ALEVE
Clinical safety rating: caution
Comprehensive clinical and safety monograph for ALEVE (ALEVE).
Naproxen, a nonsteroidal anti-inflammatory drug (NSAID), inhibits cyclooxygenase (COX-1 and COX-2) enzymes, thereby reducing prostaglandin synthesis. This leads to decreased inflammation, pain, and fever.
| Metabolism | Naproxen is extensively metabolized in the liver primarily via CYP2C9 to 6-O-desmethyl naproxen, and less than 5% is excreted unchanged in urine. |
| Excretion | Renal (95% as unchanged drug and metabolites); biliary/fecal (5%) |
| Half-life | Terminal elimination half-life is 12-17 hours; allows twice-daily dosing for steady-state concentrations. |
| Protein binding | >99% bound to albumin; saturable at high concentrations. |
| Volume of Distribution | 0.16 L/kg; indicates distribution primarily in extracellular fluid. |
| Bioavailability | Oral: ~95%; immediate-release formulation. |
| Onset of Action | Oral: 30-60 minutes; onset of analgesic effect within 1 hour. |
| Duration of Action | Analgesic duration 8-12 hours; anti-inflammatory effect sustained with regular dosing. |
220 mg orally every 8 to 12 hours as needed; maximum 660 mg per day.
| Dosage form | TABLET |
| Renal impairment | GFR 30-59 mL/min: reduce dose and avoid long-term use; GFR <30 mL/min: contraindicated. |
| Liver impairment | Child-Pugh class A: no adjustment; Child-Pugh class B or C: avoid use. |
| Pediatric use | 2-12 years: 2.5-5 mg/kg/dose orally every 8-12 hours; maximum 10 mg/kg/day. 12 years and older: same as adult. |
| Geriatric use | Initiate at lowest effective dose (220 mg every 12 hours); maximum 440 mg per day; monitor renal function and GI bleeding risk. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for ALEVE (ALEVE).
| Breastfeeding | Excreted in breast milk in low concentrations (M/P ratio ~0.12); relative infant dose <1% of maternal weight-adjusted dose. Compatible with breastfeeding; monitor infant for potential adverse effects (gastrointestinal upset, rash) at higher doses. |
| Teratogenic Risk | First trimester: Risk of spontaneous abortion and cardiac defects (odds ratio 1.86 for NSAIDs). Second trimester: Possible fetal renal dysfunction and oligohydramnios; ductus arteriosus premature closure risk begins. Third trimester: High risk of premature closure of ductus arteriosus, oligohydramnios, necrotizing enterocolitis, intracranial hemorrhage, and renal impairment; avoid after 30 weeks. |
■ FDA Black Box Warning
Nonsteroidal anti-inflammatory drugs (NSAIDs) cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, which can be fatal. This risk may increase with duration of use. Patients with cardiovascular disease or risk factors may be at greater risk. Naproxen is contraindicated for treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery. NSAIDs cause an increased risk of serious gastrointestinal adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients and patients with a prior history of peptic ulcer disease or GI bleeding are at greater risk.
| Serious Effects |
["History of asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs","Peri-operative pain in the setting of CABG surgery","Advanced renal disease","History of gastrointestinal bleeding or perforation related to previous NSAID therapy","Active gastrointestinal bleed"]
| Precautions | ["Cardiovascular thrombotic events","Gastrointestinal bleeding, ulceration, and perforation","Hypertension","Heart failure and edema","Renal toxicity","Anaphylactoid reactions","Serious skin reactions (e.g., Stevens-Johnson syndrome)","Hematologic toxicity (inhibition of platelet aggregation)","Exacerbation of asthma","Hepatic effects","Pregnancy: avoid during third trimester"] |
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| Fetal Monitoring | Monitor maternal renal function, blood pressure, and signs of fluid retention. Fetal monitoring: ultrasound for oligohydramnios and ductus arteriosus patency if used after 20 weeks of gestation; daily fetal movement counts. Monitor for prolonged gestation and increased blood loss during delivery. |
| Fertility Effects | Reversible inhibition of ovulation due to prostaglandin synthesis inhibition; may delay or prevent conception. Effects resolve upon discontinuation. No permanent impact on female or male fertility. |
| Food/Dietary | Avoid concurrent use of alcohol as it increases GI bleeding risk. No specific food restrictions; taking with food or milk may reduce dyspepsia. High potassium foods (e.g., bananas, spinach) may increase hyperkalemia risk in patients with renal impairment. |
| Clinical Pearls | ALEVE (naproxen sodium) is a nonsteroidal anti-inflammatory drug (NSAID) with a longer half-life (12-17 hours) allowing twice-daily dosing. It carries a boxed warning for cardiovascular and gastrointestinal risk. Use lowest effective dose for shortest duration. Contraindicated in patients with aspirin allergy, perioperative pain in CABG surgery, and significant renal impairment. Monitor renal function in elderly, volume-depleted patients, and those on ACE inhibitors or diuretics. |
| Patient Advice | Take with food or milk to reduce GI upset. · Do not exceed 2 tablets (440 mg) in 24 hours unless directed by a doctor. · Avoid alcohol consumption to lower risk of GI bleeding. · Stop use and seek medical help if you experience chest pain, weakness, slurred speech, or signs of stomach bleeding (black/tarry stools, vomit that looks like coffee grounds). · Do not use with other NSAIDs (e.g., ibuprofen, aspirin) unless prescribed. |