Prednisolone Acetate Ophthalmic Suspension, USP, 1%

Contents

Revised June 2004

Prednisolone acetate ophthalmic suspension Sterile corticosteroid product. ophthalmic suspension Veldthet active ingredient is represented by the chemical structure

Established name: PrednisolonaCetate

Chemical name: pregna-1, 4-dien-3, 20-dion, 21-(acetyloxy)-11, 17-dihydroxy, (11β)-.

For all ML: active : prednisolone acetate 1, 0%. Storage: Benzalkonium chloride 0, 01%. Vehicle: hypromellose. difficile: citric acid (for pH adjustment), sodium dibasic phosphate, disodium edetate, glycerin, polysorbate 80, clear water, sodium hydroxide (pH adjustment).

Prednisolone acetate Glucocorticoids are above the ignition inhibitory potency of hydrocortisone on a body weight basis 3-5. Glucocorticoids inhibit edema, fibrin deposits, capillary dilation, and skin cell migration in acute inflammatory reactions, as well as capillary proliferation, collagen deposition, and scarring.

Prednisolone acetate ophthalmic suspension 1, 0% is indicated for the healing of steroid-sensitive inflammation of the orbital and bulbar conjunctiva, cornea, and globus section of the anterior globe.

Steroidal inflammatory disorders of the orbital and bulboconjunctiva, cornea, and anterior aspect of the globe, including allergic conjunctivitis, rosacea with acne, superficial pitting worm, herpes zoster, and paralytic conjunctivitis. Corneal damage caused by chemicals, radiation or thermal burns, or foreign body intrusion.

Prednisolone acetate ophthalmic suspension Contraindicated in most viral disorders of the cornea and conjunctiva. Epithelial herpes includes dermatitis (dendritic keratitis), vaccinia, water cell, and mycobacterial infections of the eye and interesting diseases. Prednisolone. acetate ophthalmic suspension is also contraindicated in people with known or suspected hypersensitivity to this product and one of the other corticosteroid ingredients.

Breastfeeding mothers.

It is not known or ophthalmic admission of corticosteroids may result in systemic absorption sufficient to produce detectable amounts in breast milk. Systemically administered corticosteroids are observed in breast milk and can destroy the rise or endogenous corticosteroid production and cause other side effects. Because of the potential for serious side effects in breastfed babies prednisolone Given the importance of the product to the mother, it is a footprint to determine if breastfeeding is being phased out.

Safety and efficacy in pediatric patients have been established. Application to pediatric patients is supported by data from appropriate, well-controlled studies of prednisolone acetate ophthalmic suspension maturity using additional data from pediatric patients.