Land: USA
Sprog: engelsk
Kilde: NLM (National Library of Medicine)
PREDNISOLONE ACETATE (UNII: 8B2807733D) (PREDNISOLONE - UNII:9PHQ9Y1OLM)
NuCare Pharmaceuticals,Inc.
OPHTHALMIC
PRESCRIPTION DRUG
Prednisolone acetate ophthalmic suspension 1% is indicated for the treatment of steroid-responsive inflammation of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the globe. Prednisolone acetate ophthalmic suspension 1% is contraindicated in acute untreated purulent ocular infections, 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 1% is also contraindicated in individuals with known or suspected hypersensitivity to any of the ingredients of this preparation and to other corticosteroids.
Prednisolone acetate ophthalmic suspension, USP 1% is supplied sterile in opaque white LDPE plastic bottles with droppers with pink high impact polystyrene (HIPS) caps as follows: 5 mL in 10 mL bottle - NDC 68071-2222-5 Store at up to 25°C (77°F). Protect from freezing. Store in an upright position. Revised: 05/2020 Distributed by: Allergan USA, Inc. Madison, NJ 07940 © 2020 Allergan. All rights reserved. All trademarks are the property of their respective owners. v1.2USPI0119
New Drug Application Authorized Generic
PREDNISOLONE ACETATE- PREDNISOLONE ACETATE SUSPENSION/ DROPS NUCARE PHARMACEUTICALS,INC. ---------- PREDNISOLONE ACETATE OPHTHALMIC SUSPENSION, USP 1% STERILE DESCRIPTION Prednisolone acetate ophthalmic suspension, USP 1% is a sterile, topical anti- inflammatory agent for ophthalmic use. Its chemical name is 11ß,17, 21- Trihydroxypregna-1,4-diene-3, 20-dione 21-acetate and it has the following structure: STRUCTURAL FORMULA: prednisolone acetate Each mL of prednisolone acetate ophthalmic suspension 1% contains: ACTIVE: prednisolone acetate (microfine suspension) 1% INACTIVES: benzalkonium chloride as preservative; boric acid; edetate disodium; hypromellose; polysorbate 80; purified water; sodium bisulfite; sodium chloride; and sodium citrate. The pH during its shelf life ranges from 5.0 - 6.0. CLINICAL PHARMACOLOGY Prednisolone acetate is a glucocorticoid that, on the basis of weight, has 3 to 5 times the anti-inflammatory potency of hydrocortisone. Glucocorticoids inhibit the edema, fibrin deposition, capillary dilation, and phagocytic migration of the acute inflammatory response, as well as capillary proliferation, deposition of collagen, and scar formation. INDICATIONS AND USAGE Prednisolone acetate ophthalmic suspension 1% is indicated for the treatment of steroid-responsive inflammation of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the globe. CONTRAINDICATIONS Prednisolone acetate ophthalmic suspension 1% is contraindicated in acute untreated purulent ocular infections, 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 1% is also contraindicated in individuals with known or suspected hypersensitivity to any of the ingredients of this preparation and to other corticosteroids. WARNINGS Prolonged use of corticosteroids may result in posterior subcapsular catar Læs hele dokumentet