Aleve

naproxen

Apo-Naproxen, EC-Naprosyn, Gen Naproxen, Naprosyn, Naprosyn-E, Naprosyn-EC (UK), Naprosyn SR, Novo-Naprox, Nu-Naprox, Nycopren (UK), PMS-Naproxen EC, Riva-Naproxen

naproxen sodium

Aflaxen, Aleve, Anaprox, Anaprox DS, Apo-Napro-Na, Apo-Napro-Na DS Arthroxen (UK), Gen-Naproxen EC, Napratec (UK), Naprelan, Novo-Naprox Sodium, Novo-Naprox Sodium DS, Riva-Naproxen Sodium, Synflex, 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)

Action

Unknown. Thought to inhibit prostaglandin synthesis.

Availability

naproxen

Oral suspension: 125 mg/5 ml

Tablets: 250 mg, 375 mg, 500 mg

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

naproxen sodium

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

Tablets (controlled-release): 375 mg, 500 mg, 750 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)

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.

➣ 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. On day 1,1,000 to 1,500 mg (naproxen sodium controlled-release formulation) P.O. once daily, followed by 1,000 mg once daily until attack has subsided.

➣ Management of pain, primary dysmenorrhea, acute tendinitis and bursitis

Adults: Initially, two 500-mg naproxen sodium controlled-release tablets P.O. once daily. Or, for patients requiring greater analgesic benefit, two 750-mg naproxen sodium controlled-release tablets P.O. once daily. Or, three 500-mg naproxen sodium controlled-release tablets may be used for a limited period. Thereafter, total daily dose shouldn't exceed two 500-mg tablets.

➣ Rheumatoid arthritis, osteoarthritis, ankylosing spondylitis

Adults: Initially, two 375-mg naproxen sodium controlled-release tablets P.O. once daily, one 750-mg tablet P.O. once daily, or two 500-mg tablets P.O. once daily. During long-term administration, adjust dosage up or down depending on patient's clinical response. Use lowest effective dose in all patients. (Patients already taking naproxen 250 mg, 375 mg, or 500 mg b.i.d. may have their total daily dosage replaced with naproxen sodium controlled-release tablets as a single daily dose.)

Dosage adjustment

• Renal or hepatic impairment

• Elderly patients

Contraindications

• Hypersensitivity to drug or other NSAIDs

• Asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs

• Perioperative pain in the setting of coronary artery bypass graft surgery

Precautions

Use cautiously in:

• severe cardiovascular, renal, or hepatic disease

• advanced renal disease (not recommended)

• history of ulcer disease or GI bleeding (use with extreme caution)

• chronic alcohol use or abuse

• elderly patients

• pregnant patients

• breastfeeding patients (avoid use)

• children (naproxen sodium controlled-release) and naproxen use in children younger than age 2 (safety not established).

Administration

• Give with food or milk to avoid GI upset.

Adverse reactions

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

CV: palpitations, tachycardia, hypertension

GU: renal toxicity (with long-term use in patients in whom renal prostaglandins have a compensatory role in maintenance of renal perfusion), renal papillary necrosis

EENT: visual disturbances, tinnitus, auditory disturbances

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

Skin: rash, pruritus, skin eruptions, sweating, photosensitivity, exfoliative dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis

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 amino-transferase, alkaline phosphatase, aspartate aminotransferase, blood urea nitrogen, creatinine, lactate dehydroge-nase, 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 and renal toxicity.

• Monitor cardiovascular status for tachycardia, palpitations, hypertension, and edema.

• Monitor blood glucose level closely in diabetic patients.

Monitor patient for signs and symptoms of serious skin manifestations; discontinue drug at first appearance of rash or other signs of hypersensitivity.

Patient teaching

• Tell patient to take medication 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 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.

Instruct patient how to recognize and immediately report signs and symptoms of renal toxicity and serious skin manifestations.

• 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.

• Advise female patient to tell prescriber if she is pregnant or breastfeeding before starting drug.

• As appropriate, review all other significant and life-threatening adverse reactions and interactions, especially those related to the drugs, tests, and herbs mentioned above.

naproxen

(na-prox-en) ,

Aleve

(trade name),

Anaprox

(trade name),

Anaprox DS

(trade name),

EC-Naprosyn

(trade name),

Naprelan

(trade name),

Naprosyn

(trade name),

Naprosyn-E

(trade name),

Naprosyn-SR

(trade name)

Classification

Therapeutic: nonopioid analgesics

Pregnancy Category: B (first trimester)

Indications

Mild to moderate pain.Dysmenorrhea.Fever.Inflammatory disorders, including:

• Rheumatoid arthritis (adults and children),

• Osteoarthritis.

Action

Inhibits prostaglandin synthesis.

Therapeutic effects

Decreased pain.

Reduction of fever.

Suppression of inflammation.

Pharmacokinetics

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

Contraindications/Precautions

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; Obstetric: Avoid using during third trimester; may cause premature closure of the ductus arteriosus; Pediatric: Children <2 yr (safety not established) ; Geriatric: ↑ risk of adverse reactions.

Adverse Reactions/Side Effects

Central nervous system

• dizziness (most frequent)
• drowsiness (most frequent)
• headache (most frequent)

Ear, Eye, Nose, Throat

• tinnitus
• visual disturbances

Respiratory

• dyspnea

Cardiovascular

• edema
• palpitations
• tachycardia

Gastrointestinal

• drug-induced hepatitis (life-threatening)
• gi bleeding (life-threatening)
• constipation (most frequent)
• dyspepsia (most frequent)
• nausea (most frequent)
• anorexia
• diarrhea
• discomfort
• flatulence
• vomiting

Genitourinary

• cystitis
• hematuria
• renal failure

Dermatologic

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

Hematologic

• blood dyscrasias
• prolonged bleeding time

Miscellaneous

• allergic reactions including anaphylaxis and stevens-johnson syndrome (life-threatening)

Interactions

Drug-Drug interaction

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

Route/Dosage

275 mg naproxen sodium is equivalent to 250 mg naproxenAnti-Inflammatory/Analgesic/Antidysmenorrheal

Oral (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).

Oral (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

Oral (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)

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

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

Availability

Naproxen

Tablets (Naprosyn,): 125 mg, 250 mg, 375 mg, 500 mg

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

Delayed-release tablets (EC-Naprosyn, Naprosyn-E): 250 mg, 375 mg, 500 mg

Extended-release tablets (Naprosyn-SR): 750 mg

Oral suspension (Naprosyn): 125 mg/5 mL

Suppositories : 500 mg

In combination with: esomeprazole (Vimovo).

Naproxen Sodium

Tablets (Aleve, Anaprox, Anaprox DS): 220 mg^OTC, 275 mg, 550 mg

In combination with: pseudoephedrine (Aleve-D Sinus and Cold), sumatriptan (Treximet). See combination drugs.

Nursing implications

Nursing assessment

• 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.

Potential Nursing Diagnoses

Acute pain (Indications)
Chronic pain (Indications)
Impaired physical mobility (Indications)

Implementation

• 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.
• Oral: 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.

Patient/Family Teaching

• 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.

Evaluation/Desired Outcomes

• 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.

Aleve

(ə-lēv′)

A trademark for the drug naproxen.