Azithromycin Ophthalmic

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing or swallowing; swelling of your face, lips, tongue, or throat.

Stop using azithromycin ophthalmic and 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;
• watery eyes, increased light sensitivity;
• eye pain, redness, or swelling;
• any signs of a new infection; or
• 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.

Common side effects may include:

• dry or itchy eyes;
• blurred vision;
• changes in your sense of taste;
• stuffy nose; or
• mild stinging, burning, or irritation of your eyes.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

Your doctor will tell you how much of azithromycin to use and how often. Do not use more medicine or use it more often than your doctor tells you to. azithromycin 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 azithromycin 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 azithromycin 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 azithromycin. 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 azithromycin, 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.

• Tell all of your health care providers that you take azithromycin. This includes your doctors, nurses, pharmacists, and dentists.
• Use care when driving or doing other tasks that call for clear eyesight.
• Do not use longer than you have been told. A second infection may happen.
• Very bad and sometimes deadly allergic reactions have rarely happened with other forms of this medicine as well as drugs like this one. Talk with the doctor.
• Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using azithromycin while you are pregnant.
• Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

(az ith roe MYE sin)

Bacterial conjunctivitis: For the treatment of bacterial conjunctivitis caused by susceptible isolates of the following microorganisms: Centers for Disease Control and Prevention (CDC) coryneform group G (efficacy studied in fewer than 10 infections), Haemophilus influenzae, Staphylococcus aureus, Streptococcus mitis group, and Streptococcus pneumoniae.

Bacterial conjunctivitis: Ophthalmic: Instill 1 drop into affected eye(s) twice daily (8 to 12 hours apart) for 2 days, then 1 drop into affected eye(s) once daily for the next 5 days

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Have patient report immediately to prescriber vision changes, eye pain, severe eye irritation, or eye discharge (HCAHPS).

• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for healthcare professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience and judgment in diagnosing, treating and advising patients.

Azithromycin is a macrolide antibiotic that fights bacteria.

Azithromycin ophthalmic (for the eyes) is used to treat eye infections caused by bacteria.

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

Stop using this medicine 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.

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

FDA pregnancy category B. Azithromycin ophthalmic is not expected to harm an unborn baby. 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.

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