|Initial U.S. Approval: 2014
Mechanism of Action: The two active pharmaceutical ingredients (API) in Omidria, phenylephrine and ketorolac, act to maintain pupil size by preventing intraoperative miosis, and reducing postoperative pain.
Phenylephrine is an a 1-adrenergic receptor agonist and, in the eye, acts as a mydriatic agent by contracting the radial muscle of the iris. Ketorolac is a nonsteroidal anti-inflammatory that inhibits both cyclooxygenase enzymes (COX-1 and COX-2), resulting in a decrease in tissue concentrations of prostaglandins to reduce pain due to surgical trauma. Ketorolac, by inhibiting prostaglandin synthesis secondary to ocular surgical insult or direct mechanical stimulation of the iris, also prevents surgically induced miosis.
|INDICATIONS AND USAGE:
OMIDRIA is an alpha 1-adrenergic receptor agonist and nonselective cyclooxygenase inhibitor indicated for:
Maintaining pupil size by preventing intraoperative miosis.
Reducing postoperative pain.
OMIDRIA is added to an irrigation solution used during cataract surgery or intraocular lens replacement.
|DOSAGE AND ADMINISTRATION
Omidria must be diluted prior to intraocular use. For administration to patients undergoing cataract surgery or intraocular lens replacement, 4 mL of Omidria is diluted in 500 mL of ophthalmic irrigation solution. Irrigation solution is to be used as needed for the surgical procedure.
The storage period for the diluted product is not more than 4 hours at room temperature or 24 hours under refrigerated conditions.
Do not use if the solution is cloudy or if it contains particulate matter.
|HOW SUPPLIED: Omidria is a sterile solution concentrate containing 10.16 mg/mL (1% w/v) of phenylephrine and 2.88 mg/mL (0.3% w/v) of ketorolac in a single-patient-use vial.
National Institutes of Health, U.S. National Library of Medicine, DailyMed Database.
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