Gatifloxacin (ophthalmic route)


    Brand Name

    US Brand Name

    Zymar

    Zymaxid


    Description

    Gatifloxacin eye drops are used to treat infections of the eye, such as bacterial conjunctivitis. Gatifloxacin belongs to a group of medicines called fluoroquinolone 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 Zymaxid® in children. However, safety and efficacy have not been established in children younger than 1 year of age.

    Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of Zymar® in children.

    Geriatric

    Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of gatifloxacin eye drops 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.

    Other Medical Problems

    The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

    • Corneal problems—Use with caution. May make these conditions worse.

    Proper Use

    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 tilt the head back and pull the lower eyelid away from the eye to form a pouch. Drop the medicine into the pouch and gently close the eyes. Do not blink. Keep the eyes closed for 1 or 2 minutes to allow the medicine to come into contact with the infection.
    • 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 time of treatment, even if your symptoms have 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:
        • Zymar®:
          • Adults and children—
            • Days 1 and 2: Put 1 drop in the affected eye every 2 hours while awake, up to 8 times a day.
            • Days 3 through 7: Put 1 drop in the affected eye up to 4 times a day while awake.
        • Zymaxid®:
          • Adults and children 1 year of age and older—
            • Day 1: Put 1 drop in the affected eye every 2 hours while awake, up to 8 times.
            • Days 2 through 7: Put 1 drop in the affected eye 2 to 4 times a day while awake.
          • 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

    Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

    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.


    Precautions

    If your or your child's 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. Anaphylaxis can be life-threatening and requires immediate medical attention. Call your doctor right away if you or your child have a rash, itching, red or swollen skin around the eye or eyelid, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth while you are using this medicine.

    Serious skin reactions can occur with this medicine. Check with your doctor right away if you or your child have blistering, peeling, or loose 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.


    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:

    More common

    • Eye irritation
    • eye pain
    • eye redness

    Less common

    • Bloody eye
    • decrease in vision
    • swelling of the membrane covering the white part of the eye

    Rare

    • Blistering, peeling, or loosening of the skin
    • chills
    • cough
    • diarrhea
    • itching
    • joint or muscle pain
    • red skin lesions, often with a purple center
    • red, irritated eyes
    • sore throat
    • sores, ulcers, or white spots in the mouth or on the lips
    • unusual tiredness or weakness

    Incidence not known

    • Difficulty with swallowing
    • dizziness
    • fast heartbeat
    • hives or welts, or skin rash
    • large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
    • puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
    • redness of the skin
    • tightness in the chest
    • trouble breathing

    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:

    More common

    • Blurred vision
    • discharge from the eyes
    • itching eyes
    • stringy mucus secretions
    • swelling of the eye, eyelid, or inner lining of the eyelid
    • watering eyes

    Less common

    • Bad, unusual, or unpleasant (after) taste
    • change in taste
    • dry eye
    • headache

    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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