Apraclonidine (ophthalmic route)


    Brand Name

    US Brand Name

    Iopidine


    Description

    Apraclonidine 0.5% eye drops is used to treat glaucoma when the medications you have been using for glaucoma do not reduce your eye pressure enough.

    Apraclonidine 1% eye drops is used just before and after certain types of eye surgery (argon laser trabeculoplasty, argon laser iridotomy, and Nd:YAG laser posterior capsulotomy). The medicine is used to control or prevent a rise in pressure within the eye (ocular hypertension) that can occur after this type of surgery.

    Apraclonidine 0.5% and 1% are 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 apraclonidine 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 apraclonidine eye drops in the elderly.

    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. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

    Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

    • Amphetamine
    • Dextroamphetamine
    • Iobenguane I 131
    • Lisdexamfetamine

    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:

    • Heart attack, history of or
    • Heart or blood vessel disease (eg, Raynaud's disease, thromboangiitis obliterans) or
    • High blood pressure or
    • Kidney disease or
    • Stroke, history of or
    • Vasovagal attack (rapid decrease in heart rate and blood pressure that can lead to fainting), history of—Use with caution. May make these conditions worse.

    Proper Use

    This medicine is available in 2 forms: apraclonidine 0.5% eye drops and apraclonidine 1% eye drops. Ask your doctor or pharmacist if you have any questions.

    Apraclonidine 0.5% eye drops:

    • 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.
    • 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.
    • 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, keep the container tightly closed.
    • If your doctor ordered two different eye drops to be used together, wait at least 10 minutes between the times you apply the medicines. This will help to keep the second medicine from washing out the first one.

    Apraclonidine 1% eye drops:

    • A doctor or other trained health professional will give you this medicine.
    • You will receive one drop of this medicine in the affected eye 1 hour before surgery, then one drop in the same eye immediately after surgery.

    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 solution (eye drops) dosage form:
      • For glaucoma (0.5% apraclonidine):
        • Adults—Use one drop in each eye two or three times a day.
        • 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.

    Apraclonidine 0.5% eye drops may be stored in the refrigerator.


    Precautions

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

    This medicine may cause some people to become dizzy, drowsy, or less alert than they are normally. 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 are not alert.

    Do not use this medicine if you are also taking a MAO inhibitor (MAOI).

    Apraclonidine 0.5% eye drops 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 immediately if any of the following side effects occur:

    For 0.5% apraclonidine

    More common

    • Allergic reaction (redness, itching, tearing of the eye)

    Less common

    • Blurred vision or change in vision
    • chest pain
    • clumsiness or unsteadiness
    • depression
    • dizziness
    • eye discharge, irritation, or pain
    • irregular heartbeat
    • numbness or tingling in the fingers or toes
    • raising of the upper eyelid
    • rash around the eyes
    • redness of the eyelid or inner lining of the eyelid
    • swelling of the eye, eyelid, or inner lining of the eyelid
    • swelling of the face, hands, or feet

    For 1% apraclonidine

    Less common

    • Blurred vision
    • diarrhea
    • dry mouth
    • eye redness
    • fainting
    • feeling cold or sleepy
    • irregular heartbeat
    • lightheadedness
    • redness, swelling, or whitening of the eyelids
    • slow heartbeat
    • stomach pain
    • stuff or runny nose
    • swelling of the eyelid
    • trouble sleeping
    • unusual dreams
    • unusual taste in the mouth
    • vomiting
    • watering of eye

    Get emergency help immediately if any of the following symptoms of overdose occur:

    For 1% apraclonidine

    Symptoms of overdose

    • Confusion
    • clumsiness
    • drowsiness
    • low body temperature
    • muscle aches
    • muscle weakness
    • shivering
    • sleepiness
    • slow heartbeat
    • tiredness
    • weak or feeble pulse
    • weight gain

    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:

    For 0.5% apraclonidine

    More common

    • Dryness of the mouth
    • eye discomfort

    Less common

    • Change in taste or smell
    • constipation
    • crusting or scales on the eyelid or corner of the eye
    • discoloration of white part of the eye
    • drowsiness or sleepiness
    • dry nose or eyes
    • general feeling of discomfort or illness
    • headache
    • increased sensitivity of the eyes to light
    • muscle aches
    • nausea
    • nervousness
    • paleness of the eye or inner lining of the eyelid
    • runny nose
    • sore throat
    • tiredness or weakness
    • trouble in sleeping

    For 1% apraclonidine

    More common

    • Increase in size of the pupil of the eye
    • paleness of the eye or inner lining of the eyelid

    Less common

    • Runny nose

    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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