July 23, 2016
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Omidria

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Omidria

OMIDRIA®
(phenylephrine and ketorolac) Injection

DRUG DESCRIPTION

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.

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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