Bexipred1%

Prednisolone acetate ophthalmic suspension is a potent topical corticosteroid used for the treatment of steroid-responsive inflammatory conditions of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the eye, including inflammation following eye surgery (such as cataract surgery), uveitis, and other inflammatory eye conditions where a corticosteroid is appropriate under a doctor's diagnosis.

Contains Bexipred 1% 1% as the active ingredient in a sterile ophthalmic suspension. Some formulations contain benzalkonium chloride as a preservative, which may be absorbed by soft contact lenses.

Prednisolone acetate is a potent topical corticosteroid eye drop commonly used to control inflammation of the front part of the eye, most often following cataract or other intraocular surgery, and in various inflammatory eye conditions such as uveitis. As one of the more potent ophthalmic steroids available, it is effective at controlling inflammation but also carries a comparatively higher risk of raising intraocular pressure with use, so it requires monitoring, particularly with courses lasting more than about 10 days.

Therapeutic Class: Ophthalmic Corticosteroid

Prednisolone acetate is formulated as a suspension (rather than a solution) to enhance corneal penetration and provide a depot effect, giving it strong anti-inflammatory potency relative to some other ophthalmic corticosteroids. Corticosteroids inhibit the inflammatory response to a variety of inciting agents, suppressing oedema, fibrin deposition, capillary dilation, leukocyte migration, and scar formation, but may also delay wound healing.

• Shake the suspension well immediately before each use
• Wash hands before use
• Tilt the head back, gently pull down the lower eyelid to form a pocket, and instill the prescribed number of drops
• Avoid touching the dropper tip to the eye or any surface, to prevent contamination
• Remove contact lenses before instillation and wait at least 15 minutes before reinserting, since the preservative benzalkonium chloride may be absorbed by soft contact lenses

Systemic absorption from topical ophthalmic use is generally limited, so significant systemic drug interactions are uncommon with normal use. If other eye medicines are used at the same time, doses should be spaced apart, and any concerns should be discussed with a doctor or pharmacist.

Common side effects

• Transient burning or stinging on instillation
• Blurred vision (temporary)
• Altered taste sensation
• Foreign body sensation in the eye

Serious side effects with prolonged use

• Raised intraocular pressure, which can progress to glaucoma with optic nerve damage and visual field defects
• Posterior subcapsular cataract formation
• Corneal and scleral thinning, reported with prolonged use of topical corticosteroids across various ocular conditions
• Delayed wound healing and increased risk of secondary ocular infection, including fungal infection

Pregnancy

Prednisolone has been shown to be teratogenic in animal studies when applied ocularly at high, repeated doses; there are no adequate, well-controlled studies in pregnant women. This medicine should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus, as advised by a doctor.

Breastfeeding

It is not known whether topical ophthalmic administration of Bexipred 1% results in sufficient systemic absorption to produce detectable amounts in human milk. Caution is advised, and use should be discussed with a healthcare professional.

• Prolonged use may result in raised intraocular pressure and glaucoma with optic nerve damage; intraocular pressure should be checked frequently if this product is used for 10 days or longer.
• Prolonged use may also increase the risk of posterior subcapsular cataract formation.
• Use of ocular corticosteroids may prolong the course and worsen the severity of many viral eye infections, including herpes simplex keratitis.
• Corticosteroids can suppress the host immune response, increasing the risk of secondary ocular infection, including fungal infection, particularly with extended use; fungal infection should be suspected in any persistent corneal ulceration where a steroid has been used.
• Not more than the initial prescribed quantity should be used without further examination of the patient by a physician.
• Contact lenses should generally be removed before instillation, given the risk of preservative absorption into soft lenses.

Overdosage with the topical use of this suspension will not ordinarily cause acute problems. If accidentally swallowed, drink fluids and contact a doctor or poison control center. Excessive or prolonged topical use increases the risk of the steroid-related eye effects described above; stop use and consult a doctor if irritation or symptoms worsen.

Store as directed on the product label, typically at controlled room temperature (15-25°C), tightly closed when not in use, and protected from light. Do not use after the labeled expiry date; discard any unused portion after the manufacturer's specified in-use period once opened.

• Children: Used under an ophthalmologist's direction for conditions such as postoperative inflammation; monitoring for intraocular pressure changes applies as in adults, and prolonged frequent use in young children has rarely been associated with adrenal suppression.
• Elderly: No specific dose adjustment is generally required, but monitor for intraocular pressure changes with prolonged use, as in any patient.

Treatment duration depends on clinical response and the underlying condition (such as a defined postoperative tapering schedule after cataract surgery, or ongoing treatment for chronic uveitis under specialist supervision). Because prolonged corticosteroid use increases the risk of raised eye pressure and cataract, intraocular pressure should be checked if treatment continues for 10 days or longer, and dosing should be tapered gradually rather than stopped abruptly in chronic use.

Drug Class: Topical ophthalmic glucocorticoid

Prednisolone acetate works by suppressing the local inflammatory response in ocular tissue, reducing swelling, redness, and cellular infiltration associated with inflammation, whether from surgery, injury, or an inflammatory eye condition. The exact biochemical mechanism by which corticosteroids control ocular inflammation is not fully established, but its effect broadly parallels that of corticosteroids used elsewhere in the body.

Prednisolone acetate is used in children under an ophthalmologist's supervision for steroid-responsive eye inflammation, including after eye surgery. The lowest effective dose and duration should be used, given the (rare) risk of adrenal suppression with very frequent, prolonged use of topical ophthalmic corticosteroids in young children.