Naproxen

DEA Class; OTC, Rx

Common Brand Names; Aleve, EC Naprosyn, Anaprox, Anaprox DS, Naprosyn, Naprox Sodium, Naproxen EC, Naproxen SR, Naprelan, Menstridol

NSAIDs 

Propionic acid NSAID; has antipyretic and analgesic properties; used for OA, RA, mild to moderate pain, and migraine; all formulations liberate naproxen as the active drug; increases risk of serious GI events; may increase CV events; use lowest effective dose for shortest possible duration.

For the treatment of ankylosing spondylitis, osteoarthritis, or rheumatoid arthritis.
For the treatment of juvenile rheumatoid arthritis (JRA)/juvenile idiopathic arthritis (JIA).
For the treatment of mild pain to moderate pain, including minor aches and pains associated with arthralgia, dental pain, headache, musculoskeletal pain (including backache), and/or the common cold.

Absolute: Aspirin allergy; perioperative pain in setting of coronary artery bypass graft (CABG) surgery

Relative: Bleeding disorders, delayed esophageal transit, hepatic disease, peptic ulcer, renal impairment, stomatitis, late pregnancy (may cause premature closure of ductus arteriosus)

1-10%

Abdominal pain (3-9%)

Constipation (3-9%)

Dizziness (3-9%)

Drowsiness (3-9%)

Headache (3-9%)

Heartburn (3-9%)

Nausea (3-9%)

Edema (3-9%)

GI bleeding (1-4%)

GI perforation (1-4%)

Lightneadedness (<3%)

GI ulcers (1-4%)

Fluid retention (3-9%)

Diarrhea (1-3%)

Stomatitis (<3%)

Diverticulitis (1-3%)

Dyspnea (3-9%)

Hearing disturbances (<3%)

<1%

Meaningful (3 × upper limit of normal) elevation of serum alanine aminotransferase or aspartate aminotransferase

Use caution in asthma (bronchial), bleeding disorders, cardiac disease, hepatic impairment, hypertension, renal impairment

Therapy may lead to onset of new hypertension or worsening of preexisting hypertension, either of which may contribute to increased incidence of CV events; patients taking thiazides or loop diuretics may have impaired response to these therapies when taking NSAIDs; use with caution in patients with hypertension; monitor blood pressure (BP) closely during initiation of treatment and throughout the course of therapy

May not be sufficiently activated in patients with hepatic dysfunction; use with caution

Borderline elevations of 1 or more liver function tests may occur in up to15% of patients; laboratory abnormalities may progress, remain unchanged, or may be transient with continuing therapy; notable elevations of ALT or AST (approximately 3 or more times the upper limit of normal) reported in approximately 1% of patients in clinical trials with NSAIDs; If clinical signs and symptoms consistent with liver disease develop, or if systemic manifestations occur (e.g., eosinophilia, rash, etc.), discontinue therapy

Pregnancy; When self-medicating, if pregnant or breast-feeding, ask a health professional before use; it is especially important not to take medication at 20 weeks or later in pregnancy unless definitely directed to do so by a doctor because it may cause problems in unborn child or complications during delivery

Lactation: Based on available published clinical data, drug may be present in human milk; developmental and health benefits of breastfeeding should be considered along with mother’s clinical need for therapy and any potential adverse effects on breastfed infant from drug or from underlying maternal condition

Adults

Naproxen 1500 mg/day PO; Naproxen sodium up to 1650 mg/day PO for limited periods. For non-prescription use: 660 mg/day PO.

Geriatric

Naproxen 1500 mg/day PO; Naproxen sodium up to 1650 mg/day PO for limited periods. For non-prescription use: 660 mg/day PO.

Adolescents

Naproxen 1500 mg/day PO; Naproxen sodium up to 1650 mg/day PO for limited periods. For non-prescription use: 660 mg/day PO.

Children

>= 12 years: In clinical practice, 20 mg/kg/day PO not to exceed 1000 mg/day PO; for non-prescription use, 660 mg/day PO.
2 to < 12 years: In clinical practice, 20 mg/kg/day PO not to exceed 1000 mg/day PO; non-prescription (self medication) use is not recommended.
< 2 years: Safety and efficacy have not been established.

Infants

Safety and efficacy have not been established.

Neonates

Safety and efficacy have not been established.

tablet

  • 220mg (OTC)

  • 250mg

  • 275mg

  • 375mg

  • 500mg

  • 550mg

tablet delayed release

  • 375mg

  • 500mg

tablet extended release

  • 375mg

  • 500mg

  • 750mg

capsule

  • 220mg

oral suspension

  • 25mg/mL

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