phenylephrine and ketorolac

FDA Drug Profile — Omidria

Drug Details

Generic Name
phenylephrine and ketorolac
Brand Names
Omidria
Application Number
NDA205388
Sponsor
Hospira, Inc.
NDC Codes
3
Dosage Forms
INJECTION, SOLUTION, CONCENTRATE
Routes
INTRAOCULAR
Active Ingredients
KETOROLAC, PHENYLEPHRINE

Indications and Usage

1 INDICATIONS AND USAGE Omidria ® is added to an ocular irrigating solution used during cataract surgery or intraocular lens replacement and is indicated for maintaining pupil size by preventing intraoperative miosis and reducing postoperative ocular pain. OMIDRIA is an alpha 1-adrenergic receptor agonist and nonselective cyclooxygenase inhibitor indicated for: Maintaining pupil size by preventing intraoperative miosis ( 1 ) Reducing postoperative pain ( 1 ) OMIDRIA is added to an ocular irrigating solution used during cataract surgery or intraocular lens replacement.