Abdominal pain (3-9%)

            Constipation (3-9%)

            Dizziness (3-9%)

            Drowsiness (3-9%)

            Headache (3-9%)

            Heartburn (3-9%)

            Nausea (3-9%)

            Edema (3-9%)

            GI bleeding (1-4%)

            GI perforation (1-4%)

            Lightneadedness (<3%)

            GI ulcers (1-4%)

            Fluid retention (3-9%)

            Diarrhea (1-3%)

            Stomatitis (<3%)

            Diverticulitis (1-3%)

            Dyspnea (3-9%)

            Hearing disturbances (<3%)

            <1%

            Meaningful (3 × upper limit of normal) elevation of serum alanine aminotransferase or aspartate aminotransferase

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            Warnings

            Black Box Warnings

            Cardiovascular risk

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

            Gastrointestinal risk

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

            Contraindications

            Absolute: Aspirin allergy; perioperative pain in setting of coronary artery bypass graft (CABG) surgery

            Relative: Bleeding disorders, delayed esophageal transit, hepatic disease, peptic ulcer, renal impairment, stomatitis, late pregnancy (may cause premature closure of ductus arteriosus)

            Cautions

            Use caution in congestive heart failure (CHF), hypertension, renal/hepatic impairment, or aspirin sensitive asthma

            May increase risk of aseptic meningitis, especially in patients with systemic lupus erythematosis and mixed connective tissue disorders

            Prolonged use may increase risk of adverse cardiovascular events

            May cause anaphylactoid reactions, even in patients with no prior exposure to NSAIDs

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

            May cause drowsiness, dizziness, and blurred vision

            Platelet aggregation and adhesion may be decreased; may prolong bleeding time; monitor closely patients with coagulation disorders

            May increase risk of hyperkalemia in the elderly, renal disease, or diabetics, especially when used concomitantly with drugs that increase hyperkalemia

            May cause serious skin reactions including exfoliative dermatitis, toxic epidermal syndrome, Stevens-Johnson syndrome, and toxic epidermal necrolysis; discontinue therapy at first sign of skin rash

            May cause new-onset of hypertension; monitor blood pressure closely throughout therapy

            OTC use not for children <12 years

            Withhold for at least 4-6 half-lives prior to surgery or dental procedure

            Heart failure risk

            • NSAIDS have the potential to trigger HF by prostaglandin inhibition that leads to sodium and water retention, increased systemic vascular resistance, and blunted response to diuretics
            • NSAIDS should be avoided or withdrawn whenever possible
            • AHA/ACC Heart Failure Guidelines; Circulation. 2016; 134
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            Pregnancy & Lactation

            Pregnancy

            There are no adequate and well-controlled studies in pregnant women; data from observational studies regarding potential embryofetal risks of NSAID use in women in the first or second trimesters of pregnancy are inconclusive; NSAIDs inhibit prostaglandin synthesis, cause delayed parturition, and increase the incidence of stillbirth

            Lactation

            The naproxen anion has been found in the milk of lactating women at a concentration equivalent to approximately 1% of maximum naproxen concentration in plasma; developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for therapy and any potential adverse effects on breastfed infant from therapy or from underlying maternal condition

            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

            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, decrease proinflammatory cytokine activity, and inhibit neutrophil aggregation; these effects may contribute to anti-inflammatory activity

            Absorption

            Bioavailability: 95%

            Onset: 30-60 min

            Duration: < 12 hr

            Peak serum time: 1-4 hr (tablets); 2-12 hr (delayed release empty stomach); 4-24 hr (delayed relase with food)

            Peak plasma concentration: 62-96 mcg/mL

            Distribution

            Protein bound: <99%

            Vd: 0.16 L/kg

            Metabolism

            Metabolized in liver via conjugation

            Metabolites: 6-Desmethylnaproxen, glucuronide conjugates

            Enzymes inhibited: COX-1, COX-2

            Elimination

            Half-life: 12-17 hr

            Dialyzable: No value

            Clearance: 0.13 mL/min/kg

            Excretion: Urine (95%), feces (<3%)

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            Images

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            Formulary

            FormularyPatient Discounts

            Adding plans allows you to compare formulary status to other drugs in the same class.

            To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.

            Adding plans allows you to:

            • View the formulary and any restrictions for each plan.
            • Manage and view all your plans together – even plans in different states.
            • Compare formulary status to other drugs in the same class.
            • Access your plan list on any device – mobile or desktop.

            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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