Phenylephrine and Ketorolac

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Solution, Intraocular:

Omidria: Phenylephrine 1% and Ketorolac 0.3 % (4 mL)

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

For ophthalmic irrigation during surgery. Must be diluted prior to use. Do not use if irrigation solution is cloudy or contains particulate matter.

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.

>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)

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.

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.

• 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.