Loteprednol Etabonate Ophthalmic drops, suspension

What is this medicine?

LOTEPREDNOL (loe te PRED nol) is used in the eye to treat swelling and redness caused by certain eye conditions or surgery.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

• any active infection

• glaucoma

• wear contact lenses

• an unusual or allergic reaction to loteprednol, glycerin, benzalkonium chloride, other corticosteroids, medicines, foods, dyes, or preservatives

• pregnant or trying to get pregnant

• breast-feeding

How should I use this medicine?

This medicine is only for use in the eye. Do not take by mouth. Follow the directions on the prescription label. Shake well before using. Wash your hands before and after use. Tilt your head back slightly, and then pull your lower eyelid down with your index finger to form a pouch. Do not to touch the tip of the dropper to your eye, fingertips, or other surface. Squeeze the prescribed number of drops into the eye pouch. Gently close the eye for a few moments to spread the drops. Do not blink. Keep the eyes closed and apply gentle pressure to the inner corner of the eye with your finger for 1 or 2 minutes to allow the medicine to be absorbed by the eye. Do not use the medicine more often than directed. Do not stop using this medicine earlier than directed by your doctor or health care professional.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, use it as soon as you can. If it is almost time for your next dose, use only that dose. Do not use double or extra doses.

What may interact with this medicine?

Interactions are not expected. Do not use any other eye products without asking your doctor or health care professional.

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medicine?

Check with your doctor or health care professional if your condition gets worse or if it does not start to get better within 2 days. Tell your doctor or health care professional if you are exposed to anyone with chickenpox.

If you wear contact lenses, you should remove them before using this medicine. You should wait about 10 minutes after putting the drops in your eyes before putting your lenses back in. You should not wear your contact lenses if your eyes are red.

Wear sunglasses if this medicine makes your eyes more sensitive to sunlight.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

• blurred vision or a change in vision

• eye infection

• eye pain or discharge

• increased redness and swelling of the eyes

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

• dry, watery, itchy, or irritated eyes

• headache

• runny nose or sore throat

• sensitivity of the eyes to sunlight

• temporary blurring of vision

• the feeling that something is in your eye

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medicine?

Keep out of the reach of children.

Store at room temperature between 15 and 25 degrees C (59 and 77 degrees F). Do not freeze. Throw away any unused medicine after the expiration date.

Loteprednol Etabonate Ophthalmic gel

What is this medicine?

LOTEPREDNOL (loe te PRED nol) is used in the eye to treat swelling and pain caused by eye surgery.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

• any active infection

• glaucoma

• wear contact lenses

• an unusual or allergic reaction to loteprednol, other corticosteroids, medicines, foods, dyes, or preservatives

• pregnant or trying to get pregnant

• breast-feeding

How should I use this medicine?

This medicine is only for use in the eye. Follow the directions on the prescription label. Wash hands before and after use. Turn bottle upside down and shake once to fill tip before using. Tilt your head back slightly and pull your lower eyelid down with your index finger to form a pouch. Try not to touch the tip of the dropper or tube to your eye, fingertips, or other surface. Squeeze the prescribed number of drops into the pouch. Close the eye gently to spread the drops. Do not use your medicine more often than directed. Finish the full course of medicine prescribed by your doctor or health care professional even if your condition is better. Do not stop using except on the advice of your doctor or health care professional.

Overdosage: If you think you've taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, use it as soon as you can. If it is almost time for your next dose, use only that dose. Do not use double or extra doses.

What may interact with this medicine?

Interactions are not expected. Do not use any other eye products without asking your doctor or health care professional.

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medicine?

Tell your doctor or healthcare professional if your symptoms do not start to get better or if they get worse.

If you wear contact lenses, ask your doctor or health care professional when you can use your lenses again.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue

• changes in vision

• eye pain

Side effects that usually do not require medical attention (Report these to your doctor or health care professional if they continue or are bothersome.):

• feeling of something in the eye

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medicine?

Keep out of the reach of children.

Store between 15 and 25 degrees C (59 and 77 degrees F). Throw away any unused medicine after the expiration date.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.

Loteprednol Etabonate Ophthalmic ointment

What is this medicine?

LOTEPREDNOL (loe te PRED nol) is used in the eye to treat swelling and pain caused by eye surgery.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

• any active infection

• glaucoma

• wear contact lenses

• an unusual or allergic reaction to loteprednol, other corticosteroids, medicines, foods, dyes, or preservatives

• pregnant or trying to get pregnant

• breast-feeding

How should I use this medicine?

This medicine is only for use in the eye. Follow the directions on the prescription label. Wash hands before and after use. Tilt your head back slightly and pull your lower eyelid down with your index finger to form a pouch. Try not to touch the tip of the tube to your eye, fingertips, or other surface. Squeeze the end of the ointment tube to apply a thin layer of the ointment to the inside of the eyelid. Close the eye gently to spread the ointment. Do not use your medicine more often than directed. Finish the full course of medicine prescribed by your doctor or health care professional even if your condition is better. Do not stop using except on the advice of your doctor or health care professional.

Talk to your pediatrician regarding the use of this medicine in children. This medicine is not approved for use in children.

Overdosage: If you think you've taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, use it as soon as you can. If it is almost time for your next dose, use only that dose. Do not use double or extra doses.

What may interact with this medicine?

Interactions are not expected. Do not use any other eye products without asking your doctor or health care professional.

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medicine?

Check with your doctor or health care professional if your condition gets worse or if it does not start to get better within 2 days. Tell your doctor or health care professional if you are exposed to anyone with a viral infection.

If you wear contact lenses, you should remove them before using this medicine. You should not wear your contact lenses while taking this medicine.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

• blurred vision or a change in vision

• eye infection

Side effects that usually do not require medical attention (Report these to your doctor or health care professional if they continue or are bothersome.):

• eye pain or discharge

• headache

• increased redness and swelling of the eyes

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medicine?

Keep out of the reach of children.

Store at room temperature between 15 and 25 degrees C (59 and 77 degrees F). Throw away any unused medicine after the expiration date.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.