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. |
| Molecular Weight | 228.26 |
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 | Avoid use during first trimester due to potential risk of miscarriage and congenital malformations. Use only if benefits outweigh risks. |
| 2nd trimester | Use with caution; associated with oligohydramnios and fetal renal impairment. Avoid prolonged use. |
| 3rd trimester | Avoid during third trimester due to risk of premature ductus arteriosus closure, oligohydramnios, and neonatal renal impairment. |
Clinical note
ACE inhibitors and ARBs may have diminished antihypertensive effect Increases risk of serious cardiovascular thrombotic events and GI bleeding.
| FDA category | Positive |
| Placental transfer | Crosses placenta; fetal concentrations reach approximately 10% of maternal plasma levels. |
| Breastfeeding |
■ 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 |
Active peptic ulcer diseaseHistory of gastrointestinal bleeding or perforationSevere heart failure (NYHA class III-IV)Severe hepatic impairmentSevere renal impairment (eGFR < 30 mL/min/1.73 m²)History of hypersensitivity to ibuprofen or other NSAIDsThird trimester of pregnancyCoronary artery bypass graft surgery perioperative pain
| 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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| Ibuprofen is excreted in breast milk in very small amounts (less than 1% of maternal dose). Considered compatible with breastfeeding; use lowest effective dose for shortest duration. Monitor infant for potential adverse effects. |
| Lactation Rating | L1 (Compatible) |
| 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. |
| 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. |
| Food/Dietary | Avoid alcohol as it increases risk of GI bleeding. High-fat meals may slightly delay absorption but not clinically significant. St. John's Wort may reduce ibuprofen levels. No specific food restrictions. |
| Clinical Pearls | Ibuprofen sodium is more rapidly absorbed than ibuprofen acid, leading to faster onset of analgesia (within 30 minutes). Use with caution in patients with cardiovascular disease, renal impairment, or history of GI bleeding. Avoid in late pregnancy (risk of premature ductus arteriosus closure). Monitor renal function in elderly and volume-depleted patients. |
| Patient Advice | Take with food or milk to reduce stomach upset. · Do not exceed recommended dose (1200 mg/day OTC) or duration (10 days for pain). · Avoid alcohol while taking ibuprofen to prevent GI irritation. · Stop and seek medical attention if signs of GI bleeding (black stools, vomit with blood) occur. · Consult doctor before use if you have high blood pressure, heart disease, kidney disease, or stomach ulcers. · Do not take with other NSAIDs or aspirin without physician approval. |