naproxen

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

Distribution: Well distributed to tissues.

Protein Binding: >99%.

Metabolism/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

Contraind./Precautions ⬆ ⬇

Contraindicated in:

Hypersensitivity;
Cross-sensitivity may occur with other NSAIDs, including aspirin;
Active GI bleeding;
Ulcer disease;
Coronary artery bypass graft surgery;
Recent MI;
HF;
OB: Avoid use after 30 wk gestation;
Lactation: Lactation.

Use Cautiously in:

Cardiovascular disease or risk factors for cardiovascular disease (may ↑ risk of serious cardiovascular thrombotic events, MI, and stroke, especially with prolonged use or use of higher doses);
History of long duration of NSAID use, smoking, alcohol use, advanced liver disease, coagulopathy, or poor general health (↑ risk of GI bleeding);
History of peptic ulcer disease and/or GI bleeding;
Bleeding tendency or concurrent anticoagulant therapy;
Chronic alcohol use/abuse;
Severe renal impairment;
Severe hepatic impairment;
OB: Use at or after 20 wk gestation may cause fetal or neonatal renal impairment; if treatment is necessary between 20 wk and 30 wk gestation, limit use to the lowest effective dose and shortest duration possible;
Pedi: Children <2 yr (safety and effectiveness not established);
Geri: Appears on Beers list. ↑ risk GI bleeding or peptic ulcer disease in older adults. Avoid chronic use unless other alternatives are not effective and the patient can take a gastroprotective agent; avoid short-term use in combination with oral or parenteral corticosteroids, anticoagulants, or antiplatelet agents unless other alternatives are not effective and the patient can take a gastroprotective agent.

Adv. Reactions/Side Effects ⬆ ⬇

CV: edema, HF, hypertension, MI, palpitations, tachycardia

Derm: ↑sweating, DRUG REACTION WITH EOSINOPHILIA AND SYSTEMIC SYMPTOMS (DRESS), EXFOLIATIVE DERMATITIS, rash, GENERALIZED BULLOUS FIXED DRUG ERUPTION, photosensitivity, pseudoporphyria (↑ in children with juvenile rheumatoid arthritis), rash, STEVENS-JOHNSON SYNDROME (SJS), TOXIC EPIDERMAL NECROLYSIS (TEN)

EENT: tinnitus, visual disturbances

F and E: hyperkalemia

GI: constipation, dyspepsia, nausea, anorexia, diarrhea, discomfort, flatulence, GI BLEEDING, GI PERFORATION, GI ULCERATION, HEPATITIS, vomiting

GU: cystitis, hematuria, renal failure

Hemat: blood dyscrasias, prolonged bleeding time

Neuro: dizziness, drowsiness, headache, STROKE

Resp: dyspnea

Misc: HYPERSENSITIVITY REACTIONS (INCLUDING ANAPHYLAXIS AND SERIOUS SKIN REACTIONS)

Interactions ⬆ ⬇

Drug-drug:

May limit the cardioprotective (antiplatelet) effects of aspirin.
↑risk of GI bleeding with anticoagulants, aspirin, clopidogrel, ticagrelor, prasugrel, corticosteroids, fibrinolytics, SNRIs, or SSRIs.
Probenecid may ↑ levels and risk of toxicity.
May ↑ risk of toxicity from methotrexate, antineoplastics, or radiation therapy.
May ↑ levels and risk of toxicity of lithium.
↑risk of nephrotoxicity with cyclosporine, ACE inhibitors, angiotensin II antagonists, or chronic use of acetaminophen.
May ↓ effectiveness of antihypertensives or diuretics.
May ↑ risk of hypoglycemia with insulin or oral hypoglycemic agents.Oral potassium supplements may ↑ GI adverse effects.

Drug-Natural Products:

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

Route/Dosage ⬆ ⬇

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 every 8–12 hr. Inflammatory disease: 10–15 mg/kg/day divided every 12 hr, maximum: 1000 mg/day.

Gout

PO (Adults ): Naproxen: 750 mg initially, then 250 mg every 8 hr. Naproxen sodium: 825 mg initially, then 275 mg every 8 hr.

OTC Use (Naproxen Sodium)

PO (Adults ): 200 mg every 8–12 hr or 400 mg followed by 200 mg every 12 hr (not to exceed 600 mg/24 hr).
PO Geriatric Patients >65 yr): Not to exceed 200 mg every 12 hr.

Availability ⬆ ⬇

Naproxen

(Generic available)

Immediate-release tablets: 125 mg; 250 mg; 375 mg; 500 mg
Delayed-release tablets (EC-Naprosyn): 375 mg; 500 mg
Extended-release tablets: 750 mg
Oral suspension: 125 mg/5 mL
In combination with:
esomeprazole (generic only).

Naproxen Sodium

(Generic available)

Immediate-release tablets (Aleve): 220 mg^OTC; 275 mg; 550 mg
Immediate-release capsules (Maxidol): 220 mg^OTC
Extended-release tablets (Naprelan): 375 mg; 500 mg; 750 mg
In combination with:
pseudoephedrine (Aleve-D Sinus and Cold), sumatriptan (Treximet). See Combination Drugs.

Assessment ⬆ ⬇

Patients who have asthma, aspirin-induced allergy, and nasal polyps are at ↑ risk for developing hypersensitivity reactions. Assess for rhinitis, asthma, and urticaria.
Monitor BP during initiation and periodically during therapy. May cause fluid retention and edema leading to new onset or worsening hypertension.
Assess for signs and symptoms of HF (dyspnea, peripheral edema, rales/crackles, jugular venous distension) during therapy.
Monitor patients for development of severe cutaneous adverse reactions, including exfoliative dermatitis, SJS, and TEN, including signs and symptoms of prodrome of fever, malaise, mucosal lesions, progressive skin rash, blisters, lymphadenopathy, conjunctivitis, myalgias, hepatitis, or eosinophilia. If a severe cutaneous adverse reaction is suspected, interrupt therapy until etiology of reaction is determined. Consultation with a dermatologist is recommended. If a severe cutaneous adverse reaction is confirmed, permanently discontinue naproxen.
Monitor for signs and symptoms of DRESS (fever, rash, lymphadenopathy, facial swelling) periodically during therapy. If signs/symptoms of DRESS occur, discontinue naproxen.
Monitor for signs/symptoms of GI bleeding, ulceration, or perforation (fatigue, weakness, pallor, hematochezia, melena, coffee ground emesis, hematemesis, abdominal pain or distention) especially with prolonged therapy.
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. May ↓ blood glucose, hemoglobin, hematocrit, WBCs, and platelets.
- May ↓ C-reactive protein levels and erythrocyte sedimentation rate in patients with rheumatoid arthritis.
- 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.

Implementation ⬆ ⬇

Administration in higher than recommended doses does not provide ↑ effectiveness but may cause ↑ risk of side effects. Use lowest effective dose for the shortest duration possible to minimize risk of cardiovascular thrombotic events.
- Coadministration with opioid analgesics may have additive analgesic effects and may permit lower opioid doses.
- Naproxen 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 ↓ GI irritation. Food slows but does not ↓ the extent of absorption. DNC: 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 ⬆ ⬇

Explain the purpose and side effects of naproxen. 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. Advise patient to read Patient Information before starting and with each Rx refill in case of changes.
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 not to take OTC naproxen preparations for >3 days for fever and to consult health care provider if symptoms persist or worsen.
May cause drowsiness or dizziness. Advise patient to avoid driving or other activities requiring alertness until response to the medication is known.
Advise patient to notify health care provider of all Rx or OTC medications, vitamins, or herbal products being taken and to consult with health care provider before taking other medications.
Inform patient of ↑ risk of MI and stroke. Use lowest effective dose for shortest time. Advise patient to notify health care provider immediately if signs and symptoms (shortness of breath or trouble breathing, chest pain, weakness in one part or side of body, slurred speech, swelling of the face or throat) occur.
Advise patient to notify health care provider promptly if signs or symptoms of GI toxicity (abdominal pain, black stools) occur.
Caution patient to avoid the concurrent use of alcohol, aspirin, acetaminophen, or other OTC medications without consulting health care provider. Use of naproxen with ≥3 glasses of alcohol per day may ↑ risk of GI bleeding.
Advise patient to inform health care provider of medication regimen prior to treatment or surgery.
Caution patient to wear sunscreen and protective clothing to prevent photosensitivity reactions (especially in children with juvenile rheumatoid arthritis).
Advise patient to consult health care provider if rash, itching, visual disturbances, tinnitus, weight gain, edema, persistent headache, or flu-like syndrome (chills, fever, muscle aches, pain) occurs.
Rep: May cause fetal harm. Advise women of reproductive potential to notify health care provider if pregnancy is planned or suspected or if breastfeeding. Advise women to avoid naproxen in the 3rd trimester of pregnancy (after 29 wk); may cause premature closure of the fetal ductus arteriosus. Use of naproxen after 20 wk may cause fetal renal impairment, leading to oligohydramnios. May cause reversible infertility in women attempting to conceive; may consider discontinuing naproxen.

section name header

Pronunciation ⬇

Classifications ⬆ ⬇

Indications ⬆ ⬇

Action ⬆ ⬇

Pharmacokinetics ⬆ ⬇

Time/Action Profile ⬆ ⬇

Contraind./Precautions ⬆ ⬇

Adv. Reactions/Side Effects ⬆ ⬇

Interactions ⬆ ⬇

Route/Dosage ⬆ ⬇

Availability ⬆ ⬇

Assessment ⬆ ⬇

Implementation ⬆ ⬇

Patient/Family Teaching ⬆ ⬇

Evaluation/Desired Outcomes ⬆ ⬇

US Brand Names ⬆ ⬇

Canadian Brand Names ⬆ ⬇

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