Brand Name

    US Brand Name

    Betagan

    Betimol

    Betoptic S

    Istalol

    Ocupress

    Optipranolol

    Timoptic Ocudose

    Timoptic Ocumeter

    Timoptic Ocumeter Plus

    Timoptic-XE Ocumeter

    Timoptic-XE Ocumeter Plus

    Canadian Brand Name

    Alti-Timolol Maleate

    Apo-Levobunolol

    Apo-Timop

    Betagan 0.25%

    Betagan 0.5%

    Betoptic

    Crown-Tim

    Dom-Timolol

    Novo-Betaxolol

    Novo-Timol

    Ophtho-Bunolol

    Pms-Levobunolol


    Description

    Beta-adrenergic blocking agents for the eye are used to treat certain types of glaucoma. They appear to work by reducing the production of fluid in the eye. This lowers the pressure in the eye.

    These medicines are available only with your doctor's prescription.

    This product is available in the following dosage forms:

    • Suspension
    • Solution
    • Gel Forming Solution

    Before Using

    Allergies

    Tell your doctor if you have ever had any unusual or allergic reaction to medicines in this group 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

    Infants may be especially sensitive to the effects of ophthalmic beta-adrenergic blocking agents. This may increase the chance of side effects during treatment.

    Geriatric

    Elderly people are especially sensitive to the effects of ophthalmic beta-adrenergic blocking agents. If too much medicine is absorbed into the body, the chance of side effects during treatment may be increased.

    Pregnancy

    Ophthalmic beta-adrenergic blocking agents may be absorbed into the body. These medicines have not been studied in pregnant women. Studies in animals have not shown that betaxolol, levobunolol, metipranolol, or timolol causes birth defects. However, high doses of levobetaxolol given by mouth to pregnant rabbits have been shown to cause birth defects in rabbit babies, and very large doses of carteolol given by mouth to pregnant rats have been shown to cause wavy ribs in rat babies. In addition, some studies in animals have shown that beta-adrenergic blocking agents increase the chance of death in the animal fetus. Before using ophthalmic beta-adrenergic blocking agents, make sure your doctor knows if you are pregnant or if you may become pregnant.

    Breastfeeding

    Betaxolol and timolol, and maybe other beta-adrenergic blocking agents, when taken by mouth, may pass into the breast milk. Since ophthalmic beta-adrenergic blocking agents may be absorbed into the body, they, too, may pass into the breast milk. However, it is not known whether ophthalmic beta-adrenergic blocking agents pass into the breast milk, and these medicines have not been reported to cause problems in nursing babies.

    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 any of these medicines, 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 medicines in this class 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.

    • Albuterol
    • Ceritinib
    • Clonidine
    • Cobicistat
    • Crizotinib
    • Darunavir
    • Desvenlafaxine
    • Diltiazem
    • Dronedarone
    • Duloxetine
    • Epinephrine
    • Escitalopram
    • Fenoldopam
    • Fingolimod
    • Fluoxetine
    • Formoterol
    • Indacaterol
    • Iohexol
    • Lacosamide
    • Levalbuterol
    • Olodaterol
    • Oxymetazoline
    • Paroxetine
    • Ponesimod
    • Rivastigmine
    • Salmeterol
    • Sertraline
    • Terbutaline
    • Verapamil
    • Vilanterol

    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 medicines in this class. Make sure you tell your doctor if you have any other medical problems, especially:

    • Allergic reactions, severe (history of)���Use of an ophthalmic beta-adrenergic blocking agent may reduce the effectiveness of the medicine (epinephrine) used to treat severe allergic reactions.
    • Asthma (or history of), chronic bronchitis, emphysema, or other lung disease—Severe breathing problems, including death due to bronchospasm (spasm of the bronchial tubes), have been reported in patients with asthma following use of some ophthalmic beta-adrenergic blocking agents (carteolol, levobunolol, metipranolol, and timolol). Although most often not a problem, the possibility of wheezing or troubled breathing also exists with betaxolol and levobetaxolol.
    • Type 2 diabetes mellitus or
    • Hypoglycemia (low blood sugar)—Ophthalmic beta-adrenergic blocking agents may cover up some signs and symptoms of hypoglycemia (low blood sugar), such as fast heartbeat and trembling, although they do not cover up other signs, such as dizziness or sweating.
    • Heart or blood vessel disease—Ophthalmic beta-adrenergic blocking agents may decrease heart activity.
    • Myasthenic conditions—Ophthalmic beta-adrenergic blocking agents may worsen muscle weakness caused by diseases such as myasthenia gravis.
    • Overactive thyroid—Ophthalmic beta-adrenergic blocking agents may cover up certain signs and symptoms of hyperthyroidism (overactive thyroid). Suddenly stopping the use of ophthalmic beta-adrenergic blocking agents may cause a sudden and dangerous increase in thyroid symptoms.

    Proper Use

    To use:

    • First, wash your hands. With the middle finger, apply pressure to the inside corner of the eye (and continue to apply pressure for 1 or 2 minutes after the medicine has been placed in the eye). This is especially important if the ophthalmic beta-adrenergic blocking agent is used to treat infants and children. Tilt the head back and with the index finger of the same hand, pull the lower eyelid away from the eye to form a pouch. Drop the medicine into the pouch and gently close the eyes. Do not blink. Keep the eyes closed for 1 or 2 minutes to allow the medicine to be absorbed.
    • Immediately after using the eye drops, wash your hands to remove any medicine that may be on them.
    • 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 you are using levobunolol with the compliance cap (C Cap):
      • Before using the eye drops for the first time, make sure the number 1 or the correct day of the week appears in the window on the cap.
      • Remove the cap and use the eye drops as directed.
      • Replace the cap. Holding the cap between your thumb and forefinger, rotate the bottle until the cap clicks to the next position. This will tell you the time of your next dose.
      • After every dose, rotate the bottle until the cap clicks to the position that tells you the time of your next dose.
    • If you are using the gel-forming timolol solution:
      • Before using the eye drops each time, turn the closed bottle upside-down and shake once.
      • If you use other eye drops in addition to the gel-forming solution, the other eye drops should be used first, then wait at least ten minutes before using this medicine.
    • If you wear soft contact lenses and your eye drops contain benzalkonium chloride:
      • Remove your contacts before you use your eye drops. Wait for fifteen minutes after using the eye drops before putting your contacts in your eyes.

    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.

    Dosing

    The dose medicines in this class 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 these medicines. 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 betaxolol, carteolol, or metipranolol

    • For ophthalmic dosage form:
      • For glaucoma:
        • Adults and older children—Topical, to the conjunctiva, 1 drop two times a day.
        • Infants and younger children—Dose must be determined by the doctor.

    For levobetaxolol

    • For ophthalmic dosage form:
      • For glaucoma:
        • Adults—Topical, to the conjunctiva, 1 drop two times a day.
        • Children—Use and dose must be determined by the doctor.

    For levobunolol or timolol

    • For ophthalmic dosage form:
      • For glaucoma:
        • Adults and older children—Topical, to the conjunctiva, 1 drop one or two times a day.
        • Infants and younger children—Dose must be determined by the doctor.

    Missed Dose

    Call your doctor or pharmacist for instructions.

    If you miss a dose of this medicine and your dosing schedule is:

    • One dose a day—Use the missed dose as soon as possible. However, if you do not remember the missed dose until the next day, skip the missed dose and go back to your regular dosing schedule. Do not double doses.
    • More than one dose a day—Use the missed dose 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.

    If you have any questions about this, check with your doctor.

    Storage

    Keep out of the reach of children.

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

    Do not keep outdated medicine or medicine no longer needed.

    Store levobetaxolol in an upright position.


    Precautions

    Your doctor should check your eye pressure at regular visits to make certain that your glaucoma is being controlled.

    Contact your physician 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.

    For a short time after you use this medicine, your vision may be blurred. Make sure your vision is clear before you drive, use machines, or do anything else that could be dangerous if you are not able to see well.

    Before you have any kind of surgery, dental treatment, or emergency treatment, tell the medical doctor or dentist in charge that you are using this medicine. Using an ophthalmic beta-adrenergic blocking agent during this time may cause an increased risk of side effects.

    For diabetic patients:

    • Ophthalmic beta-adrenergic blocking agents may affect blood sugar levels. They may also cover up some signs of hypoglycemia (low blood sugar), such as trembling or increase in pulse rate or blood pressure. However, other signs of low blood sugar, such as dizziness or sweating, are not affected. If you notice a change in the results of your blood or urine sugar tests or if you have any questions, check with your doctor.

    Some ophthalmic beta-adrenergic blocking agents (betaxolol, carteolol, and metipranolol) 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:

    More common

    • Redness of eyes or inside of eyelids

    Less common or rare

    • Blurred vision or other change in vision
    • different size pupils of the eyes
    • discoloration of the eyeball
    • droopy upper eyelid
    • eye pain
    • redness or irritation of the tongue
    • seeing double
    • swelling, irritation or inflammation of eye or eyelid

    Symptoms of too much medicine being absorbed into the body

    • Ankle, knee, or great toe joint pain
    • ankle, knee, or great toe joint swelling
    • anxiety or nervousness
    • bloody or cloudy urine
    • breast pain
    • burning or prickling feeling on body
    • change in taste
    • chest pain
    • chills
    • clumsiness or unsteadiness
    • confusion or mental depression
    • coughing, wheezing, or troubled breathing
    • decreased sexual ability
    • diarrhea
    • difficult, burning, or painful urination
    • dizziness or feeling faint
    • drowsiness
    • dryness or soreness of throat
    • ear pain
    • feeling of constant movement
    • fever
    • hair loss
    • hallucinations (seeing, hearing, or feeling things that are not there)
    • headache
    • hoarseness
    • irregular, fast, slow, or pounding heartbeat
    • lightheadedness
    • lower back or side pain
    • muscle or joint aches or pain
    • muscle tightness or stiffness
    • nausea or vomiting
    • raw, red, blistering, scaly, or crusted areas of the skin
    • ringing or buzzing in the ears
    • runny, stuffy, or bleeding nose
    • skin rash, hives, or itching
    • swelling of feet, ankles, or lower legs
    • trouble in sleeping
    • unusual tiredness or weakness

    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

    The side effect of blurred vision is associated primarily with levobetaxolol and the timolol gel-forming solution and usually lasts from thirty seconds to five minutes.

    • Blurred vision, temporary
    • decreased night vision
    • stinging of eye or other eye irritation (when medicine is applied)

    Less common or rare

    • Acid or sour stomach
    • belching
    • browache
    • constipation
    • crusting of eyelashes
    • dryness of eye
    • dry skin
    • feeling of something in the eye
    • increased sensitivity of eye to light
    • indigestion
    • itching, stinging, burning, or watering of eye or other eye irritation
    • pain, redness, warmth, or swelling of muscles

    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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