Source: FDA, National Drug Code (US) Revision Year: 2017
Omidria is a sterile aqueous solution, containing the α1-adrenergic receptor agonist phenylephrine HCl and the nonsteroidal anti-inflammatory ketorolac tromethamine, for addition to ocular irrigating solution.
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: C9H13NO2 · HCl
Molecular Weight: 203.67 g/mole
Figure 1. Chemical Structure for Phenylephrine HCl:
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: C15H13NO3 · C4H11NO3
Molecular Weight: 376.40 g/mole
Figure 2. Chemical Structure for Ketorolac Tromethamine:
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.
| Dosage Forms and Strengths |
|---|
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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. |
| How Supplied |
|---|
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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 62225-600-04 or 10 vials: NDC 62225-600-10 Omeros Corporation, 201 Elliott Avenue West, Seattle, WA 98119 |
| Drug | Countries | |
|---|---|---|
| OMIDRIA | Austria, Estonia, Croatia, Ireland, Italy, Lithuania, United States |
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