July 23, 2016
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(phenylephrine and ketorolac) Injection


Omidria is a sterile aqueous solution concentrate containing the α1-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: C9H13NO2 • HCl Molecular Weight: 203.67 g/mole

Figure 1: Chemical Structure for Phenylephrine HCl

Phenylephrine HCl - Structural Formula Illustration

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

Ketorolac Tromethamine - Structural Formula Illustration

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.

Last reviewed on RxList: 1/28/2016
This monograph has been modified to include the generic and brand name in many instances.

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