May 28, 2016
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Omidria

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Omidria

Indications
Dosage
How Supplied

INDICATIONS

Omidria® is added to an ophthalmic irrigation 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.

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 ophthalmic irrigation solution. Irrigation solution is to be used as needed for the surgical procedure.

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.

HOW SUPPLIED

Dosage Forms And Strengths

Omidria is a sterile solution concentrate containing 10.16 mg/mL (1% w/v) of phenylephrine and 2.88 mg/mL (0.3% w/v) of ketorolac in a single-patient-use vial.

Storage And Handling

Omidria is supplied as a sterile solution concentrate in a clear, 5-mL glass, single-patient-use vial containing 4 mL of sterile solution.

Omidria is supplied in a multi-pack containing:

4 single-patient-use vials: NDC 62225-600-04 or
10 single-patient-use vials: NDC 62225-600-10

Storage: Store at 20° to 25°C (68° to 77°F). Protect from light.

Omeros Corporation, 201 Elliott Avenue West, Seattle, WA 98119. Revised: Jun 2015

This monograph has been modified to include the generic and brand name in many instances.

Last reviewed on RxList: 1/28/2016

Indications
Dosage
How Supplied

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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