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Naproxen

Pronunciation

Class: Other Nonsteroidal Anti-inflammatory Agents
CAS Number: 22204-53-1
Brands: Aleve, Anaprox, Naprelan, Naprosyn, Treximet, Vimovo

Warning(s)

  • Cardiovascular Risk
  • Possible increased risk of serious (sometimes fatal) cardiovascular thrombotic events (e.g., MI, stroke).225 Risk may increase with duration of use.225 Individuals with cardiovascular disease or risk factors for cardiovascular disease may be at increased risk.225 (See Cardiovascular Effects under Cautions.)

  • Contraindicated for the treatment of pain in the setting of CABG surgery.225

  • GI Risk
  • Increased risk of serious (sometimes fatal) GI events (e.g., bleeding, ulceration, perforation of the stomach or intestine).225 Serious GI events can occur at any time and may not be preceded by warning signs and symptoms.225 Geriatric individuals are at greater risk for serious GI events.225 (See GI Effects under Cautions.)

Introduction

Prototypical NSAIA; propionic acid derivative.225 230

Uses for Naproxen

Consider potential benefits and risks of naproxen therapy as well as alternative therapies before initiating therapy with the drug.225 Use lowest effective dosage and shortest duration of therapy consistent with the patient’s treatment goals.225

Inflammatory Diseases

Symptomatic treatment of osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis.59 104 202 204 205 206 225 230 May be used in fixed combination with esomeprazole in patients at risk of developing gastric ulcers associated with NSAIA therapy.267

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Symptomatic treatment of tendinitis, bursitis, and acute gout.225 230

Management of juvenile rheumatoid arthritis in children ≥2 years of age.225

Pain

Relief of pain.225 230

NSAIAs considered first-line agents for mild to moderate migraine attacks or for severe attacks that have responded in the past to NSAIAs or nonopiate analgesics.105

Self-medication in children ≥12 years of age and adults for the temporary relief of minor aches and pain associated with the common cold, headache, toothache, muscular aches, backache, and minor pain of arthritis.200

Dysmenorrhea

Symptomatic management of primary dysmenorrhea.225 230

Self-medication for the temporary relief of minor aches and pain associated with menstrual cramps.200

Fever

Self-medication for reduction of fever in children ≥12 years of age and adults.200

Naproxen Dosage and Administration

General

  • Consider potential benefits and risks of naproxen therapy as well as alternative therapies before initiating therapy with the drug.225

Administration

Oral Administration

Formulation Considerations

Naproxen oral suspension is the preferred dosage form for children because of suitability for providing the calculated dosage.208 225

Naproxen sodium is preferred for management of acute painful conditions when prompt onset of pain relief is desired.225

Naproxen delayed-release preparations are not recommended for management of acute gout, tendinitis, bursitis, acute pain, or dysmenorrhea because of slow onset of action.225 267

Naproxen or Naproxen Sodium Conventional (Immediate-release) Tablets and Naproxen Suspension

Usually administered orally twice daily.225 When used for the management of osteoarthritis, rheumatoid arthritis, or ankylosing spondylitis, the morning and evening doses may be unequal in size.225

Administration with meal, milk, or antacids may minimize adverse GI effects.a

Naproxen Delayed-release Tablets

Usually administered orally twice daily.225 When used for the management of osteoarthritis, rheumatoid arthritis, or ankylosing spondylitis, the morning and evening doses may be unequal in size.225

Do not break, crush, or chew naproxen delayed-release tablets.225

Administration with meal, milk, or antacids may minimize adverse GI effects.a

Naproxen Sodium Extended-release Tablets

Administer orally once daily.230

Administration with meal, milk, or antacids may minimize adverse GI effects.a

Tablets Containing Delayed-release Naproxen and Immediate-release Esomeprazole

Administer orally twice daily.267

Swallow whole with liquid; do not split, chew, crush, or dissolve tablets.267

Administer at least 30 minutes before meals; patient may use antacids during therapy.267

Tablets Containing Naproxen Sodium and Sumatriptan

Administer with or without food; do not split, crush, or chew.268

Dosage

Available as naproxen or naproxen sodium; each 220, 275, 412.5, or 550 mg of naproxen sodium is approximately equivalent to 200, 250, 375, or 500 mg of naproxen, respectively.200 225 230

If changing from one strength to another or one dosage form to another, be aware that different dose strengths and formulations are not necessarily bioequivalent.225

To minimize the potential risk of adverse cardiovascular and/or GI events, use lowest effective dosage and shortest duration of therapy consistent with the patient’s treatment goals.225 Adjust dosage based on individual requirements and response; attempt to titrate to the lowest effective dosage.225

Pediatric Patients

Inflammatory Diseases
Juvenile Rheumatoid Arthritis
Oral

Naproxen 10 mg/kg daily in 2 divided doses.104 204 205 225

Pain
Oral

Naproxen sodium self-medication in children ≥12 years of age: Initially, 440 mg; usual dosage is 220 mg every 8–12 hours.200

Fever
Oral

Naproxen sodium self-medication in children ≥12 years of age: Initially, 440 mg; usual dosage is 220 mg every 8–12 hours.200

Adults

Inflammatory Diseases
Osteoarthritis, Rheumatoid Arthritis, or Ankylosing Spondylitis
Oral

Preparation

Dosage

Naproxen conventional tablets, delayed-release tablets, or suspension

250–500 mg twice daily; may increase dosage to 1.5 g daily for up to 6 months225

Naproxen sodium conventional tablets

275–550 mg twice daily; may increase dosage to 1.65 g daily for up to 6 months225

Naproxen sodium extended-release tablets

825 mg or 1.1 g once daily; may increase dosage to 1.65 g daily for up to 6 months230

Tablets containing delayed-release naproxen and immediate-release esomeprazole

375 or 500 mg of naproxen (with esomeprazole 20 mg) twice daily267

Acute Tendinitis/Bursitis
Oral

Preparation

Dosage

Naproxen conventional tablets or suspension

500 mg initially, followed by 500 mg every 12 hours or 250 mg every 6–8 hours as needed225

Naproxen sodium conventional tablets

550 mg initially, followed by 550 mg every 12 hours or 275 mg every 6–8 hours as needed225

Naproxen sodium extended-release tablets

1.1 g once daily; may increase dosage to 1.65 g once daily for limited period230

Gout
Oral

Preparation

Dosage

Naproxen conventional tablets or suspension

750 mg initially, followed by 250 mg every 8 hours until attack subsides225

Naproxen sodium conventional tablets

825 mg initially, followed by 275 mg every 8 hours until attack subsides225

Naproxen sodium extended-release tablets

1.1–1.65 g once on first day, followed by 1.1 g once daily until attack subsides230

Pain
Oral

Preparation

Dosage

Naproxen conventional tablets or suspension

500 mg initially, followed by 500 mg every 12 hours or 250 mg every 6–8 hours as needed225

Naproxen sodium conventional tablets

550 mg initially, followed by 550 mg every 12 hours or 275 mg every 6–8 hours as needed225

Naproxen sodium extended-release tablets

1.1 g once daily; may increase dosage to 1.65 g once daily for limited period230

Naproxen sodium for self-medication of minor aches and pain: Initially, 440 mg; usual dosage is 220 mg every 8–12 hours.200

Acute Migraine Attack
Oral

Naproxen sodium/sumatriptan fixed combination: Naproxen sodium 500 mg (with sumatriptan 85 mg) as a single dose.268 Efficacy of >1 dose not established.268 If a second dose is administered, allow ≥2 hours to elapse between the first and second doses.268

Dysmenorrhea
Oral

Preparation

Dosage

Naproxen conventional tablets or suspension

500 mg initially, followed by 500 mg every 12 hours or 250 mg every 6–8 hours as needed225

Naproxen sodium conventional tablets

550 mg initially, followed by 550 mg every 12 hours or 275 mg every 6–8 hours as needed225

Naproxen sodium extended-release tablets

1.1 g once daily; may increase dosage to 1.65 g once daily for limited period230

Naproxen sodium self-medication: Initially, 440 mg; usual dosage is 220 mg every 8–12 hours.200

Fever
Oral

Naproxen sodium self-medication: Initially, 440 mg; usual dosage is 220 mg every 8–12 hours.200

Prescribing Limits

Pediatric Patients

Pain
Oral

Naproxen sodium self-medication in children ≥12 years of age: Maximum 440 mg in 8–12 hours; 660 mg in 24 hours.200 Self-medication should not exceed 10 days.200

Fever
Oral

Naproxen sodium self-medication in children ≥12 years of age: Maximum 440 mg in 8–12 hours; 660 mg in 24 hours.200 Self-medication should not exceed 3 days.200

Adults

Inflammatory Diseases
Osteoarthritis, Rheumatoid Arthritis, or Ankylosing Spondylitis
Oral

As naproxen, maximum 1.5 g daily.225

As naproxen sodium, maximum 1.65 g daily.230

Acute Tendinitis/Bursitis
Oral

As naproxen, maximum 1.25 g on the first day; thereafter, 1 g daily.225 Maximum 1.5 g daily for limited period.230

As naproxen sodium, maximum 1.375 g on the first day; thereafter, 1.1 g daily.225 Maximum 1.65 g daily for limited period.230

Pain
Oral

As naproxen, maximum 1.25 g on the first day; thereafter, 1 g daily.225 Maximum 1.5 g daily for limited period.230

As naproxen sodium, maximum 1.375 g on the first day; thereafter, 1.1 g daily.225 Maximum 1.65 g daily for limited period.230

Naproxen sodium for self-medication of minor aches and pain: Maximum 440 mg in 8–12 hours; 660 mg in 24 hours.200 Self-medication should not exceed 10 days.200

Acute Migraine Attack
Oral

Naproxen sodium/sumatriptan fixed combination: Maximum 2 doses (total sumatriptan dosage of 170 mg) in any 24-hour period.268 Safety of treating an average of >5 headaches per 30-day period not established.268

Dysmenorrhea
Oral

As naproxen, maximum 1.25 g on the first day; thereafter, 1 g daily.225

As naproxen sodium, maximum 1.375 g on the first day; thereafter, 1.1 g daily.225

Naproxen sodium self-medication: Maximum 440 mg in 8–12 hours; 660 mg in 24 hours.200

Fever
Oral

Naproxen sodium self-medication: Maximum 440 mg in 8–12 hours; 660 mg in 24 hours.200 Self-medication should not exceed 3 days.200

Special Populations

Hepatic Impairment

Dosage adjustment may be needed if high doses required.225 Consider reduced initial dosage.225 Use lowest effective dosage.225

Tablets containing delayed-release naproxen and immediate-release esomeprazole not recommended for patients with severe hepatic impairment; an appropriate esomeprazole dosage is not available as a fixed-ratio preparation for twice-daily dosing.267

Do not use tablets containing naproxen sodium and sumatriptan in patients with hepatic impairment; sumatriptan dosage cannot be appropriately adjusted.268

Renal Impairment

Consider reduced initial dosage.225

Not recommended for use in patients with moderate to severe renal impairment (Clcr <30 mL/minute).225 267

Geriatric Patients

Dosage adjustment may be needed if high doses required.225 Consider reduced initial dosage.225 Use lowest effective dosage.225

Maximum for self-medication, naproxen sodium 220 mg twice daily unless otherwise directed by a clinician.200

Cautions for Naproxen

Contraindications

  • Known hypersensitivity to naproxen or any ingredient in the formulation.225 230

  • History of asthma, urticaria, or other sensitivity reaction precipitated by aspirin or other NSAIAs.225 230

  • Treatment of perioperative pain in the setting of CABG surgery.225

Warnings/Precautions

Warnings

Cardiovascular Effects

Selective COX-2 inhibitors have been associated with increased risk of cardiovascular events in certain situations.253 Several prototypical NSAIAs also have been associated with an increased risk of cardiovascular events.258 259 260 Naproxen does not appear to be associated with increased or decreased cardiovascular risk.258 259 260 264

Use NSAIAs with caution and careful monitoring (e.g., monitor for development of cardiovascular events), and at the lowest effective dosage for the shortest duration necessary.225

Short-term use to relieve acute pain, especially at low dosages, does not appear to be associated with increased risk of serious cardiovascular events (except immediately following CABG surgery).253

No consistent evidence that concomitant use of low-dose aspirin mitigates the increased risk of serious adverse cardiovascular events associated with NSAIAs.225 (See Specific Drugs under Interactions.)

Hypertension and worsening of preexisting hypertension reported; either event may contribute to the increased incidence of cardiovascular events.225 Use with caution in patients with hypertension; monitor BP.225 Impaired response to certain diuretics may occur.225 (See Specific Drugs under Interactions.)

Fluid retention and edema reported.225 Caution in patients with fluid retention or heart failure.225

Each 220-, 275-, 412.5-, or 550-mg naproxen sodium tablet contains about 0.87, 1, 1.5, or 2 mEq of sodium, respectively; each mL of naproxen suspension contains about 0.3 mEq of sodium.225 230 Caution in patients with fluid retention, hypertension, or heart failure.225 230

GI Effects

Serious GI toxicity (e.g., bleeding, ulceration, perforation) can occur with or without warning symptoms; increased risk in those with a history of GI bleeding or ulceration, geriatric patients, smokers, those with alcohol dependence, and those in poor general health.208 209 210 214 225 230 238 247

For patients at high risk for complications from NSAIA-induced GI ulceration (e.g., bleeding, perforation), consider concomitant use of misoprostol;212 238 239 240 alternatively, consider concomitant use of a proton-pump inhibitor (e.g., esomeprazole, omeprazole)212 238 239 or use of an NSAIA that is a selective inhibitor of COX-2 (e.g., celecoxib).239

Renal Effects

Direct renal injury, including renal papillary necrosis, reported in patients receiving long-term NSAIA therapy.225

Potential for overt renal decompensation.225 230 Increased risk of renal toxicity in patients with renal or hepatic impairment or heart failure, in patients with volume depletion, in geriatric patients, and in those receiving a diuretic, ACE inhibitor, or angiotensin II receptor antagonist.225 230 257 (See Renal Impairment under Cautions.)

Sensitivity Reactions

Hypersensitivity Reactions

Anaphylactoid reactions reported.200 225

Immediate medical intervention and discontinuance for anaphylaxis.225 230

Avoid in patients with aspirin triad (aspirin sensitivity, asthma, nasal polyps);225 230 caution in patients with asthma.225 230

Dermatologic Reactions

Serious skin reactions (e.g., exfoliative dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis) reported; can occur without warning.225 Discontinue at first appearance of rash or any other sign of hypersensitivity (e.g., blisters, fever, pruritus).225

General Precautions

Do not use multiple naproxen-containing preparations concomitantly.225 230

Hepatic Effects

Severe reactions including jaundice, fatal fulminant hepatitis, liver necrosis, and hepatic failure (sometimes fatal) reported rarely with NSAIAs.225 230

Elevations of serum ALT or AST reported.225 230

Monitor liver function periodically during long-term therapy.a Monitor for symptoms and/or signs suggesting liver dysfunction; monitor abnormal liver function test results.225 230 Discontinue if signs or symptoms of liver disease or systemic manifestations (e.g., eosinophilia, rash) occur or if liver function test abnormalities persist or worsen.225 230

Hematologic Effects

Anemia reported rarely.225 230 Periodically determine hemoglobin concentrations during long-term therapy in patients with initial values ≤10 g/dL.225 230 Determine hemoglobin concentration or hematocrit in patients receiving long-term therapy if signs or symptoms of anemia occur.225

May inhibit platelet aggregation and prolong bleeding time.225 230

CNS Effects

Drowsiness and dizziness reported; may impair ability to perform activities requiring mental alertness.225 230

Ocular Effects

Visual disturbances reported; ophthalmic evaluation recommended if visual changes occur.225 230

Other Precautions

Not a substitute for corticosteroid therapy; not effective in the management of adrenal insufficiency.225 230

May mask certain signs of infection.225 230

Obtain CBC and chemistry profile periodically during long-term use.225

Use of Fixed Combinations

When used in fixed combination with other agents, consider the cautions, precautions, and contraindications associated with the concomitant agents.267 268

Specific Populations

Pregnancy

Category C.225 Avoid use in third trimester because of possible premature closure of the ductus arteriosus.225 230

Lactation

Distributed into milk; use not recommended.225 230

Pediatric Use

Safety and efficacy not established in children <2 years of age.225

Should not be used for self-medication in children <12 years of age unless otherwise directed by a clinician.200

Dosing recommendations for juvenile rheumatoid arthritis based on well-controlled studies.225

Safety of extended-release naproxen sodium tablets not established in children.230

Risk of overdosage and toxicity (including death) in children <2 years of age receiving OTC preparations containing antihistamines, cough suppressants, expectorants, and nasal decongestants alone or in combination for relief of symptoms of upper respiratory tract infection.265 266 Such preparations also may contain analgesics and antipyretics.265 Limited evidence of efficacy for these preparations in this age group; appropriate dosages not established.265 Therefore, FDA recommends not to use such preparations in children <2 years of age; safety and efficacy in older children currently under evaluation. Because children 2–3 years of age also are at increased risk of overdosage and toxicity, some manufacturers of oral nonprescription cough and cold preparations recently agreed to voluntarily revise the product labeling to state that such preparations should not be used in children <4 years of age. During the transition period, some preparations on pharmacy shelves will have the new recommendation (“do not use in children <4 years of age”), while others will have the previous recommendation (“do not use in children <2 years of age”). FDA recommends that parents and caregivers adhere to dosage instructions and warnings on the product labeling that accompanies the preparation and consult a clinician about any concerns.

Geriatric Use

Geriatric patients appear to tolerate GI ulceration and bleeding less well than other individuals.225 230 Fatal adverse GI effects reported more frequently in geriatric patients than younger adults.225 230

Select dosage with caution because of age-related decreases in renal function.225 May be useful to monitor renal function.225

Caution advised if high dosages required.225

Hepatic Impairment

Caution advised if high dosages required.225 230

Renal Impairment

Use not recommended in patients with moderate to severe renal impairment (Clcr <30 mL/minute); close monitoring of renal function advised if used.225

Metabolites eliminated principally via the kidney.225

Common Adverse Effects

Abdominal pain, constipation, dizziness, drowsiness, dyspnea, edema, ecchymoses, headache, heartburn, nausea, pruritus, skin eruptions, tinnitus.225 230

Interactions for Naproxen

Extensively metabolized by CYP1A2 and CYP2C9.267 Does not induce drug-metabolizing enzymes.225

Protein-bound Drugs

Pharmacokinetic interaction possible; caution advised. Observe for adverse effects if used with other protein-bound drugs.225 230

Drugs Affecting Gastric pH

Concomitant administration of delayed-release naproxen tablets with drugs that increase gastric pH not recommended; possible pharmacokinetic interaction.225

Specific Drugs

Drug

Interaction

Comments

ACE inhibitors

Reduced BP response to ACE inhibitor225

Possible deterioration of renal function in individuals with renal impairment257

Monitor BP225

Alcohol

Increased risk of GI bleeding200 226 227 228 229

Angiotensin II receptor antagonists

Reduced BP response to angiotensin II receptor antagonist257

Possible deterioration of renal function in individuals with renal impairment257

Monitor BP257

Antacids

Delayed absorption of naproxen225

Concomitant use of intensive antacid therapy with delayed-release naproxen tablets not recommended225

Anticoagulants (warfarin)

Possible bleeding complications225

Caution advised225 230

Aspirin

Increased risk of GI ulceration and other complications225

No consistent evidence that low-dose aspirin mitigates the increased risk of serious cardiovascular events associated with NSAIAs225

Concomitant administration may interfere with the antiplatelet effect of low-dose aspirin261 262 263

Manufacturers state that concomitant use not recommended225 230

β-Adrenergic blocking agents

Reduced BP response225 230

Monitor BP225 230

Cholestyramine

Delayed absorption of naproxen225

Diuretics (furosemide, thiazides)

Reduced natriuretic effects225 230

Monitor for diuretic efficacy and renal failure225

Lithium

Increased plasma lithium concentrations225 230

Monitor for lithium toxicity225 230

Methotrexate

Possible toxicity associated with increased plasma methotrexate concentrations225

Caution advised225 230

Probenecid

Increased plasma concentrations and half-life of naproxen225 230

Sucralfate

Delayed absorption of naproxen225

Concomitant use with delayed-release naproxen tablets not recommended225

Naproxen Pharmacokinetics

Absorption

Bioavailability

Well absorbed following oral administration; bioavailability is about 95%.225 230

Extent of absorption similar for commercially available formulations; peak plasma concentrations also similar, although about 36% lower with conventional tablets containing naproxen sodium 500 mg and sumatriptan than with conventional naproxen sodium 550-mg tablets.225 267 268 a

Rate of absorption varies depending on formulation used.225 267 268 a Peak plasma concentration usually attained within about 1–2 hours (naproxen sodium conventional tablets), 2–4 hours (naproxen conventional tablets), 1–4 hours (naproxen suspension), 3 hours (tablets containing delayed-release naproxen and immediate-release esomeprazole), 3–5 hours (naproxen sodium extended-release tablets), 5 hours (conventional tablets containing naproxen sodium and sumatriptan), or 4–6 hours (naproxen delayed-release tablets).225 230 267 268

Onset

Naproxen sodium conventional tablets and extended-release tablets provide pain relief within 30 minutes; naproxen conventional tablets provide pain relief within 1 hour.225 230

Duration

Analgesic effect lasts up to 12 hours.225

Food

Food delays time to peak plasma concentration by about 6–8 hours following administration as naproxen delayed-release tablets.225

High-fat meal delays time to peak plasma naproxen concentration by 10 hours and decreases peak plasma naproxen concentration by about 12% following administration as tablets containing delayed-release naproxen and immediate-release esomeprazole.267

Food does not substantially affect bioavailability of naproxen from naproxen sodium/sumatriptan tablets.268

Distribution

Plasma Protein Binding

>99%.225 230

Elimination

Metabolism

Extensively metabolized in the liver by CYP1A2 and CYP2C9 to 6-desmethylnaproxen.225 230 267

Elimination Route

Excreted in urine (95%) mainly as conjugates of naproxen or 6-desmethylnaproxen.225 230

Half-life

12–17 hours.225 230 267

Special Populations

In patients with renal impairment, possible accumulation of naproxen metabolites.225 230

Stability

Storage

Oral

Conventional and Delayed-release Tablets

15–30°C.225

Extended-release Tablets

20–25°C.230

Tablets Containing Delayed-release Naproxen and Immediate-release Esomeprazole

25°C (may be exposed to 15–30°C).267

Tablets Containing Naproxen Sodium and Sumatriptan

25°C (may be exposed to 15–30°C).268 Store in original container with desiccant packet; do not repackage.268

Suspension

15–30°C in light-resistant container.225

Actions

  • Inhibits cyclooxygenase-1 (COX-1) and COX-2.231 232 233 234 235 236

  • Pharmacologic actions similar to those of other prototypical NSAIAs; exhibits anti-inflammatory, analgesic, and antipyretic activity.225 230

Advice to Patients

  • Importance of reading the medication guide for NSAIAs that is provided each time the drug is dispensed.225

  • When used for self-medication, importance of reading the product labeling.200

  • When used for self-medication, importance of using the lowest effective dosage and of not exceeding the recommended dosage or duration of therapy.200

  • When used for self-medication, importance of reviewing the warning information provided by the manufacturer.200

  • Risk of serious cardiovascular events with long-term use.225

  • Risk of GI bleeding and ulceration.225 230

  • Risk of serious skin reactions.225 Risk of anaphylactoid and other sensitivity reactions.225 230

  • Risk of hepatotoxicity.225 230

  • Importance of notifying clinician if signs and symptoms of a cardiovascular event (chest pain, dyspnea, weakness, slurred speech) occur.225

  • Importance of notifying clinician if signs and symptoms of GI ulceration or bleeding, unexplained weight gain, or edema develops.225 230

  • Importance of discontinuing naproxen and contacting clinician if rash or other signs of hypersensitivity (blisters, fever, pruritus) develop.225 Importance of seeking immediate medical attention if an anaphylactic reaction occurs.225 230

  • Importance of discontinuing therapy and contacting clinician immediately if signs and symptoms of hepatotoxicity (nausea, fatigue, lethargy, pruritus, jaundice, upper right quadrant tenderness, flu-like symptoms) occur.225 230

  • Important of not engaging in activities requiring alertness if adverse CNS effects (drowsiness, dizziness, vertigo, depression) occur.225

  • Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.225 230 Importance of avoiding naproxen in late pregnancy (third trimester).225 230

  • Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs.225 230

  • Importance of informing patients of other important precautionary information.225 (See Cautions.)

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

Naproxen

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Oral

Suspension

125 mg/5 mL*

Naprosyn

Roche

Naproxen Suspension

Tablets

250 mg*

Naprosyn

Roche

Naproxen Tablets

375 mg*

Naprosyn

Roche

Naproxen Tablets

500 mg*

Naprosyn

Roche

Naproxen Tablets

Tablets, delayed-release (enteric-coated)

375 mg*

EC-Naprosyn

Roche

Naproxen Delayed-release Tablets

500 mg*

EC-Naprosyn (scored)

Roche

Naproxen Delayed-release Tablets

Naproxen Combinations

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Oral

Tablets, delayed-release core (naproxen only)

375 mg with Esomeprazole Magnesium 20 mg (of esomeprazole)

Vimovo

AstraZeneca

500 mg with Esomeprazole Magnesium 20 mg (of esomeprazole)

Vimovo

AstraZeneca

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

Naproxen Sodium

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Oral

Tablets

220 mg (equivalent to naproxen 200 mg)*

Aleve Caplets

Bayer

Aleve Tablets

Bayer

Naproxen Sodium Tablets

Tablets, extended-release

412.5 mg (equivalent to 375 mg naproxen)

Naprelan

Carnrick

550 mg (equivalent to 500 mg naproxen)

Naprelan

Carnrick

Tablets, film-coated

275 mg (equivalent to naproxen 250 mg)*

Anaprox

Roche

Naproxen Sodium Film Coated Tablets

550 mg (equivalent to naproxen 500 mg)*

Anaprox DS (scored)

Roche

Naproxen Sodium Film Coated Tablets

Naproxen Sodium Combinations

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Oral

Tablets, extended release

220 mg (equivalent to 200 mg naproxen) with Pseudoephedrine Hydrochloride 120 mg

Aleve Cold and Sinus

Roche

Tablets, film-coated

500 mg (equivalent to 455 mg naproxen) with Sumatriptan Succinate 85 mg (of sumatriptan)

Treximet

GlaxoSmithKline

Comparative Pricing

This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 02/2014. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.

Aleve 220MG Tablets (BAYER CONSUMER): 100/$24.93 or 300/$52.13

Anaprox 275MG Tablets (GENENTECH): 30/$75.99 or 90/$215.97

Anaprox DS 550MG Tablets (GENENTECH): 30/$117.99 or 90/$328.97

EC-Naprosyn 375MG Enteric-coated Tablets (GENENTECH): 30/$57.99 or 90/$165.97

EC-Naprosyn 500MG Enteric-coated Tablets (GENENTECH): 30/$74.99 or 90/$205.96

Naprelan 375MG 24-hr Tablets (SHIONOGI PHARMA): 30/$278.77 or 90/$729.70

Naprelan 500MG 24-hr Tablets (SHIONOGI PHARMA): 30/$270.00 or 90/$740.00

Naprelan 750MG 24-hr Tablets (SHIONOGI PHARMA): 30/$250.00 or 90/$709.94

Naprosyn 125MG/5ML Suspension (GENENTECH): 300/$54.33 or 900/$145.34

Naprosyn 375MG Tablets (GENENTECH): 100/$180.71 or 300/$506.76

Naprosyn 500MG Tablets (GENENTECH): 30/$76.99 or 90/$214.81

Naproxen 125MG/5ML Suspension (ROXANE): 500/$51.49 or 1500/$119.45

Naproxen 250MG Tablets (GLENMARK PHARMACEUTICALS): 90/$15.99 or 180/$20.97

Naproxen 375MG Tablets (GLENMARK PHARMACEUTICALS): 90/$18.99 or 180/$24.98

Naproxen 500MG Tablets (GLENMARK PHARMACEUTICALS): 60/$19.99 or 180/$47.97

Naproxen DR 375MG Enteric-coated Tablets (TEVA PHARMACEUTICALS USA): 60/$39.99 or 180/$99.97

Naproxen DR 500MG Enteric-coated Tablets (TEVA PHARMACEUTICALS USA): 60/$64.99 or 180/$186.99

Naproxen Sodium 275MG Tablets (TEVA PHARMACEUTICALS USA): 60/$15.99 or 180/$40.97

Naproxen Sodium 550MG Tablets (TEVA PHARMACEUTICALS USA): 30/$14.99 or 90/$25.99

Treximet 85-500MG Tablets (GLAXO SMITH KLINE): 9/$219.98 or 27/$629.97

Vimovo 375-20MG Enteric-coated Tablets (ASTRAZENECA LP): 60/$109.99 or 180/$305.97

Vimovo 500-20MG Enteric-coated Tablets (ASTRAZENECA LP): 60/$109.99 or 180/$309.96

AHFS DI Essentials. © Copyright, 2004-2014, Selected Revisions August 1, 2013. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

References

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a. AHFS drug information 2003. McEvoy GK, ed. Naproxen. Bethesda, MD: American Society of Health-System Pharmacists; 2003:1986-92.

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