Description
NDC: 61314-0637-10
Prednisolone Acetate 1% Ophthalmic Suspension, 10 mL — Lupin Pharmaceuticals
| Active ingredient | Prednisolone acetate 1% |
| Dosage form | Ophthalmic suspension |
| Route | Topical ophthalmic |
| Size | 10 mL |
| Manufacturer | Lupin Pharmaceuticals |
| NDC | 61314-0637-10 |
Indications and Usage
A corticosteroid indicated for the treatment of steroid-responsive inflammatory conditions 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. Reduce dosing gradually rather than discontinuing abruptly.
Warnings and Precautions
- Prolonged use may cause glaucoma, elevated intraocular pressure, optic nerve damage, and posterior subcapsular cataract; monitor IOP if used 10 days or longer
- May mask or enhance existing infection and suppress the host immune response
- May thin the cornea or sclera and cause perforation; avoid in herpes simplex
- Not for injection
Contraindications
Contraindicated in most viral diseases of the cornea and conjunctiva including herpes simplex keratitis, vaccinia and varicella, mycobacterial eye infection, fungal ocular disease, and hypersensitivity to any component.
Adverse Reactions
Reactions include elevated intraocular pressure and glaucoma, cataract formation, delayed wound healing, secondary ocular infection, and transient stinging or burning.
Storage and Handling
Store at 8°C to 24°C (46°F to 75°F) in an upright position.
How Supplied
Sterile 1% ophthalmic suspension in plastic dropper bottles, including 10 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.
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