ADVIL
Clinical safety rating: caution
Comprehensive clinical and safety monograph for ADVIL (ADVIL).
Non-selective cyclooxygenase (COX-1 and COX-2) inhibitor, reducing prostaglandin synthesis, thereby reducing pain, fever, and inflammation.
| Metabolism | Primarily hepatic metabolism via CYP2C9; also undergoes glucuronidation. Metabolites are eliminated renally. |
| Excretion | Renal: ~95% (hepatic metabolites and conjugates, <1% unchanged); biliary/fecal: ~5% |
| Half-life | 2-4 hours (terminal elimination half-life in adults; prolonged in overdose or renal impairment: up to 8-12 hours) |
| Protein binding | >99% bound primarily to albumin |
| Volume of Distribution | 0.1-0.2 L/kg (low Vd, indicating limited tissue distribution, primarily in plasma and interstitial fluid) |
| Bioavailability | Oral: 80-100% (immediate-release) |
| Onset of Action | Oral: 30-60 minutes (analgesic); Topical: 1-2 hours |
| Duration of Action | Oral: 4-6 hours (analgesic); Topical: 4-6 hours |
| Molecular Weight | 206.28 |
200-400 mg orally every 4-6 hours as needed; maximum 1200 mg/day (OTC). For prescription: 400-800 mg orally 3-4 times daily; maximum 3200 mg/day.
| Dosage form | TABLET |
| Renal impairment | CrCl 30-89 mL/min: No adjustment. CrCl <30 mL/min: Avoid use due to increased risk of renal toxicity. Hemodialysis: Not dialyzable; avoid. |
| Liver impairment | Child-Pugh A: No adjustment. Child-Pugh B: Use lowest effective dose, monitor closely. Child-Pugh C: Avoid use due to risk of bleeding and fluid retention. |
| Pediatric use | 6 months to 12 years: 5-10 mg/kg/dose orally every 6-8 hours; maximum 40 mg/kg/day. For fever: 5-10 mg/kg/dose; for pain: 10 mg/kg/dose. Do not exceed adult doses. |
| Geriatric use | Start at lowest effective dose (e.g., 200 mg every 6-8 hours). Maximum 2000 mg/day. Monitor renal function and GI bleeding risk; avoid long-term use. |
| 1st trimester | Avoid use during first trimester unless clearly needed. NSAIDs are associated with increased risk of miscarriage and congenital malformations (e.g., cardiac defects). |
| 2nd trimester | Use lowest effective dose for shortest duration. Risk of oligohydramnios and fetal renal dysfunction. |
| 3rd trimester | Contraindicated after 30 weeks gestation due to risk of premature closure of ductus arteriosus and oligohydramnios. |
Clinical note
Comprehensive clinical and safety monograph for ADVIL (ADVIL).
| Placental transfer | Ibuprofen crosses the placenta; measurable fetal concentrations are found. Transfer is limited due to high protein binding (>99%). |
| Breastfeeding | Ibuprofen is excreted into breast milk in very low amounts (less than 1% of maternal dose). Considered compatible with breastfeeding. Use lowest effective dose for shortest duration and monitor infant for adverse effects. |
■ FDA Black Box Warning
Increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, which can be fatal. Increased risk of serious gastrointestinal adverse events including bleeding, ulceration, and perforation of the stomach or intestines.
| Serious Effects |
History of hypersensitivity to ibuprofen or any NSAIDActive peptic ulcer disease or gastrointestinal bleedingSevere heart failure (NYHA III-IV)Coronary artery bypass graft surgery (CABG) perioperative painThird trimester of pregnancy (after 30 weeks)History of asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs
| Precautions | Cardiovascular risk: avoid in patients with recent CABG; use with caution in patients with CV disease or risk factors., GI risk: history of peptic ulcer disease or GI bleeding; concomitant use of aspirin, corticosteroids, or anticoagulants., Renal effects: monitor renal function in patients with renal impairment, heart failure, or on diuretics., Hepatic effects: monitor liver function; avoid in severe hepatic impairment., Anaphylactoid reactions: avoid in patients with aspirin triad (asthma, nasal polyps, urticaria)., Pregnancy: avoid in late pregnancy (third trimester) due to risk of premature ductus arteriosus closure., Hypertension: monitor blood pressure; may worsen hypertension. |
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| Lactation Rating | L1 (Compatible) |
| Teratogenic Risk | First trimester: Increased risk of spontaneous abortion and congenital malformations (cardiac, gastroschisis) associated with NSAID use. Avoid if possible. Second trimester: Use only if clearly needed; no evidence of major teratogenicity. Third trimester: Contraindicated after 30 weeks gestation due to risk of premature closure of ductus arteriosus and oligohydramnios. |
| Fetal Monitoring | Monitor for signs of oligohydramnios and ductus arteriosus constriction via ultrasound if used after 20 weeks. Assess maternal renal function and bleeding time if used near term. |
| Fertility Effects | Reversible impairment of female fertility via inhibition of prostaglandin synthesis affecting ovulation and implantation. Use in preconception period may delay conception. Effect resolves upon discontinuation. |
| Food/Dietary | Alcohol increases risk of GI bleeding and hepatotoxicity. Avoid high-fat meals as they may delay absorption. No other significant food interactions; may be taken with food to reduce GI irritation. |
| Clinical Pearls | Ibuprofen (Advil) is a non-selective NSAID; use lowest effective dose for shortest duration to minimize GI and cardiovascular risks. Avoid in patients with aspirin-sensitive asthma. Monitor renal function in elderly or those with pre-existing renal disease. Onset of analgesia is ~30min; duration 4-6h. Can be used as antipyretic (preferred over aspirin in children due to Reye's syndrome risk). |
| Patient Advice | Take with food or milk to reduce stomach upset. · Do not exceed 1200mg per day unless directed by physician. · Avoid alcohol while taking this medication. · Inform your doctor if you have history of stomach ulcers, bleeding disorders, or kidney disease. · Stop use and seek medical help if signs of allergic reaction (rash, swelling, difficulty breathing) or stomach pain/black stools. · Do not use with other NSAIDs (including aspirin) without doctor's approval. |