Aleve

A·leve (-lv)

A trademark for the drug naproxen.

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naproxen sodium

Aflaxen, Aleve, Anaprox, Anaprox DS, Apo-Napro-Na (CA), Apo-Napro-Na DS (CA), Arthroxen (UK), Napratec (UK), Naprelan, Novo-Naprox Sodium (CA), Novo-Naprox Sodium DS (CA), Synflex (CA), Synflex (UK)

Pharmacologic class: Nonsteroidal anti-inflammatory drug (NSAID)

Therapeutic class: Nonopioid analgesic, antipyretic, anti-inflammatory

Pregnancy risk category B (first and second trimesters), D (third trimester)

FDA Boxed Warning

• Drug may increase risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke (which can be fatal). Risk may increase with duration of use. Patients with cardiovascular disease or risk factors for it may be at greater risk.
• Drug increases risk of serious GI adverse events, including bleeding, ulcers, and stomach or intestinal perforation (which can be fatal). These events can occur at any time during use and without warning. Elderly patients are at greater risk.
• Drug is contraindicated for treatment of perioperative pain in setting of coronary artery bypass graft surgery.

Action

Unknown. Thought to inhibit prostaglandin synthesis.

Availability

naproxen

Oral suspension: 125 mg/5 ml

Suppositories: 500 mg

Tablets: 125 mg, 250 mg, 375 mg, 500 mg

Tablets (controlled-release): 375 mg, 500 mg

Tablets (delayed-release): 250 mg, 375 mg, 500 mg

Tablets (extended-release): 750 mg

naproxen sodium

Caplets, tablets: 220 mg, 275 mg, 550 mg

⊘Indications and dosages

➣ Pain; osteoarthritis; ankylosing spondylitis; dysmenorrhea; bursitis; acute tendinitis

Adults: 250 to 500 mg (naproxen) P.O. b.i.d. (up to 1.5 g/day); 375 to 500 mg (naproxen delayed-release) P.O. t.i.d.; 250 mg, 375 mg, or 500 mg (naproxen oral suspension) P.O. b.i.d.; 275 to 550 mg (naproxen sodium) P.O. b.i.d. (up to 1.65 g/day); or 750 or 1,000 mg/day (naproxen controlled-release) P.O., not to exceed 1,500 mg/day

Children: 10 mg/kg P.O. daily in two divided doses (naproxen only)

➣ Mild to moderate pain; primary dysmenorrhea

Adults: Initially, 500 mg (naproxen) P.O., followed by 250 mg q 6 to 8 hours p.r.n., to a maximum of 1.25 g/day. Or initially, 550 mg (naproxen sodium) P.O., followed by 275 mg q 6 to 8 hours p.r.n., to a maximum of 1,375 mg/day. Or 1,000 mg/day (naproxen controlled-release) P.O., to a maximum of 1,500 mg/day for a limited time; then no more than 1,000 mg/day.

➣ Gout

Adults: Initially, 750 mg (naproxen) P.O., followed by 250 mg q 8 hours; or initially, 825 mg (naproxen sodium) P.O., followed by 275 mg q 8 hours. Or 1,000 to 1,500 mg (naproxen controlled-release) P.O. once on day 1, followed by 1,000 mg daily.

Contraindications

• Hypersensitivity to drug or other NSAIDs
• Active GI bleeding or ulcer disease
• Asthma
• Pregnancy (third trimester)

Precautions

Use cautiously in:
• severe cardiovascular, renal, or hepatic disease
• history of ulcer disease
• chronic alcohol use or abuse
• pregnant (first and second trimesters) or breastfeeding patients
• children younger than age 2 (safety not established).

Administration

• Give with food or milk to avoid GI upset.

Route	Onset	Peak	Duration
P.O. (analgesia)	1 hr	2-4 hr	8-12 hr
P.O. (anti-inflamm.)	14 days	2-4 wk	Unknown

Adverse reactions

CNS: dizziness, drowsiness, headache, vertigo, light-headedness

CV: palpitations, tachycardia

EENT: visual disturbances, tinnitus, auditory disturbances

GI: nausea, diarrhea, constipation, heartburn, abdominal pain, stomatitis, GI bleeding

Skin: rash, pruritus, skin eruptions, sweating, photosensitivity

Other: thirst, edema, allergic reactions including anaphylaxis

Interactions

Drug-drug. Acetaminophen (chronic use), cyclosporine: increased risk of adverse renal effects

Anticoagulants, thrombolytics: increased anticoagulant effect

Antihypertensives, cefamandole, cefoperazone, cefotetan, diuretics, eptifibatide: decreased response

Antineoplastics, methotrexate: increased risk of nephrotoxicity

Aspirin: decreased naproxen efficacy

Aspirin, corticosteroids, other NSAIDs: additive adverse GI effects

Clopidogrel, plicamycin, ticlopidine, valproic acid: increased risk of bleeding

Insulin, oral hypoglycemics: increased risk of hypoglycemia

Lithium: increased lithium blood level and risk of nephrotoxicity

Other photosensitizing agents: increased risk of photosensitivity

Probenecid: increased naproxen blood level, increased risk of toxicity

Drug-diagnostic tests . Alanine aminotransferase, alkaline phosphatase, aspartate aminotransferase, blood urea nitrogen, creatinine, lactate dehydrogenase, potassium: increased levels

Bleeding time: prolonged for up to 4 days after therapy ends

Creatinine clearance, glucose, hematocrit, hemoglobin, leukocytes, platelets: decreased values

Urine 5-hydroxy-indoleacetic acid, urine steroids: test interference

Drug-herbs. Anise, arnica, chamomile, clove, dong quai, fenugreek, feverfew, garlic, ginger, ginkgo, ginseng, licorice: increased anticoagulant effect, increased risk of bleeding

Patient monitoring

• Monitor GI status. Stay alert for signs and symptoms of GI bleeding.
• In long-term use, assess CBC with white cell differential and coagulation studies, and monitor for visual and hearing impairment.
• Monitor cardiovascular status for tachycardia, palpitations, and edema.
• Monitor blood glucose level closely in diabetic patients.

Patient teaching

• Tell patient to take with food or milk followed by 8 oz of water, and to stay upright for 30 minutes afterward.
• Inform patient that he may crush or break regular tablets but must swallow extended-, delayed-, or controlled-release form whole.
• Tell patient that drug's full therapeutic effect may take up to 2 weeks.
• Caution patient not to exceed recommended dosage.
• Advise patient to use sunscreen to prevent photosensitivity reaction.
• Instruct patient not to take over-the-counter medications unless prescribed.
• Tell patient to consult prescriber before taking herbs.
• Caution pregnant patient not to take drug, especially during third trimester.
• As appropriate, review all other significant and life-threatening adverse reactions and interactions, especially those related to the drugs, tests, and herbs mentioned above.