PRED FORTE- 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:

Allergan, Inc.

Administration route:

OPHTHALMIC

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

PRED FORTE ® is indicated for the treatment of steroid-responsive inflammation of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the globe. PRED FORTE ® suspension 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. PRED FORTE ® suspension is also contraindicated in individuals with known or suspected hypersensitivity to any of the ingredients of this preparation and to other corticosteroids.

Product summary:

PRED FORTE ® (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:       1 mL in 5 mL bottle     - NDC 11980-180-01 5 mL in 10 mL bottle   - NDC 11980-180-05 10 mL in 15 mL bottle - NDC 11980-180-10 15 mL in 15 mL bottle - NDC 11980-180-15 Storage : Store at up to 25°C (77°F). Protect from freezing. Store in an upright position. Revised : 02 / 2024 Distributed by: AbbVie, Inc. North Chicago, IL 60064 © 2024 AbbVie. All rights reserved.        Pred Forte and its design are trademarks of Allergan, Inc., an AbbVie company. v2.0USPI180

Authorization status:

New Drug Application

Summary of Product characteristics

PRED FORTE- PREDNISOLONE ACETATE SUSPENSION/ DROPS
ALLERGAN, INC.
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PRED FORTE
(PREDNISOLONE ACETATE OPHTHALMIC SUSPENSION, USP) 1%
STERILE
DESCRIPTION
PRED FORTE (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:
Each mL of PRED FORTE 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
PRED FORTE is indicated for the treatment of steroid-responsive
inflammation of the
palpebral and bulbar conjunctiva, cornea, and anterior segment of the
globe.
CONTRAINDICATIONS
PRED FORTE suspension 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.
PRED FORTE suspension 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
cataract formation
and may increase intraocular pressure in susceptible individuals,
resulting in glaucoma
with damage to the optic nerve, defects