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Naproxen

Pronunciation

Pronunciation: nay-PROX-ehn
Class: NSAID

Trade Names

EC Naprosyn
- Tablets, delayed-release 375 mg
- Tablets, delayed-release 500 mg

Naprosyn
- Tablets 250 mg
- Tablets 375 mg
- Tablets 500 mg
- Suspension 125 mg/5 mL

Apo-Naproxen (Canada)
Apo-Naproxen EC (Canada)
Apo-Naproxen SR (Canada)
Gen-Naproxen EC (Canada)
Novo-Naprox (Canada)
Novo-Naprox EC (Canada)
Nu-Naprox (Canada)
Naproxen Sodium

Aleve
- Capsules, liquid-filled 200 mg (220 mg naproxen sodium)
- Tablets 200 mg (220 mg naproxen sodium)

Anaprox
- Tablets 250 mg (275 mg naproxen sodium)

Anaprox DS
- Tablets 500 mg (550 mg naproxen sodium)

Naprelan
- 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 (Canada)
Apo-Napro-Na DS (Canada)
Novo-Naprox Sodium (Canada)
Novo-Naprox SR (Canada)
Novo-Naprox Sodium DS (Canada)

Pharmacology

Decreases inflammation, pain, and fever, probably through inhibition of cyclooxygenase activity and prostaglandin synthesis.

Slideshow: Is it Safe to Give Human Medicine to Pets?

Always get your pet's drug and dose recommendation from the veterinarian.

Pharmacokinetics

Absorption

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.

Distribution

Vd is 0.16 L/kg and protein binding is 99% albumin-bound.

Elimination

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 Populations

Renal Function Impairment

Metabolites and conjugates may accumulate.

Indications and Usage

Rx

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.

Unlabeled Uses

Sunburn, migraine, PMS.

Contraindications

Allergy to aspirin, iodides or any NSAID; patients in whom aspirin or other NSAIDs induce symptoms of asthma, rhinitis or nasal polyps.

Dosage and Administration

Naproxen
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.

Storage/Stability

Store at 59° to 86°F.

Drug Interactions

Anticoagulants

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.

Adverse Reactions

Cardiovascular

Edema; weight gain; CHF; alterations in BP; vasodilation; palpitations; tachycardia; chest pain; bradycardia.

CNS

Headache; dizziness; drowsiness; vertigo; lightheadedness; mental depression; nervousness; irritability; fatigue; malaise; insomnia; sleep disorders; dream abnormalities; aseptic meningitis.

Dermatologic

Rash; urticaria; purpura; skin eruptions.

EENT

Visual changes; tinnitus; rhinitis; pharyngitis, stomatitis.

GI

Constipation; heartburn; abdominal pain; peptic ulceration and bleeding; nausea; dyspepsia; diarrhea; vomiting; anorexia; colitis; flatulence.

Genitourinary

Glomerulonephritis; interstitial nephritis; nephrotic syndrome; acute renal insufficiency and renal failure; dysuria; hyperkalemia; hyponatremia; renal papillary necrosis.

Hepatic

Increased LFT results.

Hematologic

Increased bleeding time; leukopenia; thrombocytopenia; granulocytopenia; eosinophilia; ecchymosis.

Respiratory

Bronchospasm; laryngeal edema; dyspnea; shortness of breath.

Precautions

Warnings

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.


Pregnancy

Category B .

Lactation

Excreted in breast milk.

Children

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).

Elderly

Increased risk of adverse reactions.

Renal Function

Assess function before and during therapy in patients with renal function impairment because NSAID metabolites are eliminated renally.

Hepatic Function

May need to reduce dose in patients with hepatic failure.

CV disease

Drug may worsen CHF and may decrease hypertension control.

Concomitant therapy

Do not use naproxen sodium and naproxen concomitantly; both drugs circulate as naproxen anion.

GI effects

Serious GI toxicity (eg, bleeding, ulceration, perforation) can occur at any time, with or without warning symptoms.

Overdosage

Symptoms

Drowsiness, nausea, heartburn, vomiting, indigestion, seizures.

Patient Information

  • 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.

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