Omidria

Mydriatics and Cycloplegics

Ophthalmic Surgical Irrigation
Phenylephrine; ketorolac sterile solution is only for ophthalmic irrigation during ophthalmic surgery as directed. Take care NOT to administer parenterally by any route.
Visually inspect solution and do not use if the solution is colored or cloudy, or if it contains particulate matter.
Phenylephrine; ketorolac injection solution must be diluted prior to intraocular use.
Using aseptic technique, dilute 4 ml of phenylephrine; ketorolac sterile solution in 500 ml of ophthalmic irrigation solution.
Once the phenylephrine; ketorolac solution is diluted, the storage period for the diluted product is not more than 4 hours at room temperature or 24 hours under refrigerated conditions. Do not freeze.

ocular hypertension / Delayed / 4.0-4.0

ocular inflammation / Early / 24.0-24.0

ocular irritation / Rapid / 2.0-2.0
foreign body sensation / Rapid / 2.0-2.0

Omidria

Rx

Combination of an alpha 1-adrenergic receptor agonist (phenylephrine) and a non-selective cyclooxygenase inhibitor (ketorolac)
Used during cataract surgery or intraocular lens replacement and is indicated for maintaining pupil size by preventing intraoperative miosis and reducing post-operative pain
Solution must be diluted in ophthalmic irrigation solution and used during surgery

4 mL of phenylephrine; ketorolac sterile solution is diluted in 500 mL of ophthalmic irrigation solution. Irrigation solution is to be used as needed for the surgical procedure.

4 mL of phenylephrine; ketorolac sterile solution is diluted in 500 mL of ophthalmic irrigation solution. Irrigation solution is to be used as needed for the surgical procedure.

4 mL of phenylephrine; ketorolac sterile solution is diluted in 500 mL of ophthalmic irrigation solution. Irrigation solution is to be used as needed for the surgical procedure.

No dosage adjustments are needed.

No dosage adjustments are needed.

There are no drug interactions associated with Phenylephrine; Ketorolac products.

Omidria Intraocular Sol: 1-0.3%
Omidria Irrigation Sol: 1-0.3%
Omidria Ophthalmic Sol: 1-0.3%

4 mL of phenylephrine (1%); ketorolac (0.3%) solution diluted in 500 mL of ophthalmic irrigation solution. Solution is used as needed during surgery.

4 mL of phenylephrine (1%); ketorolac (0.3%) solution diluted in 500 mL of ophthalmic irrigation solution. Solution is used as needed during surgery.

4 mL of phenylephrine (1%); ketorolac (0.3%) solution diluted in 500 mL of ophthalmic irrigation solution. Solution is used as needed during surgery.

4 mL of phenylephrine (1%); ketorolac (0.3%) solution diluted in 500 mL of ophthalmic irrigation solution. Solution is used as needed during surgery.

4 mL of phenylephrine (1%); ketorolac (0.3%) solution diluted in 500 mL of ophthalmic irrigation solution. Solution is used as needed during surgery.

4 mL of phenylephrine (1%); ketorolac (0.3%) solution diluted in 500 mL of ophthalmic irrigation solution. Solution is used as needed during surgery.

Phenylephrine is a sympathomimetic agent and ketorolac is a nonsteroidal antiinflammatory drug (NSAID); the drugs are used together to prevent miosis and decrease pain following cataract surgery.
 
Phenylephrine: Phenylephrine stimulates alpha-adrenergic receptors (direct effect). Stimulation of these receptors on the dilator muscle and arterioles of the conjunctiva leads to profound mydriasis and vasoconstriction, respectively.
Ketorolac: Ketorolac is a nonsteroidal anti-inflammatory (NSAID) 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. Following topical application to the eye, ketorolac inhibits miosis by inhibiting the biosynthesis of ocular prostaglandins. Prostaglandins play a role in the miotic response produced during ocular surgery by constricting the iris sphincter independently of cholinergic mechanisms. In the eye, prostaglandins also have been shown to disrupt the blood-aqueous humor barrier, cause vasodilation, increase vascular permeability, promote leukocytosis, and increase intraocular pressure (IOP). The degree of ocular inflammatory response is correlated with prostaglandin-induced increases in ciliary epithelium permeability. When applied topically to the eye, NSAIDs inhibit the synthesis of prostaglandins in the iris, ciliary body, and conjunctiva. Thus, NSAIDs may prevent many of the manifestations of ocular inflammation. Ketorolac does not affect intraocular pressure or tonographic aqueous outflow resistance and does not interfere with the action of acetylcholine administered during ocular surgery. Ketorolac also does not prevent increases in intraocular pressure or decreases in aqueous outflow induced by topical corticosteroids.

Phenylephrine; ketorolac is administered as part of an ophthalmic irrigation solution.

Ophthalmic Route
In a pharmacokinetic study evaluating phenylephrine; ketorolac, systemic exposure to both phenylephrine and ketorolac was low or undetectable after ophthalmic irrigation.
Phenylephrine: A single-dose of phenylephrine; ketorolac as part of the irrigation solution was administered in 14 patients during lens replacement surgery. The volume of irrigation solution used during surgery ranged between 150 ml to 300 ml (median 212.5 ml). During the first 2 hours after the initiation of phenylephrine; ketorolac, detectable phenylephrine plasma concentrations were observed in one of 14 subjects (range 1.2 to 1.4 ng/ml). The observed phenylephrine plasma concentrations could not be distinguished from the preoperative administration of phenylephrine 2.5% ophthalmic solution prior to exposure to phenylephrine; ketorolac.
Ketorolac: Ketorolac plasma concentrations were detected in 10 of 14 subjects (range 1 to 4.2 ng/ml) during the first 8 hours after the initiation of phenylephrine; ketorolac. The maximum ketorolac concentration was 15 ng/ml at 24 hours after the initiation of phenylephrine; ketorolac, which may have been attributable to application of postoperative ketorolac ophthalmic solution.

There are no data available on the presence of phenylephrine; ketorolac ophthalmic irrigation in human milk, the effect on the breastfed infant, or the effect on milk production. However, systemic exposure to phenylephrine; ketorolac ophthalmic irrigation after a lens replacement procedure is low. Any detectable concentrations (e.g., 1 to 4.2 ng/mL) usually occur during the first 8 hours after initiation of the irrigation during surgery. Previous American Academy of Pediatrics recommendations considered ketorolac to be compatible with breast-feeding; however, caution is advised with systemic use. Consider the benefits of breast-feeding, the risk of potential infant drug exposure, and the risk of an untreated or inadequately treated condition. If a breast-feeding infant experiences an adverse effect related to a maternally ingested drug, healthcare providers are encouraged to report the adverse effect to the FDA.