Dosing and uses of Omidria (ketorolac/phenylephrine ophthalmic)
Adult dosage forms and strengths
ketorolac/phenylephrine
sterile solution concentrate
- 0.3%/1%
Cataracts & Intraocular Lens Replacement Surgery
Concentrated sterile solution is added to standard irrigation solution that is used in cataract and other lens-replacement surgery and is delivered directly into the anterior chamber of the eye to maintain mydriasis, to prevent surgically induced miosis, and to reduce postoperative pain and irritation
Dilute 4 mL in 500 mL ophthalmic irrigating solution
Use irrigation solution as needed for the surgical procedure
Administration
Must dilute before use
Do not use if the solution is colored or cloudy, or if it contains particulate matter
Diluted product storage
- Room temperature: Not to exceed 4 hr
- Refrigerated: Not to exceed 24 hr
Pediatric dosage forms and strengths
Safey and efficacy not established
Omidria (ketorolac/phenylephrine ophthalmic) adverse (side) effects
>10%
Anterior chamber inflammation (24%; placebo 22%)
1-10%
Increased intraocular pressure (IOP) (4%; placebo 3%)
Posterior capsule opacification (4%); placebo 4%)
Eye irritation (2%; placebo 1%)
Foreign body sensation in eyes (2%; placebo 2%)
Warnings
Contraindications
Hypersensitivity
Cautions
Systemic exposure of phenylephrine can cause elevations in blood pressure
Potential for cross-sensitivity to acetylsalicylic acid, phenylacetic acid derivatives, and other NSAIDs
Pregnancy and lactation
Pregnancy category: C
Lactation: Unknown if distributed in human breast milk
Pregnancy categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.
C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.
D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.
X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.
NA: Information not available.
Pharmacology of Omidria (ketorolac/phenylephrine ophthalmic)
Mechanism of action
Ketorolac: Anti-inflammatory; nonsteroidal anti-inflammatory agent (NSAID); inhibits COX-1 and COX-2 which results in decreased tissue concentrations of prostaglandins to reduce pain caused by surgical trauma
Phenylephrine: α1-adrenergic receptor agonist; acts as a mydriatic agent by contracting the radial muscle of the iris
Pharmacokinetics
Systemic exposure to both phenylephrine and ketorolac was low or undetectable in clinical trials
