Naproxen (Lexi-Drugs)

ALERT: US Boxed Warning
  Serious cardiovascular thrombotic events:
  Serious gastrointestinal bleeding, ulceration, and perforation:
Pronunciation

(na PROKS en)

Brand Names: US

Aleve [OTC]; All Day Relief [OTC]; Anaprox DS [DSC]; EC-Naprosyn; EC-Naproxen; Flanax Pain Relief; Flanax Pain Relief [OTC]; GoodSense Naproxen Sodium [OTC]; Mediproxen [OTC]; Naprelan; Naprosyn; Naproxen Comfort Pac; Naproxen DR; Naproxen Kit [DSC]

Brand Names: Canada

Anaprox; Anaprox DS; APO-Napro-Na; APO-Naproxen; APO-Naproxen EC; APO-Naproxen SR; MYLAN-Naproxen EC [DSC]; MYLAN-Naproxen [DSC]; Naprelan [DSC]; Naprosyn; Naproxen-Na [DSC]; Naxen EC; NTP-Naproxen EC [DSC]; NTP-Naproxen Sodium DS [DSC]; NTP-Naproxen Sodium [DSC]; NTP-Naproxen [DSC]; Pediapharm Naproxen; PMS-Naproxen; PMS-Naproxen EC; PRO-Naproxen EC; PRO-Naproxen EC-500; RATIO-Naproxen E [DSC]; TEVA-Naproxen; TEVA-Naproxen EC; TEVA-Naproxen Sodium; TEVA-Naproxen Sodium DS; TEVA-Naproxen SR [DSC]

Dosing: Adult

Note: Dosage expressed as naproxen base; 200 mg naproxen base is equivalent to 220 mg naproxen sodium. For relief of acute pain, naproxen sodium may be preferred due to more rapid absorption and onset; naproxen base may also be used however EC-Naprosyn is not recommended.

Ankylosing spondylitis, osteoarthritis, rheumatoid arthritis: Oral: 500 to 1,000 mg daily in 2 divided doses; in patients who require higher level of anti-inflammatory/analgesic activity and have tolerated lower doses, may increase to 1,500 mg/day for limited time period (<6 months)

Naproxen extended-release tablets: Initial: 750 to 1,000 mg once daily; in patients who require higher level of anti-inflammatory/analgesic activity and have tolerated lower doses, may temporarily increase to 1,500 mg once daily

Rectal suppository [Canadian product]: Insert one 500 mg suppository into the rectum once daily (Note: Suppository may be used to substitute for one oral dose in patients receiving 1,000 mg naproxen daily).

Gout, acute flares (alternative agent): Oral: 500 mg twice daily (Janssens 2008); initiate within 24 to 48 hours of flare onset preferably; discontinue 2 to 3 days after resolution of clinical signs; usual duration: 5 to 7 days (ACR [Khanna 2012]; Becker 2018)

Manufacturer’s labeling: Dosing in the prescribing information may not reflect current clinical practice.

Immediate release: Initial: 750 mg followed by 250 mg every 8 hours

Extended-release tablets: Initial: 1,000 to 1,500 mg once daily followed by 1,000 mg once daily. Note: Naproxen delayed-release tablets are not recommended because of the delay in absorption.

Pain (mild to moderate), dysmenorrhea, acute tendonitis, bursitis: Oral: Initial: 500 mg, followed by 500 mg every 12 hours or 250 mg every 6 to 8 hours; maximum daily dose: Day 1: 1,250 mg; subsequent daily doses should not exceed 1,000 mg

Naproxen extended-release tablets: Oral: Initial: 1,000 mg once daily; may temporarily increase to 1,500 mg once daily if greater pain relief is needed. Dose should be subsequently reduced to a maximum of 1,000 mg daily.

Episodic migraine prevention (off-label use): Oral: 250 to 500 mg twice daily (EFNS [Evers 2009]). Continue treatment for 2 to 3 months to assess clinical benefit; consider tapering or discontinuing dose if headaches are well-controlled after 3 to 6 months (AAN [Silberstein 2000]).

Migraine, acute (off label use): Initial: 750 mg; an additional 250 to 500 mg may be given if needed (maximum: 1,250 mg in 24 hours) (Andersson, 1989; Nestvold, 1985).

OTC labeling: Pain, fever: 200 mg every 8 to 12 hours; if needed, may take 400 mg for the initial dose; maximum: 400 mg in any 8- to 12-hour period or 600 mg/24 hours

Dosing: Geriatric

Use with caution; consider using a reduced dose. Refer to adult dosing.

Dosing: Renal Impairment: Adult

CrCl ≥30 mL/minute: There are no specific dosage adjustments provided in the manufacturer’s labeling; use with caution and consider using a reduced dose.

CrCl <30 mL/minute: Use is not recommended; avoid use in patients with advanced renal disease.

Hemodialysis: Not dialyzable (NCS/SCCM [Frontera 2016])

KDIGO 2012 guidelines provide the following recommendations for NSAIDs:

eGFR 30 to <60 mL/minute/1.73 m2:Temporarily discontinue in patients with intercurrent disease that increases risk of acute kidney injury.

eGFR <30 mL/minute/1.73 m2: Avoid use.

Dosing: Hepatic Impairment: Adult

There are no specific dosage adjustments provided in the manufacturer’s labeling; use with caution and consider using a reduced dose.

Dosing: Pediatric

Note: Dosage expressed as naproxen base; 200 mg naproxen base is equivalent to 220 mg naproxen sodium. In pediatric patients, all dosing is for the immediate release preparations.

Analgesia/pain, mild to moderate:

Children and Adolescents <60 kg: Limited data available: Oral: 5 to 6 mg/kg/dose every 12 hours; maximum daily dose: 1,000 mg/day (Berde 2002); doses as high as 10 mg/kg/dose have also been recommended (APS 2008)

Children and Adolescents ≥60 kg: Limited data available: Oral: 250 to 375 mg twice daily; maximum daily dose: 1,000 mg/day (Berde 2002)

OTC labeling: Children ≥12 years and Adolescents: Oral: 200 mg every 8 to 12 hours; if needed may take 400 mg for the initial dose; maximum daily dose: 600 mg/day

Fever: OTC labeling: Children ≥12 years and Adolescents: Oral: 200 mg every 8 to 12 hours; if needed may take 400 mg for the initial dose; maximum daily dose: 600 mg/day

Juvenile idiopathic arthritis: Children and Adolescents: Oral: 10 to 15 mg/kg/day in 2 divided doses; Maximum daily dose: 1,000 mg/day (Hollingsworth 1993; Kliegman 2016; Litalien 2001)

Ankylosing spondylitis: Limited data available: Children and Adolescents: Oral: 15 to 20 mg/kg/day in 2 divided doses; maximum daily dose: 1,500 mg/day; adult dosing suggests limiting this maximum daily dose to <6 months of therapy (APS 2008; Kliegman 2016)

Dosing: Renal Impairment: Pediatric

Manufacturer’s labeling: Children ≥2 years and Adolescents:

CrCl ≥30 mL/minute: There are no specific dosage adjustments provided in the manufacturer’s labeling; use with caution and consider using a reduced dose. Use is not recommended in patients with moderate renal impairment.

CrCl <30 mL/minute: Use is not recommended; avoid use in patients with advanced renal disease.

KDIGO 2012 guidelines provide the following recommendations for NSAIDs (KDIGO 2013): Children and Adolescents:

eGFR 30 to <60 mL/minute/1.73 m2: Temporarily discontinue in patients with intercurrent disease that increases risk of acute kidney injury

eGFR <30 mL/minute/1.73 m2: Avoid use

Dosing: Hepatic Impairment: Pediatric

There are no specific dosage adjustments provided in the manufacturer’s labeling; use with caution and consider using a reduced dose.

Use: Labeled Indications

Ankylosing spondylitis, bursitis, gout (acute flares), polyarticular juvenile idiopathic arthritis, osteoarthritis, rheumatoid arthritis, tendonitis (Rx products only): Relief of the signs and symptoms of acute flares of gout, ankylosing spondylitis, bursitis, polyarticular juvenile idiopathic arthritis (excluding ER tablets), osteoarthritis, rheumatoid arthritis, and tendonitis. Delayed-release naproxen is not recommended for initial treatment of acute pain.

Pain, primary dysmenorrhea (Rx and OTC products): Relief of mild to moderate pain and the treatment of primary dysmenorrhea. Delayed-release naproxen is not recommended for initial treatment of acute pain.

Use: Off-Label: Adult

  Migraine, acute (treatment)Level of Evidence [C]

Data from two randomized, double-blind, placebo-controlled, crossover studies support the use of naproxen in the treatment of acute migraine Ref. Additional trials may be necessary to further define the role of naproxen in this condition.

Level of Evidence Definitions
  Level of Evidence Scale
Clinical Practice Guidelines

Ankylosing Spondylitis:

ACR/SAA/SPARTAN, “Recommendations for the Treatment of Ankylosing Spondylitis and Nonradiographic Axial Spondyloarthritis,” 2016

Drug-Induced Liver Injury:

American College of Gastroenterology (ACG), “2014 ACG Guideline for Idiosyncratic Drug-induced Liver Injury,” July 2014

Gout:

3e Initiative, Guidelines for the Management of Gout, 2014

American College of Rheumatology (ACR), Guideline for the Management of Acute Gout, 2012

BSR/BHPR, Guideline for the Management of Gout, 2007

Juvenile Idiopathic Arthritis:

American College of Rheumatology, “2013 Update of the 2011 American College of Rheumatology Recommendations for the Treatment of Juvenile Idiopathic Arthritis,” 2013

Osteoarthritis:

American College of Rheumatology, “Recommendations for the Use of Nonpharmacologic and Pharmacologic Therapies in Osteoarthritis of the Hand, Hip, and Knee,” 2012

Surgery:

STS, “2012 Update to the Society of Thoracic Surgeons Guideline on Use of Antiplatelet Drugs in Patients Having Cardiac and Noncardiac Operations,” November 2012

Other:

“The Use of Antiplatelet Therapy in the Outpatient Setting: Canadian Cardiovascular Society Guidelines,” 2011

Administration: Oral

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

Suspension: Shake suspension well before administration.

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

Administration: Rectal

Rectal suppository [Canadian product]: Insert suppository into rectum.

Administration: Pediatric

Oral: Administer with food, milk, or antacids to decrease GI adverse effects. Shake suspension well before use. Do not chew, crush, or break delayed or controlled release tablet, swallow whole. Separate administration of naproxen and antacids, sucralfate, or cholestyramine by 2 hours.

Dietary Considerations

Sodium content: Naproxen sodium products contain about 50 mg (2 mEq) of sodium per 500 mg of naproxen. Naprosyn suspension contains 39 mg of sodium per 5 mL (125 mg). Consider this in patients whose overall intake of sodium must be severely restricted.

Storage/Stability

Store at 15°C to 30°C (59°F to 86°F); suspension should not be exposed to excessive heat (>40°C [104°F]).

Medication Patient Education with HCAHPS Considerations

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Patient may experience heartburn, nausea, vomiting, diarrhea, constipation, flatulence, or fatigue. Have patient report immediately to prescriber signs of abdominal ulcers (severe abdominal or back pain; black, tarry, or bloody stools; vomiting blood or vomit that looks like coffee grounds; or weight gain or abnormal swelling), signs of kidney problems (urinary retention, hematuria, change in amount of urine passed, or weight gain), signs of bleeding (vomiting blood or vomit that looks like coffee grounds; coughing up blood; hematuria; black, red, or tarry stools; bleeding from the gums; abnormal vaginal bleeding; bruises without a reason or that get bigger; or any severe or persistent bleeding), signs of severe cerebrovascular disease (change in strength on one side is greater than the other, difficulty speaking or thinking, change in balance, or vision changes), signs of high potassium (abnormal heartbeat, confusion, dizziness, passing out, weak, shortness of breath, numbness or tingling feeling), signs of liver problems (dark urine, fatigue, lack of appetite, nausea, abdominal pain, light-colored stools, vomiting, or jaundice), shortness of breath, excessive weight gain, swelling of arms or legs, angina, tachycardia, severe headache, severe dizziness, passing out, severe loss of strength and energy, tinnitus, mood changes, depression, severe abdominal pain, severe back pain, or signs of Stevens-Johnson syndrome/toxic epidermal necrolysis (red, swollen, blistered, or peeling skin [with or without fever]; red or irritated eyes; or sores in mouth, throat, nose, or eyes) (HCAHPS).

• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for health care professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience, and judgment in diagnosing, treating, and advising patients.

Medication Safety Issues
  Sound-alike/look-alike issues:
  Geriatric Patients: High-Risk Medication:
  International issues:
Contraindications

Hypersensitivity to naproxen (eg, anaphylactic reactions, serious skin reactions) or any component of the formulation; history of asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs; use in the setting of coronary artery bypass graft (CABG) surgery

Canadian labeling: Additional contraindications (not in US labeling): Active gastric, duodenal, or peptic ulcers; active GI bleeding; cerebrovascular bleeding or other bleeding disorders; active GI inflammatory disease; severe liver impairment or active liver disease; severe renal impairment (CrCl <30 mL/minute) or deteriorating renal disease; severe uncontrolled heart failure; known hyperkalemia; third trimester of pregnancy; breast-feeding; inflammatory lesions or recent bleeding of the rectum or anus (suppository only); use in patients <16 years of age (suppository only); use in patients <18 years of age (naproxen enteric coated and sustained release tablets and naproxen sodium tablets); use in children <2 years (naproxen tablets and suspension).

Warnings/Precautions

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. Contraindicated in patients who experience bronchospasm, asthma, rhinitis, or urticaria with NSAID or aspirin therapy.

• Cardiovascular events: [US Boxed Warning]: NSAIDs cause an increased risk of serious (and potentially fatal) adverse cardiovascular thrombotic events, including MI and stroke. Risk may occur early during treatment and may increase with duration of use. Relative risk appears to be similar in those with and without known cardiovascular disease or risk factors for cardiovascular disease; however, absolute incidence of serious cardiovascular thrombotic events (which may occur early during treatment) was higher in patients with known cardiovascular disease or risk factors and in those receiving higher doses. New-onset hypertension or exacerbation of hypertension may occur (NSAIDs may also impair response to ACE inhibitors, thiazide diuretics, or loop diuretics); may contribute to cardiovascular events; monitor blood pressure; use with caution in patients with hypertension. May cause sodium and fluid retention, use with caution in patients with edema. Avoid use in heart failure (ACCF/AHA [Yancy 2013]). Avoid use in patients with a recent MI unless benefits outweigh risk of cardiovascular thrombotic events. 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.

• CNS effects: May cause drowsiness, dizziness, blurred vision, and other neurologic effects which may impair physical or mental abilities; patients must be cautioned about performing tasks which require mental alertness (eg, operating machinery or driving). Discontinue use with blurred or diminished vision and perform ophthalmologic exam. Periodically evaluate vision in all patients receiving long term therapy.

• Gastrointestinal events: [US Boxed Warning]: NSAIDs cause increased risk of serious gastrointestinal inflammation, ulceration, bleeding, and perforation (may be fatal); elderly patients and patients with history of peptic ulcer disease and/or GI bleeding are at greater risk of serious GI events. These events may occur at any time during therapy and without warning. Avoid use in patients with active GI bleeding. Use caution with a history of GI ulcers, concurrent therapy known to increase the risk of GI bleeding (eg, aspirin, anticoagulants and/or corticosteroids, selective serotonin reuptake inhibitors), advanced hepatic disease, coagulopathy, smoking, use of alcohol, or in 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. When used concomitantly with aspirin, a substantial increase in the risk of gastrointestinal complications (eg, ulcer) occurs; concomitant gastroprotective therapy (eg, proton pump inhibitors) is recommended (Bhatt 2008).

• Hematologic effects: 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. Rarely, NSAID use has been associated with potentially severe blood dyscrasias (eg, agranulocytosis, thrombocytopenia, aplastic anemia).

• Hepatic effects: Transaminase elevations have been reported with use; closely monitor patients with any abnormal LFT. Rare (sometimes fatal) severe hepatic reactions (eg, fulminant hepatitis, hepatic necrosis, hepatic failure) have occurred with NSAID use; discontinue immediately if signs or symptoms of hepatic disease develop or if systemic manifestations occur.

• Hyperkalemia: NSAID use may increase the risk of hyperkalemia, particularly in the elderly, diabetics, renal disease, and with concomitant use of other agents capable of inducing hyperkalemia (eg, ACE-inhibitors). Monitor potassium closely.

• Renal effects: 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 (usually reversible). Patients with impaired renal function, dehydration, hypovolemia, heart failure, hepatic impairment, 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. Long-term NSAID use may result in renal papillary necrosis and other renal injury.

• Skin reactions: NSAIDs may cause potentially fatal serious skin adverse events including exfoliative dermatitis, Stevens-Johnson syndrome (SJS), and toxic epidermal necrolysis (TEN); may occur without warning; discontinue use at first sign of skin rash (or any other hypersensitivity).

Disease-related concerns:

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

• Asthma: Contraindicated in patients with aspirin-sensitive asthma; severe and potentially fatal bronchospasm may occur. Use caution in patients with other forms of asthma.

• Coronary artery bypass graft surgery: [US Boxed Warning]: Use is contraindicated 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 hepatic impairment; patients with advanced hepatic disease are at an increased risk of GI bleeding with NSAIDs.

• Renal impairment: Avoid use in patients with advanced renal disease; discontinue use with persistent or worsening abnormal renal function tests.

Concurrent drug therapy issues:

• Drug-drug interactions: Potentially significant interactions may exist, requiring dose or frequency adjustment, additional monitoring, and/or selection of alternative therapy. Consult drug interactions database for more detailed information.

Special populations:

• Elderly: Elderly patients are at greater risk for serious GI, cardiovascular, and/or renal adverse events; use with caution.

• Pediatric: Not for self-medication (OTC use) in children <12 years.

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, asthma, high blood pressure, heart or kidney disease, other serious medical problems, are currently taking a diuretic, anticoagulant, other NSAIDs, or are ≥60 years of age. Recommended dosages and duration should not be exceeded, due to an increased risk of GI bleeding, MI, and stroke. Patients should stop use and consult a healthcare provider if symptoms get worse, newly appear, or continue; if an allergic reaction occurs; if feeling faint, vomit blood or have bloody/black stools; if having difficulty swallowing or heartburn, or if fever lasts for >3 days or pain >10 days. 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 to 6 half-lives prior to surgical or dental procedures.

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 CrCl 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.

Warnings: Additional Pediatric Considerations

Pseudoporphyria (ie, increased skin fragility and blistering with scarring in sun-exposed skin) has been reported in naproxen-treated children with JIA (reported incidence, 12%); discontinue therapy if this occurs (Lang 1994).

Pregnancy Considerations

Naproxen crosses the placenta (Brogden 1975). Birth defects have been observed following in utero NSAID exposure in some studies; however, data is conflicting (Bloor 2013). Nonteratogenic effects, including prenatal constriction of the ductus arteriosus, persistent pulmonary hypertension of the newborn, oligohydramnios, necrotizing enterocolitis, renal dysfunction or failure, and intracranial hemorrhage have been observed in the fetus/neonate following in utero NSAID exposure. In addition, nonclosure of the ductus arteriosus postnatally may occur and be resistant to medical management (Bermas 2014; Bloor 2013). Because NSAIDs may cause premature closure of the ductus arteriosus, product labeling for naproxen specifically states use should be avoided starting at 30-weeks gestation. Use of NSAIDs can be considered for the treatment of mild rheumatoid arthritis flares in pregnant women; however, use should be minimized or avoided early and late in pregnancy (Bermas 2014; Saavedra Salinas 2015).

The chronic use of NSAIDs in women of reproductive age may be associated with infertility that is reversible upon discontinuation of the medication. Consider discontinuing use in women having difficulty conceiving or those undergoing investigation of fertility. The use of NSAIDs close to conception may be associated with an increased risk of miscarriage (Bloor 2013; Bermas 2014).

Breast-Feeding Considerations

Naproxen is present in breast milk.

The relative infant dose (RID) of naproxen is 3.3% when calculated using the highest breast milk concentration located and compared to a weight-adjusted maternal dose of 750 mg/day. In general, breastfeeding is considered acceptable when the RID is <10% (Anderson 2016; Ito 2000). Using the highest milk concentration (2.37 mcg/mL), the estimated daily infant dose via breast milk is 0.36 mg/kg/day. This milk concentration was obtained following maternal administration of oral naproxen 375 mg twice daily. Naproxen was detected in the urine of the breastfeeding infant (Jamali 1982; Jamali 1983).

In a study which included 20 mother-infant pairs, there were two cases of drowsiness and one case of vomiting in the breastfed infants (Ito 1993).

In general, NSAIDs may be used in postpartum women who wish to breastfeed; however, agents other than naproxen may be preferred (Montgomery 2012) and use should be avoided in women breastfeeding infants with platelet dysfunction or thrombocytopenia (Bloor 2013; Sammaritano 2014). When needed, naproxen may be considered for short-term use (<1 week) (Montgomery 2012). Other agents are preferred for treatment of migraine in a woman who is breastfeeding because the risk profile of naproxen is less certain (Amundsen 2015). According to the manufacturer, the decision to breastfeed during therapy should consider the risk of infant exposure, the benefits of breastfeeding to the infant, and benefits of treatment to the mother.

Lexicomp Pregnancy & Lactation, In-Depth
Briggs’ Drugs in Pregnancy & Lactation
Adverse Reactions

1% to 10%:

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

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

Dermatologic: Pruritus (3% to 9%), skin rash (3% to 9%), ecchymoses (3% to 9%), diaphoresis (<3%)

Endocrine & metabolic: Fluid retention (3% to 9%), increased thirst (<3%)

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, gastrointestinal hemorrhage, gastrointestinal perforation, gastrointestinal ulcer, vomiting

Hematologic & oncologic: Hemolysis (3% to 9%), purpura (<3%), anemia, prolonged bleeding time

Hepatic: Increased liver enzymes

Ophthalmic: Visual disturbance (<3%)

Otic: Tinnitus (3% to 9%), auditory disturbance (<3%)

Renal: Renal function abnormality

Respiratory: Dyspnea (3% to 9%)

<1%, postmarketing, and/or case reports: Abnormal dreams, agranulocytosis, alopecia, anaphylactoid reaction, anaphylaxis, angioedema, aphthous stomatitis, aseptic meningitis, asthma, blurred vision, cardiac arrhythmia, cardiac failure, cognitive dysfunction, colitis, coma, confusion, conjunctivitis, cystitis, depression, dysuria, eosinophilia, eosinophilic pneumonitis, erythema multiforme, exfoliative dermatitis, fever, glossitis, granulocytopenia, hallucination, hematemesis, hepatic failure, hepatitis, hepatotoxicity (idiosyncratic) (Chalasani, 2014), hyperglycemia, hypertension, hypoglycemia, hypotension, infection, interstitial nephritis, melena, jaundice, leukopenia, lymphadenopathy, menstrual disease, malaise, myalgia, myasthenia, myocardial infarction, oliguria, pancreatitis, pancytopenia, paresthesia, pneumonia, polyuria, proteinuria, rectal hemorrhage, renal failure, renal papillary necrosis, respiratory depression, sepsis, skin photosensitivity, Stevens-Johnson syndrome, tachycardia, seizure, syncope, thrombocytopenia, toxic epidermal necrolysis, vasculitis

Allergy and Idiosyncratic Reactions
Metabolism/Transport Effects

Substrate of CYP1A2 (minor), CYP2C9 (minor); Note: Assignment of Major/Minor substrate status based on clinically relevant drug interaction potential

Drug Interactions 

5-Aminosalicylic Acid Derivatives: Nonsteroidal Anti-Inflammatory Agents may enhance the nephrotoxic effect of 5-Aminosalicylic Acid Derivatives. Risk C: Monitor therapy

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

Agents with Antiplatelet Properties (e.g., P2Y12 inhibitors, NSAIDs, SSRIs, etc.): May enhance the antiplatelet effect of other Agents with Antiplatelet Properties. Risk C: Monitor therapy

Alcohol (Ethyl): May enhance the adverse/toxic effect of Nonsteroidal Anti-Inflammatory Agents. Specifically, the risk of GI bleeding may be increased with this combination. Risk C: Monitor therapy

Aliskiren: Nonsteroidal Anti-Inflammatory Agents may diminish the antihypertensive effect of Aliskiren. Nonsteroidal Anti-Inflammatory Agents may enhance the nephrotoxic effect of Aliskiren. Management: Monitor renal function periodically in patients receiving aliskiren and any nonsteroidal anti-inflammatory agent. Patients at elevated risk of renal dysfunction include those who are elderly, are volume depleted, or have pre-existing renal dysfunction. Risk C: Monitor therapy

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

Aminolevulinic Acid (Systemic): Photosensitizing Agents may enhance the photosensitizing effect of Aminolevulinic Acid (Systemic). Risk X: Avoid combination

Aminolevulinic Acid (Topical): Photosensitizing Agents may enhance the photosensitizing effect of Aminolevulinic Acid (Topical). Risk C: Monitor therapy

Angiotensin II Receptor Blockers: May enhance the adverse/toxic effect of Nonsteroidal Anti-Inflammatory Agents. Specifically, the combination may result in a significant decrease in renal function. Nonsteroidal Anti-Inflammatory Agents may diminish the therapeutic effect of Angiotensin II Receptor Blockers. The combination of these two agents may also significantly decrease glomerular filtration and renal function. Risk C: Monitor therapy

Angiotensin-Converting Enzyme Inhibitors: May enhance the adverse/toxic effect of Nonsteroidal Anti-Inflammatory Agents. Specifically, the combination may result in a significant decrease in renal function. Nonsteroidal Anti-Inflammatory Agents may diminish the antihypertensive effect of Angiotensin-Converting Enzyme Inhibitors. Risk C: Monitor therapy

Anticoagulants: Agents with Antiplatelet Properties may enhance the anticoagulant effect of Anticoagulants. Risk C: Monitor therapy

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

Apixaban: Naproxen may enhance the adverse/toxic effect of Apixaban. Specifically, the risk for bleeding may be increased. Naproxen may increase the serum concentration of Apixaban. Risk D: Consider therapy modification

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

Cephalothin: Agents with Antiplatelet Properties may enhance the adverse/toxic effect of Cephalothin. Specifically, the risk for bleeding may be increased. Risk C: Monitor therapy

Collagenase (Systemic): Agents with Antiplatelet Properties may enhance the adverse/toxic effect of Collagenase (Systemic). Specifically, the risk of injection site bruising and/or bleeding may be increased. Risk C: Monitor therapy

Corticosteroids (Systemic): May enhance the adverse/toxic effect of Nonsteroidal Anti-Inflammatory Agents (Nonselective). Risk C: Monitor therapy

CycloSPORINE (Systemic): Nonsteroidal Anti-Inflammatory Agents may enhance the nephrotoxic effect of CycloSPORINE (Systemic). CycloSPORINE (Systemic) may increase the serum concentration of Nonsteroidal Anti-Inflammatory Agents. Nonsteroidal Anti-Inflammatory Agents may increase the serum concentration of CycloSPORINE (Systemic). Management: Consider alternatives to nonsteroidal anti-inflammatory agents (NSAIDs). Monitor for evidence of nephrotoxicity, as well as increased serum cyclosporine concentrations and systemic effects (eg, hypertension) during concomitant therapy with NSAIDs. Risk D: Consider therapy modification

Dabigatran Etexilate: Nonsteroidal Anti-Inflammatory Agents (Nonselective) may enhance the adverse/toxic effect of Dabigatran Etexilate. Specifically, the risk of bleeding may be increased. Management: A comprehensive risk to benefit assessment should be done for all patients before any concurrent use of dabigatran and nonsteroidal anti-inflammatory drugs (NSAIDs). If combined, monitor patients extra closely for signs and symptoms of bleeding. Risk D: Consider therapy modification

Dasatinib: May enhance the anticoagulant effect of Agents with Antiplatelet Properties. Management: Drugs listed as exceptions to this monograph are discussed in further detail in separate drug interaction monographs. Risk C: Monitor therapy

Deferasirox: Nonsteroidal Anti-Inflammatory Agents may enhance the adverse/toxic effect of Deferasirox. Specifically, the risk for GI ulceration/irritation or GI bleeding may be increased. Risk C: Monitor therapy

Deoxycholic Acid: Agents with Antiplatelet Properties may enhance the adverse/toxic effect of Deoxycholic Acid. Specifically, the risk for bleeding or bruising in the treatment area may be increased. Risk C: Monitor therapy

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

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

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

Diclofenac (Systemic): May enhance the adverse/toxic effect of Nonsteroidal Anti-Inflammatory Agents. Management: Seek alternatives to the combined use of diclofenac with other nonsteroidal anti-inflammatory agents (NSAIDs). Avoid the use of diclofenac/misoprostol with other NSAIDs. Risk D: Consider therapy modification

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

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

Edoxaban: Nonsteroidal Anti-Inflammatory Agents (Nonselective) may enhance the adverse/toxic effect of Edoxaban. Specifically, the risk of bleeding may be increased. Management: A comprehensive risk to benefit assessment should be done for all patients before any concurrent use of edoxaban and nonsteroidal anti-inflammatory drugs (NSAIDs). If combined, monitor patients extra closely for signs and symptoms of bleeding. Risk D: Consider therapy modification

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

Fat Emulsion (Fish Oil Based): May enhance the adverse/toxic effect of Agents with Antiplatelet Properties. Risk C: Monitor therapy

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

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

Glucosamine: May enhance the antiplatelet effect of Agents with Antiplatelet Properties. Risk C: Monitor therapy

Haloperidol: Nonsteroidal Anti-Inflammatory Agents may enhance the adverse/toxic effect of Haloperidol. Specifically including drowsiness and confusion. Risk C: Monitor therapy

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

Herbs (Anticoagulant/Antiplatelet Properties) (eg, Alfalfa, Anise, Bilberry): May enhance the adverse/toxic effect of Nonsteroidal Anti-Inflammatory Agents. Bleeding may occur. Management: Concomitant treatment with these agents should generally be avoided. If used concomitantly, increased diligence in monitoring for adverse effects (eg, bleeding, bruising, altered mental status due to CNS bleeds) must be employed. Risk D: Consider therapy modification

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

Ibritumomab Tiuxetan: Agents with Antiplatelet Properties may enhance the adverse/toxic effect of Ibritumomab Tiuxetan. Both agents may contribute to impaired platelet function and an increased risk of bleeding. Risk C: Monitor therapy

Ibrutinib: May enhance the adverse/toxic effect of Agents with Antiplatelet Properties. Risk C: Monitor therapy

Inotersen: May enhance the antiplatelet effect of Agents with Antiplatelet Properties. Risk C: Monitor therapy

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

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

Limaprost: May enhance the antiplatelet effect of Agents with Antiplatelet Properties. Risk C: Monitor therapy

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. Loop Diuretics may enhance the nephrotoxic effect of Nonsteroidal Anti-Inflammatory Agents. Management: Monitor for evidence of kidney injury or decreased therapeutic effects of loop diuretics with concurrent use of an NSAID. Consider avoiding concurrent use in CHF or cirrhosis. Concomitant use of bumetanide with indomethacin is not recommended. Risk D: Consider therapy modification

Macimorelin: Nonsteroidal Anti-Inflammatory Agents may diminish the diagnostic effect of Macimorelin. Risk X: Avoid combination

Methotrexate: Nonsteroidal Anti-Inflammatory Agents may increase the serum concentration of Methotrexate. Management: Alternative anti-inflammatory therapy should be considered whenever possible, especially if the patient is receiving higher, antineoplastic doses of methotrexate. Risk D: Consider therapy modification

Mifamurtide: Nonsteroidal Anti-Inflammatory Agents may diminish the therapeutic effect of Mifamurtide. Risk X: Avoid combination

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

Multivitamins/Fluoride (with ADE): May enhance the antiplatelet effect of Agents with Antiplatelet Properties. Risk C: Monitor therapy

Multivitamins/Minerals (with ADEK, Folate, Iron): May enhance the antiplatelet effect of Agents with Antiplatelet Properties. Risk C: Monitor therapy

Multivitamins/Minerals (with AE, No Iron): May enhance the antiplatelet effect of Agents with Antiplatelet Properties. Risk C: Monitor therapy

Naftazone: May enhance the antiplatelet effect of Nonsteroidal Anti-Inflammatory Agents. Risk C: Monitor therapy

Nonsteroidal Anti-Inflammatory Agents (COX-2 Selective): Nonsteroidal Anti-Inflammatory Agents may enhance the adverse/toxic effect of Nonsteroidal Anti-Inflammatory Agents (COX-2 Selective). Risk X: Avoid combination

Obinutuzumab: Agents with Antiplatelet Properties may enhance the adverse/toxic effect of Obinutuzumab. Specifically, the risk of serious bleeding-related events may be increased.Risk C: Monitor therapy

Omacetaxine: Nonsteroidal Anti-Inflammatory Agents may enhance the adverse/toxic effect of Omacetaxine. Specifically, the risk for bleeding-related events may be increased. Management: Avoid concurrent use of nonsteroidal antiinflammatory drugs (NSAIDs) with omacetaxine in patients with a platelet count of less than 50,000/uL. Risk X: Avoid combination

Omega-3 Fatty Acids: May enhance the antiplatelet effect of Agents with Antiplatelet Properties. Risk C: Monitor therapy

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

Pentosan Polysulfate Sodium: May enhance the adverse/toxic effect of Agents with Antiplatelet Properties. Specifically, the risk of bleeding may be increased by concurrent use of these agents. Risk C: Monitor therapy

Pentoxifylline: May enhance the antiplatelet effect of Agents with Antiplatelet Properties. Risk C: Monitor therapy

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

Porfimer: Photosensitizing Agents may enhance the photosensitizing effect of Porfimer. Risk C: Monitor therapy

Potassium-Sparing Diuretics: Nonsteroidal Anti-Inflammatory Agents may diminish the antihypertensive effect of Potassium-Sparing Diuretics. Nonsteroidal Anti-Inflammatory Agents may enhance the hyperkalemic effect of Potassium-Sparing Diuretics. Risk C: Monitor therapy

PRALAtrexate: Nonsteroidal Anti-Inflammatory Agents may increase the serum concentration of PRALAtrexate. More specifically, NSAIDS may decrease the renal excretion of pralatrexate. Management: Closely monitor for increased pralatrexate serum levels and/or toxicity if used concomitantly with an NSAID. Monitor for decreased pralatrexate serum levels with NSAID discontinuation. Risk C: Monitor therapy

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

Prostacyclin Analogues: May enhance the antiplatelet effect of Agents with Antiplatelet Properties. Risk C: Monitor therapy

Prostaglandins (Ophthalmic): Nonsteroidal Anti-Inflammatory Agents may diminish the therapeutic effect of Prostaglandins (Ophthalmic). Nonsteroidal Anti-Inflammatory Agents may also enhance the therapeutic effects of Prostaglandins (Ophthalmic). Risk C: Monitor therapy

Quinolones: Nonsteroidal Anti-Inflammatory Agents may enhance the neuroexcitatory and/or seizure-potentiating effect of Quinolones. Nonsteroidal Anti-Inflammatory Agents may increase the serum concentration of Quinolones. Risk C: Monitor therapy

Rivaroxaban: Nonsteroidal Anti-Inflammatory Agents (Nonselective) may enhance the adverse/toxic effect of Rivaroxaban. Specifically, the risk of bleeding may be increased. Management: A comprehensive risk to benefit assessment should be done for all patients before any concurrent use of rivaroxaban and nonsteroidal anti-inflammatory drugs (NSAIDs). If combined, monitor patients extra closely for signs and symptoms of bleeding. Risk D: Consider therapy modification

Salicylates: Nonsteroidal Anti-Inflammatory Agents (Nonselective) may enhance the adverse/toxic effect of Salicylates. An increased risk of bleeding may be associated with use of this combination. Nonsteroidal Anti-Inflammatory Agents (Nonselective) may diminish the cardioprotective effect of Salicylates. Salicylates may decrease the serum concentration of Nonsteroidal Anti-Inflammatory Agents (Nonselective). Exceptions: Choline Magnesium Trisalicylate. Risk D: Consider therapy modification

Salicylates: Agents with Antiplatelet Properties may enhance the adverse/toxic effect of Salicylates. Increased risk of bleeding may result. Risk C: Monitor therapy

Selective Serotonin Reuptake Inhibitors: May enhance the antiplatelet effect of Nonsteroidal Anti-Inflammatory Agents (Nonselective). Nonsteroidal Anti-Inflammatory Agents (Nonselective) may diminish the therapeutic effect of Selective Serotonin Reuptake Inhibitors. Management: Consider using alternative analgesics, when appropriate, and/or addition of a gastroprotective agent. Monitor patients closely for signs/symptoms of bleeding, and for evidence of diminished SSRI effectiveness with concurrent use. Risk D: Consider therapy modification

Serotonin/Norepinephrine Reuptake Inhibitors: May enhance the antiplatelet effect of Nonsteroidal Anti-Inflammatory Agents (Nonselective). Risk C: Monitor therapy

Sodium Phosphates: May enhance the nephrotoxic effect of Nonsteroidal Anti-Inflammatory Agents. Specifically, the risk of acute phosphate nephropathy may be enhanced. Management: Consider avoiding this combination by temporarily suspending treatment with NSAIDs, or seeking alternatives to oral sodium phosphate bowel preparation. If the combination cannot be avoided, maintain adequate hydration and monitor renal function closely. Risk D: Consider therapy modification

Tacrolimus (Systemic): Nonsteroidal Anti-Inflammatory Agents may enhance the nephrotoxic effect of Tacrolimus (Systemic). Risk C: Monitor therapy

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

Tenofovir Products: Nonsteroidal Anti-Inflammatory Agents may enhance the nephrotoxic effect of Tenofovir Products. Management: Seek alternatives to these combinations whenever possible. Avoid use of tenofovir with multiple NSAIDs or any NSAID given at a high dose. Risk D: Consider therapy modification

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

Thiazide and Thiazide-Like Diuretics: May enhance the nephrotoxic effect of Nonsteroidal Anti-Inflammatory Agents. Nonsteroidal Anti-Inflammatory Agents may diminish the therapeutic effect of Thiazide and Thiazide-Like Diuretics. Risk C: Monitor therapy

Thrombolytic Agents: Agents with Antiplatelet Properties may enhance the anticoagulant effect of Thrombolytic Agents. Risk C: Monitor therapy

Tipranavir: May enhance the antiplatelet effect of Agents with Antiplatelet Properties. Risk C: Monitor therapy

Tolperisone: Nonsteroidal Anti-Inflammatory Agents may enhance the adverse/toxic effect of Tolperisone. Specifically, the risk of hypersensitivity reactions may be increased. Tolperisone may enhance the therapeutic effect of Nonsteroidal Anti-Inflammatory Agents. Risk C: Monitor therapy

Tricyclic Antidepressants (Tertiary Amine): May enhance the antiplatelet effect of Nonsteroidal Anti-Inflammatory Agents (Nonselective). Risk C: Monitor therapy

Urokinase: Agents with Antiplatelet Properties may enhance the anticoagulant effect of Urokinase. Risk X: Avoid combination

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

Verteporfin: Photosensitizing Agents may enhance the photosensitizing effect of Verteporfin. Risk C: Monitor therapy

Vitamin E (Systemic): May enhance the antiplatelet effect of Agents with Antiplatelet Properties. Risk C: Monitor therapy

Vitamin K Antagonists (eg, warfarin): Nonsteroidal Anti-Inflammatory Agents (Nonselective) may enhance the anticoagulant effect of Vitamin K Antagonists. Risk D: Consider therapy modification

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

Food Interactions

Naproxen absorption rate/levels may be decreased if taken with food. Management: Administer with food, milk, or antacids to decrease GI adverse effects.

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. May lead to false-positive aldosterone/renin ratio (ARR) (Funder 2016).

Genes of Interest
Monitoring Parameters

CBC (if hemoglobin ≤10 g at initiation, continue to monitor hemoglobin periodically during long-term therapy), chemistry profile (periodically during long-term therapy), liver function tests, renal function tests (urine output, serum BUN and creatinine), blood pressure (at initiation and during therapy), signs/symptoms of fluid retention, periodic ophthalmic exam (with any vision changes occurring during long-term therapy), signs of bleeding (occult or gross blood loss).

Advanced Practitioners Physical Assessment/Monitoring

Evaluate cardiac risk and potential for GI bleeding prior to prescribing this medication. Monitor blood pressure at the beginning of therapy and periodically during use. Monitor for GI effects, hepatotoxicity, and ototoxicity at beginning of therapy and periodically throughout. Schedule ophthalmic evaluations for patients who develop eye complaints during long-term NSAID therapy. Monitor renal function prior to and during therapy. Monitor coagulation studies. Monitor electrolytes. Discontinue therapy if the patient develops a skin reaction. Observe patient for signs of an allergic reaction. Discontinue medication if patient will be having heart surgery.

Nursing Physical Assessment/Monitoring

Monitor blood pressure at the beginning of therapy and periodically during use. Monitor for GI effects, hepatotoxicity, and ototoxicity at beginning of therapy and periodically throughout. Schedule ophthalmic evaluations for patients who develop eye complaints during long-term NSAID therapy. Monitor renal function prior to and during therapy. Monitor coagulation studies and report abnormal results. Monitor electrolytes. Monitor for and report skin rash during therapy. Observe patient for signs of an allergic reaction. Discontinue medication if patient will be having heart surgery.

Dosage Forms Considerations

EnovaRX-Naproxen and Equipto-Naproxen creams are compounded from a kit. Refer to manufacturer’s package insert for compounding instructions.

Naproxen Comfort Pac kit contains naproxen tablets and Duraflex Comfort Gel

Flanax Pain Relief kit contains naproxen tablets and Flanax Liniment

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product

Capsule, Oral, as sodium:

Aleve: 220 mg [contains brilliant blue fcf (fd&c blue #1)]

Generic: 220 mg

Kit, Combination:

Flanax Pain Relief: 500 mg [contains cetearyl alcohol, cremophor el, propylparaben]

Naproxen Comfort Pac: 500 mg [contains methylparaben, trolamine (triethanolamine)]

Suspension, Oral:

Naprosyn: 125 mg/5 mL (473 mL) [contains fd&c yellow #6 (sunset yellow), methylparaben, sorbitol; pineapple-orange flavor]

Generic: 125 mg/5 mL (473 mL, 500 mL)

Tablet, Oral:

Naprosyn: 500 mg [DSC] [scored]

Naproxen Kit: 500 mg [DSC] [scored]

Generic: 250 mg, 375 mg, 500 mg

Tablet, Oral, as sodium:

Aleve: 220 mg [contains fd&c blue #2 aluminum lake]

All Day Relief: 220 mg [DSC] [contains fd&c blue #2 aluminum lake]

All Day Relief: 220 mg [gluten free; contains fd&c blue #2 aluminum lake]

Anaprox DS: 550 mg [DSC] [scored]

Flanax Pain Relief: 220 mg [contains fd&c blue #2 (indigotine)]

GoodSense Naproxen Sodium: 220 mg [gluten free; contains fd&c blue #2 aluminum lake]

Mediproxen: 220 mg [contains fd&c blue #2 (indigotine)]

Generic: 220 mg, 275 mg, 550 mg

Tablet Delayed Release, Oral:

EC-Naprosyn: 375 mg, 500 mg [DSC]

EC-Naproxen: 375 mg, 500 mg

Naproxen DR: 375 mg, 500 mg

Tablet Extended Release 24 Hour, Oral, as sodium [strength expressed as base]:

Naprelan: 375 mg, 500 mg, 750 mg

Generic: 375 mg, 500 mg

Dosage Forms: Canada

Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product

Suppository, Rectal:

Generic: 500 mg (10ea, 30ea)

Suspension, Oral:

Generic: 125 mg/5 mL (474ml, 500ml)

Tablet, Oral:

Generic: 125 mg, 250 mg, 375 mg, 500 mg

Tablet, Oral, as sodium:

Anaprox: 275 mg [contains FD&C BLUE #2 ALUMINUM LAKE]

Anaprox DS: 550 mg [contains FD&C BLUE #2 ALUMINUM LAKE]

Generic: 275 mg, 550 mg

Tablet Delayed Release, Oral:

Naprosyn: 375 mg, 500 mg

Naxen EC: 250 mg, 375 mg, 500 mg

Generic: 250 mg, 375 mg, 500 mg

Tablet Extended Release 24 Hour, Oral:

Naprosyn: 750 mg [contains FD&C YELLOW #6 (SUNSET YELLOW)]

Generic: 750 mg

Tablet Extended Release 24 Hour, Oral, as sodium [strength expressed as base]:

Naprelan: 375 mg [DSC], 500 mg [DSC]

Anatomic Therapeutic Chemical (ATC) Classification
  • G02CC02
  • M01AE02
  • M02AA12
Generic Available (US)

May be product dependent

Pricing: US

Capsules (Aleve Oral)

220 mg (per each): $0.13

Capsules (Naproxen Sodium Oral)

220 mg (per each): $0.34

Kit (Naproxen Comfort Pac Combination)

500 mg (per each): $74.75

Suspension (Naprosyn Oral)

125 mg/5 mL (per mL): $2.66

Suspension (Naproxen Oral)

125 mg/5 mL (per mL): $1.96

Tablet, 24-hour (Naprelan Oral)

375 mg (per each): $26.14

500 mg (per each): $23.94

750 mg (per each): $27.71

Tablet, 24-hour (Naproxen Sodium ER Oral)

375 mg (per each): $21.52 – $21.55

500 mg (per each): $21.52 – $21.55

Tablet, EC (EC-Naprosyn Oral)

375 mg (per each): $2.75

Tablets (Aleve Oral)

220 mg (per each): $0.06

Tablets (Flanax Pain Relief Oral)

220 mg (per each): $0.14

Tablets (Mediproxen Oral)

220 mg (per each): $0.18

Tablets (Naproxen Oral)

250 mg (per each): $0.08 – $0.80

375 mg (per each): $0.11 – $1.10

500 mg (per each): $0.13 – $2.79

Tablets (Naproxen Sodium Oral)

220 mg (per each): $0.08 – $0.11

275 mg (per each): $2.29

550 mg (per each): $3.56 – $3.57

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer’s AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Mechanism of Action

Reversibly inhibits cyclooxygenase-1 and 2 (COX-1 and 2) enzymes, which results in decreased formation of prostaglandin precursors; has antipyretic, analgesic, and anti-inflammatory properties

Other proposed mechanisms not fully elucidated (and possibly contributing to the anti-inflammatory effect to varying degrees), include inhibiting chemotaxis, altering lymphocyte activity, inhibiting neutrophil aggregation/activation, and decreasing proinflammatory cytokine levels.

Pharmacodynamics/Kinetics

Onset of action: Analgesic: 30 to 60 minutes

Duration: Analgesic: <12 hours

Absorption: Oral: Almost 100%

Distribution: 0.16 L/kg

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

Metabolism: Extensively metabolized in the liver to 6-0-desmethyl naproxen; parent drug and desmethyl metabolite undergo further metabolism to their respective acylglucuronide conjugated metabolites

Bioavailability: 95%

Half-life elimination:

Children: Range: 8 to 17 hours

Children 8 to 14 years: 8 to 10 hours

Adults: Normal renal function: 12 to 17 hours; Moderate-to-severe renal impairment: ~15 to 21 hours (Anttila 1980)

Time to peak, serum:

Tablets, naproxen: 2 to 4 hours

Tablets, naproxen sodium: 1 to 2 hours

Tablets, delayed-release (empty stomach): 4 to 6 hours; range: 2 to 12 hours

Tablets, delayed-release (with food): 12 hours; range: 4 to 24 hours

Suspension: 1 to 4 hours

Suppository [Canadian product]: 2 to 3 hours

Excretion: Urine (95%; primarily as metabolites); feces (≤3%)

Pharmacodynamics/Kinetics: Additional Considerations

Renal function impairment: Metabolites and conjugates may accumulate.

Dental Use

Management of pain and swelling

Local Anesthetic/Vasoconstrictor Precautions

No information available to require special precautions

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. See Effects on Bleeding.

Effects on Bleeding

Nonselective NSAIDs, such as naproxen, inhibit platelet aggregation and prolong bleeding time in some patients. Unlike aspirin, the NSAID effect on platelet function is quantitatively less, of shorter duration, and reversible. Normal platelet function should occur in ~5 elimination half-lives or in <10 hours after discontinuation of naproxen. Concomitant use of other NSAIDs should be avoided.

Dental Usual Dosing

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

Pain/fever (OTC labeling): Children ≥12 years and Adults: 200 mg naproxen base every 8 to 12 hours; if needed, may take 400 mg naproxen base for the initial dose; maximum: 400 mg naproxen base in any 8- to 12-hour period or 600 mg naproxen base/24 hours

Index Terms

Naproxen Sodium

FDA Approval Date
March 11, 1976
References

Aleve (naproxen) [prescribing information]. Whippany, NJ: Bayer; September 2017.

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.[PubMed 3723650]

American Geriatrics Society 2015 Beers Criteria Update Expert Panel. American Geriatrics Society 2015 updated Beers Criteria for potentially inappropriate medication use in older adults. J Am Geriatr Soc. 2015;63(11):2227-2246. doi:10.1111/jgs.13702.[PubMed 26446832]

Amundsen S, Nordeng H, Nezvalová-Henriksen K, Stovner LJ, Spigset O. Pharmacological treatment of migraine during pregnancy and breastfeeding. Nat Rev Neurol. 2015;11(4):209-219.[PubMed 25776823]

Anderson PO, Sauberan JB. Modeling drug passage into human milk. Clin Pharmacol Ther. 2016;100(1):42-52.[PubMed 27060684]

Andersson PG, Hinge HH, Johansen O, et al, “Double-Blind Study of Naproxen vs Placebo in the Treatment of Acute Migraine Attacks,” Cephalgia, 1989, 9(1): 29-32.[PubMed 2650879]

Anttila M, Haataja M, and Kasanen A, “Pharmacokinetics of Naproxen in Subjects With Normal and Impaired Renal Function,” Eur J Clin Pharmacol, 1980, 18(3):263-8.[PubMed 7439246]

Apo-Napro-NA (naproxen sodium) [product monograph]. Toronto, Ontario, Canada: Apotex Inc; May 2014.

Becker MA. Treatment of gout flares. Post TW, ed. UpToDate. Waltham, MA: UpToDate Inc. http://www.uptodate.com. Accessed November 5, 2018.

Bell AD, Roussin A, Cartier R, et al, “The Use of Antiplatelet Therapy in the Outpatient Setting: Canadian Cardiovascular Society Guidelines,” Can J Cardiol, 2011, 27(Suppl A):1-59.[PubMed 21640290]

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.[PubMed 2216644]

Bermas BL. Non-steroidal anti inflammatory drugs, glucocorticoids and disease modifying anti-rheumatic drugs for the management of rheumatoid arthritis before and during pregnancy. Curr Opin Rheumatol. 2014;26(3):334-340. doi: 10.1097/BOR.0000000000000054.[PubMed 24663106]10.1097/BOR.0000000000000054

Bhatt DL, Scheiman J, Abraham NS, et al, “ACCF/ACG/AHA 2008 Expert Consensus Document on Reducing the Gastrointestinal Risk of Antiplatelet Therapy and NSAID Use. A Report of the American College of Cardiology Foundation Task Force on Clinical Expert Consensus Documents,” J Am Coll Cardiol, 2008, 52(18):1502-17.[PubMed 19017521]

Bloor M, Paech M. Nonsteroidal anti-inflammatory drugs during pregnancy and the initiation of lactation. Anesth Analg. 2013;116(5):1063-1075.[PubMed 23558845]

Brogden RN, Pinder RM, Sawyer PR, Speight TM, Avery GS. Naproxen: a review of its pharmacological properties and therapeutic efficacy and use. Drugs. 1975;9(5):326-363.[PubMed 1097233]

Brooks PM and Day RO, “Nonsteroidal Anti-inflammatory Drugs – Differences and Similarities,” N Engl J Med, 1991, 324(24):1716-25.[PubMed 2034249]

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.[PubMed 15837265]

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.[PubMed 11752357]

Chalasani NP, Hayashi PH, Bonkovsky HL, et al. ACG Clinical Guideline: the diagnosis and management of idiosyncratic drug-induced liver injury. Am J Gastroenterol. 2014;109(7):950-966.[PubMed 24935270]

Clinch D, Banerjee AK, and Ostick G, “Absence of Abdominal Pain in Elderly Patients With Peptic Ulcer,” Age Ageing, 1984, 13(2):120-3.[PubMed 6731166]

Clive DM and Stoff JS, “Renal Syndromes Associated With Nonsteroidal Anti-inflammatory Drugs,” N Engl J Med, 1984, 310(9):563-72.[PubMed 6363936]

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.[PubMed 10988282]

Dionne R, “Additive Analgesia Without Opioid Side Effects,” Compend Contin Educ Dent, 2000, 21(7):572-4, 576-7.[PubMed 11199661 ]

Dionne RA and Berthold CW, “Therapeutic Uses of Nonsteroidal Anti-inflammatory Drugs in Dentistry,” Crit Rev Oral Biol Med, 2001, 12(4):315-30.[PubMed 11603504 ]

EC-Naprosyn, Naprosyn, Anaprox/Anaprox DS, Naprosyn suspension (naproxen) [prescribing information]. Alpharetta, GA: Canton Laboratories; 2016.

EC-Naprosyn, Naprosyn, Anaprox DS (naproxen) tablets [prescribing information]. Alpharetta, GA: Canton Laboratories LLC: March 2017.

“Drugs for Pain,” Med Lett Drugs Ther, 2000, 42(1085):73-8.[PubMed 10951654]

Evers S, Afra J, Frese A, et al; European Federation of Neurological Societies. EFNS guideline on the drug treatment of migraine—revised report of an EFNS task force. Eur J Neurol. 2009;16(9):968-981.[PubMed 19708964]10.1111/j.1468-1331.2009.02748.x

Ferraris VA, Saha SP, Oestreich JH, et al, “2012 Update to the Society of Thoracic Surgeons Guideline on Use of Antiplatelet Drugs in Patients Having Cardiac and Noncardiac Operations,” Ann Thorac Surg, 2012, 94(5):1761-81.[PubMed 23098967]

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.[PubMed 3540871]

Frontera JA, Lewin JJ 3rd, Rabinstein AA, et al; Guideline for reversal of antithrombotics in intracranial hemorrhage: a statement for healthcare professionals from the Neurocritical Care Society and Society of Critical Care Medicine. Neurocrit Care. 2016;24(1):6-46.[PubMed 26714677]

Funder JW, Carey RM, Mantero F, et al. The management of primary aldosteronism: case detection, diagnosis, and treatment: an Endocrine Society Clinical Practice Guideline. J Clin Endocrinol Metab. 2016;101(5):1889-1916. doi: 10.1210/jc.2015-4061.[PubMed 26934393]

Graham DY, “Prevention of Gastroduodenal Injury Induced by Chronic Nonsteroidal Anti-inflammatory Drug Therapy,” Gastroenterology, 1989, 96(2 Pt 2 Suppl):675-81.[PubMed 2642452]

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.[PubMed 2366280]

Hawkey CJ, Karrasch JA, Szczepañski L, et al, “Omeprazole Compared With Misoprostol for Ulcers Associated With Nonsteroidal Anti-inflammatory Drugs,” N Engl J Med, 1998, 338(11):727-34.[PubMed 9494149]

Heerdink ER, Leufkens HG, Herings RM, et al, “NSAIDs Associated With Increased Risk of Congestive Heart Failure in Elderly Patients Taking Diuretics,” Arch Intern Med, 1998, 158(10):1108-12.[PubMed 9605782]

Hochberg MC, Altman RD, April KT, et al, “American College of Rheumatology 2012 Recommendations for the Use of Nonpharmacologic and Pharmacologic Therapies in Osteoarthritis of the Hand, Hip, and Knee,” Arthritis Care Res (Hoboken), 2012, 64(4):465-74.[PubMed 22563589]

Hoppmann RA, Peden JG, and Ober SK, “Central Nervous System Side Effects of Nonsteroidal Anti-inflammatory Drugs. Aseptic Meningitis, Psychosis, and Cognitive Dysfunction,” Arch Intern Med, 1991, 151(7):1309-13.[PubMed 2064481]

Ito S, Blajchman A, Stephenson M, Eliopoulos C, Koren G. Prospective follow-up of adverse reactions in breast-fed infants exposed to maternal medication. Am J Obstet Gynecol. 1993;168(5):1393-1399.[PubMed 8498418]

Ito S. Drug therapy for breast-feeding women. N Engl J Med. 2000;343(2):118-126.[PubMed 10891521]

Jacobi J, Fraser GL, Coursin DB, et al, “Clinical Practice Guidelines for the Sustained Use of Sedatives and Analgesics in the Critically Ill Adult,” Crit Care Med, 2002, 30(1):119-41. Available at http://www.sccm.org/pdf/sedatives.pdf[PubMed 11902253]

Jamali F, Stevens DR. Naproxen excretion in milk and its uptake by the infant. Drug Intell Clin Pharm. 1983;17(12):910-911.[PubMed 6653409]

Jamali F, Tam YK, Stevens RD. Naproxen excretion in breast milk and its uptake by suckling infant. Drug Intell Clin Pharm. 1982;16(6):475.

Janssens HJ, Janssen M, van de Lisdonk EH, van Riel PL, van Weel C. Use of oral prednisolone or naproxen for the treatment of gout arthritis: a double-blind, randomised equivalence trial. Lancet. 2008;371(9627):1854-1860. doi: 10.1016/S0140-6736(08)60799-0.[PubMed 18514729]

Khanna D, Khanna PP, Fitzgerald JD, et al; American College of Rheumatology. 2012 American College of Rheumatology guidelines for management of gout. Part 2: therapy and antiinflammatory prophylaxis of acute gouty arthritis. Arthritis Care Res (Hoboken). 2012;64(10):1447-1461. doi: 10.1002/acr.21773.[PubMed 23024029]

Kidney Disease: Improving Global Outcomes (KDIGO) CKD Work Group. KDIGO 2012 Clinical Practice Guidelines for the Evaluation and Management of Chronic Kidney Disease. Kidney Inter. 2013;3(suppl):1-150.

Knodel LC, “Preventing NSAID-Induced Ulcers: The Role of Misoprostol,” Consult Pharm, 1989, 4:37-41.

Lang BA and Finlayson LA, “Naproxen-Induced Pseudoporphyria in Patients With Juvenile Rheumatoid Arthritis,” J Pediatr, 1994, 124(4):639-42.[PubMed 8151484]

Martinez R, Smith DW, and Frankel LR, “Severe Metabolic Acidosis After Acute Naproxen Sodium Ingestion,” Ann Emerg Med, 1989, 18(10):1102-4.[PubMed 2552870]

Montgomery A, Hale TW, Academy Of Breastfeeding Medicine. ABM clinical protocol #15: analgesia and anesthesia for the breastfeeding mother, revised 2012. Breastfeed Med. 2012;7(6):547-553.[PubMed 23215911]

Morgan TO, Anderson A, and Bertram D, “Effect of Indomethacin on Blood Pressure in Elderly People With Essential Hypertension Well Controlled on Amlodipine or Enalapril,” Am J Hypertens, 2000, 13(11):1161-7.[PubMed 11078175]

Nader DA and Schillaci RF, “Pulmonary Infiltrates With Eosinophilia Due to Naproxen,” Chest, 1983, 83(2):280-2.[PubMed 6822116]

Naprelan (naproxen) [prescribing information]. Pine Brook, BJ: Almatica Pharma Inc; September 2017.

Naprosyn (naproxen) [product monograph]: Mississauga, Ontario, Canada: Hoffmann-La Roche Limited; June 2014.

Naprosyn (naproxen) oral suspension [prescribing information]. Athenes, GA: Athena Bioscience LLC; October 2017.

Naproxen Oral Suspension [prescribing information]. Columbus, OH: Roxane; November 2015.

Naproxen tablets [prescribing information]. Pulaski, TN: AvKARE Inc; February 2018.

Nestvold K, Kloster R, Partinen M, et al, “Treatment of Acute Migraine Attack: Naproxen and Placebo Compared,” Cephalgia, 1985, 5(2): 115-9.[PubMed 3893730]

Nguyen AM, Graham DY, Gage T, et al, “Nonsteroidal Anti-inflammatory Drug Use in Dentistry: Gastrointestinal Implications,” Gen Dent, 1999, 47(6):590-6.[PubMed 10687453 ]

Page J and Henry D, “Consumption of NSAIDs and the Development of Congestive Heart Failure in Elderly Patients: An Underrecognized Public Health Problem,” Arch Intern Med, 2000, 160(6):777-84.[PubMed 10737277]

pms-Naproxen (naproxen) [prescribing information]. Montreal, Quebec, Canada: Pharmascience Inc; June 2010.

Pope JE, Anderson JJ, and Felson DT, “A Meta-analysis of the Effects of Nonsteroidal Anti-inflammatory Drugs on Blood Pressure,” Arch Intern Med, 1993, 153(4):477-84.[PubMed 8435027]

Pounder R, “Silent Peptic Ulceration: Deadly Silence or Golden Silence?” Gastroenterology, 1989, 96(2 Pt 2 Suppl):626-31.[PubMed 2642448]

Saavedra Salinas MÁ, Barrera Cruz A, Cabral Castañeda AR, et al. Clinical practice guidelines for the management of pregnancy in women with autoimmune rheumatic diseases of the Mexican College of Rheumatology. Part II. Reumatol Clin. 2015;11(5):305-315. doi: 10.1016/j.reuma.2014.12.004.[PubMed 25683368]10.1016/j.reuma.2014.12.004

Sammaritano LR, Bermas BL. Rheumatoid arthritis medications and lactation. Curr Opin Rheumatol. 2014;26(3):354-360.[PubMed 24614280]

Shaunak S, Brown P, and Morgan-Hughes JA, “Exacerbation of Idiopathic Parkinson’s Disease by Naproxen,” BMJ, 1995, 311(7002):422.[PubMed 7640588]

Silberstein SD. Practice parameter: evidence-based guidelines for migraine headache (an evidence-based review): report of the Quality Standards Subcommittee of the American Academy of Neurology [published correction appears in Neurology. 2000;56(1):142]. Neurology. 2000;55(6):754-762.[PubMed 10993991]

Sivera F, Andrés M, Carmona L, et al. Multinational Evidence-Based Recommendations for the Diagnosis and Management of Gout: Integrating Systematic Literature Review and Expert Opinion of a Broad Panel of Rheumatologists in the 3e Initiative. Ann Rheum Dis. 2014;73(2):328-335.[PubMed 23868909]

Snow V, Weiss K, Wall EM, et al, “Pharmacologic Management of Acute Attacks of Migraine and Prevention of Migraine Headache,” Ann Intern Med, 2002, 137(10):840-9.[PubMed 12435222]

Steinhubl SR, “The Use of Anti-Inflammatory Analgesics in the Patient With Cardiovascular Disease: What a Pain,” J Am Coll Cardiol, 2005, 45(8):1302-3.[PubMed 15837266]

Verbeeck RK, “Pharmacokinetic Drug Interactions With Nonsteroidal Anti-inflammatory Drugs,” Clin Pharmacokinet, 1990, 19(1):44-66.[PubMed 2199127]

Wallace CA, Farrow D, and Sherry DD, “Increased Risk of Facial Scars in Children Taking Nonsteroidal Anti-inflammatory Drugs,” J Pediatr, 1994, 125(5 Pt 1):819-22.[PubMed 7965441]

Wells TG, Mortensen ME, Dietrich A, et al, “Comparison of the Pharmacokinetics of Naproxen Tablets and Suspension in Children,” J Clin Pharmacol, 1994, 34(1):30-3.[PubMed 8132849]

Yancy CW, Jessup M, Bozkurt B, et al; American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. 2013 ACCF/AHA guideline for the management of heart failure: a report of the American College of Cardiology Foundation/American Heart Association Task Force on practice guidelines. Circulation. 2013;128(16):e240-e327.[PubMed 23741058]

Yeomans ND, Tulassay Z, Juhasz L, et al, “A Comparison of Omeprazole With Ranitidine for Ulcers Associated With Nonsteroidal Anti-inflammatory Drugs,” N Engl J Med, 1998, 338(11):719-26.[PubMed 9494148]

Zhang W, Doherty M, Bardin T, et al. EULAR Evidence Based Recommendations for Gout. Part II: Management. Report of a Task Force of the EULAR Standing Committee for International Clinical Studies Including Therapeutics (ESCISIT). Ann Rheum Dis. 2006;65(10):1312-1324.[PubMed 16707532]

Brand Names: International

Acusprain (ZA); Aflamax (PE); Aleve (AT, BH, EE, HU, LU, NL, PL, PY, SG, UY); Anaflex (BD); Anexopen (GR); Antalgin (ES); Apranax (CR, DO, FR, GT, HN, HU, LU, NI, PA, RU, SV, VE, VN); Aprelax (PH); Apronax (EC); Artagen (IN); Artroxen (IT); Bei Li (CN); Bonyl (DK); Bumaflex N (PY); Cefecon N (UA); Clerinax (PY); Crysanal (AU); Daprox (DK); Dysmenalgit (DE); Emox (LV); Flanax (BR, EC); Floginax (IT); Gibixen (IT); Inza (AU, HK); Iraxen (PE); Laser (IT); Leniartil (IT); Licorax (KR); Lundiran (ES); Mobilon (EG); Momen (ES); Momendol (IE, MT); Myoprox (EG); Nafasol (ZA); Naflax (PH); Naldorex (RO); Nalgedol (LV); Nalgesin (BG, HR, LV, UA); Naposin (TW); Napoxen (PH); Napren E (NO); Naprex (PK); Naprium (AE, BF, BJ, CI, CY, ET, GH, GM, GN, IQ, IR, JO, KE, LR, LY, MA, ML, MR, MU, MW, NE, NG, OM, SA, SC, SD, SL, SN, SY, TN, TZ, UG, YE, ZM); Naprius (IT); Napro (LK); Napro A (BD); Naprodil (MX); Naprofazt Clearcap (TH); Naproff (UA); Naproflex (TH); Naprontag (AR); Naproplat (ZW); Naprorex (AE, CY, IQ, IR, JO, LY, MT, OM, SA, SY, TR, YE); Naproscript (ET, ZW); Naprosyn (AE, AU, BB, BF, BJ, BM, BS, BZ, CI, CY, CZ, DK, EC, EG, ES, ET, FI, GB, GH, GM, GN, GR, GY, HU, IE, IN, IQ, IR, IT, JM, JO, KE, LR, LY, MA, ML, MR, MT, MU, MW, NE, NG, OM, PE, PT, PY, QA, RU, SA, SC, SD, SE, SL, SN, SR, SY, TN, TT, TZ, UG, YE, ZM); Naprosyn LE (TH); Naprosyn LLE (PH); Naprosyn LLE Forte (PH); Naprosyn SR (AU); Naprosyne (BE, FR, LU); Naprox (LK, QA); Naproxavi (NL); Naprux (AR); Naxen (LK, MX, NZ); Naxen F (KR); Naxen-F CR (KR); Naxopren (FI); Naxyn 250 (IL); Naxyn 500 (IL); Noflam (NZ); Noken (JO); Nopain (KW, LB, QA); Nopen (PH); Norswel (BF, BJ, CI, ET, GH, GM, GN, KE, LR, MA, ML, MR, MU, MW, NE, NG, SC, SD, SL, SN, TN, TZ, UG, ZM); Novaxen (MX); Nycopren (AT, DK, FI); Pairox (BD); Penles (PH); Prexan (IT); Priaxen (BF, BJ, BM, BS, BZ, CI, ET, GH, GM, GN, GY, JM, KE, LR, MA, ML, MR, MU, MW, NE, NG, SC, SD, SL, SN, SR, TN, TR, TT, TZ, UG, ZM); Primeral (IT); Prodexin (AE, CY, IQ, IR, JO, LY, OM, SA, SY, YE); Progend (BD); Proken (AE, JO, LB, QA, SA); Pronaxen (SE); Proxen (AE, AT, BH, CH, CY, IQ, IR, JO, LY, OM, QA, SA, SY, TW, VN, YE); Proxidol D.S. (QA); Reuxen (RO); Safrosyn S (MY); Seladin (MY, SG); Sindolan (EC); Snofin (HK); Soden (SG); Sutolin (TW); Synflex (AU); Tormax (LK); U-Ritis (TW); Ultranax (BD); Veradol (AR); Xenar (IT); Xenifar (ID, IE); Xynap (LK)

Naproxen (Patient Education – Adult Medication)
You must carefully read the “Consumer Information Use and Disclaimer” below in order to understand and correctly use this information
Pronunciation

(na PROKS en)

Brand Names: US

Aleve [OTC]; All Day Relief [OTC]; Anaprox DS [DSC]; EC-Naprosyn; EC-Naproxen; Flanax Pain Relief; Flanax Pain Relief [OTC]; GoodSense Naproxen Sodium [OTC]; Mediproxen [OTC]; Naprelan; Naprosyn; Naproxen Comfort Pac; Naproxen DR; Naproxen Kit [DSC]

Brand Names: Canada

Aleve; Anaprox; Anaprox DS; Maxidol; Naprosyn; Pediapharm Naproxen Suspension; PMS-Naproxen Suppository [DSC]

Warning
  • This drug may raise the chance of heart and blood vessel side effects like heart attack and stroke. If these happen, they can be deadly. The risk of these side effects may be greater if you have heart disease or risks for heart disease. However, the risk may also be raised in people who do not have heart disease or risks for heart disease. The risk of these health problems can happen as soon as the first weeks of using this drug and may be greater with higher doses or with long-term use. Do not use this drug right before or after bypass heart surgery.
  • This drug may raise the chance of very bad and sometimes deadly stomach or bowel side effects like ulcers or bleeding. The risk is greater in older people. The risk is also greater in people who have had stomach or bowel ulcers or bleeding before. These problems may occur without warning signs. Talk with the doctor.
What is this drug used for?
  • It is used to ease pain, swelling, and fever.
  • It is used to ease painful period (menstrual) cycles.
  • It is used to treat arthritis.
  • It is used to treat ankylosing spondylitis.
  • It is used to treat gout attacks.
  • It may be given to you for other reasons. Talk with the doctor.
What do I need to tell my doctor BEFORE I take this drug?
  • If you have an allergy to naproxen or any other part of this drug.
  • If you have an allergy to aspirin or NSAIDs.
  • If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
  • If you have any of these health problems: GI (gastrointestinal) bleeding or kidney problems.
  • If you are having trouble getting pregnant or you are having your fertility checked.
  • If you are pregnant or may be pregnant. Do not take this drug if you are in the third trimester of pregnancy. You may also need to avoid this drug at other times during pregnancy. Talk with your doctor to see when you need to avoid taking this drug during pregnancy.
  • If you are taking any of these drugs: Antacids, cholestyramine, cimetidine, famotidine, nizatidine, ranitidine, or sucralfate.
  • If you are taking any other NSAID.
  • If you are taking a salicylate drug like aspirin.
  • If you are taking pemetrexed.
  • This is not a list of all drugs or health problems that interact with this drug.
  • Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this drug with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.
What are some things I need to know or do while I take this drug?
  • Tell all of your health care providers that you take this drug. This includes your doctors, nurses, pharmacists, and dentists.
  • Have your blood work checked if you are on this drug for a long time. Talk with your doctor.
  • This drug may affect certain lab tests. Tell all of your health care providers and lab workers that you take this drug.
  • High blood pressure has happened with drugs like this one. Have your blood pressure checked as you have been told by your doctor.
  • Talk with your doctor before you drink alcohol.
  • If you smoke, talk with your doctor.
  • Do not take more than what your doctor told you to take. Taking more than you are told may raise your chance of very bad side effects.
  • Do not take this drug for longer than you were told by your doctor.
  • If you have asthma, talk with your doctor. You may be more sensitive to this drug.
  • You may bleed more easily. Be careful and avoid injury. Use a soft toothbrush and an electric razor.
  • The chance of heart failure is raised with the use of drugs like this one. In people who already have heart failure, the chance of heart attack, having to go to the hospital for heart failure, and death is raised. Talk with the doctor.
  • The chance of heart attack and heart-related death is raised in people taking drugs like this one after a recent heart attack. People taking drugs like this one after a first heart attack were also more likely to die in the year after the heart attack compared with people not taking drugs like this one. Talk with the doctor.
  • If you are taking aspirin to help prevent a heart attack, talk with your doctor.
  • If you are on a low-sodium or sodium-free diet, talk with your doctor. Some of these products have sodium.
  • Do not switch brands or types of this drug (like tablets, liquid) unless you talk with the doctor. They may not work the same.
  • This drug may affect how much of some other drugs are in your body. If you are taking other drugs, talk with your doctor. You may need to have your blood work checked more closely while taking this drug with your other drugs.
  • Liver problems have happened with drugs like this one. Sometimes, this has been deadly. Call your doctor right away if you have signs of liver problems like dark urine, feeling tired, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes.
  • If you are 60 or older, use this drug with care. You could have more side effects.
  • NSAIDs like this drug may affect egg release (ovulation) in women. This may cause you to not be able to get pregnant. This goes back to normal when this drug is stopped. Talk with your doctor.
  • This drug may cause harm to the unborn baby if you take it while you are pregnant. If you are pregnant or you get pregnant while taking this drug, call your doctor right away.
  • Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.
What are some side effects that I need to call my doctor about right away?
  • WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:
  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • Signs of bleeding like throwing up blood or throw up that looks like coffee grounds; coughing up blood; blood in the urine; black, red, or tarry stools; bleeding from the gums; vaginal bleeding that is not normal; bruises without a reason or that get bigger; or any bleeding that is very bad or that you cannot stop.
  • Signs of kidney problems like unable to pass urine, change in how much urine is passed, blood in the urine, or a big weight gain.
  • Signs of high potassium levels like a heartbeat that does not feel normal; feeling confused; feeling weak, lightheaded, or dizzy; feeling like passing out; numbness or tingling; or shortness of breath.
  • Signs of high blood pressure like very bad headache or dizziness, passing out, or change in eyesight.
  • Shortness of breath, a big weight gain, or swelling in the arms or legs.
  • Chest pain or pressure or a fast heartbeat.
  • Weakness on 1 side of the body, trouble speaking or thinking, change in balance, drooping on one side of the face, or blurred eyesight.
  • Feeling very tired or weak.
  • Ringing in ears.
  • Mood changes.
  • Low mood (depression).
  • Very bad belly pain.
  • Very bad back pain.
  • A very bad skin reaction (Stevens-Johnson syndrome/toxic epidermal necrolysis) may happen. It can cause very bad health problems that may not go away, and sometimes death. Get medical help right away if you have signs like red, swollen, blistered, or peeling skin (with or without fever); red or irritated eyes; or sores in your mouth, throat, nose, or eyes.
What are some other side effects of this drug?
  • All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:
  • Headache.
  • Belly pain or heartburn.
  • Upset stomach or throwing up.
  • Diarrhea.
  • Constipation.
  • Gas.
  • Dizziness.
  • Feeling sleepy.
  • These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.
  • You may report side effects to your national health agency.
How is this drug best taken?
  • Use this drug as ordered by your doctor. Read all information given to you. Follow all instructions closely.
  • All products:
  • Take with or without food. Take with food if it causes an upset stomach.
  • Take with a full glass of water.
  • Long-acting products:
  • Swallow whole. Do not chew, break, or crush.
  • Suspension:
  • Shake well before use.
  • Measure liquid doses carefully. Use the measuring device that comes with this drug. If there is none, ask the pharmacist for a device to measure this drug.
What do I do if I miss a dose?
  • If you take this drug on a regular basis, take a missed dose as soon as you think about it.
  • If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
  • Do not take 2 doses at the same time or extra doses.
  • Many times this drug is taken on an as needed basis. Do not take more often than told by the doctor.
How do I store and/or throw out this drug?
  • Store at room temperature.
  • Protect from light.
  • Store in a dry place. Do not store in a bathroom.
  • Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
  • Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.
General drug facts
  • If your symptoms or health problems do not get better or if they become worse, call your doctor.
  • Do not share your drugs with others and do not take anyone else’s drugs.
  • Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
  • Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
  • Some drugs may have another patient information leaflet. If you have any questions about this drug, please talk with your doctor, nurse, pharmacist, or other health care provider.
  • If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.
Naproxen (Patient Education – Pediatric Medication)
You must carefully read the “Consumer Information Use and Disclaimer” below in order to understand and correctly use this information
Pronunciation

(na PROKS en)

Brand Names: US

Aleve [OTC]; All Day Relief [OTC]; Anaprox DS [DSC]; EC-Naprosyn; EC-Naproxen; Flanax Pain Relief; Flanax Pain Relief [OTC]; GoodSense Naproxen Sodium [OTC]; Mediproxen [OTC]; Naprelan; Naprosyn; Naproxen Comfort Pac; Naproxen DR; Naproxen Kit [DSC]

Brand Names: Canada

Aleve; Anaprox; Anaprox DS; Maxidol; Naprosyn; Pediapharm Naproxen Suspension; PMS-Naproxen Suppository [DSC]

Warning
  • This drug may raise the chance of heart and blood vessel side effects like heart attack and stroke. If these happen, they can be deadly. The risk of these side effects may be greater if your child has heart disease or risks for heart disease. However, the risk may also be raised in people who do not have heart disease or risks for heart disease. The risk of these health problems can happen as soon as the first weeks of using this drug and may be greater with higher doses or with long-term use. Do not give this drug to your child right before or after bypass heart surgery.
  • This drug may raise the chance of very bad and sometimes deadly stomach or bowel side effects like ulcers or bleeding. The risk is greater in older people. The risk is also greater in people who have had stomach or bowel ulcers or bleeding before. These problems may occur without warning signs. Talk with the doctor.
What is this drug used for?
  • It is used to ease pain, swelling, and fever.
  • It is used to ease painful period (menstrual) cycles.
  • It is used to treat arthritis.
  • It is used to treat ankylosing spondylitis.
  • It is used to treat gout attacks.
  • It may be given to your child for other reasons. Talk with the doctor.
What do I need to tell the doctor BEFORE my child takes this drug?
  • If your child has an allergy to this drug or any part of this drug.
  • If your child has an allergy to aspirin or NSAIDs.
  • If your child is allergic to any drugs like this one or any other drugs, foods, or other substances. Tell the doctor about the allergy and what signs your child had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
  • If your child has kidney disease.
  • If your child has GI (gastrointestinal) bleeding.
  • If your child is having her fertility checked.
  • If your child is taking any of these drugs: Antacids, cholestyramine, cimetidine, famotidine, nizatidine, ranitidine, or sucralfate.
  • If your child is taking any other NSAID.
  • If your child is taking a salicylate drug like aspirin.
  • If your child is taking pemetrexed.
  • If your child is pregnant:
  • Do not give this drug to your child if she is in the third trimester of pregnancy. You may also need to avoid giving this drug to your child at other times during pregnancy. Talk with your child’s doctor to see when you need to avoid giving this drug to your child during pregnancy.
  • Tell the doctor and pharmacist about all of your child’s drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for your child to take this drug with all of his/her drugs and health problems. Do not start, stop, or change the dose of any drug your child takes without checking with the doctor.
  • This is not a list of all drugs or health problems that interact with this drug.
What are some things I need to know or do while my child takes this drug?
  • Tell all of your child’s health care providers that your child is taking this drug. This includes your child’s doctors, nurses, pharmacists, and dentists.
  • Have your child’s blood work checked if he/she is on this drug for a long time. Talk with your child’s doctor.
  • This drug may affect certain lab tests. Tell all of your child’s health care providers and lab workers that your child takes this drug.
  • High blood pressure has happened with drugs like this one. Have your child’s blood pressure checked as you have been told by the doctor.
  • Alcohol may interact with this drug. Be sure your child does not drink alcohol.
  • If your child smokes, talk with the doctor.
  • Do not give your child more of this drug than what the doctor told you to give. Giving more of this drug than you are told may raise the chance of very bad side effects.
  • Do not have your child use longer than you have been told by your child’s doctor.
  • If your child has asthma, talk with the doctor. He/she may be more sensitive to this drug.
  • Your child may bleed more easily. Make sure your child is careful and avoids injury. Be sure your child has a soft toothbrush.
  • If your child is taking aspirin to help prevent a heart attack, talk with the doctor.
  • If your child is on a low-salt or salt-free diet, talk with your child’s doctor.
  • Do not switch brands or types of this drug (like tablets, liquid) unless you talk with the doctor. They may not work the same.
  • The chance of heart failure is raised with the use of drugs like this one. In people who already have heart failure, the chance of heart attack, having to go to the hospital for heart failure, and death is raised. Talk with the doctor.
  • The chance of heart attack and heart-related death is raised in people taking drugs like this one after a recent heart attack. People taking drugs like this one after a first heart attack were also more likely to die in the year after the heart attack compared with people not taking drugs like this one. Talk with the doctor.
  • This drug may affect how much of some other drugs are in the body. If your child is taking other drugs, talk with the doctor. Your child may need to have blood work checked more closely while taking this drug with other drugs.
  • If your child is or may be sexually active:
  • NSAIDs like this drug may affect egg release (ovulation) in females. This may affect being able to get pregnant. This goes back to normal when this drug is stopped. Talk with the doctor.
  • If your child is pregnant or breast-feeding a baby:
  • This drug may cause harm to the unborn baby if your child takes it during pregnancy. If your child is pregnant or gets pregnant while taking this drug, call the doctor right away.
  • Tell the doctor if your child is breast-feeding a baby. You will need to talk about any risks to the baby.
What are some side effects that I need to call my child’s doctor about right away?
  • WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your child’s doctor or get medical help right away if your child has any of the following signs or symptoms that may be related to a very bad side effect:
  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • Signs of bleeding like throwing up blood or throw up that looks like coffee grounds; coughing up blood; blood in the urine; black, red, or tarry stools; bleeding from the gums; vaginal bleeding that is not normal; bruises without a reason or that get bigger; or any bleeding that is very bad or that you cannot stop.
  • Signs of kidney problems like unable to pass urine, change in how much urine is passed, blood in the urine, or a big weight gain.
  • Signs of high potassium levels like a heartbeat that does not feel normal; feeling confused; feeling weak, lightheaded, or dizzy; feeling like passing out; numbness or tingling; or shortness of breath.
  • Signs of high blood pressure like very bad headache or dizziness, passing out, or change in eyesight.
  • Shortness of breath, a big weight gain, or swelling in the arms or legs.
  • Chest pain or pressure or a fast heartbeat.
  • Weakness on 1 side of the body, trouble speaking or thinking, change in balance, drooping on one side of the face, or blurred eyesight.
  • Feeling very tired or weak.
  • Ringing in ears.
  • Mood changes.
  • Low mood (depression).
  • Very bad belly pain.
  • Very bad back pain.
  • Liver problems have happened with drugs like this one. Sometimes, this has been deadly. Call the doctor right away if your child has signs of liver problems like dark urine, feeling tired, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes.
  • A very bad skin reaction (Stevens-Johnson syndrome/toxic epidermal necrolysis) may happen. It can cause very bad health problems that may not go away, and sometimes death. Get medical help right away if your child has signs like red, swollen, blistered, or peeling skin (with or without fever); red or irritated eyes; or sores in the mouth, throat, nose, or eyes.
What are some other side effects of this drug?
  • All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your child’s doctor or get medical help if any of these side effects or any other side effects bother your child or do not go away:
  • Headache.
  • Belly pain or heartburn.
  • Upset stomach or throwing up.
  • Diarrhea.
  • Constipation.
  • Gas.
  • Dizziness.
  • Feeling sleepy.
  • These are not all of the side effects that may occur. If you have questions about side effects, call your child’s doctor. Call your child’s doctor for medical advice about side effects.
  • You may report side effects to your national health agency.
How is this drug best given?
  • Give this drug as ordered by your child’s doctor. Read all information given to you. Follow all instructions closely.
  • All products:
  • Give this drug with or without food. Give with food if it causes an upset stomach.
  • Give this drug with a full glass of water.
  • Long-acting products:
  • Have your child swallow long-acting products whole. Do not let your child chew, break, or crush.
  • Suspension:
  • Shake well before use.
  • Measure liquid doses carefully. Use the measuring device that comes with this drug. If there is none, ask the pharmacist for a device to measure this drug.
What do I do if my child misses a dose?
  • If your child takes this drug on a regular basis, give a missed dose as soon as you think about it.
  • If it is close to the time for your child’s next dose, skip the missed dose and go back to your child’s normal time.
  • Do not give 2 doses at the same time or extra doses.
  • Many times this drug is given on an as needed basis. Do not give to your child more often than told by the doctor.
How do I store and/or throw out this drug?
  • Store at room temperature.
  • Protect from light.
  • Store in a dry place. Do not store in a bathroom.
  • Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
  • Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.
General drug facts
  • If your child’s symptoms or health problems do not get better or if they become worse, call your child’s doctor.
  • Do not share your child’s drug with others and do not give anyone else’s drug to your child.
  • Keep a list of all your child’s drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your child’s doctor.
  • Talk with your child’s doctor before giving your child any new drug, including prescription or OTC, natural products, or vitamins.
  • Some drugs may have another patient information leaflet. If you have any questions about this drug, please talk with your child’s doctor, nurse, pharmacist, or other health care provider.
  • If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.