Naproxen

The selected IR label covers RA, OA, ankylosing spondylitis and polyarticular juvenile idiopathic arthritis, plus tendonitis, bursitis, acute gout, pain and primary dysmenorrhea. The suspension provides the corresponding uses with weight-flexible pediatric administration.

Selected Aleve caplets temporarily relieve minor arthritis / muscle / back / menstrual / headache / toothache / common-cold pain and fever. The selected delayed-release product covers RA / OA / ankylosing spondylitis and polyarticular JIA, but is not recommended for initial acute pain or acute gout because absorption is delayed. Extended-release and fixed combinations require their own labels.

Adults and children age 12 or older: 1 caplet every 8–12 hours while symptoms last; the first dose may be 2 caplets within the first hour. Do not exceed 2 caplets in any 8–12-hour period or 3 caplets (660 mg sodium salt) in 24 hours. Drink a full glass of water with each dose. Under 12: ask a doctor. Stop and ask a doctor if pain lasts over 10 days or fever over 3 days, or symptoms worsen.

Selected prescription labels permit increasing to naproxen 1500 mg / day for limited periods up to 6 months in patients tolerating lower doses when added benefit outweighs risk; this is not an OTC limit or routine target. For polyarticular JIA from age 2, the selected suspension gives about 10 mg / kg / day in 2 divided doses (5 mg / kg twice daily). The selected IR tablet label states tablets are inappropriate below 50 kg; do not extrapolate the arthritis regimen to every childhood pain / fever illness.

Selected suspension is 125 mg/5 mL (25 mg / mL): 250 mg = 10 mL; 500 mg = 20 mL; 750 mg = 30 mL. Shake gently before use and use a calibrated device, not a household spoon. Naproxen products are not recommended with CrCl below 30 mL / min; no validated numerical renal or hepatic adjustment algorithm is provided. Use the lowest effective dose and monitor closely in organ disease. Do not combine naproxen formulations.

Prescription products contraindicate naproxen / component hypersensitivity, prior asthma / urticaria or allergic-type reactions to aspirin / other NSAIDs, and use in the setting of CABG surgery. Selected Aleve Drug Facts also prohibit use after allergic reactions to other pain relievers / fever reducers and immediately before / after heart surgery.

Prescription naproxen labels warn of potentially fatal MI / stroke and serious GI bleeding, ulceration or perforation. CV risk may start early and increase with duration; older patients and those with ulcer / GI-bleeding history have greater GI risk. CABG use is contraindicated. OTC Drug Facts communicate corresponding serious risks without a prescription-style box.

Common reactions include dyspepsia, abdominal pain, nausea, headache, rash, bruising and edema; dizziness, drowsiness and tinnitus also occur. Serious postmarketing reports include liver injury, renal failure, severe skin reactions and hematologic or allergic reactions. Trial frequencies depend on population / dose and cannot establish universal rates.

Anticoagulants, antiplatelets, SSRIs / SNRIs and other NSAIDs increase bleeding risk. Naproxen can interfere with low-dose aspirin’s antiplatelet action, including during naproxen washout; no universally protective timing rule is supplied here. Review alternatives and monitor bleeding. Analgesic-dose aspirin or another NSAID adds GI toxicity with little additional benefit.

ACE inhibitors / ARBs / beta-blockers can lose BP effect; diuretics can lose natriuretic effect. Dehydrated, older or renally impaired patients on ACE inhibitors / ARBs have increased kidney-injury risk. Naproxen can increase digoxin or lithium exposure, methotrexate toxicity and cyclosporine nephrotoxicity; monitor the relevant drug level, labs and clinical response.

Pemetrexed requires an oncology-specific interruption / monitoring plan, particularly with renal impairment; long-half-life NSAIDs may require interruption at least 5 days before, the day of and 2 days after treatment under the cited label. Probenecid increases naproxen exposure. Antacids / sucralfate or cholestyramine can delay absorption and are not recommended concomitantly in selected labels. Review highly protein-bound medicines. Naproxen can alter bleeding-time, some adrenal-function and urinary 5-HIAA tests; coordinate testing rather than stopping independently.

Between about 20 and 30 weeks, use only if needed at the lowest dose / shortest duration; consider amniotic-fluid ultrasound beyond 48 hours and stop if oligohydramnios occurs. Avoid around 30 weeks and later. Earlier-pregnancy risk evidence is inconclusive. Naproxen enters milk; balance maternal need with breastfeeding / infant risks. NSAIDs may reversibly delay ovulation; consider withdrawal when investigating infertility.

Prescription safety / effectiveness below age 2 are unestablished. The supported pediatric regimen is polyarticular JIA, preferably with suspension for dose flexibility. OTC directions start at age 12. Older people have greater GI / CV / renal risk: start at the low end if treatment is justified and monitor closely.

Avoid routine use at CrCl below 30 mL / min; metabolites can accumulate. Advanced renal disease requires an exceptional benefit / risk assessment with monitoring. Hepatic disease may increase free drug despite lower total concentrations, and no validated dose table is supplied; use the lowest effective dose and assess toxicity. Correct dehydration before treatment.

Naproxen inhibits COX-1/COX-2 and prostaglandin synthesis, producing analgesic, anti-inflammatory and antipyretic effects. The full mechanism is incompletely understood. Reduced protective prostaglandins help explain GI and renal toxicity.

Bioavailability is about 95%; half-life about 12–17 hours and steady state 4–5 days. IR base peaks around 2–4 hours, sodium around 1–2 hours; suspension around 1–4 hours. Delayed-release absorption is slower and food can further delay it. Protein binding exceeds 99%; liver metabolism and urinary elimination of metabolites / conjugates predominate. These differences prevent unreviewed formulation substitution.

Assess pain / function, BP, edema, kidney function / potassium and bleeding risk. Consider periodic CBC and chemistry for long-term treatment; check hemoglobin / hematocrit with anemia symptoms. Investigate visual disturbances. Increase assessment with organ disease or interacting medicines; no universal lab interval is specified.

Read the Medication Guide / Drug Facts and avoid duplicate NSAIDs. For selected Aleve, use a full glass of water; food or milk may help stomach upset but does not prevent bleeding. Seek urgent care for chest pain, focal weakness, GI bleeding, airway swelling or serious rash. Report jaundice, reduced urine or edema and discuss pregnancy before use.

Contact medical services or Poison Control promptly. Overdose can cause GI symptoms / bleeding, drowsiness, renal injury and severe neurologic / respiratory effects. There is no specific antidote; management is supportive. High protein binding limits dialysis usefulness. Historical label emesis suggestions are not instructions for home treatment.

Appearance

Light orange, capsule-shaped, uncoated

Debossing

G / 32 around break line · 500 reverse

Example package

NDC 60687-491-01 · unit dose 100

Distributor

American Health Packaging; Glenmark product

Selected IR package contains 500 mg base tablets; its full PI also describes sodium 550 mg tablets/275 mg half-tablets. Selected delayed-release tablets are 375/500 mg and suspension is 125 mg/5 mL with 39 mg sodium per 5 mL. Selected OTC Aleve has 220 mg sodium salt (200 mg base), with 20 mg sodium per caplet. ER formulations and combinations, including sumatriptan / naproxen, require separate labels.

Selected Rx products: 20–25°C, excursions 15–30°C. Protect delayed-release tablets / suspension from light; shake suspension gently before dosing and avoid heat over 40°C. Do not use torn / broken IR unit-dose blisters. Selected Aleve: 20–25°C; avoid high humidity and heat over 40°C. Keep away from children.