Levobunolol (Ophthalmic)

Levobunolol eye drops are used by themselves or with other medicines to reduce pressure inside the eye caused by open-angle glaucoma or ocular (eye) hypertension. This medicine is a beta-blocker.

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

It is very important that your eye doctor (ophthalmologist) check your progress at regular visits to make sure this medicine is working properly and to check for unwanted effects.

Do not use this medicine if you are also using a beta-blocker medicine that is taken by mouth.

If itching, redness, swelling, or other signs of eye or eyelid irritation occur, check with your doctor right away. This 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, or weight gain.

This medicine may cause changes in your blood sugar levels. It may also 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.

This medicine may cause choroidal detachment (bleeding inside the eye). Talk to your doctor if you have concerns.

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.

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.

In deciding to use a medicine, you need to consider the risks of taking it against the benefits it may provide. This is a decision you will make with your doctor. For this medicine, you should think about the following:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also inform your healthcare professional about any other types of allergies you have, such as allergies to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been done on the effects of levobunolol eye drops in children. Safety and effectiveness have not been established for this age group.

Geriatric

Appropriate studies conducted so far have not shown any specific problems in elderly people that would limit the usefulness of levobunolol eye drops in this population.

Interactions with Medicines

Some medicines should not be used together at all, while others may be used together even if they could interact. In these situations, your doctor may adjust the dose, or other precautions may be necessary. When taking this medicine, it is very important that your healthcare professional knows if you are taking any of the following medicines. The interactions listed below are based on their potential significance and are not an exhaustive list.

Using this medicine with any of the following medicines is usually not recommended, but may be necessary in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both medicines.

• Albuterol
• Ceritinib
• Crizotinib
• Darunavir
• Diltiazem
• Dronedarone
• Epinephrine
• Fenoldopam
• Fingolimod
• Formoterol
• Indacaterol
• Iobenguane I 131
• Iohexol
• Lacosamide
• Levalbuterol
• Olodaterol
• Oxymetazoline
• Ponesimod
• Rivastigmine
• Salmeterol
• Terbutaline
• Verapamil
• Vilanterol

Using this medicine with any of the following medicines may increase the risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both medicines.

• Acarbose
• Aceclofenac
• Acemetacin
• Acetyldigoxin
• Albiglutide
• Alfuzosin
• Alogliptin
• Amtolmetin Guacil
• Aspirin
• Bromfenac
• Bufexamac
• Bunazosin
• Canagliflozin
• Celecoxib
• Chlorpropamide
• Choline Salicylate
• Clonixin
• Dapagliflozin
• Deslanoside
• Dexibuprofen
• Dexketoprofen
• Diclofenac
• Diflunisal
• Digitoxin
• Digoxin
• Dipyrone
• Doxazosin
• Droxicam
• Dulaglutide
• Empagliflozin
• Ertugliflozin
• Etodolac
• Etofenamate
• Etoricoxib
• Exenatide
• Felbinac
• Fenoprofen
• Fepradinol
• Feprazone
• Floctafenine
• Flufenamic Acid
• Flurbiprofen
• Glimepiride
• Glipizide
• Glyburide
• Ibuprofen
• Indomethacin
• Insulin Aspart, Recombinant
• Insulin Degludec
• Insulin Detemir
• Insulin Glargine, Recombinant
• Insulin Glulisine
• Insulin Human Inhaled
• Insulin Human Isophane (NPH)
• Insulin Human Regular
• Insulin Lispro, Recombinant
• Ketoprofen
• Ketorolac
• Linagliptin
• Liraglutide
• Lixisenatide
• Lornoxicam
• Loxoprofen
• Lumiracoxib
• Meclofenamate
• Mefenamic Acid
• Meloxicam
• Metformin
• Metildigoxin
• Miglitol
• Morniflumate
• Moxisylyte
• Nabumetone
• Naproxen
• Nateglinide
• Nepafenac
• Niflumic Acid
• Nimesulide
• Nimesulide Beta Cyclodextrin
• Oxaprozin
• Oxyphenbutazone
• Parecoxib
• Phenoxybenzamine
• Phentolamine
• Phenylbutazone
• Piketoprofen
• Pioglitazone
• Piroxicam
• Pramlintide
• Pranoprofen
• Prazosin
• Proglumetacin
• Propyphenazone
• Proquazone
• Repaglinide
• Rofecoxib
• Rosiglitazone
• Salicylic Acid
• Salsalate
• Saxagliptin
• Sitagliptin
• Sodium Salicylate
• St John's Wort
• Sulindac
• Tamsulosin
• Tenoxicam
• Terazosin
• Tiaprofenic Acid
• Tolazamide
• Tolbutamide
• Tolfenamic Acid
• Tolmetin
• Trimazosin
• Urapidil
• Valdecoxib
• Vildagliptin

Interactions with Food/Tobacco/Alcohol

Some medicines should not be taken with food or certain types of food because interactions may happen. Using alcohol or tobacco with some medicines may also lead to interactions. Talk to your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Other medical problems may affect the use of this medicine. Be sure to tell your doctor if you have any other medical issues, especially:

• Asthma, or a history of it
• Bradycardia (slow heartbeat)
• Chronic obstructive pulmonary disease (COPD), severe
• Heart block
• Heart failure—This medicine should not be used in patients with these conditions.

• Blood vessel disease, particularly in the brain (e.g., Raynaud’s disease)
• Lung or breathing issues
• History of stroke—Use with caution, as it may worsen these conditions.

• Diabetes
• Hyperthyroidism (overactive thyroid)
• Hypoglycemia (low blood sugar)—This medicine may hide some signs and symptoms of these conditions, like a fast heartbeat.

• Myasthenia gravis—Use with caution. It may worsen side effects.

• Sulfite allergy—Use with caution. This medicine contains sodium metabisulfite.

Along with its necessary effects, a medicine may cause some unwanted effects. Not all of these side effects may happen, but if they do, they may need medical attention.

Check with your doctor right away if any of the following side effects happen:

More common

• Burning or stinging in the eye
• Drainage from the eye
• Redness, swelling, or itching of the eye and eyelid

Less common

• Blurred vision
• Chest pain or discomfort
• Confusion
• Dizziness, faintness, or lightheadedness when getting up suddenly from lying or sitting
• Slow or irregular heartbeat
• Sweating
• Unusual tiredness or weakness

Rare

• Eye pain
• Headache
• Hives or welts, itching, or skin rash
• Redness of the skin
• Shakiness and unsteady walk
• Tearing
• Unsteadiness, trembling, or other problems with muscle control or coordination
• Unusual drowsiness, dullness, or feeling sluggish

Incidence not determined

• Blistering, peeling, or loosening of the 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 chewing, swallowing, or talking
• Dilated neck veins
• Disturbed color perception
• Double vision
• Drooping eyelids
• Extreme tiredness or weakness
• Fast, pounding, or racing heartbeat or pulse
• Fever
• Halos around lights
• Hoarseness
• Inability to speak
• Irregular, fast or slow, or shallow breathing
• Joint pain, stiffness, or swelling
• Muscle pain or 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
• Slurred speech
• Sore throat
• Sores, ulcers, or white spots in the mouth or on the lips
• Stopping of the heart
• Swelling of the eyelids, face, lips, hands, fingers, feet, or lower legs
• Temporary blindness
• Tightness in the chest
• Tunnel vision
• Unconsciousness
• Sudden and severe weakness in the arm or leg on one side of the body
• Weight gain

Some side effects may happen that usually do not need medical attention. These side effects may go away as your body adjusts to the medicine. Your health care professional may also have ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue, are bothersome, or if you have questions about them:

Incidence not determined

• Decreased interest in sexual intercourse
• Discouragement
• Feeling like there is something in the eye
• 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
• Trouble concentrating
• Trouble sleeping

Other side effects not listed may also happen 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.

In the U.S.

• Betagan

In Canada

• Ratio-Levobunolol

Available Dosage Forms:

• Solution

Therapeutic Class: Antiglaucoma

Pharmacologic Class: Beta-Adrenergic Blocker, Nonselective

Use this medicine exactly as directed by your doctor. Do not use more of it, do not use it more often, and do not use it for it for a longer time than your doctor ordered. To do so may increase the chance of side effects.

Shake the medicine well just before each use.

To use the eye drops (solution):

• Wash your hands with soap and water before and after you use this medicine.
• Tilt the head back. Press your finger gently on the skin just beneath the lower eyelid and 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.
• 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.

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 15 minutes after you use the medicine before putting the contact lenses back in.

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, as 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.