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Flurbiprofen (EENT) (Monograph)

Brand name: Ocufen
Drug class: Nonsteroidal Anti-inflammatory Agents
- Nonsteroidal Anti-inflammatory Agents, Ophthalmic
- NSAIAs, EENT
- NSAIDs, EENT

Introduction

Prototypical NSAIA; propionic acid derivative.1 2 3 4 16 17 18 19 20 21 23

Uses for Flurbiprofen (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 (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 (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 (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

≥99% (mainly albumin).3 67 69

May bind to erythrocytes.68

Stability

Storage

Ophthalmic

Solution

Tight, light-resistant containers105 at 15–25°C.1

Actions

Advice to Patients

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.

Flurbiprofen Sodium

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 2024, Selected Revisions August 1, 2007. 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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