FLURBIPROFEN 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 cyclooxygenase (COX-1 and COX-2) inhibitor, thereby decreasing prostaglandin synthesis, which mediates inflammation, pain, and fever.
| Metabolism | Primarily hepatic via glucuronidation and aromatic hydroxylation; CYP450 involvement is minimal. |
| Excretion | Renal: 70% as conjugates (glucuronide) and unchanged drug (<1%); biliary/fecal: minimal. |
| Half-life | 3-4 hours; in elderly or hepatic impairment may extend to 5-6 hours. |
| Protein binding | >99% bound to albumin. |
| Volume of Distribution | 0.13-0.18 L/kg; low Vd indicates extensive protein binding and limited tissue distribution. |
| Bioavailability | Oral: 92-96%; ophthalmic: negligible systemic absorption. |
| Onset of Action | Ophthalmic: ~1 hour; oral: 30-60 minutes. |
| Duration of Action | Ophthalmic: 4-6 hours; oral: 4-6 hours (analgesic); inflammation suppression persists longer. |
| Molecular Weight | 244.26 |
50 mg orally every 4 to 6 hours as needed; maximum 300 mg per day.
| Dosage form | SOLUTION/DROPS |
| Renal impairment | CrCl 30-59 mL/min: reduce dose by 50% and avoid use if CrCl <30 mL/min. |
| Liver impairment | Child-Pugh Class B or C: contraindicated; for mild impairment (Child-Pugh A): use with caution at lowest effective dose. |
| Pediatric use | Not recommended for use in pediatric patients under 18 years of age. |
| Geriatric use | Initiate at lowest effective dose (e.g., 50 mg every 6-8 hours), monitor renal function and GI bleeding risk; avoid long-term use. |
| 1st trimester | Flurbiprofen is generally avoided in the first trimester due to potential increased risk of miscarriage and congenital malformations, particularly cardiac defects. Use only if clearly needed and no alternative exists. |
| 2nd trimester | Use with caution in the second trimester; avoid prolonged use or high doses as it may cause oligohydramnios and premature ductus arteriosus constriction. Short-term use at lowest effective dose is preferred. |
| 3rd trimester | Contraindicated in the third trimester due to risk of premature closure of the ductus arteriosus, oligohydramnios, neonatal renal impairment, and inhibition of labor. |
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 | Flurbiprofen crosses the placenta; studies indicate detectable levels in fetal plasma and amniotic fluid. Transfer is higher in late pregnancy due to increased placental perfusion. |
■ FDA Black Box Warning
NSAIDs cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, which can be fatal. Risk may increase with duration of use. Contraindicated for treatment of perioperative pain in the setting of coronary artery bypass graft (CABG) surgery.
| Common Effects | inflammation |
| Serious Effects |
Known hypersensitivity to flurbiprofen or any NSAIDHistory of asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDsActive peptic ulcer disease or gastrointestinal bleedingSevere heart failure (NYHA Class III-IV)Severe renal impairment (CrCl <30 mL/min)Severe hepatic impairment (Child-Pugh Class C)Third trimester of pregnancyHistory of coronary artery bypass graft (CABG) surgery within 14 daysCerebrovascular bleeding or hemorrhagic diathesis
| Precautions | Cardiovascular risk: Increased risk of serious cardiovascular thrombotic events; use with caution in patients with cardiovascular disease or risk factors., Gastrointestinal risk: Increased risk of serious GI adverse events including bleeding, ulceration, and perforation; use with caution in patients with history of GI disease., Renal effects: May cause renal toxicity, especially in patients with preexisting renal impairment, heart failure, liver dysfunction, or elderly., Ophthalmic use: Caution in patients with active epithelial herpes keratitis; risk of corneal complications (e.g., keratitis, corneal ulcer). |
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| Breastfeeding | Flurbiprofen is excreted into breast milk in low amounts. The relative infant dose is estimated to be less than 1% of the maternal weight-adjusted dose, considered safe for short-term use. However, due to potential for adverse effects in infants (e.g., renal impairment, gastrointestinal bleeding), avoid prolonged use or high doses. Monitor infant for somnolence, poor feeding, or jaundice. |
| Lactation Rating | L2 (Safer if used with caution; compatible with breastfeeding in short-term use) |
| Teratogenic Risk | First trimester: Non-steroidal anti-inflammatory drugs (NSAIDs) are associated with an increased risk of miscarriage and congenital malformations (especially cardiac defects) based on observational studies. Second trimester: Generally considered lower risk; however, NSAIDs may cause fetal renal dysfunction and oligohydramnios. Third trimester: Risk of premature closure of the ductus arteriosus, fetal nephrotoxicity, oligohydramnios, and pulmonary hypertension. Avoid after 30 weeks gestation. |
| Fetal Monitoring | Monitor maternal blood pressure, renal function, and signs of bleeding. Fetal monitoring includes ultrasound assessment of amniotic fluid volume (oligohydramnios), ductus arteriosus patency (if exposed after 30 weeks), and fetal growth. In late pregnancy, consider non-stress test or biophysical profile if prolonged use. |
| Fertility Effects | NSAIDs may impair female fertility by inhibiting prostaglandin synthesis, affecting ovulation and implantation. Reversible upon discontinuation. In males, no significant adverse effects on fertility reported. |
| Food/Dietary | Take with food or milk to minimize gastrointestinal irritation. Avoid alcohol due to increased risk of gastric bleeding. No known significant food interactions beyond general NSAID advice. |
| Clinical Pearls | Flurbiprofen sodium is a nonselective NSAID; use with caution in patients with history of GI bleeding, renal impairment, or cardiovascular disease. Opthalmic solution may cause stinging; punctual occlusion reduces systemic absorption. Onset of analgesia is rapid; max dose 300 mg/day. |
| Patient Advice | Take with food or milk to reduce GI upset. · Do not take other NSAIDs or aspirin while on this medication. · Report signs of GI bleeding (black stools, vomit with coffee grounds). · Avoid alcohol as it increases risk of stomach bleeding. · For ophthalmic use, do not touch dropper tip to eye or surfaces. |