Acuvail Drops

Acuvail Drops are used for:

Treating eye pain and swelling following cataract surgery. It may also be used for other conditions as determined by your doctor.

Acuvail Drops are a nonsteroidal anti-inflammatory drug (NSAID). It works by blocking certain substances (prostaglandins) in the eye.

Do NOT use Acuvail Drops if:

• you are allergic to any ingredient in Acuvail Drops
• if you have had a severe allergic reaction (eg, severe rash, hives, breathing difficulties, dizziness) to aspirin, an NSAID (eg, ibuprofen, naproxen, celecoxib), or phenylacetic acid
• you are in late pregnancy

Contact your doctor or health care provider right away if any of these apply to you.

Before using Acuvail Drops:

Some medical conditions may interact with Acuvail Drops. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding
• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
• if you have allergies to medicines, foods, or other substances
• if you have asthma, diabetes, bleeding problems, or rheumatoid arthritis
• if you have other eye problems (eg, dry eye syndrome, cornea problems, glaucoma or increased pressure in the eye), have had complicated eye surgery, or have had repeated eye surgeries within a short period of time
• if you have a herpes infection in the eye

Some MEDICINES MAY INTERACT with Acuvail Drops. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Anticoagulants (eg, warfarin), aspirin, corticosteroids (eg, prednisone), heparin, or NSAIDs (eg, ibuprofen) because the risk of side effects, such as bleeding, may be increased
• Topical corticosteroids for the eye (eg, dexamethasone) because they may slow or delay the healing of the eye

This may not be a complete list of all interactions that may occur. Ask your health care provider if Acuvail Drops may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Acuvail Drops:

Use Acuvail Drops as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• An extra patient leaflet is available with Acuvail Drops. Talk to your pharmacist if you have questions about this information.
• Acuvail Drops are only for the eye. Do not get it in your nose or mouth.
• To use Acuvail Drops in the eye, first, wash your hands. Tilt your head back. Using your index finger, pull the lower eyelid away from the eye to form a pouch. Drop the medicine into the pouch and gently close your eyes. Immediately use your finger to apply pressure to the inside corner of the eyelid for 1 to 2 minutes. Do not blink. Remove excess medicine around your eye with a clean, dry tissue, being careful not to touch your eye. Wash your hands to remove any medicine that may be on them.
• To prevent germs from contaminating your medicine, do not touch the applicator tip to any surface, including the eye. Keep the container tightly closed.
• Each vial of Acuvail Drops are intended for single use only. Throw away any unused medicine in the vial immediately after you have used your dose.
• If you are using other eye medicines, wait at least 5 minutes before applying them to the eye.
• Do not wear contact lenses while you are using Acuvail Drops. Take care of your contact lenses as directed by the manufacturer. Check with your doctor before you use them.
• Do not use Acuvail Drops if it is discolored or contains particles.
• If you miss a dose of Acuvail Drops and you are using it regularly, use it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once.

Ask your health care provider any questions you may have about how to use Acuvail Drops.

Important safety information:

• Acuvail Drops may cause blurred vision. This effect may be worse if you take it with alcohol or certain medicines. Use Acuvail Drops with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
• Do NOT use more than the recommended dose or use for longer than prescribed without checking with your doctor. Doing so may increase your risk for side effects, some of which may be serious.
• Using Acuvail Drops more than 24 hours before surgery or for more than 14 days after surgery may increase your risk of side effects, some of which may be serious.
• If your symptoms do not get better within a few days or if they get worse, check with your doctor.
• Tell your doctor if you have a tendency to bleed easily.
• Contact your health care provider at once if you develop another eye condition (eg, trauma, eye surgery, infection) while taking Acuvail Drops. It may be necessary to stop using Acuvail Drops.
• Acuvail Drops may cause harm if it is swallowed. If you may have taken it by mouth, contact your poison control center or emergency room right away.
• Acuvail Drops should not be used in CHILDREN; safety and effectiveness in children have not been confirmed.
• PREGNANCY and BREAST-FEEDING: Avoid using Acuvail Drops late in pregnancy. If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Acuvail Drops while you are pregnant. It is not known if Acuvail Drops are found in breast milk after topical use. If you are or will be breast-feeding while you use Acuvail Drops, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Acuvail Drops:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org), or emergency room immediately.

Store Acuvail Drops between 59 and 86 degrees F (15 and 30 degrees C). Store the vials in the pouch provided with pouch ends folded closed. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Acuvail Drops out of the reach of children and away from pets.

General information:

• If you have any questions about Acuvail Drops, please talk with your doctor, pharmacist, or other health care provider.
• Acuvail Drops are to be used only by the patient for whom it is prescribed. Do not share it with other people.
• If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Acuvail Drops. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.