Prednisolone Acetate 1% 5mL Ophthalmic Solution - Sandoz

Prednisolone Acetate 1% Ophthalmic Suspension, 5 mL — Sandoz

NDC: 61314-637-05

Product Details

Active Ingredient	Prednisolone acetate 1% (10 mg/mL)
Dosage Form	Sterile ophthalmic suspension
Route	Topical ophthalmic
Package Size	5 mL
Manufacturer	Sandoz
NDC	61314-637-05

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, dosing frequency may be increased if necessary, as directed by the prescribing healthcare professional. Care should be taken not to discontinue therapy prematurely.

Warnings and Precautions

• Intraocular pressure: Prolonged use may cause elevated intraocular pressure, glaucoma, optic nerve damage, and posterior subcapsular cataracts.
• Ocular infections: Corticosteroids may suppress the immune response and increase the risk of secondary ocular infections, including worsening of herpes simplex and fungal infections.
• Delayed healing: May delay healing and worsen corneal or scleral thinning. Monitor intraocular pressure during extended use.
• Sodium bisulfite: Contains sodium bisulfite, which may cause allergic-type reactions in susceptible individuals.

Contraindications

Contraindicated in acute untreated purulent ocular infections; most viral diseases of the cornea and conjunctiva, including herpes simplex keratitis, vaccinia, and varicella; mycobacterial and fungal ocular infections; and patients with known hypersensitivity to any ingredient in the formulation.

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 prednisolone acetate 10 mg/mL (1%) in a 5 mL bottle with a dropper tip.

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Professional use only.

Clinical information is summarized from FDA-approved prescribing information (Structured Product Labeling). Refer to the full prescribing information via DailyMed for complete details.

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