Flurbiprofen Sodium (EENT) (Monograph)
Brand name: Ocufen
Drug class: Nonsteroidal Anti-inflammatory Agents
Introduction
Prototypical NSAIA; propionic acid derivative.1 2 3 4 16 17 18 19 20 21 23
Uses for Flurbiprofen Sodium (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† [off-label] associated with argon laser trabeculoplasty and cyclocryotherapy.75 76 78
Cystoid Macular Edema
Has been used for prevention of postoperative cystoid macular edema† [off-label] associated with cataract extraction.48 120
Inhibition of Corneal Neovascularization
Has been reported to inhibit corneal neovascularization† [off-label] induced by chemical or thermal burns or prolonged use of contact lenses in preliminary research in animals.79 80 81 121
Flurbiprofen Sodium (EENT) Dosage and Administration
Administration
Ophthalmic Administration
Apply topically to the eye as an ophthalmic solution.1 74
Avoid contamination of the solution container.94
Dosage
Available as flurbiprofen sodium; dosage expressed in terms of flurbiprofen sodium.1 113
Adults
Inhibition of Intraoperative Miosis
Ophthalmic
1 drop of 0.03% solution into the eye(s) undergoing surgery beginning 2 hours before the surgery; repeat at approximately 30-minute intervals for a total of 4 drops per affected eye.1
Cautions for Flurbiprofen Sodium (EENT)
Contraindications
Known hypersensitivity to flurbiprofen sodium or any ingredient in the formulation.1
Warnings/Precautions
Warnings
Hematologic Effects
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
Hypersensitivity 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
Wound-healing Complications
May slow or delay wound healing (including corneal).1 84
Ocular Effects
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
Pregnancy
Category C.1
Lactation
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
Pediatric Use
Safety and efficacy not established.1
Geriatric Use
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
Drug Interactions
Interactions with other topical ophthalmic drugs not fully evaluated.1
Specific Drugs
Drug |
Interaction |
Comments |
---|---|---|
Acetylcholine chloride |
Diminished miotic effect reported when used with flurbiprofen, although recent clinical and animal studies suggest no interaction1 115 116 |
|
Anesthetics, local (e.g., benoxinate, capsaicin) |
Additive effects on miotic inhibition during ocular surgery demonstrated in animals40 |
|
Anticoagulants |
Possible bleeding complications1 |
Use with caution1 |
Carbachol |
Diminished miotic effect reported when used with flurbiprofen, although recent clinical and animal studies suggest no interaction1 115 116 |
Flurbiprofen Sodium (EENT) Pharmacokinetics
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
May bind to erythrocytes.68
Stability
Storage
Ophthalmic
Solution
Tight, light-resistant containers105 at 15–25°C.1
Actions
-
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).
Advice to Patients
-
Risk of ocular bleeding.1 Risk of anaphylactoid and other sensitivity reactions.1
-
Importance of learning and adhering to proper administration techniques to avoid contamination of the product.94
-
Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.1
-
Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as any concomitant illnesses.1
-
Importance of informing patients of other important precautionary information.1 (See Cautions.)
Additional Information
The American Society of Health-System Pharmacists, Inc. represents that the information provided in the accompanying monograph was formulated with a reasonable standard of care, and in conformity with professional standards in the field. Readers are advised that decisions regarding use of drugs are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and that the information contained in the monograph is provided for informational purposes only. The manufacturer’s labeling should be consulted for more detailed information. The American Society of Health-System Pharmacists, Inc. does not endorse or recommend the use of any drug. The information contained in the monograph is not a substitute for medical care.
Preparations
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.
Routes |
Dosage Forms |
Strengths |
Brand Names |
Manufacturer |
---|---|---|---|---|
Ophthalmic |
Solution |
0.03% |
Flurbiprofen Sodium Ophthalmic Solution (with thimerosal) |
Bausch & Lomb |
Ocufen (with thimerosal) |
Allergan |
AHFS DI Essentials™. © Copyright 2025, Selected Revisions September 10, 2024. American Society of Health-System Pharmacists, Inc., 4500 East-West Highway, Suite 900, Bethesda, Maryland 20814.
† Off-label: Use is not currently included in the labeling approved by the US Food and Drug Administration.
References
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