OCUFEN
Clinical safety rating: caution
Comprehensive clinical and safety monograph for OCUFEN (OCUFEN).
Nonsteroidal anti-inflammatory drug (NSAID) that inhibits cyclooxygenase (COX) enzymes, reducing prostaglandin synthesis, thereby decreasing intraocular inflammation and pain.
| Metabolism | Primarily hepatic metabolism via conjugation and hydroxylation; minor CYP450 involvement. |
| Excretion | Urinary excretion of unchanged drug accounts for approximately 82% of a topical dose; fecal excretion is minor (<5%). |
| Half-life | 1.2 to 2.0 hours (topical administration in ocular tissues); systemic half-life is 1.1 to 1.4 hours. |
| Protein binding | >99% bound to plasma proteins, primarily albumin. |
| Volume of Distribution | 0.1 to 0.2 L/kg (following IV administration in animal studies; clinical significance: low Vd indicates limited extravascular distribution). |
| Bioavailability | Topical ophthalmic: systemic bioavailability is approximately 1-5% due to nasolacrimal drainage and limited corneal penetration. |
| Onset of Action | Onset of miosis inhibition: within 30 minutes of topical application to the eye. |
| Duration of Action | Duration of effect: up to 2-4 hours after a single topical dose; may require dosing every 4-6 hours intraoperatively. |
1 drop of 0.03% solution in the affected eye(s) four times daily beginning 24 hours after cataract surgery.
| Dosage form | SOLUTION/DROPS |
| Renal impairment | No dosage adjustment required. |
| Liver impairment | No dosage adjustment required. |
| Pediatric use | Safety and efficacy not established; no specific dosing recommendations. |
| Geriatric use | No dosage adjustment required; use same dosing as adults. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for OCUFEN (OCUFEN).
| Breastfeeding | Flurbiprofen is excreted in breast milk following systemic administration, but ophthalmic use results in negligible systemic levels. The M/P ratio is not established for ophthalmic route. Caution is advised; however, the risk to the nursing infant is considered low. Consider temporary discontinuation of breastfeeding during therapy if high doses are used systemically. |
| Teratogenic Risk | OCUFEN (flurbiprofen ophthalmic) is a topical NSAID. Systemic absorption is minimal, and no teratogenic effects have been reported in animal studies with ophthalmic doses. However, NSAIDs are generally avoided in the third trimester due to risk of premature closure of the ductus arteriosus and oligohydramnios. Use during pregnancy only if potential benefit justifies risk. |
■ FDA Black Box Warning
No FDA black box warning.
| Serious Effects |
Hypersensitivity to flurbiprofen or any component of the formulation; history of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs; active epithelial herpetic keratitis.
| Precautions | May increase bleeding risk, especially in patients with known bleeding tendencies or those on anticoagulants; use with caution in patients with previous sensitivity to NSAIDs; may cause corneal epithelial defects or delayed healing; avoid in patients with active epithelial herpetic keratitis. |
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| Fetal Monitoring | No specific maternal or fetal monitoring is required for ophthalmic use due to low systemic absorption. However, if used systemically (not indicated), monitor renal function, blood pressure, and fetal ultrasound for oligohydramnios or ductus arteriosus constriction in third trimester. |
| Fertility Effects | No studies on fertility effects with ophthalmic flurbiprofen. Systemic NSAIDs may impair female fertility via prostaglandin synthesis inhibition affecting ovulation. Transient reversible effect with discontinuation. Relevance to ophthalmic use is negligible due to low systemic exposure. |