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Phenylephrine and Ketorolac

Medically reviewed by Drugs.com. Last updated on Jul 7, 2020.

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 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

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

Ozanimod: May enhance the hypertensive effect of Sympathomimetics. Management: Concomitant use of ozanimod with sympathomimetic agents is not recommended. If combined, monitor patients closely for the development of hypertension, including hypertensive crises. Consider therapy modification

Procarbazine: May enhance the adverse/toxic effect of Sympathomimetics. Management: Consider alternatives to this combination when possible. Procarbazine prescribing information states that this combination should be avoided. Consider therapy modification

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. Sympathomimetics may enhance the tachycardic 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 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

What is this drug used for?

• It is used during eye surgery.

• It is used to lower eye pain after eye surgery.

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Severe eye irritation

• Vision changes

• Passing out

• Severe headache

• Severe dizziness

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.

Note: This is not a comprehensive list of all side effects. Talk to your doctor if you have questions.

Consumer Information Use and Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a limited summary of general information about the medicine's uses from the patient education leaflet and is not intended to be comprehensive. This limited summary does NOT include all information available about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not intended to provide medical advice, diagnosis or treatment and does not replace information you receive from the healthcare provider. For a more detailed summary of information about the risks and benefits of using this medicine, please speak with your healthcare provider and review the entire patient education leaflet.

Further information

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