Pronunciation:

kee-toe-ROLE-ak, fen-il-EF-rin

Brand Names:

• Omidria

Dosage Forms:

• Solution

Classifications:

Therapeutic—

Mydriatic-Cycloplegic

Pharmacologic—

NSAID

Chemical—

Acetic Acid (class)

Uses of This Medicine:

Ketorolac and phenylephrine ophthalmic solution is combined with an eye irrigation solution used during cataract surgery or intraocular lens replacement. This is to maintain pupil size by preventing intraoperative miosis (pupil constriction) and to reduce pain after eye surgery.

This medicine is to be given only by or under the direct supervision of your eye doctor (ophthalmologist).

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of ketorolac and phenylephrine ophthalmic solution in the pediatric population.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of ketorolac and phenylephrine ophthalmic solution in the elderly.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Aceclofenac
• Acemetacin
• Amtolmetin Guacil
• Aspirin
• Bromfenac
• Bufexamac
• Celecoxib
• Choline Salicylate
• Clonixin
• Clorgyline
• Dexibuprofen
• Dexketoprofen
• Diclofenac
• Diflunisal
• Dipyrone
• Droxicam
• Etodolac
• Etofenamate
• Etoricoxib
• Felbinac
• Fenoprofen
• Fepradinol
• Feprazone
• Floctafenine
• Flufenamic Acid
• Flurbiprofen
• Ibuprofen
• Indomethacin
• Iproniazid
• Isocarboxazid
• Ketoprofen
• Linezolid
• Lornoxicam
• Loxoprofen
• Lumiracoxib
• Meclofenamate
• Mefenamic Acid
• Meloxicam
• Morniflumate
• Nabumetone
• Naproxen
• Nepafenac
• Nialamide
• Niflumic Acid
• Nimesulide
• Nimesulide Beta Cyclodextrin
• Oxaprozin
• Oxyphenbutazone
• Parecoxib
• Pentoxifylline
• Phenelzine
• Phenylbutazone
• Piketoprofen
• Piroxicam
• Procarbazine
• Proglumetacin
• Propyphenazone
• Proquazone
• Rasagiline
• Rofecoxib
• Salicylic Acid
• Salsalate
• Selegiline
• Sodium Salicylate
• Sulfasalazine
• Sulindac
• Tenoxicam
• Tiaprofenic Acid
• Tolfenamic Acid
• Tolmetin
• Tranylcypromine
• Valdecoxib

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Abciximab
• Acenocoumarol
• Anagrelide
• Apixaban
• Ardeparin
• Argatroban
• Bemiparin
• Betamethasone
• Bivalirudin
• Budesonide
• Cangrelor
• Certoparin
• Cilostazol
• Citalopram
• Clopidogrel
• Cortisone
• Dabigatran Etexilate
• Dalteparin
• Danaparoid
• Deflazacort
• Desirudin
• Desvenlafaxine
• Dexamethasone
• Dipyridamole
• Duloxetine
• Edoxaban
• Emtricitabine
• Enoxaparin
• Epoprostenol
• Eptifibatide
• Escitalopram
• Feverfew
• Fluocortolone
• Fluoxetine
• Fluvoxamine
• Fondaparinux
• Furazolidone
• Ginkgo
• Heparin
• Hydrocortisone
• Iloprost
• Lepirudin
• Levomilnacipran
• Meadowsweet
• Melphalan
• Methotrexate
• Methylprednisolone
• Midodrine
• Milnacipran
• Nadroparin
• Nefazodone
• Paramethasone
• Pargyline
• Parnaparin
• Paroxetine
• Phenindione
• Phenprocoumon
• Prasugrel
• Prednisolone
• Prednisone
• Protein C
• Reviparin
• Rivaroxaban
• Selexipag
• Sertraline
• Sibutramine
• Sulfinpyrazone
• Sulodexide
• Tenofovir Alafenamide
• Ticagrelor
• Ticlopidine
• Tinzaparin
• Tirofiban
• Treprostinil
• Venlafaxine
• Vilazodone
• Vorapaxar
• Vortioxetine
• Warfarin

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Guanethidine

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Allergy to NSAIDs (eg, aspirin, diclofenac, ibuprofen, naproxen, Advil®, Aleve®, Celebrex®, Voltaren®) or
• Asthma, or history of or
• Bronchospasm (breathing problem)—Use with caution. May make these conditions worse.

Proper Use of This Medicine:

Your eye doctor will give you this medicine in a hospital. It is injected into your eyes.

Precautions While Using This Medicine:

Your eye doctor will check your eyes closely while you are receiving this medicine to make sure it is working properly and is not causing unwanted effects.

This medicine may cause an increase in your blood pressure. Tell your doctor right away if you have blurred vision, dizziness, nervousness, headache, pounding in the ears, or slow or fast heartbeat.

Tell your doctor if you experience a sensitivity to light while receiving this medicine.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

More common

Decreased vision or other changes in vision

loss of vision

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose

Fainting

fast, pounding, or irregular heartbeat or pulse

fear or nervousness

headache

nausea

vomiting

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common

Feeling of having something in the eye

red, sore eyes

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.