Brand Name

    US Brand Name

    Ocufen


    Description

    Flurbiprofen eye drops are used to keep the pupils of the eye from getting smaller (miosis) during an eye surgery. This medicine is a topical nonsteroidal anti-inflammatory drug (NSAID).

    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 have not been performed on the relationship of age to the effects of flurbiprofen eye drops in the pediatric population. Safety and efficacy have not been established.

    Geriatric

    Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of flurbiprofen 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:

    • Allergy to NSAIDs (e.g., aspirin, diclofenac, ibuprofen, naproxen, Advil®, Aleve®, Celebrex®, Voltaren®), history of or
    • Bleeding problems—Use with caution. May make these conditions worse.

    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.

    Use one bottle for each eye before an eye surgery. Use of the same bottle of eye drops for both eyes is not recommended.

    To use the eye drops:

    • First, wash your hands. Tilt the 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 eyes. Do not blink. Keep the eyes closed for 1 or 2 minutes to allow the medicine to be absorbed by the eye.
    • Immediately after using the eye drops, wash your hands to remove any medicine that may be on them.
    • If you think you did not get the drop of medicine into your eye properly, use another drop.
    • To keep the medicine as germ-free as possible, do not touch the applicator tip to any surface (including the eye). Also, always 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 prevention of miosis during an eye surgery:
        • Adults—Use one drop in the affected eye(s) every 30 minutes beginning 2 hours before eye surgery (a total of four drops).
        • Children—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 check you closely while you are using this medicine. This is to make sure that the medicine is working properly and not causing unwanted effects.

    Slow or delayed healing may occur while you are using this medicine. Ask your doctor before using this medicine together with a steroid eye medicine (e.g., dexamethasone, prednisolone, Ciprodex®).

    If you hurt your eye or develop an eye infection, talk with your doctor right away. You may need to change your medicine or stop using it.

    While applying this medicine, your eyes will probably sting or burn for a short time. This is to be expected.

    Do not use other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.


    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:

    Incidence not known

    • Eye irritation or redness
    • increased sensitivity of the eyes to light
    • red or bloodshot eye

    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:

    Incidence not known

    • Stinging or burning of the eye when medicine is applied

    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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