Steroid-responsive inflammatory conditions of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the eye, including allergic conjunctivitis, acne rosacea, superficial punctate keratitis, herpes zoster keratitis, iritis, cyclitis, and selected infective conjunctivitides where the benefits of steroid therapy outweigh the potential risks, in order to reduce edema and inflammation. It is also indicated in corneal injuries caused by chemical, radiation, or thermal burns, as well as injuries involving foreign body penetration.

Prednisolone acetate is a corticosteroid with approximately 3 to 5 times greater anti-inflammatory potency than hydrocortisone (on a weight basis). Corticosteroids act by inhibiting edema formation, fibrin deposition, capillary dilation, leukocyte migration, capillary proliferation, fibroblast proliferation, collagen deposition, and scar formation associated with inflammation.

The exact mechanism of ocular corticosteroid action is not fully established. However, corticosteroids are believed to act through induction of phospholipase A2 inhibitory proteins known as lipocortins. These proteins suppress the biosynthesis of inflammatory mediators such as prostaglandins and leukotrienes by blocking the release of arachidonic acid, their common precursor. Arachidonic acid is released from membrane phospholipids by phospholipase A2.

Shake well before using. Instill 1 drop into the conjunctival sac two to four times daily. During the initial 24 to 48 hours, the dosing frequency may be increased if necessary. Care should be taken not to discontinue therapy prematurely.

No specific drug interaction studies have been conducted with Prednisolone Acetate BP 1% ophthalmic suspension.

Prednisolone Acetate 1% ophthalmic suspension is contraindicated in most viral infections of the cornea and conjunctiva, including epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, and varicella. It is also contraindicated in ocular tuberculosis, fungal infections of the eye, and in patients with known or suspected hypersensitivity to any component of the formulation.

Adverse reactions include, in decreasing order of frequency: increased intraocular pressure (IOP) with possible development of glaucoma, rare optic nerve damage, posterior subcapsular cataract formation, and delayed wound healing.

Corticosteroid eye preparations have also been associated with acute anterior uveitis and, in rare cases, perforation of the globe. Keratitis, conjunctivitis, corneal ulceration, mydriasis, conjunctival hyperemia, reduced accommodation, and ptosis have occasionally been reported.

Secondary ocular infections (bacterial, fungal, or viral) may also occur during prolonged use.

There are no adequate and well-controlled studies in pregnant women. Prednisolone Acetate BP 1% ophthalmic suspension should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. It is not known whether topical ophthalmic corticosteroids are absorbed systemically in sufficient amounts to appear in breast milk. Therefore, use in nursing mothers should be considered only if clearly needed.

If signs and symptoms do not improve after 2 days, the patient should be re-evaluated. Fungal infections of the cornea may develop during prolonged topical corticosteroid use; therefore, fungal infection should be suspected in any persistent corneal ulceration where steroids are used or have been used. Fungal cultures should be taken when appropriate. If used for 10 days or longer, intraocular pressure should be regularly monitored. Do not touch the dropper tip to any surface to avoid contamination.

Accidental overdose is unlikely to cause acute problems. If accidentally ingested, fluids should be taken to dilute the drug.

Glucocorticoids

Store below 30°C in a dry place, protected from light and freezing. Do not use the contents more than one month after first opening the bottle.