Pronunciation
na-PROX-en [Pronunciation]

Trade Name(s)

• Aleve

• Anaprox

• Anaprox DS

• Apo-Napro-Na [Canada]

• Apo-Naproxen [Canada]

• EC-Naprosyn

• Naprelan

• Naprosyn

• Naprosyn-E [Canada]

• Naprosyn-SR [Canada]

• Naxen [Canada]

• Novo-Naprox [Canada]

• Novo-Naprox Sodium DS [Canada]

• Nu-Naprox [Canada]

• Synflex [Canada]

• Synflex DS [Canada]

Pregnancy Category
Category B (first trimester)

Ther. class.
nonopioid analgesics
nonsteroidal anti inflammatory agents
antipyretics

• Mild to moderate pain.

• Dysmenorrhea.

• Fever.

• Inflammatory disorders, including:

» Rheumatoid arthritis (adults and children),

» Osteoarthritis.

Inhibits prostaglandin synthesis.

Therapeutic Effect(s):

• Decreased pain.

• Reduction of fever.

• Suppression of inflammation.

Absorption: Completely absorbed from the GI tract. Sodium salt is more rapidly absorbed.

Distribution: Crosses the placenta; enters breast milk in low concentrations.

Protein Binding: >99%.

Metabolism and Excretion: Mostly metabolized by the liver.

Half-life: Children <8 yr: 8–17 hr; Children 8–14 yr: 8–10 hr; Adults: 10–20 hr.

TIME/ACTION PROFILE

ROUTE	ONSET	PEAK	DURATION
PO (analgesic)	1 hr	unknown	8–12 hr
PO (anti-inflammatory)	14 days	2–4 wk	unknown

Contraindicated in:

• Hypersensitivity;

• Cross-sensitivity may occur with other NSAIDs, including aspirin;

• Active GI bleeding;

• Ulcer disease;

• Lactation: Passes into breast milk and should not be used by nursing mothers.

Use Cautiously in:

• Severe cardiovascular, renal, or hepatic disease;

• History of ulcer disease or any other history of gastrointestinal bleeding (may ↑ risk of GI bleeding);

• Underlying cardiovascular disease (may ↑ risk of MI or stroke);

• Chronic alcohol use/abuse;

• OB: Avoid using during third trimester; may cause premature closure of the ductus arteriosus;

• Pedi: Children <2 yr (safety not established) ;

• Geri: ↑ risk of adverse reactions.

CNS: dizziness, drowsiness, headache.

EENT: tinnitus, visual disturbances.

Resp: dyspnea.

CV: edema, palpitations, tachycardia.

GI: DRUG-INDUCED HEPATITIS, GI BLEEDING, constipation, dyspepsia, nausea, anorexia, diarrhea, discomfort, flatulence, vomiting.

GU: cystitis, hematuria, renal failure.

Derm: photosensitivity, rashes, sweating, pseudoporphyria (12% incidence in children with juvenile rheumatoid arthritis—discontinue therapy if this occurs).

Hemat: blood dyscrasias, prolonged bleeding time.

Misc: ALLERGIC REACTIONS INCLUDING ANAPHYLAXIS AND STEVENS-JOHNSON SYNDROME .

*CAPITALS indicates life-threatening.
*italic indicates most frequent.

Drug-Drug

• Concurrent use with aspirin ↓ levels and may ↓ effectiveness.

• ↑ risk of bleeding with anticoagulants , thrombolytic agents , eptifibatide , tirofiban , cefotetan , cefoperazone , valproic acid , corticosteroids , clopidogrel , and ticlopidine .

• Additive adverse GI side effects with aspirin , corticosteroids , alcohol , and other NSAIDs .

• Probenecid ↑ blood levels and may ↑ toxicity.

• May ↑ risk of toxicity from methotrexate , antineoplastics , or radiation therapy .

• May ↑ serum levels and risk of toxicity from lithium .

• ↑ risk of adverse renal effects with cyclosporine , ACE inhibitors , angiotensin II antagonists , or chronic use of acetaminophen .

• May ↓ response to antihypertensives or diuretics .

• May ↑ risk of hypoglycemia with insulin or oral hypoglycemic agents . Oral potassium supplements may ↑ GI adverse effects.

Drug-Natural Products
↑ anticoagulant effect and bleeding risk with anise , arnica , chamomile , clove , dong quai , feverfew , garlic , ginger , ginkgo , Panax ginseng , licorice , and others.

• 275 mg naproxen sodium is equivalent to 250 mg naproxen

Anti-Inflammatory/Analgesic/Antidysmenorrheal

• PO (Adults): Naproxen—250–500 mg twice daily (up to 1.5 g/day). Delayed-release naproxen—375–500 mg twice daily. Naproxen sodium—275–550 mg twice daily (up to 1.65 g/day)..

• PO (Children >2 yr): Analgesia: 5–7 mg/kg/dose q 8–12 hr. Inflammatory disease: 10–15 mg/kg/day divided q 12 hr, maximum: 1000 mg/day..

Antigout

• PO (Adults): Naproxen—750 mg naproxen initially, then 250 mg q 8 hr. Naproxen sodium—825 mg initially, then 275 mg q 8 hr..

OTC Use (naproxen sodium)

• PO (Adults): 200 mg q 8–12 hr or 400 mg followed by 200 mg q 12 hr (not to exceed 600 mg/24 hr)..

• PO (Geriatric Patients >65 yr): Not to exceed 200 mg q 12 hr..

Naproxen

• Tablets (Naprosyn, Apo-Naproxen, Naxen, Novo-Naprox, Nu-Naprox): 125 mg[canada], 250 mg, 375 mg, 500 mg

• Controlled-release tablets (Naprelan): 375 mg, 500 mg

• Delayed-release tablets (EC-Naprosyn, Naprosyn-E): 250 mg[canada], 375 mg, 500 mg

• Extended-release tablets (Naprosyn-SR): 750 mg[canada]

• Oral suspension (Naprosyn): 125 mg/5 mL

• Suppositories (Naprosyn, Naxen): 500 mg[canada]

• In combination with: esomeprazole (Vimovo).

Naproxen Sodium

• Tablets (Aleve, Anaprox, Anaprox DS, Novo-Naprox Sodium, Novo-Naprox Sodium DS, Synaflex, Synaflex DS): 220 mg^OTC, 275 mg, 550 mg

• In combination with: pseudoephedrine (Aleve Cold and Sinus Tablets, Aleve Sinus and Headache Tablets), sumatriptan (Treximet). See combination drugs.

• Patients who have asthma, aspirin-induced allergy, and nasal polyps are at increased risk for developing hypersensitivity reactions. Assess for rhinitis, asthma, and urticaria.

Pain

• Assess pain (note type, location, and intensity) prior to and 1–2 hr following administration.

Arthritis

• Assess pain and range of motion prior to and 1–2 hr following administration.

Fever

• Monitor temperature; note signs associated with fever (diaphoresis, tachycardia, malaise).

Lab Test Considerations

• Evaluate BUN, serum creatinine, CBC, and liver function tests periodically in patients receiving prolonged therapy.

» May ↑ serum potassium, BUN, serum creatinine, alkaline phosphatase, LDH, AST, and ALT tests levels. May ↓ blood glucose, hemoglobin, and hematocrit concentrations, leukocyte and platelet counts, and CCr.

» Bleeding time may be prolonged up to 4 days following discontinuation of therapy.

» May alter test results for urine 5-HIAA and urine steroid determinations.

• Acute pain (Indications)

• Chronic pain (Indications)

• Impaired physical mobility (Indications)

• Administration in higher than recommended doses does not provide increased effectiveness but may cause increased side effects. Use lowest effective dose for the shortest duration possible to minimize cardiac risks.

» Coadministration with opioid analgesics may have additive analgesic effects and may permit lower opioid doses.

» Analgesic is more effective if given before pain becomes severe.

• PO: For rapid initial effect, administer 30 min before or 2 hr after meals. May be administered with food, milk, or antacids to decrease GI irritation. Food slows but does not reduce the extent of absorption. Do not mix suspension with antacid or other liquid prior to administration. Swallow extended-release, delayed-release, and controlled-release tablets whole; do not break, crush, or chew.

• Dysmenorrhea: Administer as soon as possible after the onset of menses. Prophylactic treatment has not been shown to be effective.

• Advise patient to take this medication with a full glass of water and to remain in an upright position for 15–30 min after administration.

• Instruct patient to take medication as directed. Take missed doses as soon as remembered but not if almost time for the next dose. Do not double doses.

• May cause drowsiness or dizziness. Advise patient to avoid driving or other activities requiring alertness until response to the medication is known.

• Caution patient to avoid the concurrent use of alcohol, aspirin, acetaminophen, or other OTC medications without consulting health care professional. Use of naproxen with 3 or more glasses of alcohol per day may increase risk of GI bleeding.

• Advise patient to inform health care professional of medication regimen prior to treatment or surgery.

• Caution patient to wear sunscreen and protective clothing to prevent photosensitivity reactions (especially in children with JRA).

• Instruct patients not to take OTC naproxen preparations for more than 3 days for fever and to consult health care professional if symptoms persist or worsen.

• Advise patient to consult health care professional if rash, itching, visual disturbances, tinnitus, weight gain, edema, black stools, persistent headache, or influenza-like syndrome (chills, fever, muscle aches, pain) occurs.

• Relief of pain.

• Improved joint mobility. Partial arthritic relief is usually seen within 2 wk, but maximum effectiveness may require 2–4 wk of continuous therapy. Patients who do not respond to one NSAID may respond to another.

• Reduction of fever.