OMIDRIA Solution for injection Ref.[10473] Active ingredients: Ketorolac Phenylephrine

Source: FDA, National Drug Code (US)  Revision Year: 2017 

1. Indications and Usage

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.

2. Dosage 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.

10. Overdosage

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.

16.2. Storage and Handling

Store at 20˚ to 25˚C (68˚ to 77˚F). Protect from light.

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