IBUPROFEN SODIUM
Clinical safety rating: avoid
ACE inhibitors and ARBs may have diminished antihypertensive effect Increases risk of serious cardiovascular thrombotic events and GI bleeding.
Non-selective inhibitor of cyclooxygenase (COX-1 and COX-2), decreasing prostaglandin synthesis, resulting in anti-inflammatory, analgesic, and antipyretic effects.
| Metabolism | Primarily hepatic via CYP2C9; major metabolites are hydroxylated and carboxylated derivatives, with subsequent glucuronidation. |
| Excretion | Renal: 90% as metabolites and conjugates, <1% unchanged; biliary/fecal: minor. |
| Half-life | 2.0-2.5 hours (terminal); no prolongation in mild hepatic impairment; increased in renal failure. |
| Protein binding | 99% bound to albumin. |
| Volume of Distribution | 0.15-0.3 L/kg; distribution limited by high protein binding. |
| Bioavailability | Oral: 80-100% (rapid absorption); Topical: negligible systemic bioavailability (<5%). |
| Onset of Action | Oral (tablets/capsules): 30-60 min; Oral (solution): 15-30 min; Topical: 1-2 hours. |
| Duration of Action | Oral: 4-6 hours (analgesic/antipyretic); Topical: 4-6 hours; Clinical note: shorter duration in acute pain. |
200-400 mg orally every 4-6 hours, maximum 1200 mg/day; for OTC use, 200-400 mg every 6-8 hours as needed, maximum 1200 mg/day.
| Dosage form | TABLET |
| Renal impairment | GFR 30-90 mL/min: no adjustment needed. GFR <30 mL/min: avoid use; if necessary, reduce dose and extend interval (e.g., 200-400 mg every 8-12 hours). Not recommended in severe renal impairment (GFR <15 mL/min). |
| Liver impairment | Child-Pugh A: no adjustment. Child-Pugh B: reduce dose by 50% (maximum 600 mg/day). Child-Pugh C: avoid use. |
| Pediatric use | Infants and children (≥6 months): 5-10 mg/kg per dose orally every 6-8 hours, maximum 40 mg/kg/day. For fever or pain, 5 mg/kg if temperature <102.5°F, 10 mg/kg if ≥102.5°F. |
| Geriatric use | Initiate at lowest effective dose (200 mg) and titrate slowly; maximum 1200 mg/day. Monitor renal function, GI bleeding risk, and drug interactions (e.g., ACE inhibitors, diuretics). Avoid chronic use if possible. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
ACE inhibitors and ARBs may have diminished antihypertensive effect Increases risk of serious cardiovascular thrombotic events and GI bleeding.
| FDA category | Positive |
| Breastfeeding | Excreted into breast milk in low amounts (M/P ratio approximately 0.01-0.02). Considered compatible with breastfeeding due to low infant dose, but avoid if infant has thrombocytopenia or bleeding diathesis. |
| Teratogenic Risk | First trimester: Avoid; associated with increased risk of cardiac defects and gastroschisis. Second trimester: Use with caution; limited evidence of structural anomalies. Third trimester: Contraindicated; risks include premature ductus arteriosus closure, oligohydramnios, and necrotizing enterocolitis. |
■ FDA Black Box Warning
None formally required for ibuprofen sodium, but NSAIDs carry increased risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke (especially with prolonged use or in patients with cardiovascular risk factors). NSAIDs also increase risk of serious GI adverse events including bleeding, ulceration, and perforation.
| Common Effects | fever |
| Serious Effects |
["Hypersensitivity to ibuprofen or any NSAID","History of asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs","Active peptic ulcer disease or GI bleeding","Severe renal impairment (CrCl <30 mL/min)","Severe hepatic impairment","Perioperative pain in the setting of coronary artery bypass graft (CABG) surgery","Late pregnancy (third trimester) due to risk of premature closure of ductus arteriosus"]
| Precautions | ["Cardiovascular risk: increased risk of thrombotic events, MI, stroke; avoid in setting of CABG surgery.","GI risk: increased risk of bleeding, ulceration, perforation; caution in patients with history of peptic ulcer disease or GI bleeding.","Renal effects: may cause renal impairment, especially in elderly, volume-depleted, or those with pre-existing renal disease.","Anaphylactoid reactions: can occur in patients without prior exposure; cross-sensitivity with aspirin.","Hepatic effects: rare severe hepatic reactions; monitor liver function.","Hypertension: can worsen blood pressure control; monitor.","Asthma: may precipitate bronchospasm in aspirin-sensitive patients."] |
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| Fetal Monitoring | Monitor maternal renal function, blood pressure, and amniotic fluid volume. Fetal echocardiography for ductal patency if used in third trimester. Assess for signs of oligohydramnios. |
| Fertility Effects | Reversible inhibition of ovulation; may delay conception. Use of NSAIDs including ibuprofen sodium can interfere with ovulation by inhibiting prostaglandin synthesis necessary for follicle rupture. |