FLURBIPROFEN
Clinical safety rating: avoid
Positive evidence of fetus risks but benefits may outweigh risks in some cases
Cyclooxygenase (COX) inhibitor, reducing prostaglandin synthesis; nonsteroidal anti-inflammatory drug (NSAID) with anti-inflammatory, analgesic, and antipyretic effects.
| Metabolism | Hepatic metabolism via CYP2C9; forms hydroxylated metabolites (e.g., 4'-hydroxyflurbiprofen) and conjugates. Less than 5% excreted unchanged in urine. |
| Excretion | Renal: 70% as conjugated metabolites (e.g., glucuronides) and <5% unchanged; biliary/fecal: 30%, with enterohepatic circulation. |
| Half-life | Terminal elimination half-life: 3-4 hours (healthy adults) in short-term use; prolonged to 6-12 hours in elderly or renal impairment. |
| Protein binding | 99% bound to albumin primarily. |
| Volume of Distribution | 0.12-0.15 L/kg; small Vd indicates limited tissue distribution, likely due to high protein binding. |
| Bioavailability | Oral: 92-96% (extensive absorption); ophthalmic: systemic absorption negligible (<0.05% of dose). |
| Onset of Action | Oral: analgesic effect within 30-60 minutes; ophthalmic: within 30 minutes for intraoperative miosis prevention; topical: local effect within 1 hour. |
| Duration of Action | Oral: 4-6 hours for analgesia; ophthalmic: effect persists up to 4 hours following a single dose. |
Oral: 50-100 mg every 6-8 hours; maximum 300 mg/day. Ophthalmic: 1 drop every 30 minutes starting 2 hours before surgery, then 1 drop every 4-6 hours for 24-48 hours post-surgery.
| Dosage form | TABLET |
| Renal impairment | GFR >50 mL/min: no adjustment. GFR 10-50 mL/min: avoid use if possible; if necessary, reduce dose to 50% and monitor. GFR <10 mL/min: contraindicated. |
| Liver impairment | Child-Pugh A: no adjustment. Child-Pugh B: reduce dose by 50%. Child-Pugh C: contraindicated. |
| Pediatric use | Oral: Not recommended for children <12 years; safety and efficacy not established. Ophthalmic: Not approved in pediatric patients. |
| Geriatric use | Initiate at lowest effective dose; monitor renal function and GI bleeding risk; maximum 200 mg/day oral. |
| 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.
| Breastfeeding | Not recommended; M/P ratio not established; excreted in human milk in low amounts; potential adverse effects on infant cardiovascular and renal systems. |
| Teratogenic Risk | First trimester: Risk of cardiac defects and gastroschisis with NSAID use; second trimester: Potential renal dysfunction and oligohydramnios; third trimester: Premature closure of ductus arteriosus, pulmonary hypertension, oligohydramnios, and necrotizing enterocolitis. |
■ 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 occur early in treatment and may increase with duration of use. Flurbiprofen is contraindicated in the setting of coronary artery bypass graft (CABG) surgery.
| Common Effects | inflammation |
| Serious Effects |
["History of allergic-type reactions to aspirin or other NSAIDs","Perioperative pain in the setting of coronary artery bypass graft (CABG) surgery","Active gastrointestinal bleeding or ulcer disease","Advanced renal disease","Avoid in late pregnancy (third trimester)","Hypersensitivity to flurbiprofen or any excipient"]
| Precautions | ["Cardiovascular risk: increased risk of thrombosis, MI, stroke, and hypertension","Gastrointestinal risk: increased risk of serious GI adverse events including bleeding, ulceration, and perforation of stomach or intestines","Renal toxicity: impaired renal function, papillary necrosis in long-term use","Hepatic effects: elevation of liver enzymes, rare severe hepatic reactions","Anaphylactoid reactions: may occur in patients without prior exposure","Fluid retention and edema","Use in late pregnancy: avoid due to risk of premature closure of ductus arteriosus","Ophthalmic use: do not use while wearing contact lenses (for ophthalmic solution)"] |
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| Fetal Monitoring |
| Monitor amniotic fluid index, fetal echocardiography for ductus arteriosus patency, and renal function in prolonged use. |
| Fertility Effects | Reversible inhibition of ovulation and implantation due to prostaglandin inhibition; may delay or prevent conception. |