Pronunciation:

lee-voe-BYOO-noe-lole

Brand Names:

• Betagan
• Ratio-Levobunolol

Dosage Forms:

• Solution

Classifications:

Therapeutic—

Antiglaucoma

Pharmacologic—

Beta-Adrenergic Blocker, Nonselective

Uses of This Medicine:

Levobunolol is used alone or together with other medicines to treat increased pressure in the eye that is caused by open-angle glaucoma or a condition called ocular (eye) hypertension. This medicine is a beta-blocker .

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

Before Using This Medicine:

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.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of levobunolol in the pediatric population. Safety and efficacy have not been established .

Older adults—

Appropriate studies performed to date have not demonstrated geriatrics-specific problems that would limit the usefulness of levobunolol in the elderly .

Pregnancy—

	Pregnancy Category	Explanation
All Trimesters	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast-feeding—

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.

Other medicines—

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.

• Albuterol
• Amiodarone
• Arformoterol
• Bambuterol
• Bitolterol
• Broxaterol
• Clenbuterol
• Clonidine
• Colterol
• Diltiazem
• Epinephrine
• Fenoldopam
• Fenoterol
• Fentanyl
• Formoterol
• Hexoprenaline
• Isoetharine
• Levalbuterol
• Metaproterenol
• Pirbuterol
• Procaterol
• Reproterol
• Rimiterol
• Ritodrine
• Salmeterol
• Terbutaline
• Tretoquinol
• Tulobuterol
• Verapamil

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:

• Asthma or
• Bradycardia (slow heartbeat) or
• Chronic obstructive pulmonary disease (COPD), severe or
• Heart block or
• Heart failure—Should not use in patients with these conditions .

• Blood vessel disease (especially blood vessels in the brain) or
• Stroke, history of—Use with caution. This medicine may worsen these conditions .

• Diabetes or
• Hyperthyroidism (overactive thyroid) or
• Hypoglycemia (low blood sugar)—May cover up some of the signs and symptoms of these diseases, such as a fast heartbeat .

• Lung disease—Use with caution. May cause difficulty with breathing in patients with this condition .

• Myasthenia gravis—May worsen symptoms of this condition, such as muscle weakness .

• Sulfite allergy—Use with caution. This medicine contains a small amount of sodium metabisulfite .

Proper Use of This Medicine:

Shake the medicine well just before each use .

To use the eye drops (solution):

• 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.
• Immediately after using the medicine, 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. Serious damage to the eye and possible loss of vision may result from using contaminated eye medicines .

If your doctor ordered two different eye medicines to be used together, wait several minutes before using the second medicine. This will help prevent 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 solution dosage form (eye drops):
  • For glaucoma or ocular hypertension:
    • Adults—One to two drops in the affected eye(s) once a day. Your doctor may increase your dose to 1 to 2 drops two times a day, if needed.
    • 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.

Precautions While Using This Medicine:

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 .

If itching, redness, swelling, or other signs of eye or eyelid irritation occur, stop using this medicine and check with your doctor. These signs may mean that you are allergic to this medicine .

Levobunolol may cause heart failure in some patients. Check with your doctor right away if you are having chest pain or discomfort; dilated neck veins; extreme fatigue; irregular breathing; an irregular heartbeat; shortness of breath; swelling of the face, fingers, feet, or lower legs; weight gain; or wheezing .

This medicine may cause changes in your blood sugar levels. Also, this medicine may cover up signs of low blood sugar, such as a rapid pulse rate. Check with your doctor if you have these problems or if you notice a change in the results of your blood or urine sugar tests .

Make sure any doctor or dentist who treats you knows that you are using this medicine. You may need to stop using this medicine several days before having surgery .

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 immediately if any of the following side effects occur:

More common

Burning or stinging in eye

drainage from the eye

redness, swelling, and/or itching of eye and eyelid

Less common

Blurred vision

chest pain or discomfort

confusion

dizziness, faintness, or lightheadedness when getting up from a lying or sitting position suddenly

shortness of breath

slow or irregular heartbeat

sweating

unusual tiredness or weakness

Rare

Eye pain

headache

hives or welts

itching skin

redness of skin

shakiness and unsteady walk

skin rash

tearing

unsteadiness, trembling, or other problems with muscle control or coordination

unusual drowsiness, dullness, or feeling of sluggishness

Incidence not determined

Blistering, peeling, loosening of skin

blue lips, fingernails, or skin

burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings

chills

cough

decreased urine output

diarrhea

difficult or labored breathing

difficulty in chewing, swallowing, or talking

dilated neck veins

disturbed color perception

double vision

drooping eyelids

extreme fatigue

fast, pounding, or racing heartbeat or pulse

fever

halos around lights

hoarseness

inability to speak

irregular, fast or slow, or shallow breathing

irritation

joint pain, stiffness, or swelling

muscle pain

muscle weakness

night blindness

no blood pressure or pulse

noisy breathing

overbright appearance of lights

red skin lesions, often with a purple center

seeing double

seizures

severe numbness, especially on one side of the face or body

severe or sudden headache

severe tiredness

slurred speech

sore throat

sores, ulcers, or white spots in mouth or on lips

stopping of heart

swelling of eyelids, face, lips, hands, fingers, feet, or lower legs

temporary blindness

tightness in chest

troubled breathing

tunnel vision

unconsciousness

weakness in arm and/or leg on one side of the body, sudden and severe

weight gain

wheezing

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:

Incidence not determined

Decreased interest in sexual intercourse

discouragement

feeling sad or empty

inability to have or keep an erection

irritability

lack of appetite

lack or loss of strength

loss in sexual ability, desire, drive, or performance

loss of interest or pleasure

nausea

stuffy nose

tiredness

trouble concentrating

trouble sleeping

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.