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Phenylephrine and Ketorolac

Pronunciation

(fen il EF rin & KEE toe role ak)

Index Terms

  • Ketorolac and Phenylephrine

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)

Brand Names: U.S.

  • Omidria

Pharmacologic Category

  • Adrenergic Agonist Agent, Ophthalmic
  • Nonsteroidal Anti-inflammatory Drug (NSAID), Ophthalmic
  • Ophthalmic Agent, Mydriatic

Pharmacology

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

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 prevent intraoperative miosis and to reduce postoperative ocular pain during cataract surgery or intraocular lens replacement

Contraindications

Hypersensitivity to phenylephrine, ketorolac, or any component of the formulation

Dosing: Adult

Surgical irrigation: Ophthalmic: Use diluted irrigation solution as needed during the surgical procedure.

Dosing: Geriatric

Refer to adult dosing.

Dosing: Renal Impairment

There are no dosage adjustments provided in the manufacturer’s labeling.

Dosing: Hepatic Impairment

There are no dosage adjustments provided in the manufacturer’s labeling.

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

Corticosteroids (Ophthalmic): NSAID (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

Iobenguane I 123: Sympathomimetics may diminish the therapeutic effect of Iobenguane I 123. 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

MAO 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; Tedizolid. Avoid combination

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 vasopressor effect of Alpha1-Agonists. Tricyclic Antidepressants may diminish the vasopressor 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%)

<1% (Limited to important or life-threatening): Elevated blood pressure (systemic exposure to phenylephrine)

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 Risk Factor

C

Pregnancy Considerations

Animal reproduction studies have not been conducted with this combination. Low concentrations of both ketorolac and phenylephrine can be detected systemically following ophthalmic irrigation. Because premature closure of the ductus arteriosus in the fetus has occurred with third trimester use of NSAIDs, avoid 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, 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.

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