Omidria

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 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 ocular irrigating solution. Irrigation solution is to be used as needed for the surgical procedure for a single patient.

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.

Omidria is an intraocular solution containing 10.16 mg/mL (1% w/v) of phenylephrine and 2.88 mg/mL (0.3% w/v) of ketorolac for use in a single patient.

Risk Summary


There are no available data on Omidria use in pregnant women or animals to inform


any drug-associated risks. Oral administration of ketorolac to rats during late


gestation produced dystocia and increased pup mortality at a dose 740-times the


plasma exposure at the recommended human ophthalmic dose (RHOD). Since


human systemic exposure to Omidria following a lens replacement procedure is low


(see Clinical Pharmacology (12.3)], the applicability of animal findings to the risk


of Omidria in humans during pregnancy is unclear. Omidria should be used during


pregnancy only if the potential benefit justifies the potential risk to the fetus.


Clinical Considerations


Fetal/Neonatal Adverse Reactions


Premature closure of the ductus arteriosus in the fetus has occurred with third


trimester use of oral and injectable NSAIDs. Ketorolac plasma concentrations are


detectable following ocular Omidria administration [see Clinical Pharmacology (12.3)].


The use of Omidria during late pregnancy should be avoided.


.Q.a1a


Animal Data


No well-controlled animal reproduction studies have been conducted with Omidria


or phenylephrine.


Ketorolac, administered during organogenesis, did not cause embryofetal abnormalities


or mortalities in rabbits or rats at oral doses of 3.6 mg/kg/day and 10 mg/kg/day,


respectively. These doses produced systemic exposure that is 1150 times and


4960 times the plasma exposure (based on Cma,c) at the RHOD, respectively. When


administered to rats during late gestation (after Day 17 of gestation) at oral doses


up to 1.5 mg/kg/day (740 times the plasma exposure at the RHOD), ketorolac


produced dystocia and increased pup mortality.

Systemic exposure to phenylephrine can cause elevations in blood pressure (