Brand Names:

• Betagan
• Betimol
• Betoptic S
• Istalol
• Ocupress
• Optipranolol
• Timoptic Ocudose
• Timoptic Ocumeter
• Timoptic Ocumeter Plus
• Timoptic-XE Ocumeter
• Timoptic-XE Ocumeter Plus
• 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

Dosage Forms:

• Suspension
• Solution
• Gel Forming Solution

Uses of This Medicine:

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.

Before Using This Medicine:

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.

Children—

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

Older adults—

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.

Breast-feeding—

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.

Other medicines—

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
• Fenoldopam
• Fingolimod
• Fluoxetine
• Formoterol
• Indacaterol
• Iohexol
• Lacosamide
• Levalbuterol
• Olodaterol
• Oxymetazoline
• Paroxetine
• Ponesimod
• Rivastigmine
• Salmeterol
• 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 of This Medicine:

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 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 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 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 While Using This Medicine:

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 of This Medicine:

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

Blurred vision, temporary

decreased night vision

stinging of eye or other eye irritation (when medicine is applied)

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.

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.