Omidria®
GoodRxPhenylephrine 1% / Ketorolac 0.3% · intraocular solution
Mydriatics/Cycloplegics, NSAID
IndicationOmidria 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.
Contraindications
Known hypersensitivity to any of its ingredients
Available FormsPhenylephrine 1% / ketorolac 0.3% intraocular solution, 4 mL in a 5 mL single-patient-use glass vial, supplied as 4 vials or 1 vial
Mechanism of ActionThe 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 α 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.
DosageOmidria 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.
Warnings & Precautions
- Elevated Blood Pressure: Systemic exposure to phenylephrine can cause elevations in blood pressure.
- Cross-Sensitivity or Hypersensitivity: There is the potential for cross-sensitivity to acetylsalicylic acid, phenylacetic acid derivatives, and other non-steroidal anti-inflammatory drugs (NSAIDs). There have been reports of bronchospasm or exacerbation of asthma associated with the use of ketorolac in patients who either have a known hypersensitivity to aspirin/NSAIDs or a past medical history of asthma. Therefore, use Omidria with caution in individuals who have previously exhibited sensitivities to these drugs.
Common Side Effects
The most common reported adverse reactions (≥2%) are eye irritation, posterior capsule opacification, increased intraocular pressure, and anterior chamber inflammation.
Pregnancy & LactationPregnancy: 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, 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. 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, and the use of Omidria during late pregnancy should be avoided.
Lactation: There are no data on the presence of Omidria in human milk, the effects on the breastfed infant, or the effects on milk production. Systemic exposure to Omidria following a lens replacement procedure is low. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for Omidria and any potential adverse effects on the breastfed child from Omidria.
Pediatric UseThe safety and effectiveness of Omidria have been established in the pediatric population from neonates to adolescents (birth to younger than 17 years).