naproxen

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/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;
OB: Avoid use after 30 wk gestation;
Lactation: Lactation.

Use Cautiously in:

Severe renal impairment;
Severe hepatic impairment;
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); avoid use in patients with recent MI or HF;
History of ulcer disease or any other history of gastrointestinal bleeding (may ↑ risk of GI bleeding);
Chronic alcohol use/abuse;
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), photosensitivity, pseudoporphyria (12% incidence in children with juvenile rheumatoid arthritis—discontinue therapy if this occurs), rash, STEVENS-JOHNSON SYNDROME, TOXIC EPIDERMAL NECROLYSIS

EENT: tinnitus, visual disturbances

F and E: hyperkalemia

GI: constipation, dyspepsia, nausea, anorexia, diarrhea, discomfort, flatulence, GI BLEEDING, 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)

Interactions ⬆ ⬇

Drug-drug:

May limit the cardioprotective (antiplatelet) effects of aspirin.
↑risk of bleeding with anticoagulants, aspirin, clopidogrel, ticagrelor, prasugrel, corticosteroids, fibrinolytics, SNRIs, or SSRIs.
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.

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

Naproxen Sodium

(Generic available)

Immediate-release tablets (Aleve, Anaprox DS): 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 Appendix [not included in this PDA edition].

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.
Monitor BP during initiation and periodically during therapy. May cause fluid retention and edema leading to new onset or worsening hypertension.
Assess for rash periodically during therapy. May cause Stevens-Johnson syndrome. Discontinue therapy if severe or if accompanied with fever, general malaise, fatigue, muscle or joint aches, blisters, oral lesions, conjunctivitis, hepatitis, and/or eosinophilia.
Monitor for signs and symptoms of DRESS (fever, rash, lymphadenopathy, facial swelling) periodically during therapy. Discontinue therapy if symptoms occur.
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.

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 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 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. 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 ⬆ ⬇

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 take this medication with a full glass of water and to remain in an upright position for 15–30 min after administration.
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 juvenile rheumatoid arthritis).
Instruct patient 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.
Rep: May cause fetal harm. Advise females of reproductive potential to notify health care professional 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 dysfunction 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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