Pronunciation:

ay-zith-roe-MYE-sin

Brand Names:

• AzaSite

Dosage Forms:

• Solution

Classifications:

Therapeutic—

Antibiotic

Chemical—

Macrolide

Uses of This Medicine:

Azithromycin ophthalmic (eye) solution is used to treat infections of the eye, such as bacterial conjunctivitis. Azithromycin belongs to a group of medicines called macrolide antibiotics. It works by killing bacteria that cause conjunctivitis.

This medicine is available only with your doctor's prescription.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of Azasite® in children. However, safety and efficacy have not been established in children younger than 1 year of age.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of Azasite® in the elderly.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Proper Use of This Medicine:

Your doctor will tell you how much of this medicine to use and how often. Do not use more medicine or use it more often than your doctor tells you to. This medicine is not for long-term use.

To use the eye drops:

• First, wash your hands. Then turn the closed bottle upside down and shake it one time before putting the medicine in your eye. Remove the cap with the bottle still being held upside down.
• Tilt your head back and pressing your finger gently on the skin just beneath the lower eyelid, pull the lower eyelid away from the eye to form a pouch. Drop the medicine into the pouch and gently close the eye. Do not blink. Keep the eye closed for 1 or 2 minutes to allow the medicine to be absorbed.
• If you think you did not get the drop of medicine into your eye properly, repeat the directions with another drop.
• Immediately after using the eye drops, wash your hands to remove any medicine that may be on them.
• To keep the medicine as germ-free as possible, do not touch the applicator tip to any surface (including the eye). Also, keep the container tightly closed.

To help clear up your eye infection completely, keep using this medicine for the full treatment time, even if your symptoms disappeared and even if you feel better after the first few doses. Your infection may not clear up if you stop using the medicine too soon. Do not miss any doses.

Dosing—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For ophthalmic dosage form (eye drops):
  • For bacterial conjunctivitis:
    • Adults, teenagers, and children 1 year of age and older—Put one drop in the affected eye(s) two times a day for 2 days, with each dose being at least 8 to 12 hours apart. Then, put one drop in the affected eye(s) once a day for the next 5 days.
    • Children younger than 1 year of age—Use and dose must be determined by your doctor.

Missed dose—

If you miss a dose of this medicine, apply it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule.

Storage—

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Store the unopened bottle in the refrigerator. Do not freeze. Once the medicine is opened, you may store it in the refrigerator or in a closed container at room temperature, away from heat, moisture, and direct light for up to 14 days.

Ask your doctor how you should dispose of any medicine you do not use. Throw away any unused medicine after 14 days.

Precautions While Using This Medicine:

If your eye infection does not improve within a few days, or if it becomes worse, check with your doctor.

This medicine may cause serious allergic reactions, including anaphylaxis, which can be life-threatening and require immediate medical attention. Call your doctor right away if you or your child have a rash; itching; hives; hoarseness; shortness of breath; trouble breathing; trouble swallowing; or any swelling of your hands, face, or mouth after you take this medicine.

Serious skin reactions can occur with this medicine. Stop using this medicine and check with your doctor right away if you or your child have blistering, peeling, or loosening of the skin; red skin lesions; severe acne or skin rash; sores or ulcers on the skin; or fever or chills while you are using this medicine.

Do not wear contact lenses while you are using this medicine to avoid further eye irritation.

Side Effects of This Medicine:

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:

Less common

Burning, redness, stinging, or other eye irritation

Rare

Blistering, burning, crusting, dryness, or flaking of the skin

blurred vision

cough

decreased vision

discharge from the eye

fever

headache

hives or welts

itching, scaling, severe redness, soreness, or swelling of the skin

pain or tenderness around the eyes and cheekbones

painful irritation of the clear front part of the eye

shortness of breath or troubled breathing

skin rash

stuffy or runny nose

swelling of the face

swelling or puffiness of the eyes

tightness of the chest or wheezing

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:

Rare

Change in taste

dry eyes

loss of taste

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.