Pred Forte®
Prednisolone Acetate 1.0% · ophthalmic suspension
Steroid
Approved uses
Steroid-responsive inflammation of the conjunctiva, cornea, and anterior segment
1 to 2 drops into the conjunctival sac 2 to 4 times daily, frequency increased during the initial 24 to 48 hours if needed
At 8 doses daily, anterior chamber cells fall 2 grades by day 14 and clear completely in 64% by day 21.
OFF-LABELNot in the FDA label for this product
Maintenance steroid after Descemet membrane endothelial keratoplasty, for rejection prophylaxis
Trial regimen, 1% suspension QID for 2 months, TID for 1 month, BID for 1 month, then QD for 7 months, started 1 month after DMEK
RCT · n=233 · higher IOP rise
Prospective randomized evaluator-masked trial, 167 patients randomized 1 to 1 at one month after DMEK with 66 fellow eyes assigned to the opposite treatment, 233 eyes in total. No immunologic rejection episode occurred in either arm (0%, P = 1). IOP elevation (IOP 24 mmHg or higher, or a rise of 10 mmHg or more over preoperative baseline) occurred in 25% of prednisolone-treated eyes versus 11% of loteprednol etabonate 0.5% gel eyes (relative risk 2.3, 95% CI 1.2 to 4.5, P = 0.016); the authors concluded loteprednol gel was as effective at preventing rejection and significantly less likely to raise IOP.
Contraindications
- Acute untreated purulent ocular infection
- Most viral diseases of the cornea and conjunctiva, including epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, and varicella
- Mycobacterial infection of the eye
- Fungal diseases of ocular structures
- Known or suspected hypersensitivity to any ingredient of the preparation or to other corticosteroids
Available Forms1% suspension, 1 mL in 5 mL bottle, 5 mL in 10 mL bottle, 10 mL in 15 mL bottle, 15 mL in 15 mL bottle
Mechanism of ActionGlucocorticoid with 3 to 5 times the anti-inflammatory potency of hydrocortisone on a weight basis. Inhibits the edema, fibrin deposition, capillary dilation, and phagocytic migration of acute inflammation, and the later capillary proliferation, collagen deposition, and scar formation.
Warnings & Precautions
- Elevated IOP: Prolonged use may increase IOP in susceptible individuals, producing glaucoma with optic nerve damage and defects in visual acuity and fields of vision; monitor IOP routinely when used 10 days or longer, and use with caution in the presence of glaucoma.
- Posterior subcapsular cataract: Prolonged corticosteroid use may produce cataract formation.
- Secondary ocular infection: Prolonged use suppresses the host immune response; acute purulent infections of the eye may be masked or their activity enhanced.
- Corneal and scleral thinning: Various ocular diseases and long-term topical corticosteroid use cause thinning, and use over thin corneal or scleral tissue may lead to perforation.
- Fungal invasion: Suspect fungal infection in any persistent corneal ulceration where a corticosteroid has been used or is in use, and take fungal cultures when appropriate.
- Viral keratitis exacerbation: Ocular steroids may prolong the course and exacerbate the severity of many viral eye infections including herpes simplex; a history of herpes simplex demands great caution and frequent slit lamp microscopy.
- Delayed healing after cataract surgery: Steroid use may delay healing and increase the incidence of bleb formation.
- Sulfite sensitivity: Contains sodium bisulfite, which may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people; sulfite sensitivity is seen more frequently in asthmatic than in non-asthmatic people, and its overall prevalence is unknown and probably low.
- Benzalkonium chloride: May be absorbed by soft contact lenses; remove lenses before instillation and reinsert no sooner than 15 minutes afterward.
Common Side Effects
- Ocular, steroid class: Elevated IOP with possible development of glaucoma and infrequent optic nerve damage, posterior subcapsular cataract formation, delayed wound healing.
- Ocular irritation: Transient burning and stinging on instillation, eye pain, foreign body sensation, blurred vision, other minor irritation.
- Secondary ocular infection: Bacterial, fungal, and viral infection has occurred; fungal and viral corneal infection is particularly prone to develop with long-term use.
- Corticosteroid class reports: Keratitis, conjunctivitis, corneal ulcers, mydriasis, conjunctival hyperemia, loss of accommodation, and ptosis occasionally follow local corticosteroid use, and corticosteroid-containing preparations have been reported to cause acute anterior uveitis and perforation of the globe.
- Systemic: Allergic reactions, dysgeusia, headache, pruritus, rash, urticaria.
Pregnancy & LactationPregnancy: Prednisolone is teratogenic in mice at 1 to 10 times the human dose, with a significant increase in cleft palate in fetuses after ocular application 5 times daily on gestation days 10 through 13; no adequate well-controlled studies in pregnant women, so use only if the potential benefit justifies the potential risk to the fetus.
Lactation: Unknown whether topical ophthalmic corticosteroid produces detectable quantities in breast milk; systemically administered corticosteroids do appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects, so weigh discontinuing nursing against discontinuing the drug.
Pediatric UseSafety and effectiveness established in pediatric patients.