Brand Name

Omidria

Generic Name
Ketorolac
View Brand Information
FDA approval date: July 01, 2023
Classification: alpha-1 Adrenergic Agonist
Form: Injection

What is Omidria (Ketorolac)?

Omidria ® is added to an ocular irrigating solution used during cataract surgery or intraocular lens replacement and is indicated for maintaining pupil size by preventing intraoperative miosis and reducing postoperative ocular pain. OMIDRIA is an alpha 1-adrenergic receptor agonist and nonselective cyclooxygenase inhibitor indicated for: Maintaining pupil size by preventing intraoperative miosis Reducing postoperative pain OMIDRIA is added to an ocular irrigating solution used during cataract surgery or intraocular lens replacement.

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Brand Information

Omidria (phenylephrine and ketorolac)
1INDICATIONS AND USAGE
Omidria
2DOSAGE AND ADMINISTRATION
Omidria must be diluted prior to intraocular use. For administration to patients undergoing cataract surgery or intraocular lens replacement, 4 mL of Omidria is diluted in 500 mL of ocular irrigating solution. Irrigation solution is to be used as needed for the surgical procedure for a single patient.
The storage period for the diluted product is not more than 4 hours at room temperature or 24 hours under refrigerated conditions.
Do not use if the solution is cloudy or if it contains particulate matter.
3DOSAGE FORMS AND STRENGTHS
Omidria is an intraocular solution containing 10.16 mg/mL (1% w/v) of phenylephrine and 2.88 mg/mL (0.3% w/v) of ketorolac for use in a single patient.
4CONTRAINDICATIONS
Omidria is contraindicated in patients with a known hypersensitivity to any of its ingredients.
5OVERDOSAGE
Systemic overdosage of phenylephrine may cause a rise in blood pressure. It may also cause headache, anxiety, nausea, vomiting, and ventricular arrhythmias. Supportive care is recommended.
6DESCRIPTION
Omidria is a sterile aqueous solution, containing the α
The descriptions and structural formulae are:
Phenylephrine Hydrochloride Drug Substance:
Figure 1: Chemical Structure for Phenylephrine HCl
Figure 1
Ketorolac Tromethamine Drug Substance:
Figure 2: Chemical Structure for Ketorolac Tromethamine
Figure 2
Omidria is a clear, colorless to slightly yellow, sterile solution concentrate with a pH of approximately 6.3.
Each vial of Omidria contains:
Actives: phenylephrine hydrochloride 12.4 mg/mL equivalent to 10.16 mg/mL of phenylephrine and ketorolac tromethamine 4.24 mg/mL equivalent to 2.88 mg/mL of ketorolac.
Inactives: citric acid monohydrate; sodium citrate dihydrate; water for injection; may include sodium hydroxide and/or hydrochloric acid for pH adjustment.
7HOW SUPPLIED/STORAGE AND HANDLING
Omidria (phenylephrine and ketorolac intraocular solution) 1%/0.3% is supplied in a clear, 5-mL glass, single-patient-use vial containing 4 mL of sterile solution, for addition to ocular irrigating solution.
Omidria is supplied in a multi-pack containing:
4 vials : NDC 82604-600-04 or
1 vials: NDC 82604-600-00
8PATIENT COUNSELING INFORMATION
Inform patients that they may experience sensitivity to light.
Rayner Surgical Inc.
© Rayner 2023

Patented product; see www.rayner.com/patents for further details.
OMIDRIA®and the OMIDRIA® Logo are registered trademarks of Rayner Surgical Inc.

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9PRINCIPAL DISPLAY PANEL
NDC 82604-600-04
OMIDRIA®
(phenylephrine and ketorolac intraocular solution)
1% / 0.3%
For Intraocular use.
Must Be Diluted.
Single-Patient vial
Sterile 4 mL
Quantity: 4
Rx Only
omi00-0003-05
NDC 82604-600-00
OMIDRIA ®
(phenylephrine and ketorolac intraocular solution)
1% / 0.3%
For Intraocular use.
Must Be Diluted.
Single-Patient vial
Sterile 4 mL
Quantity: 1
Rx Only
omi00-0003-06