Prednisolone Acetate (Suspension)
SHAKE WELL BEFORE USING. Two drops in the eye(s) four times daily. In cases of bacterial infections, concomitant use of anti-infective agents is mandatory. Care should be taken not to discontinue therapy prematurely. If signs and symptoms fail to improve after two days, the patient should be re-evaluated (SEE PRECAUTIONS). The dosing of Prednisolone Acetate Ophthalmic Suspension USP, 1% may be reduced, but care should be taken not to discontinue therapy prematurely. In chronic conditions, withdrawal of treatment should be carried out by gradually decreasing the frequency of applications. FOR TOPICAL OPHTHALMIC USE ONLY.
Prednisolone Acetate Ophthalmic Suspension USP, 1% is an adrenocortical steroid product prepared as a sterile ophthalmic suspension. The active ingredient is represented by the chemical structure: Each mL contains: Active: Prednisolone Acetate 1.0%. Preservative: Benzalkonium Chloride 0.01%. Vehicle: Hypromellose 2910. Inactives: Dibasic Sodium Phosphate, Polysorbate 80, Edetate Disodium, Glycerin, Citric Acid and/or Sodium Hydroxide (to adjust pH), and Purified Water.
Corticosteroids inhibit the inflammatory response to a variety of inciting agents and probably delay or slow healing. They 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 Ainhibitory 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 the release of their common precursor arachidonic acid. Arachidonic acid is released from membrane phospholipids by phospholipase A. Corticosteroids are capable of producing a rise in intraocular pressure.
Prednisolone Acetate Ophthalmic Suspension USP, 1% is contraindicated in most viral diseases of the cornea and conjunctiva including epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, and varicella, and also in mycobacterial infection of the eye and fungal diseases of ocular structures. Prednisolone Acetate Ophthalmic Suspension USP, 1% is also contraindicated in individuals with known or suspected hypersensitivity to any of the ingredients of this preparation and to other corticosteroids.
5mL, 10mL and 15mL in plastic DROP-TAINER* dispensers. 5 mL - NDC 61314-637-05 10 mL - NDC 61314-637-10 15 mL - NDC 61314-637-15 STORAGE: Store at 8��- 24��C (46��- 75��F) in an UPRIGHT position. Rx Only Revised: August 2003 *DROP-TAINER is a registered trademark of Alcon Manufacturing, Ltd. Dist. by:FALCON Pharmaceuticals Ltd.Fort Worth, Texas 76134 USA Mfd. by:ALCON LABORATORIES, INC.Fort Worth, Texas 76134 USA Printed in USA 340904-0803
dailymed-ingredient:benzalkonium_chloride, dailymed-ingredient:citric_acid, dailymed-ingredient:dibasic_sodium_phosphate, dailymed-ingredient:edetate_disodium, dailymed-ingredient:glycerin, dailymed-ingredient:hypromellose_2910, dailymed-ingredient:polysorbate_80, dailymed-ingredient:sodium_hydroxide, dailymed-ingredient:water
Prednisolone Acetate (Suspension)
Adverse reactions include, in decreasing order of frequency, elevation of intraocular pressure (IOP) with possible development of glaucoma and infrequent optic nerve damage, posterior subcapsular cataract formation, and delayed wound healing. Although systemic effects are extremely uncommon, there have been rare occurrences of systemic hypercorticoidism after use of topical steroids. 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. Fungal and viral infections of the cornea are particularly prone to develop coincidentally with long-term applications of steroid. The possibility of fungal invasion should be considered in any persistent corneal ulceration where steroid treatment has been used (SEE WARNINGS).
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 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.