Dosage Forms
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Solution, Intraocular:
Omidria: Phenylephrine 1% and Ketorolac 0.3 % (4 mL)
Pharmacology
Mechanism of Action
Ketorolac: NSAID that inhibits both COX-1 and COX-2 cyclooxygenase enzymes; it decreases prostaglandin concentrations which reduces surgical pain and also prevents surgically induced contraction of the pupil.
Phenylephrine: Alpha1-adrenergic receptor agonist; it causes dilation of the pupil by contracting the radial muscle of the iris
Pharmacokinetics/Pharmacodynamics
Absorption
Systemic absorption following irrigation is low to undetectable. Following irrigation with diluted phenylephrine/ketorolac solution, plasma concentrations of phenylephrine were 1.2 to 1.4 ng/mL within 2 hours and plasma concentrations of ketorolac were 1 to 4.2 ng/mL within 8 hours.
Use: Labeled Indications
Ophthalmic surgical irrigation: Added to an ophthalmic irrigation solution to maintain pupil size by preventing intraoperative miosis and reducing postoperative ocular pain during cataract surgery or intraocular lens replacement.
Contraindications
Hypersensitivity to phenylephrine, ketorolac, or any component of the formulation
Dosage and Administration
Dosing: Adult
Surgical irrigation: Ophthalmic: Use diluted irrigation solution as needed during the surgical procedure.
Dosing: Geriatric
Refer to adult dosing.
Dosing: Pediatric
Surgical irrigation: Infants, Children, and Adolescents: Ophthalmic: Use diluted irrigation solution as needed during the surgical procedure for a single patient.
Reconstitution
Prior to use, dilute 4 mL of phenylephrine 1%/ketorolac 0.3% solution in 500 mL of ophthalmic irrigation solution.
Administration
For ophthalmic irrigation during surgery. Must be diluted prior to use. Do not use if irrigation solution is cloudy or contains particulate matter.
Storage
Store between 20°C and 25°C (68°F and 77°F). Protect from light. Following dilution in ophthalmic irrigation solution, do not store for more than 4 hours at room temperature or 24 hours under refrigeration.
Drug Interactions
Alpha1-Blockers: May diminish the vasoconstricting effect of Alpha1-Agonists. Similarly, Alpha1-Agonists may antagonize Alpha1-Blocker vasodilation. Monitor therapy
AtoMOXetine: May enhance the hypertensive effect of Sympathomimetics. AtoMOXetine may enhance the tachycardic effect of Sympathomimetics. Monitor therapy
Cannabinoid-Containing Products: May enhance the tachycardic effect of Sympathomimetics. Exceptions: Cannabidiol. Monitor therapy
Cocaine (Topical): May enhance the hypertensive effect of Sympathomimetics. Management: Consider alternatives to use of this combination when possible. Monitor closely for substantially increased blood pressure or heart rate and for any evidence of myocardial ischemia with concurrent use. Consider therapy modification
Corticosteroids (Ophthalmic): Nonsteroidal Anti-Inflammatory Agents (Ophthalmic) may enhance the adverse/toxic effect of Corticosteroids (Ophthalmic). Healing of ophthalmic tissue during concomitant administration of ophthalmic products may be delayed. Exceptions: Loteprednol. Monitor therapy
Doxofylline: Sympathomimetics may enhance the adverse/toxic effect of Doxofylline. Monitor therapy
Ergot Derivatives: May enhance the hypertensive effect of Alpha1-Agonists. Ergot Derivatives may enhance the vasoconstricting effect of Alpha1-Agonists. Exceptions: Ergoloid Mesylates; Nicergoline. Avoid combination
Guanethidine: May enhance the arrhythmogenic effect of Sympathomimetics. Guanethidine may enhance the hypertensive effect of Sympathomimetics. Monitor therapy
Iobenguane Radiopharmaceutical Products: Alpha1-Agonists may diminish the therapeutic effect of Iobenguane Radiopharmaceutical Products. Management: Discontinue all drugs that may inhibit or interfere with catecholamine transport or uptake for at least 5 biological half-lives before iobenguane administration. Do not administer these drugs until at least 7 days after each iobenguane dose. Avoid combination
Linezolid: May enhance the hypertensive effect of Sympathomimetics. Management: Reduce initial doses of sympathomimetic agents, and closely monitor for enhanced pressor response, in patients receiving linezolid. Specific dose adjustment recommendations are not presently available. Consider therapy modification
Monoamine Oxidase Inhibitors: May enhance the hypertensive effect of Alpha1-Agonists. While linezolid is expected to interact via this mechanism, management recommendations differ from other monoamine oxidase inhibitors. Refer to linezolid specific monographs for details. Exceptions: Linezolid. Avoid combination
Prostaglandins (Ophthalmic): Nonsteroidal Anti-Inflammatory Agents (Ophthalmic) may diminish the therapeutic effect of Prostaglandins (Ophthalmic). Nonsteroidal Anti-Inflammatory Agents (Ophthalmic) may enhance the therapeutic effect of Prostaglandins (Ophthalmic). Monitor therapy
Solriamfetol: Sympathomimetics may enhance the hypertensive effect of Solriamfetol. Monitor therapy
Sympathomimetics: May enhance the adverse/toxic effect of other Sympathomimetics. Monitor therapy
Tedizolid: May enhance the hypertensive effect of Sympathomimetics. Tedizolid may enhance the tachycardic effect of Sympathomimetics. Monitor therapy
Tricyclic Antidepressants: May enhance the therapeutic effect of Alpha1-Agonists. Tricyclic Antidepressants may diminish the therapeutic effect of Alpha1-Agonists. Monitor therapy
Adverse Reactions
>10%: Ophthalmic: Anterior chamber inflammation (24%)
1% to 10%:
Central nervous system: Foreign body sensation of eye (2%)
Ophthalmic: Increased intraocular pressure (4%), posterior capsule opacification (4%), eye irritation (2%)
Warnings/Precautions
Concerns related to adverse effects:
- Hypersensitivity: Cross sensitivity or hypersensitivity may occur in patients with previous sensitivities to acetylsalicylic acid, phenylacetic acid, or other nonsteroid anti-inflammatory drugs (NSAIDs). Use caution in patients with known sensitivities to these medications. Bronchospasm or exacerbation of asthma has been reported following ketorolac use in patients with previous sensitivity to aspirin/NSAIDs or history of asthma.
- Hypertension: Low concentrations of phenylephrine can be detected systemically following ophthalmic irrigation and may cause elevations in blood pressure.
- Light sensitivity (ocular): May cause sensitivity to light.
Pregnancy
Pregnancy Considerations
Systemic exposure following ophthalmic irrigation is low. Because premature closure of the ductus arteriosus in the fetus has occurred with third trimester use of nonsteroidal anti-inflammatory drugs (NSAIDs), the manufacturer recommends avoiding use of this product in late in pregnancy.
Patient Education
- Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)
- Have patient report immediately to prescriber severe eye irritation, vision changes, passing out, severe headache, or severe dizziness (HCAHPS).
- Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.
Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for health care professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience, and judgment in diagnosing, treating, and advising patients.
