Omidria 2.88 mg/mL
phenylephrine and ketorolac · INJECTION, SOLUTION, CONCENTRATE · Omeros Corporation
Omidria is a injection, solution, concentrate containing phenylephrine and ketorolac at 2.88 mg/mL, taken intraocular. Manufactured by Omeros Corporation.
Key Facts
- Brand Name
- Omidria
- Generic Name
- phenylephrine and ketorolac
- NDC Code (Product)
62225-600- Manufacturer
- Omeros Corporation
- Strength
- 2.88 mg/mL
- Dosage Form
- INJECTION, SOLUTION, CONCENTRATE
- Route
- INTRAOCULAR
- Marketing Status
- Application #
- NDA205388
- Drug Class
- Nonsteroidal Anti-inflammatory Drug [EPC]; Cyclooxygenase Inhibitor [EPC]
- Marketing Start
- 06/13/2014
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
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. OMIDRIA is an alpha 1-adrenergic receptor agonist and nonselective cyclooxygenase inhibitor indicated for: Maintaining pupil size by preventing intraoperative miosis ( 1 ) Reducing postoperative pain ( 1 ) OMIDRIA is added to an ocular irrigating solution used during cataract surgery or intraocular lens replacement.
Dosage & Administration
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. Each vial of OMIDRIA must be diluted prior to use for administration to a single patient undergoing cataract surgery or intraocular lens replacement. Dilute 4 mL of OMIDRIA in 500 mL of ocular irrigating solution. Irrigation solution is to be used as needed for the surgical procedure. ( 2 )
Contraindications
4 CONTRAINDICATIONS Omidria is contraindicated in patients with a known hypersensitivity to any of its ingredients. Hypersensitivity to any component of this product ( 4 )
Adverse Reactions
6 ADVERSE REACTIONS The most common reported adverse reactions (≥2%) are eye irritation, posterior capsule opacification, increased intraocular pressure, and anterior chamber inflammation. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Omeros Corporation at 1-844-OMEROS1 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Studies Experience Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to the rates in the clinical studies of another drug and may not reflect the rates observed in practice. Table 1 shows frequently reported ocular adverse reactions with an incidence of ≥ 2% of adult patients as seen in the combined clinical trial results from three randomized, placebo-controlled studies [see Clinical Studies ( 14 )] . Table 1: Ocular Adverse Reactions Reported by ≥ 2% of Adult Patients MedDRA Preferred Term Placebo (N=462) Omidria (N=459) n (%) n (%) Ocular Events Anterior Chamber Inflammation 102 (22%) 111 (24%) Intraocular Pressure Increased 15 (3%) 20 (4%) Posterior Capsule Opacification 16 (4%) 18 (4%) Eye Irritation 6 (1%) 9 (2%) Foreign Bod…
Frequently Asked Questions
What is Omidria used for?
Omidria contains phenylephrine and ketorolac. It is a injection, solution, concentrate taken intraocular. Consult your doctor for specific uses.
Is Omidria a controlled substance?
Omidria is not classified as a controlled substance by the DEA.
What is the generic name for Omidria?
The generic name for Omidria is phenylephrine and ketorolac. There are no other listed brand versions of phenylephrine and ketorolac.
What is the NDC code for Omidria 2.88 mg/mL?
The NDC (National Drug Code) for Omidria 2.88 mg/mL is 62225-600, listed by Omeros Corporation.
Product NDC
62225-600
Other Omidria Dosages
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)