Classes
DEA Class; OTC, Rx
Common Brand Names; Aleve, EC Naprosyn, Anaprox, Anaprox DS, Naprosyn, Naprox Sodium, Naproxen EC, Naproxen SR, Naprelan, Menstridol
NSAIDs
Description
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.
Indications
Contraindications
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)
Adverse Effects
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
Warnings
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 and Lactation
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
Maximum Dosage
Naproxen 1500 mg/day PO; Naproxen sodium up to 1650 mg/day PO for limited periods. For non-prescription use: 660 mg/day PO.
Naproxen 1500 mg/day PO; Naproxen sodium up to 1650 mg/day PO for limited periods. For non-prescription use: 660 mg/day PO.
Naproxen 1500 mg/day PO; Naproxen sodium up to 1650 mg/day PO for limited periods. For non-prescription use: 660 mg/day PO.
>= 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.
Safety and efficacy have not been established.
Safety and efficacy have not been established.
How supplied
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