- Prednisolone Acetate USP 1% w/v
- Benzalkonium Chloride 0.006% w/v (as preservative)
- Sterile Aqueous Vehicle Q.S.
Pharmacological classification: Corticosteroids
Prednisolone acetate is a synthetic adrenocorticoid with the general properties of prednisolone. Adrenocorticoids diffuse across cell membranes to complex with cytoplasmic receptors and subsequently stimulate synthesis of enzymes with anti-inflammatory effects. Glucocorticoids inhibits the oedema, fibrin deposition, capillary dilation and phargocytic migration of the acute inflammatory responses as well as capillary proliferation, deposition of collagen and scar formation. Prednisolone acetate has, on weight to weight basis, a potency three to five times that of hydrocortisone.
Prednisolone acetate has been shown to penetrate rapidly the cornea after topical application of a suspension preparation. Aqueous humour Tmax occurs between 30 and 45 minutes after installation. The half-life of prednisolone acetate in human aqueous humour is approximately 30 minutes.
Acute untreated purulent ocular infections. Acute superficial herpes simplex (dendritic keratitis); vaccinia, varicella and most other viral diseases of the cornea and conjunctiva. Fungal diseases of the eye. Mycobacterial infections such as tuberculosis of the eye.
Special precautions and warnings
Acute purulent infections of the eye may be masked or enhanced by the use of topical steroids. If infection is present, appropriate measures must be taken to counteract the infective organisms. Prolonged use may also suppress the host immune response and thus increase the hazard of secondary ocular infections.
Various ocular diseases and long-term use of topical corticosteroids have been known to cause corneal or scleral thinning. Use of topical corticosteroids in the presence of thin corneal or scleral tissue may lead to perforation.
Use of intraocular steroids may prolong the course and may exacerbate the severity of many viral infections on the eye (including herpes simplex). Patients with a history of herpes simplex keratitis should be treated with caution. Use of steroid medication in the presence of stromal herpes simplex requires caution and should be followed by frequent, mandatory, slit-lamp microscopy.
Prolonged use of topical corticosteroids may cause an increase in intraocular pressure in certain individuals. This may result in glaucoma with damage to the optic nerve with resultant defects in visual acuity and visual fields. Steroids should be used with caution in the presence of glaucoma. It is advisable that intraocular pressure be checked frequently during treatment with prednisolone acetate ophthalmic suspension.
Eye drops containing corticosteroids should not be used for more than 10 days except under strict ophthalmic supervision with regular checks for intraocular pressure.
Pregnancy: Prednisolone acetate ophthalmic suspension should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Lactation: It is not known whether topical administration of prednisolone acetate ophthalmic suspension could result in sufficient systemic absorption to produce detectable quantities in breast milk. Therefore, use is not recommended in women breast-feeding infants.
Dosage and directions for use
Shake well before using. Instill one to two drops 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. If signs and symptoms fail to improve after 2 days, the patient should be re-evaluated.
Adverse reactions include elevation of intraocular pressure with possible development of glaucoma and infrequent optic nerve damage, posterior subcapsular cataract formation, and delayed wound healing.
The development of secondary ocular infection may occur. Fungal and viral infections of the cornea are particularly prone to develop coincidentally with long-term applications of steroids. The possibility of fungal invasion should be considered in any persistent corneal ulceration.
Other adverse reactions are: allergic reations, dysgeusia; foreign body sensation; headache; pruritus; rash; transient burning and stinging upon instillation and other minor symptoms of ocular irritation; urticaria; and visual disturbance (blurry vision), keratitis, conjunctivitis, corneal ulcers, mydriasis, conjunctival hyperemia, loss of accommodation and ptosis.
Corticosteroid-containig preparations may cause anterior uveitis and perforation of the globe.