Ocufen eent

Inhibition of Intraoperative Miosis

Prophylactically before ocular surgery (e.g., cataract extraction)74 102 to prevent or reduce intraoperative miosis.1 74 102

Postoperative Ocular Inflammation

Has been used for prevention and management of postoperative ocular inflammation† associated with argon laser trabeculoplasty and cyclocryotherapy.75 76 78

Cystoid Macular Edema

Has been used for prevention of postoperative cystoid macular edema† associated with cataract extraction.48 120

Inhibition of Corneal Neovascularization

Has been reported to inhibit corneal neovascularization† induced by chemical or thermal burns or prolonged use of contact lenses in preliminary research in animals.79 80 81 121

Contraindications

Known hypersensitivity to flurbiprofen sodium or any ingredient in the formulation.1

Warnings/Precautions

Warnings

May inhibit platelet aggregation and prolong bleeding time.1 4 28 29 30 31 32 33

May cause increased bleeding of ocular tissues (including hyphemas) when used in conjunction with ocular surgery.1

Use with caution in patients with underlying bleeding tendencies or in those receiving drugs known to prolong bleeding time.1 (See Specific Drugs under Interactions.)

Sensitivity Reactions

Possible cross-sensitivity with aspirin and other NSAIAs.1 3 Use with caution in patients with history of hypersensitivity to these drugs (severe, nearly fatal anaphylactic reaction to oral flurbiprofen reported)86 and in whom asthma, rhinitis, or urticaria is precipitated by aspirin or other NSAIAs.1 3

General Precautions

May slow or delay wound healing (including corneal).1 84

Exacerbation of active epithelial herpes simplex keratitis (dendritic keratitis), more severe conjunctivitis, corneal perforation, and/or clouding of cornea reported in animals.85 Use with extreme caution in patients with active epithelial herpes simplex keratitis.103

Specific Populations

Category C.1

Distributed into milk after systemic administration;117 118 not known whether distributed into milk after topical application to the eye.1 Discontinue nursing or the drug.1

Safety and efficacy not established.1

No substantial differences in safety and efficacy relative to younger adults.1

Common Adverse Effects

Ocular stinging,1 74 101 burning,1 76 78 101 or discomfort78 and other minor symptoms of ocular irritation1 (e.g., tearing, dry eye sensation, dull eye pain, photophobia);101 103 105 itching;78 101 105 foreign body sensation;78 105 fibrosis;1 miosis;1 and mydriasis.1

Absorption

Bioavailability

Ophthalmic: Absorbed through the aqueous humor.119 Extent of systemic absorption not fully elucidated.1 101 104

Distribution

Extent

Distribution into human ocular tissues and fluids not fully characterized to date.101 103 104

Not known whether flurbiprofen crosses the placenta.103 Distributed into milk after systemic administration;117 118 not known whether distributed into milk after topical application to the eye.1

Plasma Protein Binding

≥99% (mainly albumin).3 67 69

May bind to erythrocytes.68

• Systemic pharmacologic actions similar to other prototypical NSAIAs; exhibits anti-inflammatory, analgesic, and antipyretic activity.1 3 7 8 10 11 12 14 15 16 17 21 26 27 However, risk of systemic effects appears minimal following topical ophthalmic use.1 74 75 76 78 103 105

• Exact mechanism of ocular effects not clearly established, but inhibits ocular prostaglandin synthesis by inhibiting COX-1 and COX-2.1 3 4 18 19 20 21 23 24 25 35 36 37 39 40 43 45 51 52 59 64 74 101 107 108 109 110 111 112

• Prostaglandins are mediators of intraocular and extraocular inflammation.1 35 36 37 39 40 52 57 58 74 75 76 Prostaglandins also appear to produce a miotic response during ocular surgery by constricting the iris sphincter1 35 51 64 74 independently of cholinergic mechanisms.1 74

• Following topical application to the eye, flurbiprofen inhibits or reduces miosis1 35 40 74 102 and ocular inflammation75 76 78 84 120 induced by ocular trauma (e.g., ocular surgery).

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.