Acuvail

Before using ketorolac eye drops,

• tell your doctor or pharmacist if you are allergic to ketorolac, aspirin, or any other medications.
• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention any of the following: anticoagulants ('blood thinners') such as warfarin (Coumadin); aspirin; nonsteroidal anti-inflammatory agents, such as celecoxib (Celebrex), diclofenac (Voltaren), etodolac (Lodine), fenoprofen (Nalfon), flurbiprofen (Ansaid), ibuprofen (Advil, Motrin, Midol), indomethacin (Indocin), ketoprofen (Orudis, Oruvail), ketorolac (Toradol), meclofenamate, mefenamic (Ponstel), nabumetone (Relafen), naproxen (Aleve, Naprosyn), oxaprozin (Daypro), Piroxicam (Feldene), sulindac (Clinoril), and tolmetin (Tolectin).
• tell your doctor if you have or have ever had heart, kidney, or liver disease or bleeding problems.
• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding.
• tell your doctor if you wear soft contact lenses. You should not use ketorolac eye drops while wearing your soft contact lenses.
• use caution when driving or operating machinery because your vision may be blurred after you instill the drops.

An overdose of ketorolac ophthalmic is not expected to be dangerous. Seek emergency medical attention or call the Poison Help line at 1-800-222-1222 if anyone has accidentally swallowed the medication.

It is not likely that other drugs you take orally or inject will have an effect on ketorolac used in the eyes. But many drugs can interact with each other. Tell each of your healthcare providers about all medicines you use, including prescription and over-the-counter medicines, vitamins, and herbal products.

Your eye doctor will check your or your child's eyes at regular visits to make sure it is working properly and is not causing unwanted effects.

If your or your child's symptoms do not improve within a few days or if they become worse, check with your doctor.

Slow or delayed healing may occur while you or your child are using this medicine. Ask your doctor before using this medicine together with a topical corticosteroid (eg, betamethasone, hydrocortisone).

Using this medicine may increase risk of having corneal (front part of the eye) problems, including keratitis. Check with your eye doctor right away if you or your child have blurred vision, changes in vision, or eye redness, irritation, or pain while using this medicine.

Make sure your doctor knows if you are pregnant. Do not use this medicine during the later part of a pregnancy, unless your doctor tells you to.

If you hurt your eye, develop an eye infection, or need to have eye surgery, talk with your doctor right away. You may need to change your medicine or stop using it.

While applying this medicine, your eyes will probably sting or burn for a short time. This is to be expected.

Do not use other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

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 immediately if any of the following side effects occur:

• Itching, redness, tearing, or other sign of eye irritation not present before use of this medicine or becoming worse during use
• redness of the clear part of the eye
• sensitivity to light
• swelling of the eye
• tearing
• throbbing pain

• Blurred vision or other change in vision
• eye irritation or redness

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:

• Stinging or burning of the eye when medicine is applied

• Dry eyes
• headache

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.

• If you have an allergy to ketorolac tromethamine or any other part of Acuvail (ketorolac tromethamine eye drops).
• If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
• If you are more than 24 weeks pregnant.

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 this medicine with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

• Tell all of your health care providers that you take Acuvail. This includes your doctors, nurses, pharmacists, and dentists.
• Tell your doctor if you have an eye infection, eye injury, or will be having eye surgery.
• If you have an eye wound or irritation that does not heal, talk to your doctor.
• Use care when driving or doing other tasks that call for clear eyesight.
• Do not take this medicine for more than 2 weeks unless told to do so by your doctor.
• Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using Acuvail while you are pregnant.
• Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
• Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
• Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about this medicine, please talk with your doctor, nurse, pharmacist, or other health care provider.
• 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.

This information should not be used to decide whether or not to take Acuvail or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Acuvail. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.

Review Date: October 4, 2017

Mechanism of Action

Ketorolac tromethamine is a nonsteroidal anti-inflammatory drug which, when administered systemically, has demonstrated analgesic, anti-inflammatory, and anti-pyretic activity. The mechanism of its action is thought to be due to its ability to inhibit prostaglandin biosynthesis.

Pharmacokinetics

Two drops of 0.5% ketorolac tromethamine ophthalmic solution instilled into the eyes of patients 12 hours and 1 hour prior to cataract extraction achieved a mean ketorolac concentration of 95 ng/mL in the aqueous humor of 8 of 9 eyes tested (range 40 to 170 ng/mL).

One drop of 0.5% ketorolac tromethamine ophthalmic solution was instilled into 1 eye and 1 drop of vehicle into the other eye three times daily in 26 healthy subjects. Five (5) of 26 subjects had detectable concentrations of ketorolac in their plasma (range 11 to 23 ng/mL) at Day 10 during topical ocular treatment. The range of concentrations following three times daily dosing of 0.5% ketorolac tromethamine ophthalmic solution are approximately 4 to 8% of the steady state mean minimum plasma concentration observed following four times daily oral administration of 10 mg ketorolac in humans (290 ± 70 ng/mL).

Acuvail (ketorolac) 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.

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.

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.