Land: Verenigde Staten
Taal: Engels
Bron: NLM (National Library of Medicine)
prednisolone acetate (UNII: 8B2807733D) (prednisolone - UNII:9PHQ9Y1OLM)
H.J. Harkins Company, Inc.
prednisolone acetate
prednisolone acetate 10 mg in 1 mL
OPHTHALMIC
PRESCRIPTION DRUG
Prednisolone acetate ophthalmic suspension 1.0% 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 1.0% 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 1.0% 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 1.0% is supplied sterile in opaque white LDPE plastic bottles with droppers with white high impact polystyrene (HIPS) caps as follows: 5mL in 10mL bottle - NDC 60758-119-05 10mL in 15mL bottle - NDC 60758-119-10 15mL in 15mL bottle - NDC 60758-119-15 Note: Store at temperatures up to 25°C (77°F). Protect from freezing. Store in an upright position. Rx only Revised June 2004 © 2004 PACIFIC PHARMA Irvine, CA 92612 U.S.A. Printed in U.S.A. 6294X 71592PY10P Repacked by:
New Drug Application Authorized Generic
PREDNISOLONE ACETATE - PREDNISOLONE ACETATE SUSPENSION/ DROPS H.J. HARKINS COMPANY, INC. ---------- PREDNISOLONE ACETATE OPHTHALMIC SUSPENSION, USP 1.0% sterile DESCRIPTION Prednisolone acetate ophthalmic suspension, USP 1.0% is a topical anti-inflammatory agent for ophthalmic use. CHEMICAL NAME: 11ß,17, 21-Trihydroxypregna-1,4-diene-3, 20-dione 21-acetate CONTAINS: ACTIVE: prednisolone acetate (microfine suspension) 1.0%. PRESERVATIVE: benzalkonium chloride. INACTIVES: 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. STRUCTURAL FORMULA: PREDNISOLONE ACETATE 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 1.0% 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 1.0% 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 1.0% 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 glaucoma with damage to the optic nerve, defects in visual acuity and fields of vision, and in posterior subcapsular cataract formation. Prolonged use may also suppress the Lees het volledige document