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Omidria®

GoodRx

Phenylephrine 1% / Ketorolac 0.3% · intraocular solution

Mydriatics/Cycloplegics, NSAID

Indication
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 ocular irrigating solution used during cataract surgery or intraocular lens replacement.
Contraindications
Omidria is contraindicated in patients with a known hypersensitivity to any of its ingredients. Hypersensitivity to any component of this product.
Available Forms
1%, 0.3%, 4 mL
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 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.
Dosage
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.
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).
Common Side Effects
The most common reported adverse reactions (≥2%) are eye irritation, posterior capsule opacification, increased intraocular pressure, and anterior chamber inflammation.
Pregnancy & Lactation
Pregnancy: 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).
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. Howerver, systemic exposure to Omidria, following a lens replacement procedure is low .
Pediatric Use
The safety and effectiveness of Omidria have been established in the pediatric population from neonates to adolescents (birth to younger than 17 years).