Flurbiprofen (EENT) (monograph)
Flurbiprofen (EENT) (monograph)
introduction
Prototypical NSAIA; Propionic acid derivative.
Uses for flurbiprofen (EENT)
Inhibition of intraoperative miosis
Postoperative eye inflammation
Used to prevent and treat postoperative ocular inflammation† [off-label] associated with argon laser trabeculoplasty and cyclocryotherapy.
Cystoid macular edema
Used to prevent postoperative cystoid macular edema† [off-label] associated with cataract extraction.
Inhibition of corneal neovascularization
It has been reported to inhibit corneal neovascularization† [off-label] caused by chemical or thermal burns or prolonged contact lens use in preliminary animal studies.
Dosage and administration of flurbiprofen (EENT).
Administration
Ophthalmological administration
Apply topically to the eye as an ophthalmic solution.
Avoid contamination of the solution container.
dosage
Available as flurbiprofen sodium; Dosage expressed in flurbiprofen sodium.
Adult
Inhibition of intraoperative miosis
Ophthalmology
1 drop of 0.03% solution into the eye(s) to be operated on, starting 2 hours before surgery; Repeat at approximately 30 minute intervals for a total of 4 drops per affected eye.
Flurbiprofen (EENT) Precautions
Contraindications
Known hypersensitivity to flurbiprofen sodium or any of the components of the formulation.
Warnings/Precautions
Warnings
Hematological effects
May inhibit platelet aggregation and prolong bleeding time.
May cause increased bleeding of ocular tissue (including hyphema) when used in conjunction with eye surgery.
Caution should be exercised in patients with an underlying bleeding tendency or in patients taking medications known to prolong bleeding time. (See “Specific Medications” under “Interactions.”)
Sensitivity reactions
Hypersensitivity reactions
Possible cross-sensitivity with aspirin and other NSAIAs. Caution should be exercised in patients with a history of hypersensitivity to these drugs (severe, almost fatal, anaphylactic reaction to oral flurbiprofen has been reported) and in whom asthma, rhinitis, or urticaria are triggered by aspirin or other NSAIAs.
General precautions
Complications in wound healing
May slow or delay wound healing (including calluses).
Eye effects
Exacerbation of active epithelial herpes simplex keratitis (dendritic keratitis), more severe conjunctivitis, corneal perforation and/or corneal opacity have been reported in animals. Use with extreme caution in patients with active epithelial herpes simplex keratitis.
Specific populations
pregnancy
Category C
lactation
Excreted in milk after systemic administration; It is not known whether it passes into milk after topical application to the eye. Stop breast-feeding or taking the medicine.
Pediatric use
Safety and effectiveness not proven.
Geriatric use
No significant differences in safety and effectiveness compared to younger adults.
Common side effects
Stinging, burning or discomfort in the eye and other minor symptoms of eye irritation (e.g. tearing, dry eyes, dull eye pain, photophobia); Itching; Foreign body sensation; fibrosis; miosis; and mydriasis.
Interactions with other medications
Interactions with other topical eye medications have not been fully studied.
Specific medications
|
drug |
interaction |
Comments |
|---|---|---|
|
Acetylcholine chloride |
Decreased miotic effects have been reported when used with flurbiprofen, although recent clinical and animal studies do not suggest interactions |
|
|
Anesthetics, local (e.g. benoxinate, capsaicin) |
Additive effects on miotic inhibition during eye surgery have been demonstrated in animals |
|
|
Anticoagulants |
Possible bleeding complications |
Use with caution |
|
Carbachol |
Decreased miotic effects have been reported when used with flurbiprofen, although recent clinical and animal studies do not suggest interactions |
Flurbiprofen (EENT) pharmacokinetics
absorption
Bioavailability
Ophthalmic: Absorbed through the aqueous humor. Extent of systemic absorption not fully understood.
distribution
extent
The distribution in human ocular tissues and fluids has not yet been fully characterized.
It is not known whether flurbiprofen crosses the placenta. Excreted in milk after systemic administration; It is not known whether it passes into milk after topical application to the eye.
Plasma protein binding
≥99% (mainly albumin).
Can bind to erythrocytes.
stability
storage
Ophthalmology
Solution
Tight, light-resistant containers at 15-25°C.
Actions
-
Systemic pharmacological effects similar to other prototypical NSAIAs; has anti-inflammatory, analgesic and antipyretic effects. However, the risk of systemic effects following topical ophthalmic use appears to be minimal.
-
The exact mechanism of ocular action is not clearly understood, but it inhibits prostaglandin synthesis in the eye by inhibiting COX-1 and COX-2.
-
Prostaglandins are mediators of intraocular and extraocular inflammation. Prostaglandins also appear to produce a miotic response during eye surgery by constricting the iris sphincter independently of cholinergic mechanisms.
-
When applied topically to the eye, flurbiprofen inhibits or reduces miosis and ocular inflammation caused by ocular trauma (e.g., eye surgery).
Advice for patients
-
Risk of eye bleeding. Risk of anaphylactoid and other hypersensitivity reactions.
-
It is important to learn and follow proper administration techniques to avoid product contamination.
-
It is important for women to tell doctors if they are pregnant, plan to become pregnant, or want to breastfeed.
-
It is important to inform physicians about any existing or planned concomitant therapies, including prescription and over-the-counter medications, as well as any comorbidities.
-
It is important to inform patients of other important precautionary information. (See Precautions.)
More information
The American Society of Health-System Pharmacists, Inc. certifies that the information provided in the accompanying monograph has been formulated with reasonable care and in accordance with professional standards in the field. Readers are cautioned that drug use decisions are complex medical decisions that require the independent, informed decision of an appropriate health care professional and that the information contained in the monograph is provided for informational purposes only. For more detailed information, the manufacturer's label should be consulted. 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 commercial drug preparations may have clinically significant effects in some individuals; Details can be found on the respective product labeling.
For information about shortages of one or more of these drugs, visit the ASHP Drug Shortages Resource Center.
|
Routes |
Dosage forms |
Strengthen |
Brand names |
Manufacturer |
|---|---|---|---|---|
|
Ophthalmology |
Solution |
0.03% |
Flurbiprofen sodium ophthalmic solution (with thimerosal) |
Bausch & Lomb |
|
Ocufen (with thimerosal) |
Allergan |
AHFS DI Essentials™. © Copyright 2024, Selected changes 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 U.S. Food and Drug Administration-approved labeling.
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Flurbiprofen (EENT) (monograph)