OMIDRIA
Clinical safety rating: caution
Comprehensive clinical and safety monograph for OMIDRIA (OMIDRIA).
OMIDRIA is a fixed-dose combination of ketorolac tromethamine, a nonsteroidal anti-inflammatory drug (NSAID) that inhibits cyclooxygenase (COX) activity, reducing prostaglandin synthesis, and phenylephrine hydrochloride, an alpha-1 adrenergic receptor agonist that causes vasoconstriction.
| Metabolism | Ketorolac: Primarily hepatic via conjugation; CYP450 involvement minimal. Phenylephrine: Metabolized by monoamine oxidase (MAO) and catechol-O-methyltransferase (COMT). |
| Excretion | Renal elimination of ketorolac accounts for approximately 91% of the dose, with approximately 60% as unchanged drug and the remainder as metabolites; phenylephrine is primarily metabolized and excreted in urine as sulfate conjugates, with <20% excreted unchanged. |
| Half-life | Ketorolac: terminal half-life of 5.3 hours (range 3.8-8.2 hours) in adults; phenylephrine: terminal half-life of 2-3 hours. Clinically, ketorolac's half-life supports twice-daily dosing. |
| Protein binding | Ketorolac: 99% bound primarily to albumin; phenylephrine: negligible protein binding (<5%). |
| Volume of Distribution | Ketorolac: Vd of 0.15 L/kg (range 0.10-0.20 L/kg), indicating distribution primarily into extracellular fluid; phenylephrine: Vd approximately 0.5 L/kg due to moderate tissue distribution. |
| Bioavailability | Not applicable for intraocular route; systemic bioavailability from ophthalmic administration is negligible due to low dose and local retention. |
| Onset of Action | Intraocular administration: miosis inhibition and analgesia begin within 30 minutes; peak effect by 1-2 hours. |
| Duration of Action | Intraocular: inhibition of intraoperative miosis lasts up to 4-6 hours; analgesic effect may persist for 6-8 hours post-surgery. |
1 mL of the fixed-dose combination (ketorolac 0.45% / phenylephrine 1%) administered intracamerally as a single dose at the time of cataract surgery.
| Dosage form | SOLUTION |
| Renal impairment | No dose adjustment required for renal impairment. However, caution is advised in patients with severe renal impairment or those at risk for renal failure due to ketorolac component. |
| Liver impairment | No specific dosing recommendation for hepatic impairment. Use with caution in patients with hepatic impairment due to ketorolac component; phenylephrine is not affected. |
| Pediatric use | Safety and efficacy in pediatric patients have not been established. |
| Geriatric use | No specific dose adjustment required. Clinical studies included patients aged 65 and older; no overall differences in safety or efficacy were observed. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for OMIDRIA (OMIDRIA).
| Breastfeeding | It is not known whether ketorolac or phenylephrine are excreted in human milk. Ketorolac is excreted in animal milk. The M/P ratio is unknown. Caution should be exercised when administered to a nursing woman. Consider the importance of the drug to the mother and potential risks to the infant. |
| Teratogenic Risk | FDA Pregnancy Category C. There are no adequate and well-controlled studies in pregnant women. In animal studies, ketorolac tromethamine, a component of OMIDRIA, caused increased fetal mortality and reduced fetal weight when administered during organogenesis at doses equivalent to the maximum recommended human dose. Phenylephrine hydrochloride has been associated with fetal hypoxia and bradycardia due to maternal vasoconstriction and reduced uterine blood flow. Risk cannot be ruled out; use only if potential benefit justifies potential risk to fetus. |
■ FDA Black Box Warning
No FDA boxed warning.
| Serious Effects |
["Hypersensitivity to any component","Patients with active peptic ulcer disease, gastrointestinal bleeding, or bleeding diathesis","Severe hypertension or hypertensive crisis","Use during labor and delivery (phenylephrine may cause uterine vasoconstriction)","Concurrent administration with MAO inhibitors or within 14 days of discontinuing MAO inhibitors (risk of hypertensive crisis)"]
| Precautions | ["Avoid use in patients with active bleeding or known bleeding tendencies","Use with caution in patients with coronary artery disease, hypertension, or history of myocardial infarction (phenylephrine may increase blood pressure)","May cause corneal edema or endothelial damage with improper injection","Hypersensitivity reactions including anaphylaxis","Avoid concurrent use with NSAIDs or corticosteroids due to increased risk of adverse effects"] |
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| Fetal Monitoring | Monitor for maternal hypertension, reflex bradycardia, and fetal heart rate changes during administration. No specific fetal monitoring required post-administration unless maternal adverse effects occur. |
| Fertility Effects | No studies on fertility effects in humans. In animal studies, ketorolac did not impair fertility. Phenylephrine may alter uterine blood flow; no direct fertility data. |