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Naproxen

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Naproxen (sodium; free acid)
Aleve (OTC), Naprosyn (Rx), Anaprox (Rx), Naprelan (ER), EC-Naprosyn (enteric-coated), Vimovo (with esomeprazole)

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Summary
Common uses
Mild-to-moderate pain (FDA)0, Fever (FDA)0, Osteoarthritis (FDA)0, Rheumatoid arthritis (FDA)0, Ankylosing spondylitis (FDA)0, Primary dysmenorrhea (FDA)0, Tendinitis and bursitis (FDA)0, Acute gout (FDA)0
Pharmacy
Starting dose
OTC: 220 mg PO every 8-12 hours, max 660 mg/24h. Rx: 250-500 mg PO BID. Acute gout: 750 mg loading then 250 mg every 8 hours
Preparations
OTC tablets 220 mg; Rx tablets 250, 375, 500 mg; ER tablets 375, 500, 750 mg (Naprelan); oral suspension 125 mg/5 mL; enteric-coated tablets (EC-Naprosyn)
US FDA Max
1500 mg/day (Rx); 660 mg/24h (OTC, without provider direction)
Pharmacology
Routes
Oral
Onset
30-60 minutes
Duration
8-12 hours (the long-duration feature relative to ibuprofen)
Half-life
12-17 hours[1]
Bioavailability
~95% (oral)[1]
Pregnancy
Avoid from 20 weeks gestation onward per FDA's 2020 expanded NSAID warning (fetal renal dysfunction, oligohydramnios); contraindicated from 30 weeks (risk of premature ductus arteriosus closure)[1]
Legal status
OTC in US at ≤220 mg/tablet and ≤660 mg/day; Rx-only at higher strengths
Purported mechanism
Non-selective inhibitor of both COX-1 and COX-2, with slight COX-1 preference at therapeutic doses (in contrast to ibuprofen's roughly balanced profile). Anti-inflammatory and analgesic effect derives from reduced prostaglandin synthesis.0 Among the lower-cardiovascular-risk NSAIDs per PRECISION-trial-era data, the basis for the guideline preference of naproxen over other NSAIDs in patients with elevated cardiovascular risk who still require NSAID therapy. The long half-life allows twice-daily dosing, a clinical advantage over ibuprofen's QID-to-q8h requirements. Same GI bleeding, renal impairment, and Boxed-Warning class effects as other NSAIDs[1].

References

  1. 1.0 1.1 1.2 1.3 FDA Prescribing Information, Naprosyn (naproxen), Roche/Atnahs, current revision. https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/017581s113lbl.pdf