Omidria
Name: Omidria
What are some other side effects of Omidria?
All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:
- Eye irritation.
These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.
You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.
Contraindications
Omidria is contraindicated in patients with a known hypersensitivity to any of its ingredients.
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.
Omidria Description
Omidria is a sterile aqueous solution concentrate containing the α 1-adrenergic receptor agonist phenylephrine HCl and the nonsteroidal anti-inflammatory ketorolac tromethamine.
The descriptions and structural formulae are:
Phenylephrine Hydrochloride Drug Substance:
| Common Name: | phenylephrine hydrochloride |
| Chemical Name: | (‑)‑ m‑Hydroxy‑α‑[(methylamino)methyl]benzyl alcohol hydrochloride |
| Molecular Formula: | C 9H 13NO 2 · HCl |
| Molecular Weight: | 203.67 g/mole |
Ketorolac Tromethamine Drug Substance:
| Common Name: | ketorolac tromethamine |
| Chemical Name: | (±)-5-Benzoyl-2,3-dihydro-1H-pyrrolizine-1-carboxylic acid : 2-amino-2-(hydroxymethyl)-1,3-propanediol (1:1) |
| Molecular Formula: | C 15H 13NO 3 · C 4H 11NO 3 |
| Molecular Weight: | 376.40 g/mole |
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.
Patient Counseling Information
Inform patients that they may experience sensitivity to light.
Omeros Corporation
201 Elliott Avenue West
Seattle, WA 98119
© Omeros 2013-2016
US Patents 8,173,707, 8,586,633, 9,066,856, and 9,278,101; additional patents pending.
Omidria ® and the Omidria ® Logo are registered trademarks of Omeros Corporation.
Revised: 05/2016