PREDNISOLONE ACETATE- 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:

NuCare Pharmaceuticals,Inc.

Administration route:

OPHTHALMIC

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 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.

Product summary:

Prednisolone acetate ophthalmic suspension, USP 1% is supplied sterile in opaque white LDPE plastic bottles with droppers with white high impact polystyrene (HIPS) caps as follows: NDC 68071-1722-5 Box of 5 mL Storage: Store at temperatures up to 25°C (77°F). Protect from freezing. Store in an upright position. Revised: 03/2014 © 2014 Allergan, Inc. Irvine, CA 92612, U.S.A. ® marks owned by Allergan, Inc. Made in the U.S.A. 71592PY11

Authorization status:

New Drug Application Authorized Generic

Summary of Product characteristics

PREDNISOLONE ACETATE- PREDNISOLONE ACETATE SUSPENSION/ DROPS
NUCARE PHARMACEUTICALS,INC.
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PREDNISOLONE ACETATE
OPHTHALMIC SUSPENSION, USP 1%
S TERILE
DESCRIPTION
Prednisolone acetate ophthalmic suspension, USP 1% 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%
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% 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
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 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 host immune