Loteprednol Ophthalmic

WHY is this medicine prescribed?

Ophthalmic loteprednol products are used to treat different eye conditions:

• Loteprednol (Inveltys, Lotemax, Lotemax SM) is used to treat swelling and pain after cataract surgery (procedure to treat clouding of the lens in the eye).
• Loteprednol (Alrex) is used to reduce eye redness, itching, and swelling caused by seasonal allergies.
• Loteprednol (Lotemax) is used to reduce eye swelling caused by allergies, certain eye infections, ocular rosacea (condition that can cause swelling, redness, and itching of the eye), herpes zoster (shingles; a rash that can occur in people who have had chickenpox in the past and can affect the eyes), and other eye conditions.
• Loteprednol (Eysuvis) is used to treat dry eye disease (an eye disorder in which tears do not provide sufficient eye lubrication).

Loteprednol is in a class of medications called corticosteroids. It works by stopping the release of certain natural substances that cause swelling, itching, and pain.

Are there OTHER USES for this medicine?

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

HOW should this medicine be used?

Ophthalmic loteprednol comes as a suspension (liquid) and a gel to instill in the eyes and as an eye ointment to apply to the eye. When used to treat eye swelling and pain after eye surgery, loteprednol 0.5% (Lotemax) eye drops, eye gel and eye ointment are usually applied 4 times a day beginning the day after surgery and continuing for 2 weeks. Loteprednol 0.38% gel (Lotemax SM) is usually instilled 3 times a day beginning the day after surgery and continuing for 2 weeks. Loteprednol 1% eye drops (Inveltys) are usually instilled 2 times a day beginning the day after surgery and continuing for 2 weeks. When used to treat seasonal allergies, loteprednol 0.2% eye drops (Alrex) are usually instilled in the affected eye(s) 4 times a day. When used to reduce eye swelling due to certain conditions, loteprednol 0.5% eye drops (Lotemax) are usually instilled in the affected eye(s) 4 times a day, but during the first week of treatment your doctor may tell you to it more often. When used to treat dry eye, loteprednol 0.25% (Eysuvis) eye drops are usually instilled in the affected eye(s) 4 times daily for 2 weeks. Use loteprednol at around the same times every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Use loteprednol ophthalmic exactly as directed. Do not use more or less of it or use it more often than prescribed by your doctor.

When you use ophthalmic loteprednol, be careful not to let the tip of the bottle or tube touch your eyes, fingers, face, or any surface. If the tip does touch another surface, bacteria may get into the medication. Using eye medication that is contaminated with bacteria may cause serious damage to the eye or loss of vision. If you think your eye drops/gel/ointment has become contaminated, call your doctor or pharmacist.

To use the eye drops or gel follow these steps:

1. Wash your hands thoroughly with soap and water.
2. If using the eye drops, shake the bottle well for at least 3 seconds. If using the gel, turn the closed bottle upside down and shake once.
3. Check the dropper tip to make sure that it is not chipped or cracked.
4. Avoid touching the dropper tip against your eye or anything else; eye drops and dropper must be kept clean.
5. While tilting your head back, pull down the lower lid of your eye with your index finger to form a pocket.
6. Hold the dropper (tip down) with the other hand, as close to the eye as possible without touching it.
7. Brace the remaining fingers of that hand against your face.
8. While looking up, gently squeeze the dropper so that a single drop falls into the pocket made by the lower eyelid. Remove your index finger from the lower eyelid.
9. Close your eye for 2 to 3 minutes and tip your head down as though looking at the floor. Try not to blink or squeeze your eyelids.
10. Place a finger on the tear duct and apply gentle pressure.
11. Wipe any excess liquid or gel from your face with a tissue.
12. If you are to use more than 1 drop in the same eye, wait at least 5 minutes before instilling the next drop.
13. Replace and tighten the cap on the dropper bottle. Do not wipe or rinse the dropper tip.
14. Wash your hands to remove any medication.

To use the eye ointment, follow these instructions:

1. Wash your hands thoroughly with soap and water.
2. Use a mirror or have someone else apply the ointment.
3. Avoid touching the tip of the tube against your eye or anything else. The ointment must be kept clean.
4. Tilt your head forward slightly.
5. Holding the tube between your thumb and index finger, place the tube as near as possible to your eyelid without touching it.
6. Brace the remaining fingers of that hand against your cheek or nose.
7. With the index finger of your other hand, pull the lower lid of your eye down to form a pocket.
8. Place a small amount of ointment into the pocket made by the lower lid and the eye. A 1/2-inch (1.25-centimeter) strip of ointment usually is enough unless otherwise directed by your doctor.
9. Gently close your eyes and keep them closed for 1 to 2 minutes to allow the medication to be absorbed.
10. Replace and tighten the cap right away.
11. Wipe off any excess ointment from your eyelids and lashes with a clean tissue. Wash your hands again.

What SPECIAL PRECAUTIONS should I follow?

Before using loteprednol eye drops,

• tell your doctor and pharmacist if you are allergic to loteprednol, any other medications, or any of the ingredients in loteprednol eye drops, gel, or ointment. Ask your pharmacist for a list of the ingredients.

• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.

• tell your doctor if you currently have any type of eye infection. Your doctor may tell you not to use ophthalmic loteprednol.

• tell your doctor if you have or have ever had glaucoma (condition in which increased pressure in the eye can lead to gradual loss of vision), any other eye disease, or herpes simplex virus (a virus that causes sores to form on the face, lips, genitals, and rectum and can also cause eye infections.)

• tell your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. If you become pregnant while using ophthalmic loteprednol, call your doctor.

• tell your doctor if you wear contact lenses. Your doctor may tell you not to wear contact lenses during your treatment with ophthalmic loteprednol. If your doctor tells you that you may wear contact lenses during your treatment, you should know that loteprednol eye drops contain benzalkonium chloride, which can be absorbed by soft contact lenses. Remove your soft contact lenses before you instill the eye drops and put them back in at least 10 to 15 minutes later. You should not wear contact lenses during your treatment with loteprednol gel or ointment.

• if you are using loteprednol after surgery you should know that loteprednol may slow healing after surgery, increase the risk of certain complications after cataract surgery, and increase your chances of getting an eye infection or worsen an infection that you already have. Call your doctor right away if you develop new eye pain, or if your eye pain, redness, itching or swelling becomes worse, or does not improve after 2 days.

• if you are using loteprednol eye drops for seasonal allergies or to reduce eye swelling caused by certain other conditions, call your doctor if your symptoms do not improve after 2 days.

What SPECIAL DIETARY instructions should I follow?

Unless your doctor tells you otherwise, continue your normal diet.

What should I do IF I FORGET to take a dose?

Use the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not use extra eye drops, gel, or ointment to make up for a missed dose.

What SIDE EFFECTS can this medicine cause?

Loteprednol may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• burning feeling when the eye drops are instilled
• headache
• dry, red, or itchy eyes
• teary eyes
• runny nose

Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately:

• blurred vision or vision changes
• eye pain
• sensitivity to light
• eye discharge or crusting
• feeling that something is in the eye

Ophthalmic loteprednol may increase the risk of developing glaucoma when used for a longer period of time. If you use loteprednol eye drops, eye gel, or ointment for 10 days or longer, your doctor will probably monitor the pressure in your eyes. Talk to your doctor about the risks of using this medication.

Ophthalmic loteprednol may cause other side effects. Call your doctor if you have any unusual problems while using this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

What should I know about STORAGE and DISPOSAL of this medication?

Keep this medication in the original container, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Do not freeze.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

What should I do in case of OVERDOSE?

If someone swallows ophthalmic loteprednol, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.

What OTHER INFORMATION should I know?

Keep all appointments with your doctor.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.