AzaSite is an eye drop containing azithromycin, a macrolide antibiotic that fights bacteria.

AzaSite is used to treat eye infections caused by bacteria.

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

Use AzaSite for the full prescribed length of time. Your symptoms may improve before the infection is completely cleared.

Stop using AzaSite and get emergency medical help if you have any signs of a rare but serious reaction: fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.

Do not use this medication while wearing contact lenses. AzaSite may contain a preservative that can discolor soft contact lenses. Wait at least 15 minutes after using AzaSite before putting your contact lenses in.

You should not wear contact lenses while you still have active symptoms of the eye infection you are treating.

Serious side effects of AzaSite may include eye drainage or crusting, severe eye irritation, feeling like there is something in your eye, watery eyes, increased light sensitivity, eye redness or swelling, any signs of new infection.

Before taking this medicine

You should not use AzaSite if you are allergic to azithromycin (Zithromax).

Tell your doctor if you are pregnant or plan to become pregnant during treatment.

It is not known whether azithromycin ophthalmic passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

AzaSite should not be used in a child younger than 1 year old.

AzaSite eye drops are usually applied twice daily for 2 days, and then once daily for 5 more days. Follow your doctor's dosing instructions very carefully.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Do not use AzaSite eye drops while wearing soft contact lenses. A preservative in this medicine could permanently stain the lenses. Use the medicine at least 15 minutes before inserting your contact lenses.

Wash your hands before using eye medication.

Turn the bottle upside down and shake it once just before each use.

To apply the AzaSite eye drops: Tilt your head back slightly and pull down your lower eyelid to create a small pocket. Hold the dropper above the eye and squeeze a drop into this pocket. Close your eyes for 1 or 2 minutes.

Use only the number of drops your doctor has prescribed.

• Use only the number of drops your doctor has prescribed. If you use more than one drop, wait about 5 minutes between drops.

• Wait at least 10 minutes before using any other eye drops your doctor has prescribed.

Do not touch the tip of the eye dropper or place it directly on your eye. A contaminated dropper can infect your eye, which could lead to serious vision problems.

Do not AzaSite eye drops if the liquid has changed colors or has particles in it. Call your pharmacist for new medicine.

Use this medicine for the full prescribed length of time, even if your symptoms quickly improve. Skipping doses can increase your risk of infection that is resistant to medication.

Store an unopened bottle of AzaSite eye drops in the refrigerator. Do not freeze.

After opening the bottle, store at room temperature for up to 14 days. Keep the bottle tightly closed when not in use.

Usual Adult Dose for Bacterial Conjunctivitis:

Days 1 and 2: Instill 1 drop in the affected eye(s) twice a day, 8 to 12 hours apart.
Days 3 through 7: Instill 1 drop in the affected eye(s) once a day.

Usual Pediatric Dose for Bacterial Conjunctivitis:

1 year or older:
-Days 1 and 2: Instill 1 drop in the affected eye(s) twice a day, 8 to 12 hours apart.
-Days 3 through 7: Instill 1 drop in the affected eye(s) once a day.

Use: For the treatment of bacterial conjunctivitis due to susceptible isolates of CDC coryneform group G, H influenzae, S aureus, S mitis group, S pneumoniae

You should not use AzaSite if you are allergic to azithromycin (Zithromax).

Tell your doctor if you are pregnant or plan to become pregnant during treatment.

It is not known whether azithromycin ophthalmic passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

AzaSite should not be used in a child younger than 1 year old.

Use the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not use two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

You should not wear contact lenses while you still have active symptoms of the eye infection you are treating (eye redness, irritation, or drainage).

Stop using this medicine and get emergency medical help if you have signs of an allergic reaction to AzaSite (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).

Call your doctor at once if you have:

• drainage or crusting of your eye;

• severe burning, stinging, itching, or other irritation after using the eye drops;

• feeling like something is in your eye;

• changes to the surface of your eye;

• eye pain or swelling;

• eyelid irritation; or

• any signs of a new infection.

Common AzaSite side effects may include:

• eye irritation;

• dry or itchy eyes;

• blurred vision;

• stuffy nose; or

• changes in your sense of taste.

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.