Brimonidine (ophthalmic route)


    Brand Name

    US Brand Name

    Alphagan P

    Lumify


    Description

    Brimonidine eye drops is used alone or together with other medicines to lower pressure inside the eye that is caused by open-angle glaucoma or ocular (eye) hypertension. This medicine is an alpha-adrenergic agonist.

    Brimonidine eye drops is also used to relieve redness of the eye caused by minor eye irritations.

    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 Alphagan® P eye drops in children 2 years of age and older. Because of brimonidine's toxicity, use in children younger than 2 years of age is not recommended.

    Appropriate studies have not been performed on the relationship of age to the effects of Lumify™ eye drops in children younger than 5 years of age. 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 brimonidine 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. 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:

    • Depression or
    • Heart attack, history of or
    • Heart disease or
    • Orthostatic hypotension (low blood pressure when standing up) or
    • Raynaud disease (blood vessel disease) or
    • Stroke, history of or
    • Thromboangiitis obliterans (blood vessel disease)—Use with caution. May make these conditions worse.

    Proper Use

    Use this medicine only as directed by your doctor. Do not use more of it, do not use it more often, and do not use it for a longer time than your doctor ordered.

    If your doctor ordered two different eye drops to be used together, wait at least 5 minutes after you put the first medicine in your eye to use the second medicine. This will prevent the second medicine from “washing out” the first one.

    To use the eye drops:

    • Wash your hands with soap and water before and after using this medicine.
    • Shake the eye drops well just before each use.
    • Tilt your head back and press 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, repeat the directions with a second drop.
    • To keep the medicine as germ-free as possible, do not touch the applicator tip to any surface, including the eye. Keep the container tightly closed when you are not using the drops.
    • If germs get in the bottle, your eye could become infected. Serious eye infections can cause blindness.
    • The eye drops will normally be a clear liquid with a greenish-yellow color. If the color changes or the liquid becomes cloudy, do not use the medicine. Get a new bottle from the pharmacy.

    You should not use the eye drops if you have contact lenses in your eyes. Remove your contact lenses before you use this medicine. Wait at least 10 minutes after you use the medicine before putting the contact lenses back in.

    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 ocular hypertension:
        • Adults and children 2 years of age and older—One drop in the affected eye 3 times a day, about 8 hours apart.
        • Children younger than 2 years of age—Use is not recommended.
      • For redness of the eye:
        • Adults and children 5 years of age and older—One drop in the affected eye every 6 to 8 hours.
        • Children younger than 5 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

    It is very important that your eye doctor (ophthalmologist) check your or your child's progress at regular visits to make sure the medicine is working properly and is not causing unwanted effects.

    If itching, redness, swelling, or other signs of eye or eyelid irritation occur, check with your doctor.

    If you or your child have an eye injury or infection, or need to have eye surgery, talk with your doctor right away. You may need to change the medicine or stop using it.

    This medicine may cause some people to become lightheaded, dizzy, drowsy, tired, or less alert than they are normally. Do not drive or do anything else that could be dangerous until you know how this medicine affects you.

    This medicine may add to the effects of alcohol and other CNS depressants (medicines that make you drowsy or less alert). Some examples of CNS depressants are antihistamines or medicines for allergies, sedatives or sleeping medicine, prescription pain medicine or narcotics, medicine for seizures or barbiturates, muscle relaxants, or anesthetics, including some dental anesthetics. Check with your doctor before taking any of the above while you are using this medicine.

    Brimonidine 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:

    More common

    • Blurred or loss of vision
    • burning, dry, or itching eyes
    • discharge or excessive tearing
    • disturbed color perception
    • double vision
    • halos around lights
    • headache
    • itching of the eye
    • night blindness
    • overbright appearance of lights
    • redness of the eye or inner lining of the eyelid
    • swelling of the eyelid
    • tearing of the eye
    • tunnel vision

    Less common

    • Ache or pain in the eye
    • blindness
    • bloody eye
    • blurred vision or other change in vision
    • change in color vision
    • confusion
    • decreased vision
    • difficult or labored breathing
    • difficulty seeing at night
    • dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
    • drainage from the eye
    • fainting
    • fast heartbeat
    • feeling of something in the eye
    • gradual blurring or loss of vision
    • increased blood pressure
    • increased sensitivity of the eye to light
    • mental depression
    • muscle pain
    • nausea
    • oozing in the eye
    • redness, swelling, or itching of the eye or eyelid
    • runny or stuffy nose
    • seeing flashes or sparks of light
    • seeing floating dark spots or material before eyes
    • seeing floating spots before the eyes or a veil or curtain appearing across part of vision
    • skin rash
    • sneezing
    • sweating
    • swelling of the eye
    • tightness in the chest
    • unusual tiredness or weakness
    • vomiting
    • watery eyes

    Incidence not known

    • Bluish lips or skin
    • chest pain or discomfort
    • confusion
    • fast, pounding, or irregular heartbeat or pulse
    • feeling of warmth or heat
    • flushing or redness of the skin, especially on the face and neck
    • irregular, fast, slow, or shallow breathing
    • low body temperature
    • muscle aches or weakness
    • shivering
    • slow or irregular heartbeat
    • 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:

    More common

    • Burning, stinging, or tearing of the eye
    • drowsiness or tiredness
    • dryness of the mouth

    Less common

    • Anxiety
    • bad, unusual, or unpleasant (after) taste
    • belching
    • body aches or pain
    • change in taste
    • chills
    • congestion
    • cough
    • cough producing mucus
    • crusting on the eyelid or on the corner of the eye
    • diarrhea
    • difficulty breathing
    • discoloration of the white part of the eye
    • dryness of the eye
    • dryness or soreness of the throat
    • fever
    • general feeling of discomfort or illness
    • hoarseness
    • indigestion
    • joint pain
    • lack or loss of strength
    • large amounts of cholesterol in the blood
    • lid disorder
    • loss of appetite
    • muscle aches and pains
    • pain or tenderness around the eyes and cheekbones
    • paleness of the eye or inner lining of the eyelid
    • passing of gas
    • pounding heartbeat
    • rash
    • shivering
    • sleepiness or unusual drowsiness
    • sneezing
    • sore throat
    • stomach discomfort, fullness, upset, or pain
    • tender, swollen glands in the neck
    • trouble with sleeping
    • trouble with swallowing
    • troubled breathing
    • unable to sleep
    • voice changes

    Incidence not known

    • Constricted, pinpoint, or small pupils (black part of the eye)
    • redness of the skin
    • sensitivity to light
    • throbbing pain
    • unusual drowsiness, dullness, or feeling of sluggishness
    • unusual weak feeling
    • unusually warm skin

    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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