PREDNISOLONE ACETATE suspension/ drops

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

prednisolone acetate (UNII: 8B2807733D) (prednisolone - UNII:9PHQ9Y1OLM)

Available from:

H.J. Harkins Company, Inc.

INN (International Name):

prednisolone acetate

Composition:

prednisolone acetate 10 mg in 1 mL

Administration route:

OPHTHALMIC

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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.

Product summary:

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:

Authorization status:

New Drug Application Authorized Generic

Summary of Product characteristics

PREDNISOLONE ACETATE - PREDNISOLONE ACETATE SUSPENSION/ DROPS
H.J. HARKINS COMPANY, INC.
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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