PRED FORTE ® (prednisolone acetate ophthalmic suspension, USP) 1% sterile

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:

The following structure for PRED FORTE® (prednisolone acetate ophthalmic suspension, USP) 1% is a sterile, topical anti-inflammatory agent for ophthalmic use. Its chemical name ...

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.

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.

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.

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 in visual acuity and fields of vision. Prolonged use may also suppress the host immune response and thus increase the hazard of secondary ocular infections.

If this product is used for 10 days or longer, intraocular pressure should be routinely monitored even though it may be difficult in children and uncooperative patients. Steroids should be used with caution in the presence of glaucoma. Intraocular pressure should be checked frequently.

Various ocular diseases and long-term use of topical corticosteroids have been known to cause corneal and scleral thinning. Use of topical corticosteroids in the presence of thin corneal or scleral tissue may lead to perforation.

Acute purulent infections of the eye may be masked or activity enhanced by the presence of corticosteroid medication.

The use of steroids after cataract surgery may delay healing and increase the incidence of bleb formation.

Use of ocular steroids may prolong the course and may exacerbate the severity of many viral infections of the eye (including herpes simplex). Employment of a corticosteroid medication in the treatment of patients with a history of herpes simplex requires great caution; frequent slit lamp microscopy is recommended.

PRED FORTE^® suspension contains sodium bisulfite, a sulfite that may cause allergic-type reactions, including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown and probably low. Sulfite sensitivity is seen more frequently in asthmatic than in non-asthmatic people.

Prednisolone has been shown to be teratogenic in mice when given in doses 1-10 times the human dose. Dexamethasone, hydrocortisone, and prednisolone were ocularly applied to both eyes of pregnant mice five times per day on days 10 through 13 of gestation. A significant increase in the incidence of cleft palate was observed in the fetuses of the treated mice. There are no adequate well-controlled studies in pregnant women. Prednisolone should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

The following adverse reactions have been identified during use of PRED FORTE ^®. Because reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Adverse reactions include elevation of intraocular pressure (IOP) with possible development of glaucoma and infrequent optic nerve damage, posterior subcapsular cataract formation, and delayed wound healing.

The development of secondary ocular infection (bacterial, fungal, and viral) has occurred. Fungal and viral infections of the cornea are particularly prone to develop coincidentally with long-term applications of steroids. The possibility of fungal invasion should be considered in any persistent corneal ulceration where steroid treatment has been used (see PRECAUTIONS).

Other adverse reactions reported with the use of prednisolone acetate ophthalmic suspension include: allergic reactions; dysgeusia; eye pain; foreign body sensation; headache; pruritus; rash; transient burning and stinging upon instillation and other minor symptoms of ocular irritation; urticaria; and visual disturbance (blurry vision).

Keratitis, conjunctivitis, corneal ulcers, mydriasis, conjunctival hyperemia, loss of accommodation and ptosis have occasionally been reported following local use of corticosteroids. Corticosteroid-containing preparations have also been reported to cause acute anterior uveitis and perforation of the globe.

Overdosage will not ordinarily cause acute problems. If accidentally ingested, drink fluids to dilute.

Shake well before using. Instill one to two drops into the conjunctival sac two to four times daily. During the initial 24 to 48 hours, the dosing frequency may be increased if necessary. Care should be taken not to discontinue therapy prematurely.

If signs and symptoms fail to improve after 2 days, the patient should be re-evaluated (see PRECAUTIONS).

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.

Shape Description automatically generated

v2.0USPI180

NDC 11980-180-05
abbvie
Rx Only
PRED FORTE ^®
(prednisolone
acetate
ophthalmic
suspension,
USP) 1%
sterile
5 mL

PRINCIPAL DISPLAY PANEL NDC 11980-180-05 abbvie Rx Only PRED FORTE® (prednisolone acetate ophthalmic suspension, USP) 1% sterile 5 mL

NDC 11980-180-10
a bbvie
Rx Only
PRED FORTE ^®
(prednisolone
acetate
ophthalmic
suspension,
USP) 1%
sterile
10 mL

PRINCIPAL DISPLAY PANEL NDC 11980-180-10 abbvie Rx Only PRED FORTE® (prednisolone acetate ophthalmic suspension, USP) 1% sterile 10 mL

NDC 11980-180-15
abbvie
Rx Only
PRED FORTE ^®
(prednisolone
acetate
ophthalmic
suspension,
USP) 1%
sterile
15 mL

PRINCIPAL DISPLAY PANEL NDC 11980-180-15 abbvie Rx Only PRED FORTE® (prednisolone acetate ophthalmic suspension, USP) 1% sterile 15 mL