Dosing & Uses
Dosage Forms & Strengths
ketorolac/phenylephrine
sterile opthalmic solution concentrate
- 0.3%/1%
Cataracts & Intraocular Lens Replacement Surgery
Concentrated sterile ophthalmic solution is added to standard irrigation solution that is used in cataract and other lens-replacement surgery and is delivered directly into the anterior chamber of the eye to maintain mydriasis, to prevent surgically induced miosis, and to reduce postoperative pain and irritation
Dilute 4 mL in 500 mL ophthalmic irrigating solution
Use irrigation solution as needed for the surgical procedure
Dosage Forms & Strengths
ketorolac/phenylephrine
sterile ophthalmic solution concentrate
- 0.3%/1%
Cataracts & Intraocular Lens Replacement Surgery
Concentrated sterile ophthalmic solution is added to standard irrigation solution that is used in cataract and other lens-replacement surgery and is delivered directly into the anterior chamber of the eye to maintain mydriasis, to prevent surgically induced miosis, and to reduce postoperative pain and irritation
Safety and effectiveness have been established in the pediatric population from neonates to adolescents (birth to <17 years)
Dilute 4 mL in 500 mL ophthalmic irrigating solution
Use irrigation solution as needed for the surgical procedure
Adverse Effects
>10%
Anterior chamber inflammation (24%)
1-10%
Increased intraocular pressure (4%)
Posterior capsule opacification (4%)
Eye irritation (2%)
Foreign body sensation in eyes (2%)
Warnings
Contraindications
Hypersensitivity
Cautions
Systemic exposure of phenylephrine can cause elevations in blood pressure
Potential for cross-sensitivity to acetylsalicylic acid, phenylacetic acid derivatives, and other NSAIDs
Pregnancy & Lactation
Pregnancy
No available data on ketorolac/phenylephrine ophthalmic use in pregnant women or animals to inform any drug associated risks
No well-controlled animal reproduction studies have been conducted with ketorolac/phenylephrine or phenylephrine
Ketorolac
- Oral administration of ketorolac to rats during late gestation produced dystocia and increased pup mortality at a dose 740-times the plasma exposure at the recommended human ophthalmic dose [RHOD]
- Since human systemic exposure to ketorolac/phenylephrine ophthalmic following a lens replacement procedure is low, the applicability of animal findings to the risk of ketorolac/phenylephrine ophthalmic in humans during pregnancy is unclear
- Weigh the potential benefit justifies the potential risk to the fetus prior to use during pregnancy
- Premature closure of the ductus arteriosus in the fetus has occurred with third trimester use of oral and injectable; avoid use during last trimester
Lactation
Data are not available on the presence of ketorolac/phenylephrine in human milk, the effects on the breastfed infant, or the effects on milk production
Systemic exposure to ketorolac/phenylephrine ophthalmic, following a lens replacement procedure is low
Pregnancy Categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk. C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done. D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk. X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist. NA: Information not available.Pharmacology
Mechanism of Action
Ketorolac: Anti-inflammatory; nonsteroidal anti-inflammatory agent (NSAID); inhibits COX-1 and COX-2 which results in decreased tissue concentrations of prostaglandins to reduce pain caused by surgical trauma
Phenylephrine: α1-adrenergic receptor agonist; acts as a mydriatic agent by contracting the radial muscle of the iris
Absorption
Phenylephrine plasma concentration, during the first 2 hr after initiation of treatment: 1.2-1.4 ng/mL
Ketorolac plasma concentrations, during the first 8 hr after the initiation of treatment: 1.0 to 4.2 ng/mL
Peak ketorolac concentration, at 24 hr after the initiation: 15 ng/mL
Administration
Intraocular Administration
Intraocular use only
Dilute 4 mL of ketorolac/phenylephrine ophthalmic is with 500 mL of ocular irrigating solution
Irrigation solution is to be used as needed for the surgical procedure for a single patient
Do not use if solution appears cloudy or contains particulate matter
Storage
Diluted product: Store at room temperature for up to 4 hr or refrigerate for up to 24 hr
Vials: Store at 20° to 25°C (68° to 77°F); protect from light
Images
Formulary
Adding plans allows you to compare formulary status to other drugs in the same class.
To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.
Adding plans allows you to:
- View the formulary and any restrictions for each plan.
- Manage and view all your plans together – even plans in different states.
- Compare formulary status to other drugs in the same class.
- Access your plan list on any device – mobile or desktop.
