Azithromycin (ophthalmic route)


    Brand Name

    US Brand Name

    AzaSite


    Description

    Azithromycin eye drops is used to treat infections of the eye, including 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.

    This product is available in the following dosage forms:

    • Solution

    Before Using

    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.

    Pediatric

    Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of Azasite® in children. Safety and efficacy have been established.

    Geriatric

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

    Breastfeeding

    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.

    Drug Interactions

    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

    Your eye 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.

    This medicine comes with a patient information leaflet and patient instructions. Read and follow the instructions in the insert carefully. Ask your doctor if you have any questions.

    To use the eye drops:

    • Wash your hands before and after you use this medicine.
    • 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 make a space. Drop the medicine into the space and gently close the eyes. 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.
    • 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 and children—Use one drop in the affected eye 2 times a day, 8 to 12 hours apart for the first 2 days and then one drop in the affected eye once a day for the next 5 days.

    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.

    Ask your healthcare professional how you should dispose of any medicine you do not use.

    Store in the refrigerator. Do not freeze.

    You may store opened medicine at room temperature or in the refrigerator for up to 14 days. Throw away unused medicine after 14 days.


    Precautions

    Your eye doctor will check your or your child's eyes at regular visits to make sure the medicine is working properly and is not causing unwanted effects.

    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 have a rash, itching, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth while you are using this medicine.

    Serious skin reactions (eg, Stevens-Johnson syndrome, toxic epidermal necrolysis) can occur with this medicine. Check with your doctor right away if you have blistering, peeling, or loosening of the skin, chills, cough, diarrhea, itching, joint or muscle pain, red irritated eyes, red skin lesions, often with a purple center, sore throat, sores, ulcers, or white spots in the mouth or on the lips, or unusual tiredness or weakness.

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


    Side Effects

    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
    • chest tightness
    • 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
    • skin rash
    • stuffy or runny nose
    • swelling of the face
    • swelling or puffiness of the eyes
    • trouble breathing

    Incidence not known

    • Blistering, peeling, or loosening of the skin
    • chills
    • diarrhea
    • difficulty swallowing
    • dizziness
    • fast heartbeat
    • joint or muscle pain
    • puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
    • red irritated eyes
    • red skin lesions, often with a purple center
    • sore throat
    • sores, ulcers, or white spots in the mouth or on the lips
    • unusual tiredness or weakness

    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.






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