Omidria

What is Omidria used for?

Omidria is a prescription medicine that is used during eye surgery. It is used to lower eye pain after eye surgery.

Description

Omidria is a sterile aqueous solution, containing the α1-adrenergic receptor agonist phenylephrine HCl and the nonsteroidal anti-inflammatory ketorolac tromethamine, for addition to ocular irrigating solution.

The descriptions and structural formulae are:

Phenylephrine Hydrochloride Drug Substance:

Figure 1: Chemical Structure for Phenylephrine HCl

Ketorolac Tromethamine Drug Substance:

Figure 2: Chemical Structure for Ketorolac Tromethamine

Omidria is a clear, colorless to slightly yellow, sterile solution concentrate with a pH of approximately 6.3.

Each vial of Omidria contains:

Actives: phenylephrine hydrochloride 12.4 mg/mL equivalent to 10.16 mg/mL of phenylephrine and ketorolac tromethamine 4.24 mg/mL equivalent to 2.88 mg/mL of ketorolac.

Inactives: citric acid monohydrate; sodium citrate dihydrate; water for injection; may include sodium hydroxide and/or hydrochloric acid for pH adjustment.

Mechanism of Action

The two active pharmaceutical ingredients (API) in Omidria, phenylephrine and ketorolac, act to maintain pupil size by preventing intraoperative miosis, and reducing postoperative pain.

Phenylephrine is an α1-adrenergic receptor agonist and, in the eye, acts as a mydriatic agent by contracting the radial muscle of the iris. Ketorolac is a nonsteroidal anti-inflammatory that inhibits both cyclooxygenase enzymes (COX-1 and COX-2), resulting in a decrease in tissue concentrations of prostaglandins to reduce pain due to surgical trauma. Ketorolac, by inhibiting prostaglandin synthesis secondary to ocular surgical insult or direct mechanical stimulation of the iris, also prevents surgically induced miosis.

Before taking Omidria, tell your doctor:

• If you are allergic to Omidria; any part of this medicine; or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
• If you are pregnant or may be pregnant. Do not take Omidria if you are in the third trimester of pregnancy. You may also need to avoid Omidria at other times during pregnancy. Talk with your doctor to see when you need to avoid taking Omidria during pregnancy.

This medicine may interact with other drugs or health problems.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take Omidria with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take Omidria?

• Tell all of your health care providers that you take Omidria. This includes your doctors, nurses, pharmacists, and dentists.
• Bright lights may bother you. Wear sunglasses.
• High blood pressure has happened with Omidria. Have your blood pressure checked as you have been told by your doctor.
• Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

How is Omidria best taken?

Use Omidria as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• For the eye only.
• Your doctor will give Omidria.

What do I do if I miss a dose?

• Call your doctor to find out what to do.

What are the side effects of Omidria that I need to call my doctor about immediately?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of high blood pressure like very bad headache or dizziness, passing out, or change in eyesight.
• Very bad eye irritation.

What are some other side effects of Omidria?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if you have any side effects that bother you or do not go away.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

If overdose is suspected:

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

How do I store and/or throw out Omidria?

• If you need to store Omidria at home, talk with your doctor, nurse, or pharmacist about how to store it.

Label

PRINCIPAL DISPLAY PANEL

• NDC 62225-600-04
• OMIDRIA®
• (phenylephrine and ketorolac intraocular solution)
• 1% / 0.3%
• For Intraocular use.
• Must Be Diluted.
• Single-Patient vial
• Sterile 4 mL
• Quantity: 4
• Rx Only

SRC: NLM .