Prednisolone Acetate 1%, 5mL- Lupin

NDC: 70748-332-02

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

Indications and Usage

A corticosteroid indicated for the treatment of steroid-responsive inflammation of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the globe.

Dosage and Administration

Shake well before use. 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. Do not discontinue therapy prematurely.

Warnings and Precautions

• Prolonged use may cause glaucoma with optic nerve damage, elevated intraocular pressure, and posterior subcapsular cataract; monitor IOP if used 10 days or longer
• May suppress host response and increase the risk of secondary bacterial, fungal, or viral ocular infection
• Prolonged use may delay wound healing and, in diseases causing thinning, lead to corneal or scleral perforation
• Not for injection

Contraindications

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

Adverse Reactions

Reactions include elevated intraocular pressure with possible glaucoma and optic nerve damage, posterior subcapsular cataract, delayed wound healing, and secondary ocular infection, as well as transient burning and stinging.

Storage and Handling

Store at up to 25°C (77°F) in an upright position; protect from freezing.

How Supplied

Sterile 1% ophthalmic suspension in plastic dropper bottles, including 5 mL size.

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.