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 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.

Product summary:

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

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%
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