Prednisolone Acetate 1% 5mL Ophthalmic Solution

NDC: 60219-2550-1

Prednisolone Acetate 1% Ophthalmic Suspension, 5 mL — Amneal Pharmaceuticals

Active ingredients	Prednisolone acetate 1% (10 mg/mL)
Dosage form	Ophthalmic suspension
Route	Topical ophthalmic
Size	5 mL
Manufacturer	Amneal Pharmaceuticals
NDC	60219-2550-1

Indications and Usage

Indicated for the treatment of steroid-responsive inflammatory conditions of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the globe, when the inherent risk of corticosteroid use is accepted to obtain a decrease in inflammation and swelling.

Dosage and Administration

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.

Warnings and Precautions

• Prolonged use may result in posterior subcapsular cataracts, elevated intraocular pressure, glaucoma, and damage to the optic nerve
• Corticosteroids may suppress the immune response and increase the risk of secondary ocular infections, including exacerbation of viral (herpes simplex) and fungal infections
• May delay healing and can worsen corneal or scleral thinning; monitor intraocular pressure during extended use
• Contains sodium bisulfite, which may cause allergic-type reactions in susceptible individuals

Contraindications

Contraindicated in acute untreated purulent ocular infections, most viral corneal and conjunctival diseases including herpes simplex keratitis, vaccinia, and varicella, mycobacterial and fungal ocular infections, and in patients with known hypersensitivity to any ingredient.

Adverse Reactions

Reported reactions include elevated intraocular pressure with possible glaucoma and optic nerve damage, posterior subcapsular cataract formation, delayed wound healing, and secondary ocular infection. Transient burning or stinging may also occur.

Storage and Handling

Store at 20°C to 25°C (68°F to 77°F), with excursions permitted to 15°C to 30°C (59°F to 86°F). Protect from freezing. Store upright.

How Supplied

Supplied as a sterile ophthalmic suspension containing 10 mg per mL (1%) prednisolone acetate in a 5 mL bottle with a dropper tip.

Professional use only. Clinical information summarized from FDA-approved prescribing information (Structured Product Labeling); refer to the full prescribing information via DailyMed for complete details.