Bepotastine besilate (ophthalmic route)


    Brand Name

    US Brand Name

    Bepreve


    Description

    Bepotastine besilate eye drops is used to treat itching of the eye caused by a condition known as allergic conjunctivitis. It works by preventing the effects of certain inflammatory substances, which are produced by cells in your eyes and sometimes cause allergic reactions.

    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 bepotastine besilate in children. However, safety and efficacy have not been established in children younger than 2 years of age.

    Geriatric

    Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of bepotastine besilate 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.

    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 make a space. Drop the medicine into this space. Let go of the eyelid and gently close the eye. Do not blink. Keep the eye closed for 1 or 2 minutes to allow the medicine to cover the eye.
    • 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.

    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 itching of the eyes:
        • Adults, teenagers, and children 2 years of age and older—Use one drop in the affected eye two times a day.
        • Children younger than 2 years 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

    Your eye doctor will want to examine your eye(s) at regular visits to make sure the medicine is working properly and is not causing unwanted effects.

    If you are wearing contact lenses, remove them before putting the drops in your eyes. Wait at least 10 minutes after using this medicine before putting your contact lenses back in. You should only wear contact lenses if your eyes are not red. This medicine should not be used for irritation caused by contact lenses.

    If your symptoms do not improve within a few days or if they become worse, check with your doctor.


    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

    • Red, sore eyes

    Incidence not known

    • Body rash
    • itching
    • swelling of the lips, tongue, or throat

    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

    • Mild taste in your mouth

    Less common

    • Fever
    • headache
    • muscle aches
    • sore throat
    • stuffy or runny nose
    • unusual tiredness or weakness

    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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