Phenylephrine & Ketorolac

Phenylephrine and ketorolac is a combination of prescription medications that is added to irrigation solution during eye surgery. It is available as a single product containing 2 medications: phenylephrine and ketorolac.

Phenylephrine belongs to a group of drugs called adrenergic receptor antagonists. These work by contracting the muscle of the iris to maintain pupil size. Ketorolac belongs to a group of drugs called non-steroidal anti-inflammatory drugs. These help to reduce post-operative pain.

This medication is available in an injectable form and is diluted in ophthalmic irrigation solution.

Common side effects of phenylephrine and ketorolac include eye inflammation, increased intraocular pressure, eye irritation, foreign body sensation in the eye.

Phenylephrine and ketorolac is a combination of prescription medications that is added to irrigation solution during eye surgery. It is available as a single product containing 2 medications: phenylephrine and ketorolac.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Phenylephrine & Ketorolac may be found in some form under the following brand names:

• Omidria

Serious side effects have been reported with phenylephrine and ketorolac. See the “Phenylephrine and ketorolac Precautions” section.

Common side effects of phenylephrine and ketorolac include the following:

• eye inflammation
• increased intraocular pressure
• eye irritation
• foreign body sensation in the eye

This is not a complete list of phenylephrine and ketorolac side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that does not go away.

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

No drug interactions have been determined by the manufacturer. However, you should tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Not all drug interactions are known or reported and new drug interactions are continually being reported.

Serious side effects have been reported with phenylephrine and ketorolac including the following:

• anterior chamber inflammation
• increased intraocular pressure
• posterior capsule opacification
• eye irritation
• foreign body sensation in the eye

Do not take phenylephrine and ketorolac if you:

• are allergic to phenylephrine or ketorolac or to any of the ingredients in the combination product

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of phenylephrine and ketorolac, there are no specific foods that you must exclude from your diet when receiving this medication.

Before taking phenylephrine and ketorolac, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to phenylephrine or ketorolac or to any of the ingredients in the combination product
• have or had had sensitivities or allergies to acetylsalicylic acid (Aspirin) or other non-steroidal anti-inflammatory drugs such as ibuprofen (Advil), naproxen (Aleve), indomethacin (Indocin), meloxicam (Mobic), or celecoxib (Celebrex)
• are pregnant or breastfeeding

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Phenylephrine and ketorolac falls into category C. No studies have been done in animals with this combination product and no well-controlled studies have been done in pregnant women. Phenylephrine and ketorolac should be given to a pregnant woman only if clearly needed.

Tell your doctor if you are breastfeeding or plan to breastfeed.

It is not known if phenylephrine and ketorolac crosses into human milk. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with use of this medication, a choice should be made whether to stop nursing or stop the use of this medication. Your doctor and you will decide if the benefits outweigh the risk of using phenylephrine and ketorolac.

Use phenylephrine and ketorolac exactly as prescribed.

This medication is available in an injectable form to be diluted in ophthalmic irrigation solution.

This medication is used during eye surgery.

The dose your doctor recommends may be based on the following:

• the condition being treated

The recommended dilution of phenylephrine and ketorolac is 4 mL of the combination product in 500 mL of irrigation solution. The irrigation solution is used as needed during eye surgery.

If you take too much phenylephrine and ketorolac, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

If phenylephrine and ketorolac is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention.

• Store phenylephrine and ketorolac at room temperature.