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Brand Name :
Omidria
Synonyms :
ketorolac/phenylephrine ophthalmic
Class :
Ophthalmic NSAIDs, Cycloplegics, Mydriatics
Dosage Forms & Strengths
Sterile ophthalmic solution
0.3%/1% (ketorolac/phenylephrine)
Dilute 4 ml solution in 500 ml ophthalmic irrigating solution
Use irrigation solution for the surgical procedure as required
Dosage Forms & Strengths
Sterile ophthalmic solution
0.3%/1% (ketorolac/phenylephrine)
Dilute 4 ml solution in 500 ml ophthalmic irrigating solution
Use irrigation solution for the surgical procedure as required
Refer to adult dosing
Actions and Spectrum
ketorolac ophthalmic is a nonsteroidal anti-inflammatory medication (NSAID) that reduces inflammation, discomfort, and swelling by preventing the body’s natural production of specific molecules.
phenylephrine ophthalmic functions as an alpha-adrenergic agonist. It functions by activating the alpha receptors in the eye, which causes the pupil to enlarge and the blood vessels in the eye to constrict.
The combination of ketorolac and phenylephrine in ophthalmic form provides a dual action, providing anti-inflammatory effects from ketorolac and pupil dilation from phenylephrine.
Frequency defined
1-10%
Foreign body sensation in eyes (2%)
Eye irritation (2%)
Increased intraocular pressure (4%)
Posterior capsule opacification (4%)
>10%
Anterior chamber inflammation (24%)
Black Box Warning
None
Contraindication/Caution:
Contraindication:
Caution:
Pregnancy warnings:
Pregnancy category: N/A
Lactation: Excretion into human milk is unknown
Pregnancy Categories:
Category A: well-controlled and Satisfactory studies show no risk to the fetus in the first or later trimester.
Category B: there was no evidence of risk to the fetus in animal studies, and there were not enough studies on pregnant women.
Category C: there was evidence of risk of adverse effects in animal reproduction studies, and no adequate evidence in human studies must take care of potential risks in pregnant women.
Category D: adequate data with sufficient evidence of human fetal risk from various platforms, but despite the potential risk, and used only in emergency cases for potential benefits.
Category X: Drugs listed in this category outweigh the risks over benefits. Hence these categories of drugs need to be avoided by pregnant women.
Category N: There is no data available for the drug under this category.
Pharmacology
ketorolac works locally in the eye to reduce inflammation by preventing the formation of prostaglandins when given in ophthalmic form. It aids in reducing ocular pain and inflammation brought on by some eye disorders or operations.
Vasoconstriction results from phenylephrine’s specific stimulation of alpha-1 adrenergic receptors. phenylephrine produces pupil dilatation and can aid in lowering eye redness by tightening the blood vessels in the eye.
Pharmacodynamics
By preventing the production of prostaglandins, ketorolac has analgesic effects that can lessen ocular pain brought on by various eye disorders or procedures.
By stimulating the alpha-1 adrenergic receptors in blood vessels, phenylephrine causes vasoconstriction, which results in the narrowing of blood vessels.
Pharmacokinetics
Absorption
For ketorolac ophthalmic
ketorolac can enter the anterior chamber of the eye through the cornea when used as an ophthalmic solution.
For phenylephrine ophthalmic
When given as an ophthalmic solution, phenylephrine enters the eye through the cornea.
Distribution
For ketorolac ophthalmic
ketorolac binds extensively to plasma proteins, primarily albumin. It has a large volume of distribution, indicating widespread distribution throughout the body.
For phenylephrine ophthalmic
phenylephrine partially interacts to plasma proteins. The exact volume of distribution for phenylephrine is not readily available.
Metabolism
For ketorolac ophthalmic
ketorolac is primarily metabolized in the liver by hydroxylation and conjugation to form inactive metabolites.
For phenylephrine ophthalmic
phenylephrine undergoes hepatic metabolism, primarily through enzymatic oxidation, mediated by enzymes like catechol-O-methyltransferase.
Elimination and excretion
For ketorolac ophthalmic
The metabolites of ketorolac, including the glucuronide conjugate, are eliminated primarily through the kidneys via urine.
For phenylephrine ophthalmic
After hepatic metabolism, phenylephrine and its metabolites are excreted mainly in the urine.
Administration
ketorolac/phenylephrine ophthalmic is typically administered as an ophthalmic solution, i.e., used as an eye drops.
Patient information leaflet
Generic Name: ketorolac/phenylephrine ophthalmic
Why do we use ketorolac/phenylephrine ophthalmic?
ketorolac/phenylephrine ophthalmic is often used during various types of ocular surgeries, such as cataract extraction, corneal refractive surgery. The medication is used to facilitate eye examinations by dilating the pupil.