Naproxen Sodium

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

• 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.)

  
  

REMS:

FDA approved a REMS for naproxen to ensure that the benefits of a drug outweigh the risks. The REMS may apply to one or more preparations of naproxen and consists of the following: medication guide. See the FDA REMS page () or the ASHP REMS Resource Center ().

Introduction

Prototypical NSAIA; propionic acid derivative.^{225 230}

Uses for Naproxen Sodium

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 combination with lansoprazole in patients with these conditions who have a history of documented gastric ulcer and require continued NSAIA use.²⁵⁰

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 Sodium 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

Conventional (immediate-release) tablets, delayed-release tablets, and suspension formulations of naproxen or naproxen sodium usually are 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 When used in combination with lansoprazole, the morning dose of naproxen is administered with lansoprazole before eating.²⁵⁰

Naproxen sodium extended-release tablets are administered orally once daily.²³⁰

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

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

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 tablets are not recommended for management of acute gout, tendinitis, bursitis, acute pain, or dysmenorrhea because of slow onset of action.²²⁵

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

When naproxen conventional tablets are used in combination with lansoprazole (15 mg once daily), usual naproxen dosage is 375 or 500 mg twice daily.²⁵⁰

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

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

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

Renal Impairment

Consider reduced initial dosage.²²⁵

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

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 Sodium

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., lansoprazole, 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 hemoglobulin 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 Combination

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

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 (Cl_cr <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 Sodium

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 Sodium Pharmacokinetics

Absorption

Bioavailability

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

Extent of absorption and peak plasma concentrations similar for commercially available formulations; rate of absorption varies depending on formulation used.^{225 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), 3–5 hours (naproxen sodium extended-release tablets), or 4–6 hours (naproxen delayed-release tablets).^{225 230}

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

Distribution

Plasma Protein Binding

>99%.^{225 230}

Elimination

Metabolism

Metabolized in the liver to 6-desmethylnaproxen.^{225 230}

Elimination Route

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

Half-life

12–17 hours.^{225 230}

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

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*	Naproxen Suspension
			Naprosyn	Roche
	Tablets	250 mg*	Naprosyn (Naproxen Tablets)	Roche
		375 mg*	Naprosyn (Naproxen Tablets)	Roche
		500 mg*	Naprosyn (Naproxen Tablets)	Roche
	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	Kit	14 tablets, Naproxen 375 mg (Naprosyn) 7 capsules delayed-release (containing enteric-coated granules), Lansoprazole, 15 mg (Prevacid)	Prevacid NapraPAC™ 375	TAP Pharmaceuticals
		14 tablets, Naproxen 500 mg (Naprosyn) 7 capsules delayed-release (containing enteric-coated granules), Lansoprazole, 15 mg (Prevacid)	Prevacid NapraPAC™ 500	TAP Pharmaceuticals

* 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	(Naproxen Sodium Tablets), Bayer
			Aleve Tablets	Bayer
	Tablets, extended-release*	412.5 mg (equivalent to 375 mg naproxen)	Naprelan	Carnrick
		550 mg (equivalent to 500 mg naproxen)	Naprelan ((Naproxen Sodium Film Coated Tablets)	Carnrick
	Tablets, film-coated	275 mg (equivalent to naproxen 250 mg)*	Anaprox	Roche
		550 mg (equivalent to naproxen 500 mg)*	Anaprox DS (scored)	Roche

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

Comparative Pricing

This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 10/2011. 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/$21.99 or 300/$45.97

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/$69.99 or 90/$200.97

Naprelan 375MG 24-hr Tablets (SHIONOGI PHARMA): 30/$135.99 or 90/$355.96

Naprelan 500MG 24-hr Tablets (SHIONOGI PHARMA): 30/$138.46 or 90/$400.56

Naprelan 750MG 24-hr Tablets (SHIONOGI PHARMA): 30/$237.38 or 90/$682.49

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/$75.82 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/$216.99 or 27/$607.99

Vimovo 375-20MG Enteric-coated Tablets (ASTRAZENECA LP): 60/$109.99 or 180/$299.95

Vimovo 500-20MG Enteric-coated Tablets (ASTRAZENECA LP): 60/$109.99 or 180/$299.95

Disclaimer

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.

The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. and Drugs.com do not endorse or recommend the use of any drug. The information is not a substitute for medical care.

AHFS Drug Information. © Copyright, 1959-2011, Selected Revisions October 25, 2011. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

References

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104. Moran H, Hanna DB, Ansell BM et al. Naproxen in juvenile chronic polyarthritis. Ann Rheum Dis. 1979; 38:152-4. [IDIS 123069] [PubMed 375850]

105. Matchar DB, Young WB, Rosenberg JH et al. Evidence-based guidelines for migraine headache in the primary care setting: pharmacological management of acute attacks. St. Paul, MN; 2001. From the American Academy of Neurology web site.

106. Ramadan NM, Silberstein SD, Freitag FG et al. Evidence-based guidelines for migraine headache in the primary care setting: pharmacological management for prevention of migraine. St. Paul, MN; 2001. From the American Academy of Neurology web site.

200. Bayer HealthCare. Aleve (naproxen sodium) tablet labeling. Morristown, NJ; 2006.

201. Syntex Laboratories, Palo Alto, CA: Personal communication.

202. Makela AL. Naproxen in the treatment of juvenile rheumatoid arthritis. Scand J Rheumatol. 1977; 6:193-205. [PubMed 343231]

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204. Nicholls A, Hazleman B, Todd RM et al. Long-term evaluation of naproxen suspension in juvenile chronic arthritis. Curr Med Res Opin. 1982; 8:204-7. [PubMed 7128194]

205.