ketorolac/phenylephrine ophthalmic (Rx)

Brand and Other Names:Omidria
  • Print

Dosing & Uses

AdultPediatric

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

Next:

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%)

Previous
Next:

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

Previous
Next:

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.

more...
Previous
Next:

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

Previous
Next:

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

Previous
Next:

Images

Previous
Next:

Formulary

FormularyPatient Discounts

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.

The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

Tier Description
1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
NC NOT COVERED – Drugs that are not covered by the plan.
Code Definition
PA Prior Authorization
Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
QL Quantity Limits
Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
ST Step Therapy
Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
OR Other Restrictions
Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
Additional Offers
Email to Patient

From:

To:

The recipient will receive more details and instructions to access this offer.

By clicking send, you acknowledge that you have permission to email the recipient with this information.

Email Forms to Patient

From:

To:

The recipient will receive more details and instructions to access this offer.

By clicking send, you acknowledge that you have permission to email the recipient with this information.

Previous
Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.