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Naproxen Drug Information Provided by Lexi-Comp

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This information has been developed and provided by an independent third-party source. Merck & Co., Inc. does not endorse and is not responsible for the accuracy of the content, or for practices or standards of non-Merck sources.

ALERT: U.S. Boxed Warning

The FDA-approved labeling includes a boxed warning. See Warnings/Precautions section and/or refer to product labeling for additional detail.

Medication Safety Issues

Sound-alike/look-alike issues:

Naproxen may be confused with Natacyn®, Nebcin®

Aleve® may be confused with Alesse®

Anaprox® may be confused with Anaspaz®, Avapro®

Naprelan® may be confused with Naprosyn®

Naprosyn® may be confused with Naprelan®, Natacyn®, Nebcin®

International issues:

Flogen® [Mexico] may be confused with Flovent® which is a brand name for fluticasone in the U.S.

Flogen® [Mexico] may be confused with Floxin® which is a brand name for ofloxacin in the U.S.

Pronunciation

(na PROKS en)

U.S. Brand Names

  • Aleve® [OTC]
  • Anaprox®
  • Anaprox® DS
  • EC-Naprosyn®
  • Mediproxen [OTC]
  • Midol® Extended Relief
  • Naprelan®
  • Naprosyn®
  • Pamprin® Maximum Strength All Day Relief [OTC]

Index Terms

  • Naproxen Sodium

Generic Available

Yes

Canadian Brand Names

  • Anaprox®
  • Anaprox® DS
  • Apo-Napro-Na DS®
  • Apo-Napro-Na®
  • Apo-Naproxen EC®
  • Apo-Naproxen SR®
  • Apo-Naproxen®
  • Gen-Naproxen EC
  • Naprosyn®
  • Naxen®
  • Naxen® EC
  • Novo-Naproc EC
  • Novo-Naprox
  • Novo-Naprox Sodium
  • Novo-Naprox Sodium DS
  • Novo-Naprox SR
  • Nu-Naprox
  • PMS-Naproxen EC
  • Riva-Naproxen
  • Sab-Naproxen

Pharmacologic Category

  • Nonsteroidal Anti-inflammatory Drug (NSAID), Oral

Use: Labeled Indications

Management of ankylosing spondylitis, osteoarthritis, and rheumatoid disorders (including juvenile rheumatoid arthritis); acute gout; mild-to-moderate pain; tendonitis, bursitis; dysmenorrhea; fever

Use: Dental

Management of pain and swelling

Restrictions

An FDA-approved medication guide must be distributed when dispensing an oral outpatient prescription (new or refill) where this medication is to be used without direct supervision of a healthcare provider. Medication guides are available at http://www.fda.gov/cder/Offices/ODS/medication_guides.htm.

Pregnancy Risk Factor

C/D (3rd trimester)

Lactation

Enters breast milk/not recommended (AAP rates “compatible”)

Contraindications

Hypersensitivity to naproxen, aspirin, other NSAIDs, or any component of the formulation; perioperative pain in the setting of coronary artery bypass graft (CABG) surgery

Warnings/Precautions

Boxed warnings:

• Cardiovascular events: See “Concerns related to adverse effects” below.

• Coronary artery bypass graft surgery: See “Disease-related concerns” below.

• Gastrointestinal events: See “Concerns related to adverse effects” below.

Concerns related to adverse effects:

• Anaphylactoid reactions: Even in patients without prior exposure anaphylactoid reactions may occur; patients with "aspirin triad" (bronchial asthma, aspirin intolerance, rhinitis) may be at increased risk. Do not use in patients who experience bronchospasm, asthma, rhinitis, or urticaria with NSAID or aspirin therapy.

• Aseptic meningitis: May increase the risk of aseptic meningitis, especially in patients with systemic lupus erythematosus (SLE) and mixed connective tissue disorders.

• Bleeding/hemostasis: Platelet adhesion and aggregation may be decreased; may prolong bleeding time; patients with coagulation disorders or who are receiving anticoagulants should be monitored closely. Anemia may occur; patients on long-term NSAID therapy should be monitored for anemia.

• Cardiovascular events: [U.S. Boxed Warning]: NSAIDs are associated with an increased risk of adverse cardiovascular events, including MI, stroke, and new onset or worsening of pre-existing hypertension. Risk may be increased with duration of use or pre-existing cardiovascular risk factors or disease. Carefully evaluate individual cardiovascular risk profiles prior to prescribing. Use caution with fluid retention, heart failure, or hypertension. Concurrent administration of ibuprofen, and potentially other nonselective NSAIDs, may interfere with aspirin's cardioprotective effect. Use the lowest effective dose for the shortest duration of time, consistent with individual patient goals, to reduce risk of cardiovascular events; alternate therapies should be considered for patients at high risk.

• Gastrointestinal events: [U.S. Boxed Warning]: NSAIDs may increase risk of gastrointestinal irritation, inflammation, ulceration, bleeding, and perforation. These events may occur at any time during therapy and without warning. Use caution with a history of GI disease (bleeding or ulcers), concurrent therapy with aspirin, anticoagulants and/or corticosteroids, smoking, use of alcohol, the elderly or debilitated patients. Use the lowest effective dose for the shortest duration of time, consistent with individual patient goals, to reduce risk of GI adverse events; alternate therapies should be considered for patients at high risk.

• Skin reactions: NSAIDs may cause serious skin adverse events including exfoliative dermatitis, Stevens-Johnson syndrome (SJS), and toxic epidermal necrolysis (TEN); discontinue use at first sign of skin rash or hypersensitivity.

Disease-related concerns:

• Asthma: Do not administer to patients with aspirin-sensitive asthma; severe bronchospasm may occur. Use caution in patients with other forms of asthma.

• Coronary artery bypass graft surgery: [U.S. Boxed Warning]: Use is contraindicated for treatment of perioperative pain in the setting of coronary artery bypass graft (CABG) surgery. Risk of MI and stroke may be increased with use following CABG surgery.

• Hepatic impairment: Use with caution in patients with decreased hepatic function. Closely monitor patients with any abnormal LFT. Severe hepatic reactions (eg, fulminant hepatitis, liver failure) have occurred with NSAID use, rarely; discontinue if signs or symptoms of liver disease develop, or if systemic manifestations occur.

• Renal impairment: NSAID use may compromise existing renal function; dose-dependent decreases in prostaglandin synthesis may result from NSAID use, reducing renal blood flow which may cause renal decompensation. Patients with impaired renal function, dehydration, heart failure, liver dysfunction, those taking diuretics, and ACE inhibitors, and the elderly are at greater risk of renal toxicity. Rehydrate patient before starting therapy; monitor renal function closely. Not recommended for use in patients with advanced renal disease. Long-term NSAID use may result in renal papillary necrosis.

Special populations:

• Elderly: The elderly are at increased risk for adverse effects (especially peptic ulceration, CNS effects, renal toxicity) from NSAIDs even at low doses.

• Pediatrics: Safety and efficacy have not been established in children <2 years of age. Not for self-medication (OTC use) in children <12 years of age.

Other warnings/precautions:

• Self-medication (OTC use): Prior to self-medication, patients should contact healthcare provider if they have had recurring stomach pain or upset, ulcers, bleeding problems, high blood pressure, heart or kidney disease, other serious medical problems, are currently taking a diuretic, or are ?60 years of age. Recommended dosages should not be exceeded, due to an increased risk of GI bleeding. Consuming ?3 alcoholic beverages/day or taking longer than recommended may increase the risk of GI bleeding.

• Surgical/dental procedures: Withhold for at least 4-6 half-lives prior to surgical or dental procedures.

Adverse Reactions

1% to 10%:

Cardiovascular: Edema (3% to 9%), palpitation (<3%)

Central nervous system: Dizziness (3% to 9%), drowsiness (3% to 9%), headache (3% to 9%), lightheadedness (<3%), vertigo (<3%)

Dermatologic: Pruritus (3% to 9%), skin eruption (3% to 9%), ecchymosis (3% to 9%), purpura (<3%), rash

Endocrine & metabolic: Fluid retention (3% to 9%)

Gastrointestinal: Abdominal pain (3% to 9%), constipation (3% to 9%), nausea (3% to 9%), heartburn (3% to 9%), diarrhea (<3%), dyspepsia (<3%), stomatitis (<3%), flatulence, gross bleeding/perforation, indigestion, ulcers, vomiting

Genitourinary: Abnormal renal function

Hematologic: Hemolysis (3% to 9%), ecchymosis (3% to 9%), anemia, bleeding time increased

Hepatic: LFTs increased

Ocular: Visual disturbances (<3%)

Otic: Tinnitus (3% to 9%), hearing disturbances (<3%)

Respiratory: Dyspnea (3% to 9%)

Miscellaneous: Diaphoresis (<3%), thirst (<3%)

<1%: Agranulocytosis, alopecia, anaphylactic/anaphylactoid reaction, angioneurotic edema, arrhythmia, aseptic meningitis, asthma, blurred vision, cognitive dysfunction, colitis, coma, confusion, CHF, conjunctivitis, cystitis, depression, dream abnormalities, dysuria, eosinophilia, eosinophilic pneumonitis, erythema multiforme, exfoliative dermatitis, glossitis, granulocytopenia, hallucinations, hematemesis, hepatitis, hyper-/hypoglycemia, hyper-/hypotension, infection, interstitial nephritis, melena, jaundice, leukopenia, liver failure, lymphadenopathy, menstrual disorders, malaise, MI, muscle weakness, myalgia, oliguria, pancreatitis, pancytopenia, paresthesia, photosensitivity, pneumonia, polyuria, proteinuria, pyrexia, rectal bleeding, renal failure, renal papillary necrosis, respiratory depression, sepsis, Stevens-Johnson syndrome, tachycardia, seizure, syncope, thrombocytopenia, toxic epidermal necrolysis ulcerative stomatitis, vasculitis

Metabolism/Transport Effects

Substrate (minor) of CYP1A2, 2C9

Drug Interactions

ACE Inhibitors: Nonsteroidal Anti-Inflammatory Agents may diminish the antihypertensive effect of ACE Inhibitors. Risk C: Monitor therapy

Aminoglycosides: Nonsteroidal Anti-Inflammatory Agents may decrease the excretion of Aminoglycosides. Data only in premature infants. Risk C: Monitor therapy

Angiotensin II Receptor Blockers: Nonsteroidal Anti-Inflammatory Agents may diminish the therapeutic effect of Angiotensin II Receptor Blockers. The combination of these two agents may also significantly decrease golmerular filtration and renal function. Risk C: Monitor therapy

Anticoagulants: Nonsteroidal Anti-Inflammatory Agents may enhance the anticoagulant effect of Anticoagulants. Risk C: Monitor therapy

Antidepressants (Serotonin/Norepinephrine Reuptake Inhibitor): May enhance the antiplatelet effect of NSAID (Nonselective). Risk C: Monitor therapy

Antidepressants (Tricyclic, Tertiary Amine): May enhance the antiplatelet effect of NSAID (Nonselective). Risk C: Monitor therapy

Antiplatelet Agents: Nonsteroidal Anti-Inflammatory Agents may enhance the adverse/toxic effect of Antiplatelet Agents. An increased risk of bleeding may occur. Risk C: Monitor therapy

Beta-Blockers: Nonsteroidal Anti-Inflammatory Agents may diminish the antihypertensive effect of Beta-Blockers. Exceptions: Levobunolol; Metipranolol. Risk C: Monitor therapy

Bile Acid Sequestrants: May decrease the absorption of Nonsteroidal Anti-Inflammatory Agents. Risk D: Consider therapy modification

Bisphosphonate Derivatives: Nonsteroidal Anti-Inflammatory Agents may enhance the adverse/toxic effect of Bisphosphonate Derivatives. Both an increased risk of gastrointestinal ulceration and an increased risk of nephrotoxicity are of concern. Risk C: Monitor therapy

Corticosteroids (Systemic): May enhance the adverse/toxic effect of NSAID (Nonselective). Risk C: Monitor therapy

Coumarin Derivatives: NSAID (Nonselective) may enhance the anticoagulant effect of Coumarin Derivatives. Risk D: Consider therapy modification

CycloSPORINE: Nonsteroidal Anti-Inflammatory Agents may enhance the nephrotoxic effect of CycloSPORINE. Nonsteroidal Anti-Inflammatory Agents may increase the serum concentration of CycloSPORINE. Risk D: Consider therapy modification

Eplerenone: Nonsteroidal Anti-Inflammatory Agents may diminish the antihypertensive effect of Eplerenone. Risk C: Monitor therapy

Herbs (Anticoagulant/Antiplatelet Properties) (eg, Alfalfa, Anise, Bilberry): May enhance the adverse/toxic effect of Nonsteroidal Anti-Inflammatory Agents. Bleeding may occur. Risk D: Consider therapy modification

HydrALAZINE: Nonsteroidal Anti-Inflammatory Agents may diminish the antihypertensive effect of HydrALAZINE. Risk C: Monitor therapy

Ketorolac: May enhance the adverse/toxic effect of Nonsteroidal Anti-Inflammatory Agents. Risk X: Avoid combination

Lithium: Nonsteroidal Anti-Inflammatory Agents may increase the serum concentration of Lithium. Risk D: Consider therapy modification

Loop Diuretics: Nonsteroidal Anti-Inflammatory Agents may diminish the diuretic effect of Loop Diuretics. Risk C: Monitor therapy

Methotrexate: Nonsteroidal Anti-Inflammatory Agents may decrease the excretion of Methotrexate. Risk D: Consider therapy modification

Nonsteroidal Anti-Inflammatory Agents: May enhance the adverse/toxic effect of other Nonsteroidal Anti-Inflammatory Agents. Risk C: Monitor therapy

Pemetrexed: NSAID (Nonselective) may decrease the excretion of Pemetrexed. Risk D: Consider therapy modification

Probenecid: May increase the serum concentration of Nonsteroidal Anti-Inflammatory Agents. Risk C: Monitor therapy

Quinolone Antibiotics: Nonsteroidal Anti-Inflammatory Agents may enhance the neuroexcitatory and/or seizure-potentiating effect of Quinolone Antibiotics. Risk C: Monitor therapy

Salicylates: NSAID (Nonselective) may enhance the antiplatelet effect of Salicylates. NSAID (Nonselective) may diminish the cardioprotective effect of Salicylates. Salicylates may decrease the serum concentration of NSAID (Nonselective). Exceptions: Choline Magnesium Trisalicylate. Risk D: Consider therapy modification

Selective Serotonin Reuptake Inhibitors: May enhance the antiplatelet effect of NSAID (Nonselective). Risk D: Consider therapy modification

Thiazide Diuretics: Nonsteroidal Anti-Inflammatory Agents may diminish the therapeutic effect of Thiazide Diuretics. Risk C: Monitor therapy

Treprostinil: May enhance the adverse/toxic effect of Nonsteroidal Anti-Inflammatory Agents. Bleeding may occur. Risk C: Monitor therapy

Vancomycin: Nonsteroidal Anti-Inflammatory Agents may decrease the excretion of Vancomycin. Risk C: Monitor therapy

Ethanol/Nutrition/Herb Interactions

Ethanol: Avoid ethanol (may enhance gastric mucosal irritation).

Food: Naproxen absorption rate/levels may be decreased if taken with food.

Herb/Nutraceutical: Avoid alfalfa, anise, bilberry, bladderwrack, bromelain, cat's claw, celery, chamomile, coleus, cordyceps, dong quai, evening primrose, fenugreek, feverfew, garlic, ginger, ginkgo biloba, ginseng (American, Panax, Siberian), grapeseed, green tea, guggul, horse chestnut seed, horseradish, licorice, prickly ash, red clover, reishi, SAMe (S-adenosylmethionine), sweet clover, turmeric, white willow (all have additional antiplatelet activity).

Storage

Store oral suspension and tablet at 15°C to 30°C (59°F to 86°F).

Mechanism of Action

Inhibits prostaglandin synthesis by decreasing the activity of the enzyme, cyclooxygenase, which results in decreased formation of prostaglandin precursors

Pharmacodynamics/Kinetics

Onset of action: Analgesic: 1 hour; Anti-inflammatory:~2 weeks

Peak effect: Anti-inflammatory: 2-4 weeks

Duration: Analgesic: ?7 hours; Anti-inflammatory: ?12 hours

Absorption: Almost 100%

Protein binding: >99%; increased free fraction in elderly

Half-life elimination: Normal renal function: 12-17 hours; End-stage renal disease: No change

Time to peak, serum: 1-4 hours

Excretion: Urine (95%)

Dosage

Note: Dosage expressed as naproxen base; 200 mg naproxen base is equivalent to 220 mg naproxen sodium.

Oral:

Children >2 years: Juvenile arthritis: 10 mg/kg/day in 2 divided doses

Adults:

Gout, acute: Initial: 750 mg, followed by 250 mg every 8 hours until attack subsides. Note: EC-Naprosyn® is not recommended.

Migraine, acute (unlabeled use): Initial: 500-750 mg.; an additional 250-500 mg may be given if needed (maximum: 1250 mg in 24 hours). Note: EC-Naprosyn® is not recommended.

Pain (mild-to-moderate), dysmenorrhea, acute tendonitis, bursitis: Initial: 500 mg, then 250 mg every 6-8 hours; maximum: 1250 mg/day naproxen base

Rheumatoid arthritis, osteoarthritis, and ankylosing spondylitis: 500-1000 mg/day in 2 divided doses; may increase to 1.5 g/day of naproxen base for limited time period

OTC labeling: Pain/fever:

Children ?12 years and Adults ?65 years: 200 mg naproxen base every 8-12 hours; if needed, may take 400 mg naproxen base for the initial dose; maximum: 600 mg naproxen base/24 hours

Adults >65 years: 200 mg naproxen base every 12 hours

Dosing adjustment in renal impairment: Clcr <30 mL/minute: use is not recommended

Dental Usual Dosing

Mild-to-moderate pain: Adults: Initial: 500 mg, then 250 mg every 6-8 hours; maximum: 1250 mg/day naproxen base

Pain/fever (OTC labeling):

Children ?12 years and Adults ?65 years: 200 mg naproxen base every 8-12 hours; if needed, may take 400 mg naproxen base for the initial dose; maximum: 600 mg naproxen base/24 hours

Adults >65 years: 200 mg naproxen base every 12 hours

Administration: Oral

Administer with food, milk, or antacids to decrease GI adverse effects

Suspension: Shake suspension well before administration.

Tablet, extended release: Swallow tablet whole; do not break, crush, or chew.

Monitoring Parameters

Occult blood loss, periodic liver function test, CBC, BUN, serum creatinine; urine output

Test Interactions

Naproxen may interfere with 5-HIAA urinary assays; due to an interaction with m-dinitrobenzene, naproxen should be discontinued 72 hours before adrenal function testing if the Porter-Silber test is used.

Dietary Considerations

Drug may cause GI upset, bleeding, ulceration, perforation; take with food or milk to minimize GI upset.

Patient Education

Take this medication exactly as directed; do not increase dose without consulting prescriber. Do not crush tablets. Take with food or milk to reduce GI distress. Maintain adequate hydration (2-3 L/day of fluids) unless instructed to restrict fluid intake. Do not use alcohol, aspirin or aspirin-containing medication, or any other anti-inflammatory medications without consulting prescriber. You may experience drowsiness, dizziness, lightheadedness, or headache (use caution when driving or engaging in tasks requiring alertness until response to drug is known); anorexia, nausea, vomiting, or heartburn (small frequent meals, frequent mouth care, sucking lozenges, or chewing gum may help); or fluid retention (weigh yourself weekly and report unusual [3-5 lb/week] weight gain), GI bleeding, ulceration, or perforation can occur with or without pain; or discontinue medication and contact prescriber if persistent abdominal pain or cramping, or blood in stool occurs. Report breathlessness, respiratory difficulty, or unusual cough; chest pain, rapid heartbeat, palpitations; unusual bruising/bleeding; blood in urine, stool, mouth, or vomitus; swollen extremities; skin rash or itching; acute fatigue; or changes in eyesight (double vision, color changes, blurred vision), hearing, or ringing in ears. Pregnancy/breast-feeding precautions: Notify prescriber if you are or intend to become pregnant. Do not take this drug during last trimester of pregnancy. Consult prescriber if breast-feeding.

Geriatric Considerations

Elderly are a high-risk population for adverse effects from NSAIDs. As much as 60% of the elderly can develop peptic ulceration and/or hemorrhage asymptomatically. The concomitant use of H2 blockers and sucralfate is not effective as prophylaxis with the exception of NSAID-induced duodenal ulcers which may be prevented by the use of ranitidine. Misoprostol and proton pump inhibitors are the only agents proven to help prevent the development of NSAID-induced ulcers. Also, concomitant disease and drug use contribute to the risk for GI adverse effects. Use lowest effective dose for shortest period possible. Consider renal function decline with age. Use of NSAIDs can compromise existing renal function especially when Clcr is ?30 mL/minute. Tinnitus may be a difficult and unreliable indication of toxicity due to age-related hearing loss or eighth cranial nerve damage. CNS adverse effects such as confusion, agitation, and hallucination are generally seen in overdose or high-dose situations, but elderly may demonstrate these adverse effects at lower doses than younger adults.

Anesthesia and Critical Care Concerns/Other Considerations

The 2002 ACCM/SCCM guidelines for analgesia (critically-ill adult) suggest that NSAIDs may be used in combination with opioids in select patients for pain management. Concern about adverse events (increased risk of renal dysfunction, altered platelet function and gastrointestinal irritation) limits its use in patients who have other underlying risks for these events.

In short-term use, NSAIDs vary considerably in their effect on blood pressure. When NSAIDs are used in patients with hypertension, appropriate monitoring of blood pressure responses should be completed and the duration of therapy, when possible, kept short. The use of NSAIDs in the treatment of patients with congestive heart failure may be associated with an increased risk for fluid accumulation and edema; may precipitate renal failure in dehydrated patients. Should not be used to treat perioperative pain after coronary bypass surgery (CABG).

Cardiovascular Considerations

Blood Pressure: In short-term use, NSAIDs vary considerably in their effect on blood pressure. A meta-analysis (Pope, 1993) showed that indomethacin and naproxen had the largest effect on blood pressure. Other NSAIDs, including piroxicam, ibuprofen, and sulindac had less of an effect. Ibuprofen combined with captopril or losartan may attenuate the antihypertensive effects of ACE inhibition or receptor blockade on sitting or 24-hour ambulatory diastolic blood pressure. When NSAIDs are used in patients with hypertension, appropriate monitoring of blood pressure responses should be completed and the duration of therapy, when possible, kept short.

Heart Failure: The use of NSAIDs in the treatment of patients with congestive heart failure may be associated with an increased risk for fluid accumulation and edema. One study showed that NSAID use in elderly patients had an increased risk of hospitalization for heart failure. This study gives compelling reasons to avoid or limit the use of NSAIDs in patients with congestive heart failure, particularly in the elderly population. The ACC/AHA 2005 Heart Failure Guidelines suggest that NSAIDs be avoided or withdrawn whenever possible in patients with current or prior symptoms of heart failure and reduced LVEF.

Risk of Cardiovascular Events: Patients at increased risk of cardiovascular adverse events include patients immediately postoperative (10-14 days) from CABG surgery, and those with existing CAD, CVD, or history of TIA. Prescribers are encouraged to use the lowest effective dose for the shortest duration of time based on individual patient treatment goals. Available evidence reviewed by the FDA does not suggest an increased risk of serious CV events when NSAIDs are given short term and in the lower doses used OTC.

Drug Interactions: Nonsteroidal anti-inflammatory agents, including ibuprofen and naproxen, may diminish the cardioprotective effect of aspirin (Catella-Lawson F, 2001; Capone ML, 2005). It is surmised that ibuprofen may exhibit greater affinity than aspirin for the COX-1 site or if dosed regularly (or prior to aspirin), it would gain access to the active site first. In either case, aspirin's inhibition of COX (irreversible) would be limited in favor of ibuprofen inhibition (reversible). Avoid regular use of NSAIDs (nonselective) if possible. If used occasionally, take after aspirin (immediate release) ingestion.

Dental Health: Effects on Dental Treatment

Key adverse event(s) related to dental treatment: Stomatitis.

Naproxen and naproxen sodium have the potential to interfere with the antiplatelet effect of low-dose aspirin. One study of naproxen and low-dose aspirin has suggested that naproxen may interfere with aspirin's antiplatelet activity when they are coadministered (Steinhubl, 2005). However, naproxen 500 mg administered 2 hours before or after aspirin 100 mg did not interfere with aspirin's antiplatelet effect. The FDA stated that there is no data looking at doses of naproxen <500 mg. Naproxen over-the-counter strength is 220 mg tablets.

The FDA has warned that ibuprofen can interfere with the antiplatelet effect of low-dose aspirin (81 mg/day), potentially rendering aspirin less effective when used for cardioprotection and stroke protection. In situations where these drugs could be used concomitantly, the FDA has proved the following information: Patients who use immediate release aspirin (not enteric-coated aspirin) and take single doses of ibuprofen 400 mg, should dose the ibuprofen at least 30 minutes or longer after aspirin ingestion or more than 8 hours before aspirin ingestion to avoid attenuation of aspirin's effect. Similar recommendations may hold for concomitant may hold for concomitant naproxen and aspirin use.

Dental Health: Vasoconstrictor/Local Anesthetic Precautions

No information available to require special precautions

Mental Health: Effects on Mental Status

Dizziness is common; may cause nervousness; may rarely cause drowsiness, confusion, insomnia, depression, or hallucinations

Mental Health: Effects on Psychiatric Treatment

May rarely cause agranulocytosis; use caution with clozapine and carbamazepine; may decrease lithium clearance resulting in an increase in serum lithium levels and potential lithium toxicity; monitor serum lithium levels

Nursing: Physical Assessment/Monitoring

Evaluate cardiac risk and potential for GI bleeding prior to prescribing this medication. Assess effectiveness and interactions of other medications patient may be taking. Monitor blood pressure at the beginning of therapy and periodically during use. Assess results of laboratory tests, therapeutic effectiveness, and adverse reactions (eg, GI effects, hepatotoxicity, or ototoxicity) at beginning of therapy and periodically throughout therapy. Schedule ophthalmic evaluations for patients who develop eye complaints during long-term NSAID therapy. Assess knowledge/teach patient appropriate use, interventions to reduce side effects, and adverse symptoms to report.

Dosage Forms

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Caplet, as sodium: 220 mg [equivalent to naproxen 200 mg and sodium 20 mg]

Aleve®, Midol® Extended Relief, Pamprin® Maximum Strength All Day Relief: 220 mg [equivalent to naproxen 200 mg and sodium 20 mg]

Capsule, liquid gel, as sodium:

Aleve®: 220 mg [equivalent to naproxen 200 mg and sodium 20 mg]

Gelcap, as sodium:

Aleve®: 220 mg [equivalent to naproxen 200 mg and sodium 20 mg]

Suspension, oral: 125 mg/5 mL (500 mL)

Naprosyn®: 125 mg/5 mL (480 mL) [contains sodium 39 mg (1.5 mEq/5 mL); orange-pineapple flavor]

Tablet: 250 mg, 375 mg, 500 mg

Naprosyn®: 250 mg, 375 mg, 500 mg

Tablet, as sodium: 220 mg [equivalent to naproxen 200 mg and sodium 20 mg]; 275 mg [equivalent to naproxen 250 mg and sodium 25 mg]; 550 mg [equivalent to naproxen 500 mg and sodium 50 mg]

Aleve®: 220 mg [equivalent to naproxen 200 mg and sodium 20 mg]

Anaprox®: 275 mg [equivalent to naproxen 250 mg and sodium 25 mg]

Anaprox® DS: 550 mg [equivalent to naproxen 500 mg and sodium 50 mg]

Mediproxen: 220 mg [equivalent to naproxen 200 mg and sodium 20 mg]

Tablet, controlled release, as sodium: 550 mg [equivalent to naproxen 500 mg and sodium 50 mg]

Naprelan®: 412.5 mg [equivalent to naproxen 375 mg and sodium 37.5 mg]; 550 mg [equivalent to naproxen 500 mg and sodium 50 mg]

Tablet, delayed release, enteric coated: 375 mg, 500 mg

EC-Naprosyn®: 375 mg, 500 mg

Tablet, extended release, as sodium: 550 mg [equivalent to naproxen 500 mg and sodium 50 mg]

Pricing: U.S. (www.drugstore.com)

Suspension (Naprosyn)

125 mg/5 mL (300): $42.99

Suspension (Naproxen)

125 mg/5 mL (500): $50.00

Tablet, 24-hour (Naprelan)

375 mg (30): $92.76

500 mg (30): $108.80

Tablet, 24-hour (Naproxen Sodium)

500 mg (30): $76.72

Tablet, EC (Naproxen DR)

375 mg (60): $35.99

500 mg (60): $64.99

Tablets (Anaprox)

275 mg (30): $64.39

Tablets (Anaprox DS)

550 mg (30): $87.38

Tablets (Naprosyn)

375 mg (100): $142.98

500 mg (30): $59.99

Tablets (Naproxen)

250 mg (90): $16.00

375 mg (90): $17.00

500 mg (60): $17.99

Tablets (Naproxen Sodium)

275 mg (60): $15.99

550 mg (30): $14.99

References

Alun-Jones E and Williams J, “Hyponatremia and Fluid Retention in a Neonate Associated With Maternal Naproxen Overdosage,” J Toxicol Clin Toxicol, 1986, 24(3):257-60.

Berde C, Ablin A, Glazer J, et al, “American Academy of Pediatrics Report of the Subcommittee on Disease-Related Pain in Childhood Cancer,” Pediatrics, 1990, 86(5 Pt 2):818-25.

Brooks PM and Day RO, “Nonsteroidal Anti-inflammatory Drugs - Differences and Similarities,” N Engl J Med, 1991, 324(24):1716-25.

Capone ML, Sciulli MG, Tacconelli S, et al, “Pharmacodynamic Interaction of Naproxen With Low-Dose Aspirin in Healthy Subjects,” J Am Coll Cardiol, 2005, 45(8):1295-1301.

Catella-Lawson F, Reilly MP, Kapoor SC, et al, “Cyclooxygenase Inhibitors and the Antiplatelet Effects of Aspirin,” N Engl J Med, 2001, 345(25):1809-17.

Clinch D, Banerjee AK, and Ostick G, “Absence of Abdominal Pain in Elderly Patients With Peptic Ulcer,” Age Ageing, 1984, 13(2):120-3.

Clive DM and Stoff JS, “Renal Syndromes Associated With Nonsteroidal Anti-inflammatory Drugs,” N Engl J Med, 1984, 310(9):563-72.

Conlin P, Moore T, Swartz S, et al, “Effect of Indomethacin on Blood Pressure Lowering by Captopril and Losartan in Hypertensive Patients,” Hypertension, 2000, 36(3):461-5.

Court H and Volans GN, “Poisoning After Overdose With Nonsteroidal Anti-inflammatory Drugs,” Adverse Drug React Acute Poisoning Rev, 1984, 3(1):1-21.

“Drugs for Pain,” Med Lett Drugs Ther, 2000, 42(1085):73-8.

Forbes JA, Keller CK, Smith JW, et al, “Analgesic Effect of Naproxen Sodium, Codeine, a Naproxen-Codeine Combination and Aspirin on the Postoperative Pain of Oral Surgery,” Pharmacotherapy, 1986, 6(5):211-8.

Fredell EW and Strand LJ, “Naproxen Overdose,” JAMA, 1977, 238(9):938.

Graham DY, “Prevention of Gastroduodenal Injury Induced by Chronic Nonsteroidal Anti-inflammatory Drug Therapy,” Gastroenterology, 1989, 96(2 Pt 2 Suppl):675-81.

Gurwitz JH, Avorn J, Ross-Degnan D, et al, “Nonsteroidal Anti-inflammatory Drug-Associated Azotemia in the Very Old,” JAMA, 1990, 264(4):471-5.

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International Brand Names

  • Acusprain (ZA)
  • Aflamax (PE)
  • Aleve (AU, EE, PL, PY, SG, UY)
  • Alpron (PH)
  • Anapran (PL)
  • Anexopen (GR)
  • Antalgin (ES)
  • Apo-Naproxen (PL)
  • Apranax (BG, CR, DO, FR, GT, HN, NI, PA, PL, RU, SV, VE)
  • Artagen (IN)
  • Artroxen (IT)
  • Boloxen (PL)
  • Bonyl (DK)
  • Complement (PE)
  • Crysanal (AU)
  • Daprox (DK)
  • Dysmenalgit (DE)
  • Emochol (PL)
  • Femex (NL)
  • Femme Free (AU)
  • Flanax (BR)
  • Floginax (IT)
  • Gibixen (IT)
  • Hexal Naproleve (AU)
  • Inza (AU, HK)
  • Laser (IT)
  • Leniartil (IT)
  • Nafasol (ZA)
  • Nalgesin (PL)
  • Nalgesin Forte (PL)
  • Naposin (TW)
  • Naprex (PK)
  • Naprium (AE, BF, BH, BJ, CI, CY, EG, ET, GH, GM, GN, IL, IQ, IR, JO, KE, KW, LB, LR, LY, MA, ML, MR, MU, MW, NE, NG, OM, QA, SA, SC, SD, SL, SN, SY, TN, TZ, UG, YE, ZA, ZM, ZW)
  • Naprius (IT)
  • Naprodil (MX)
  • Naproflex (TH)
  • Naprontag (AR)
  • Naprorex (AE, BH, CY, EG, HK, IL, IQ, IR, JO, KW, LB, LY, OM, QA, SA, SY, YE)
  • Naprosyn (AE, AU, BB, BF, BH, BJ, BM, BS, BZ, CI, CY, CZ, DK, EC, EG, ES, ET, FI, GB, GH, GM, GN, GR, GY, IE, IL, IN, IQ, IR, IT, JM, JO, KE, KW, LB, LR, LY, MA, ML, MR, MU, MW, MY, NE, NG, NL, NO, OM, PE, PL, PT, QA, RU, SA, SC, SD, SE, SL, SN, SR, SY, TN, TT, TZ, UG, YE, ZA, ZM, ZW)
  • Naprosyn LE (TH)
  • Naprosyn LLE (PH)
  • Naprosyn LLE Forte (PH)
  • Naprosyne (BE, FR, NL)
  • Naproxen (PL)
  • Naproxi 250 (IL)
  • Naproxi 500 (IL)
  • Naprux (AR)
  • Naxen (ID, MX, NZ)
  • Naxen F (KP)
  • Naxen-F CR (KP)
  • Naxopren (FI)
  • Naxyn 250 (IL)
  • Naxyn 500 (IL)
  • Norswel (BF, BJ, CI, ET, GH, GM, GN, KE, LR, MA, ML, MR, MU, MW, NE, NG, SC, SD, SL, SN, TN, TZ, UG, ZA, ZM, ZW)
  • Novaxen (MX)
  • Nycopren (AT, DK, FI)
  • Prexan (IT)
  • Priaxen (BB, BF, BJ, BM, BS, BZ, CI, ET, GH, GM, GN, GY, JM, KE, LR, MA, ML, MR, MU, MW, NE, NG, NL, SC, SD, SL, SN, SR, TN, TT, TZ, UG, ZA, ZM, ZW)
  • Primeral (IT)
  • Prodexin (AE, BH, CY, EG, IL, IQ, IR, JO, KW, LB, LY, OM, QA, SA, SY, YE)
  • Pronaxen (MY, SE)
  • Proxen (AE, AT, BH, CH, CY, EG, IL, IQ, IR, JO, KW, LB, LY, OM, QA, SA, SY, TW, YE)
  • Sanaprox (PL)
  • Seladin (MY, SG)
  • Sutolin (TW)
  • Synflex (GB, IE)
  • Tarproxen (PL)
  • Veradol (AR)
  • Vero (PL)
  • Vinsen (TH)
  • Xenar (IT)

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Last full review/revision August 2008

Content last modified August 2008

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