Omidria

Omidria is a prescription medication that is added to irrigation solution during eye surgery. It is 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 include eye inflammation, increased intraocular pressure, eye irritation, foreign body sensation in the eye.

Omidria 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.

• Omeros Corporation

Serious side effects have been reported with Omidria. See the “Omidria Precautions” section.

Common side effects of Omidria include the following:

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

This is not a complete list of Omidria 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 Omidria including the following:

• Anterior chamber inflammation
• Increased intraocular pressure
• Posterior capsule opacification
• Eye irritation
• Foreign body sensation in the eye

Do not take Omidria if you:

• are allergic to Omidria 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 Omidria, there are no specific foods that you must exclude from your diet when receiving this medication.

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

• are allergic to Omidria 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.

Omidria 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. Omidria 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 Omidria 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 Omidria.

Use Omidria 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 Omidria 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 Omidria, call your healthcare provider or local Poison Control Center or seek emergency medical attention right away.

If Omidria 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 Omidria at room temperature.
• Keep this and all medications out of the reach of children.