Acuvail ophthalmic solution is used to reduce swelling, pain, and burning or stinging after cataract surgery.

Ketorolac is in a group of drugs called nonsteroidal anti-inflammatory drugs (NSAIDs). Acuvail works by reducing hormones that cause inflammation and pain in the body.

Acuvail may also be used for other purposes not listed in this medication guide.

You should not use Acuvail if you are allergic to ketorolac or other NSAIDs (nonsteroidal anti-inflammatory drugs).

Before using Acuvail, tell your doctor if you are allergic to any medications, or if you have a bleeding or blood-clotting disorder, diabetes, arthritis, glaucoma, dry eye syndrome, or if you have had other recent eye surgeries.

Tell your doctor about all other medications you use, especially a blood thinner such as warfarin (Coumadin).

Use Acuvail exactly as prescribed by your doctor. Do not use it in larger amounts or for longer than recommended. Follow the directions on your prescription label. Using the medication for longer than prescribed may increase the risk of serious side effects on your eyes.

While you are using Acuvail, do not wear any contact lens that has not been approved by your doctor. Do not use any other eye medications unless your doctor has prescribed them.

Before using Acuvail

You should not use Acuvail if you are allergic to ketorolac or other NSAIDs.

If you have any of these other conditions, you may need a dose adjustment or special tests to safely use Acuvail:

• a bleeding or blood-clotting disorder;

• diabetes;

• arthritis;

• glaucoma;

• dry eye syndrome; or

• if you have had other recent eye surgeries.

FDA pregnancy category C. It is not known whether Acuvail is harmful to an unborn baby. Before taking this medication, tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether ketorolac passes into breast milk or if it could harm a nursing baby. Do not use Acuvail without telling your doctor if you are breast-feeding a baby.

Use Acuvail exactly as prescribed by your doctor. Do not use it in larger amounts or for longer than recommended. Follow the directions on your prescription label.

Acuvail is usually given 24 hours before cataract surgery, and continued for up to 14 days after surgery. Using the medication for longer than prescribed may increase the risk of serious side effects on your eyes.

Wash your hands before using the eye drops.

To apply the Acuvail eye drops:

• Tilt your head back slightly and pull down your lower eyelid to create a small pocket. Hold the dropper above the eye with the dropper tip down. Look up and away from the dropper as you squeeze out a drop, then close your eye.

• Gently press your finger to the inside corner of the eye (near your nose) for about 1 minute to keep the liquid from draining into your tear duct.

• Use the Acuvail eye drops only in the eye you are having surgery on.

• Do not allow the dropper tip to touch any surface, including the eyes or hands. If the dropper becomes contaminated it could cause an infection in your eye, which can lead to vision loss or serious damage to the eye.

Do not use the Acuvail eye drops if the liquid has changed colors or has particles in it. Call your doctor for a new prescription.

Store Acuvail at room temperature away from heat and moisture. Keep the bottle tightly closed when not in use.

You should not use Acuvail if you are allergic to ketorolac or other NSAIDs.

If you have any of these other conditions, you may need a dose adjustment or special tests to safely use Acuvail:

• a bleeding or blood-clotting disorder;

• diabetes;

• arthritis;

• glaucoma;

• dry eye syndrome; or

• if you have had other recent eye surgeries.

FDA pregnancy category C. It is not known whether Acuvail is harmful to an unborn baby. Before taking this medication, tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether ketorolac passes into breast milk or if it could harm a nursing baby. Do not use Acuvail without telling your doctor if you are breast-feeding a baby.

Use the missed dose as soon as you remember. If it is almost time for your next dose, wait until then to use the medicine and skip the missed dose. Do not use extra medicine to make up the missed dose.

Seek emergency medical attention if you think you have used too much of this medicine.

An overdose of ketorolac is not likely to cause life-threatening symptoms.

While using Acuvail, do not wear any contact lens that has not been approved by your doctor.

Do not use any other eye medications unless your doctor has prescribed them.

Get emergency medical help if you have any of these signs of an allergic reaction to Acuvail: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have a serious side effect such as:

• severe burning, stinging, or itching of your eyes;

• eye pain, redness, or watering;

• vision changes, increased sensitivity to light;

• white patches on your eyes; or

• crusting or drainage from your eyes.

Less serious Acuvail side effects may include:

• mild burning, stinging, or itching of your eyes;

• swollen or puffy eyelids; or

• headache.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Tell your doctor about all other medications you use, especially a blood thinner such as warfarin (Coumadin).

This list is not complete and there may be other drugs that can interact with Acuvail. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.