Unoprostone (ophthalmic route)


    Brand Name

    US Brand Name

    Rescula


    Description

    Unoprostone is used to treat increased pressure in the eye caused by open-angle glaucoma. It is also used to treat a condition called ocular hypertension (hypertension of the eye).

    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

    Studies on this medicine have been done only in adult patients and there is no specific information comparing use of ophthalmic unoprostone in children with use in other age groups.

    Geriatric

    This medicine has been tested and has not been shown to cause different side effects or problems in older people than it does in younger adults.

    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

    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 and apply pressure to the inner corner of the eye with your finger for 1 or 2 minutes to allow the medicine to be absorbed by the eye.
    • To keep this medicine as germ-free as possible, do not touch the applicator tip to any surface (including the eye). Also, keep the container tightly closed.

    Use this medicine only as directed. Do not use more of it and do not use it more often than your doctor ordered. To do so may increase the chance of too much medicine being absorbed into the body and the chance of side effects.

    If you wear contact lenses: These eye drops contain a preservative that could be absorbed by the contact lenses. Wait at least 15 minutes after putting these drops in before you put in your contact lenses.

    If your doctor ordered two different eye drops to be used together, wait at least 5 minutes between the times you apply the medicines.

    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 glaucoma or hypertension of the eye:
        • Adults—Use one drop in the affected eye or eyes two times a day.
        • Children—Use and dose must be determined by your doctor.

    Missed Dose

    If you miss a dose of this medicine, take 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. Do not double doses.

    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

    It is very important that your doctor check your progress at regular visits to make sure that this medicine is working and to check for unwanted effects.

    Contact your doctor immediately if you are having eye surgery, you experience trauma to your eye, or you develop an eye infection to determine if you should continue to use your present container of eye drops.

    This medicine may cause some people to have blurred vision for a short time. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you cannot see properly.

    Ophthalmic unoprostone may cause your eyes to become more sensitive to light than they are normally. Wearing sunglasses and avoiding too much exposure to bright light may help lessen the discomfort.


    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 as soon as possible if any of the following side effects occur:

    Less common

    • Blood in the whites of the eyes
    • blurred vision or eye pain
    • eye irritation or redness

    Rare

    • Blindness
    • color blindness
    • decreased vision or other changes in vision

    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

    • Abnormal tearing of eyes
    • burning or stinging of eyes
    • chills
    • cough
    • diarrhea
    • double vision
    • dry eyes
    • fever
    • general feeling of discomfort or illness
    • headache
    • itching of eyes
    • joint pain
    • loss of appetite
    • muscle aches and pains
    • nausea
    • runny nose
    • shivering
    • sore throat
    • sweating
    • trouble sleeping
    • unusual tiredness or weakness
    • vomiting

    Less common or rare

    • Discharge from eye
    • inflammation of the eye
    • redness, pain, swelling of eye, eyelid, or inner lining of eyelid
    • sensitivity to light

    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

    • Feeling of having something in the eye
    • increased or decreased length of eyelashes

    Less common or rare

    • Change in the color of the iris or eyelid
    • increase in number of eyelashes
    • difficulty seeing at night
    • increased sensitivity of eyes to sunlight

    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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