Adult Dosing

Cataracts and intraocular lens replacement surgery

• Dilute 4ml in 500 ml ophthalmic irrigation solution
• Use irrigation solution as needed for the surgical procedure

• Diluted product should not be stored for more than 4 hours at room temperature or 24 hours under refrigerated conditions

Pediatric Dosing

• Safety and effectiveness in pediatric patients have not been established

[Outline]

• Adult Dosing
• Pediatric Dosing

• Concentrated sterile solution added to the irrigation solution used in cataract or intraocular lens replacement surgery
• To maintain pupil size by preventing intraoperative miosis
• To reduce postoperative ocular pain

• Hypersensitivity to any of the ingredients of the product

• N/A

Renal Dose Adjustment

• Renal impairment: Dose adjustment not defined

Hepatic Dose Adjustment

• Hepatic impairment: Dose adjustment not defined

See Supplemental Patient Information

• Systemic exposure of phenylephrine can cause elevations in blood pressure
• Potential for cross-sensitivity to acetylsalicylic acid, phenylacetic acid and other NSAIDS
• Bronchospasm or exacerbation of asthma has been reported with the use of ketorolac in patients who either have a known hypersensitivity to aspirin/NSAIDs or a past medical history of asthma

Supplemental Patient Information

• Inform patients that they may experience sensitivity to light

Pregnancy Category:C

Breastfeeding: Phenylephrine IV or oral administration may decrease mild production of milk. Ophthalmic drops of phenylephrine are less likely to decrease lactation. Low level of ketorolac is secreted in milk with oral dosage. However milk levels have not been measured after injectable dosage, hence use with caution in nursing mothers. This information is based upon Lactmed database (available at http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT last accessed on 5th June 2014. Manufacturer advises caution.

• EENT: Anterior chamber inflammation, increased intraocular pressure, posterior capsule opacification, eye irritation, foreign body sensation in eye

Phenylephrine

• Alpha 1-adrenergic receptor agonist; stimulates postsynaptic alpha adrenergic receptors; produces mydriasis and vasoconstriction
• Extensively metabolized by liver; CYP450: Unknown
• Excretion: Unknown
• Half-life: Unknown

Ketorolac

• Nonsteroidal anti-inflammatory; inhibits both cyclooxygenase enzymes (COX-1 and COX-2), which leads to inhibition of prostaglandin synthesis
• Metabolized by liver; CYP450: unknown
• Excretion: Unknown
• Half-life: Unknown

US Trade Name(s)

• Omidria

US Availability

Omidria (phenylephrine/ketorolac)

• SOLN for INJ: 1 %/0.3 % (4ml vial)

Canadian Trade Name(s)

• N/A

Canadian Availability

• N/A

UK Trade Name(s)

• N/A

UK Availability

• N/A

Australian Trade Name(s)

• N/A

Australian Availability

• N/A

[Outline]

Ophthalmic

Ophthalmic Surgical Agents