- Tablets, delayed-release 375 mg
- Tablets, delayed-release 500 mg
- Tablets 250 mg
- Tablets 375 mg
- Tablets 500 mg
- Suspension 125 mg/5 mL
Apo-Naproxen EC (Canada)
Apo-Naproxen SR (Canada)
Gen-Naproxen EC (Canada)
Novo-Naprox EC (Canada)
- Capsules, liquid-filled 200 mg (220 mg naproxen sodium)
- Tablets 200 mg (220 mg naproxen sodium)
- Tablets 250 mg (275 mg naproxen sodium)
- Tablets 500 mg (550 mg naproxen sodium)
- Tablets, controlled-release 375 mg (412.5 mg naproxen sodium)
- Tablets, controlled-release 500 mg (550 mg naproxen sodium)
- Tablets, controlled-release 750 mg (825 mg naproxen sodium)
Apo-Napro-Na DS (Canada)
Novo-Naprox Sodium (Canada)
Novo-Naprox SR (Canada)
Novo-Naprox Sodium DS (Canada)
Decreases inflammation, pain, and fever, probably through inhibition of cyclooxygenase activity and prostaglandin synthesis.
Naproxen is completely absorbed from the GI tract. Tablet T max is 2 to 4 h (immediate-release); suspension T max is 1 to 4 h; fasted patients' T max is 4 to 6 h (delayed-release); bioavailability is 95%; steady state is reached in 4 to 5 days.
Vd is 0.16 L/kg and protein binding is 99% albumin-bound.
Naproxen is eliminated in urine (95%), primarily as naproxen less than 1%, 6-0-desmethylnaproxen less than 1%, or their conjugates (66% to 92%). Naproxen t ½ is 12 to 17 h; Cl is 0.13 mL/min/kg; t ½ of metabolites and conjugates is less than 12 h.
Special PopulationsRenal Function Impairment
Metabolites and conjugates may accumulate.
Indications and UsageRx
Management of mild to moderate pain, symptoms of rheumatoid or osteoarthritis, bursitis, tendonitis, ankylosing spondylitis, primary dysmenorrhea, acute gout. Naproxen (not naproxen sodium) also indicated for treatment of juvenile rheumatoid arthritis. Delayed-release naproxen is not recommended for initial treatment of acute pain because absorption is delayed compared to other naproxen formulations.OTC
Temporary relief of minor aches and pains associated with the common cold, headache, toothache, muscular aches, backache, minor arthritis pain, pain of menstrual cramps, and reduction of fever.
Sunburn, migraine, PMS.
Allergy to aspirin, iodides or any NSAID; patients in whom aspirin or other NSAIDs induce symptoms of asthma, rhinitis or nasal polyps.
Dosage and AdministrationNaproxen
Rheumatoid Arthritis, Osteoarthritis, Ankylosing Spondylitis Adults
PO 250 to 500 mg twice daily; max dose of 1.5 g/day should be used short term only.Delayed-release
PO 375 to 500 mg twice daily.Controlled release
PO 750 to 1,000 mg every daily. Individualize dosage. Do not exceed 1,500 mg/day.Suspension
PO 250 mg (10 mL), 375 mg (15 mL), or 500 mg (20 mL) twice daily.Pain, Dysmenorrhea, Bursitis, Tendinitis Adults
PO 500 mg initially, then 250 mg every 6 to 8 h. Do not exceed 1,250 mg/day.Juvenile Rheumatoid Arthritis Children
PO 10 mg/kg/day in 2 divided doses. For children requiring suspension, 2.5 mL twice daily can be given for weights of at least 13 kg; 5 mL twice daily for weights of at least 25 kg, or 7.5 mL twice daily for weights of at least 38 kg.Acute Gout Adults
PO 750 mg, followed by 250 mg every 8 h until the attack subsides.Naproxen Sodium
Rheumatoid Arthritis, Osteoarthritis, Ankylosing Spondylitis Adults
PO 275 to 550 mg twice daily. May increase to 1.65 g for limited periods.Controlled-release
PO 750 to 1,000 mg once daily. Adjust dose depending on clinical response. may increase to 1,500 mg once daily for a limited period.Acute Gout Adults
PO 825 mg initially, then 275 mg every 8 h prn.Controlled-release
PO 1,000 to 1,500 mg once daily on the first day, then 1,000 mg once daily until attack has subsided.Pain, Dysmenorrhea, Tendinitis, Bursitis Adults
PO 500 mg initially, then 275 mg every 6 to 8 h prn. Do not exceed 1,375 mg/day.Controlled release
PO 1,000 mg once daily initially. May increase to 1,500 mg once daily for a limited period. Thereafter, the total daily dose should not exceed 1,000 mg.
Store at 59° to 86°F.
May increase effect of anticoagulants because of decreased plasma protein binding. May increase risk of gastric erosion and bleeding.Lithium
May decrease lithium Cl.Methotrexate
May increase methotrexate levels.
Laboratory Test Interactions
May falsely increase urinary 17-ketosteroid values; may interfere with urinary assays for 5-hydroxy-indoleacetic acid.
Edema; weight gain; CHF; alterations in BP; vasodilation; palpitations; tachycardia; chest pain; bradycardia.
Headache; dizziness; drowsiness; vertigo; lightheadedness; mental depression; nervousness; irritability; fatigue; malaise; insomnia; sleep disorders; dream abnormalities; aseptic meningitis.
Rash; urticaria; purpura; skin eruptions.
Visual changes; tinnitus; rhinitis; pharyngitis, stomatitis.
Constipation; heartburn; abdominal pain; peptic ulceration and bleeding; nausea; dyspepsia; diarrhea; vomiting; anorexia; colitis; flatulence.
Glomerulonephritis; interstitial nephritis; nephrotic syndrome; acute renal insufficiency and renal failure; dysuria; hyperkalemia; hyponatremia; renal papillary necrosis.
Increased LFT results.
Increased bleeding time; leukopenia; thrombocytopenia; granulocytopenia; eosinophilia; ecchymosis.
Bronchospasm; laryngeal edema; dyspnea; shortness of breath.
NSAIDs may cause an increased risk of serious CV thrombotic events, MI, and stroke, which can be fatal. This risk may increase with length of therapy. Patients with CV disease or risk factors for CV disease may be at greater risk. NSAIDs cause an increased risk of serious GI adverse reactions, including bleeding, inflammation, perforation of the stomach or intestines, and ulceration, which can be fatal. These events can occur any time during use and without warning symptoms. Elderly patients are at greater risk of serious GI events.
Category B .
Excreted in breast milk.
Safety and efficacy in children younger than 2 yr of age not established (Rx); do not give to children younger than 12 yr of age except under the advice and supervision of a health care provider (OTC).
Increased risk of adverse reactions.
Assess function before and during therapy in patients with renal function impairment because NSAID metabolites are eliminated renally.
May need to reduce dose in patients with hepatic failure.
Drug may worsen CHF and may decrease hypertension control.
Do not use naproxen sodium and naproxen concomitantly; both drugs circulate as naproxen anion.
Serious GI toxicity (eg, bleeding, ulceration, perforation) can occur at any time, with or without warning symptoms.
Drowsiness, nausea, heartburn, vomiting, indigestion, seizures.
- Tell patient to take with milk, meals or antacids; follow with ½ to 1 glass of water to reduce GI upset.
- Advise patient to shake oral suspension before measuring.
- Explain that it may take 2 to 4 wk with naproxen and 1 to 2 days with naproxen sodium for anti-inflammatory effects to occur. Peak analgesic effect may occur in 1 to 2 h.
- Caution patient that use with aspirin, alcohol, steroids, and other GI irritants may cause increased GI upset.
- Instruct patient to report the following symptoms to health care provider: visual problems, abdominal pain, symptoms of gastric bleeding.
- Caution patient to avoid intake of alcoholic beverages and smoking.
- Advise patient to use caution while driving or performing other activities that require coordinated motor movements and mental alertness.
Copyright © 2009 Wolters Kluwer Health.
More about naproxen
- Naproxen (AHFS Monograph)
- Naproxen Sodium (AHFS Monograph)
- Naproxen (FDA)
- Naproxen Capsules (FDA)
- Naproxen Delayed Release (FDA)