Brand Name

    US Brand Name

    Azopt

    Canadian Brand Name

    Azopt 1%


    Description

    Brinzolamide ophthalmic (eye) drops is used to treat increased pressure in the eye caused by open-angle glaucoma or a condition called ocular hypertension. Both eye conditions are caused by high pressure in your eye and can lead to pain from pressure in your eye and then can eventually harm your vision. This medicine can help you keep your sight by reducing the pressure in your eye and stopping eye pain.

    This medicine is available only with your doctor's prescription.

    This product is available in the following dosage forms:

    • Suspension

    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 brinzolamide 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 brinzolamide 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.

    • Aspirin
    • Ceritinib
    • Memantine
    • Metformin
    • Topiramate

    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 sulfa drugs—Use with caution. May increase risk for more serious side effects.
    • Cornea (part of the eye) problems, history of or
    • Eye infection or
    • Eye surgery, recent—Use with caution. May make these conditions worse.
    • Kidney disease, severe—Should not be used in patients with this condition.

    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.

    If you normally wear soft contact lenses, remove them before you use brinzolamide eye drops. Wait at least 15 minutes before putting the contact lenses back in.

    To use the eye drops:

    • Wash your hands with soap and water.
    • Shake the eye drops well just before each use.
    • Lie down or tilt your head back. With your index finger, pull down the lower lid of your eye to form a pocket.
    • Hold the dropper close to your eye with the other hand. Drop the correct number of drops into the pocket made between your lower lid and eyeball.
    • Gently close your eyes. Place your index finger over the inner corner of your eye for 1 minute.
    • If you think you did not get the drop of medicine into your eye properly, repeat the process with another drop.
    • Do not rinse or wipe the dropper or allow it to touch anything, including your eye.
    • Put the cap on the bottle right away.
    • Wash your hands after using the eye drops to remove any medicine.
    • Never touch the applicator tip to any surface, including the eye, and keep the container tightly closed. This will keep the medicine as germ-free as possible.

    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.

    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 eye three 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

    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.

    Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

    You may also keep the medicine in the refrigerator. Also, keep the bottle upright when you are not using it.


    Precautions

    It is important that your doctor check your progress at regular visits to make sure that this 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. These signs may mean that you are allergic to brinzolamide.

    Serious allergic reactions may occur while using this medicine. Stop using this medicine and check with your doctor right away if you have any of the following symptoms: black, tarry stools; blistering, peeling, or loosening of the skin; chills; dark urine; joint or muscle pain; rash; red skin lesions, often with a purple center; sores, ulcers, or white spots in the mouth or on the lips; unusual bleeding or bruising; unusual tiredness or weakness; or yellow eyes or skin.

    If you hurt your eye, develop an eye infection, or need to have an eye surgery, talk with your doctor right away. Your doctor may want you to use a new bottle of the eye drops to help prevent an eye infection or keep an infection from getting worse.

    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. Also, since blurred vision may be a sign of a side effect that needs medical attention, check with your doctor if it continues.

    Do not take 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:

    More common

    • Blurred vision

    Less common

    • Discharge from the eye
    • dry eyes
    • redness, soreness, irritation, or pain of the eye or eyelid
    • skin rash

    Rare

    • Chest pain
    • cough
    • crusting in the corner of the eye
    • difficulty with swallowing
    • dizziness
    • double vision
    • excessive muscle tone
    • eye redness, irritation, or pain
    • fast heartbeat
    • hives
    • itching, swelling, or other signs of eye or eyelid irritation
    • kidney pain
    • muscle stiffness
    • muscle tension or tightness
    • puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
    • seeing double
    • shortness of breath
    • sore throat
    • tightness in the chest
    • unusual tiredness or weakness
    • wheezing

    Incidence not known

    • Abdominal or stomach pain
    • blistering, peeling, or loosening of the skin
    • chills
    • clay-colored stools
    • dark urine
    • diarrhea
    • fever with or without chills
    • general feeling of tiredness or weakness
    • headache
    • hoarseness
    • joint or muscle pain
    • loss of appetite
    • lower back or side pain
    • nausea
    • painful or difficult urination
    • red or irritated eyes
    • red skin lesions, often with a purple center
    • sores, ulcers, or white spots on the lips or in the mouth
    • swollen or painful glands
    • unpleasant breath odor
    • unusual bleeding or bruising
    • vomiting of blood
    • yellow eyes or skin

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

    Symptoms of overdose

    • Confusion
    • irregular heartbeat
    • muscle cramps or pain
    • numbness, tingling, pain, or weakness in the hands or feet
    • seizures
    • trembling
    • weakness and heaviness of the legs

    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

    • Bitter, sour, or other unusual taste

    Less common

    • Burning, stinging, or discomfort when medicine is applied
    • dry eyes
    • feeling of something in the eye
    • runny nose
    • sneezing
    • stuffy nose

    Rare

    • Acid or sour stomach
    • belching
    • body aches or pain
    • congestion
    • difficult or labored breathing
    • dry mouth
    • hair loss
    • heartburn
    • hives or welts
    • indigestion
    • stomach discomfort, upset, or pain
    • tender, swollen glands in the neck
    • thinning of the hair
    • voice changes

    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.






    CON-XXXXXXXX

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