Brand name: Ocufen
Drug class: Nonsteroidal Anti-inflammatory Agents

Medically reviewed by Drugs.com on Sep 10, 2024. Written by ASHP.

Introduction

Prototypical NSAIA; propionic acid derivative.

Uses for Flurbiprofen Sodium (EENT)

Inhibition of Intraoperative Miosis

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

Postoperative Ocular Inflammation

Has been used for prevention and management of postoperative ocular inflammation^{† [off-label]} associated with argon laser trabeculoplasty and cyclocryotherapy.

Cystoid Macular Edema

Has been used for prevention of postoperative cystoid macular edema^{† [off-label]} associated with cataract extraction.

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.

Flurbiprofen Sodium (EENT) Dosage and Administration

Administration

Ophthalmic Administration

Apply topically to the eye as an ophthalmic solution.

Avoid contamination of the solution container.

Dosage

Available as flurbiprofen sodium; dosage expressed in terms of flurbiprofen sodium.

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.

Cautions for Flurbiprofen Sodium (EENT)

Contraindications

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

Warnings/Precautions

Warnings

Hematologic Effects

May inhibit platelet aggregation and prolong bleeding time.

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

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

Sensitivity Reactions

Hypersensitivity Reactions

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

General Precautions

Wound-healing Complications

May slow or delay wound healing (including corneal).

Ocular Effects

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

Specific Populations

Pregnancy

Category C.

Lactation

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

Pediatric Use

Safety and efficacy not established.

Geriatric Use

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

Common Adverse Effects

Ocular stinging, burning, or discomfort and other minor symptoms of ocular irritation (e.g., tearing, dry eye sensation, dull eye pain, photophobia); itching; foreign body sensation; fibrosis; miosis; and mydriasis.

Drug Interactions

Interactions with other topical ophthalmic drugs not fully evaluated.

Specific Drugs

Flurbiprofen Sodium (EENT) Pharmacokinetics

Absorption

Bioavailability

Ophthalmic: Absorbed through the aqueous humor. Extent of systemic absorption not fully elucidated.

Distribution

Extent

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

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

Plasma Protein Binding

≥99% (mainly albumin).

May bind to erythrocytes.

Stability

Storage

Ophthalmic

Solution

Tight, light-resistant containers at 15–25°C.

Actions

• Systemic pharmacologic actions similar to other prototypical NSAIAs; exhibits anti-inflammatory, analgesic, and antipyretic activity. However, risk of systemic effects appears minimal following topical ophthalmic use.

• Exact mechanism of ocular effects not clearly established, but inhibits ocular prostaglandin synthesis by inhibiting COX-1 and COX-2.

• Prostaglandins are mediators of intraocular and extraocular inflammation. Prostaglandins also appear to produce a miotic response during ocular surgery by constricting the iris sphincter independently of cholinergic mechanisms.

• Following topical application to the eye, flurbiprofen inhibits or reduces miosis and ocular inflammation induced by ocular trauma (e.g., ocular surgery).

Advice to Patients

• Risk of ocular bleeding. Risk of anaphylactoid and other sensitivity reactions.

• Importance of learning and adhering to proper administration techniques to avoid contamination of the product.

• Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.

• Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as any concomitant illnesses.

• Importance of informing patients of other important precautionary information. (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.

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