Ocusol 0.01

INDICATIONS

Steroid responsive inflammatory conditions of the palpebral and bulbar conjunctiva, cornea and anterior segment of the globe such as allergic conjunctivitis, acne rosacea, superficial punctate keratitis, herpes zoster keratitis, iritis, cyclitis, selected infective conjunctivitides when the inherent ... Read moreSteroid responsive inflammatory conditions of the palpebral and bulbar conjunctiva, cornea and anterior segment of the globe such as allergic conjunctivitis, acne rosacea, superficial punctate keratitis, herpes zoster keratitis, iritis, cyclitis, selected infective conjunctivitides when the inherent hazard of steroid use is accepted to obtain an advisable diminution in edema and inflammation; corneal injury from chemical, radiation or thermal burns or penetration of foreign bodies.

PHARMACOLOGY

Prednisolone Acetate is a corticosteroid that, on the basis of weight, has 3 to 5 times the anti-inflammatory potency of Hydrocortisone.Corticosteroids inhibit the edema, fibrin deposition, capillary dilation, leukocyte migration, capillary proliferation, fibroblast proliferation, deposition of collagen and scar formation associated with inflammation.There is no generally accepted explanation for the mechanism of action of ocular corticosteroids. However, corticosteroids are thought to act by the induction of phospholipase A2 inhibitory proteins, collectively called lipocortins. It is postulated that these proteins control the biosynthesis of potent mediators of inflammation such as prostaglandins and leukotrienes by inhibiting release of their common precursor arachidonic acid. Arachidonic acid is released from membrane phospholipids by phospholipase A2.

DOSAGE & ADMINISTRATION

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.

INTERACTION

Specific drug interaction studies have not been conducted with Prednisolone Acetate BP 1% ophthalmic suspension.

SIDE EFFECTS

Adverse reactions include, in decreasing order of frequency, elevation of intraocular pressure (IOP) with possible development of glaucoma, infrequent optic nerve damage, posterior subcapsular cataract formation and delayed wound healing.Corticosteroid-containing preparations have also been reported to cause acute anterior uveitis and perforation of the globe. Keratitis, conjunctivitis, corneal ulcers, mydriasis, conjunctival hyperemia, loss of accommodation and ptosis have occasionally been reported following local use of corticosteroids.The development of secondary ocular infection (bacterial, fungal and viral) has occurred in some cases.

PREGNANCY & LACTATION

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 administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in breast milk. So, this drug should be used in nursing mother only if the potential benefit justifies the potential risk to the fetus.

PRECAUTIONS & WARNINGS

If signs and symptoms fail to improve after 2 days, the patient should be re-evaluated. As fungal infections of the cornea are particularly prone to develop coincidentally with long-term local corticosteroid applications, fungal invasion should be suspected in any persistent corneal ulceration where a corticosteroid has been used or is in use. Fungal cultures should be taken when appropriate. If this product is used for 10 days or longer, intraocular pressure should be monitored. Do not touch dropper tip to any surface as this may contaminate this preparation.

THERAPEUTIC CLASS

Glucocorticoids

STORAGE CONDITIONS

Store at below 30°C in a dry place protected from light and freezing. It is desirable that the contents should not be used more than one month after first opening of the bottle.