Dosing & Uses
Dosage Forms & Strengths
ophthalmic solution
- 0.25%
- 0.5%
Open-angle Glaucoma
0.25%: 1-2 gtt in affected eye(s) q12hr
0.5%: 1-2 gtt in affected eye(s) qDay, may increase to q12hr; >1 gtt q12hr generally not more effective; consider concomitant therapy if IOP not at satisfactory level on this regimen
Safety & efficacy not established
Adverse Effects
Frequency Not Defined
Mild ocular stinging
Ataxia
Burning
Lethargy
Discomfort
Band keratopathy
Respiratory failure
Blepharitis
Impotence
Blepharoconjunctivitis
Conjunctivitis
Decreased visual acuity
Erythema
Iridocyclitis
Itching sensation
Decreased corneal sensitivity
Tearing
Urticaria
Paresthesia
Ptosis
Cerebral ischemia
Decreased blood pressure
Hypersensitivity reactions
Heart block
Syncope
Reduction of resting heart rate
Postmarketing Reports
Special senses: Signs and symptoms of keratitis or eye allergy, blepharoptosis, visual disturbances including refractive changes (due to withdrawal of miotic therapy in some cases), diplopia, and foreign body sensation in eye
Warnings
Contraindications
Asthma, uncompensated CHF, any beta-blocker side effects, COPD, sinus bradycardia, 2°/3° AV block, hypersensitivity
Cardiogenic shock or with overt cardiac failure not adequately compensated (eg, treated with cardiac glycosides &/or diuretics)
Cautions
Caution on inadequate cardiac function, latent cardiac insufficiency, cerebrovascular insufficiency, sick sinus syndrome, peripheral vascular disease, history of psychiatric illness, heart failure, diminished pulmonary function, nonallergic bronchospasm, diabetes mellitus, myasthenia gravis
Ophthalmic beta-blockers may impair compensatory tachycardia and increase risk of hypotension
Patients receiving topical levobunolol & a systemic ß-adrenergic blocking agent concomitantly should be observed carefully for potential additive effects on IOP &/or systemic effects of ß-adrenergic blockade
May mask signs of hyperthyroidism (ie, tachycardia)
May potentiate syndromes associated with vascular insufficiency (i.e. Raynaud’s phenomenon); use with caution
Choroidal detachment after filtration procedures reported with administration of aqueous suppressant therapy
Preservative benzalkonium chloride may be absorbed by soft contact lenses; patients wearing soft (hydrophilic) contact lenses should be instructed to remove contact lenses before administration of the solution and wait at least 15 minutes after instilling therapy before reinserting soft contact lenses
Use with a miotic in angle-closure glaucoma
Pregnancy & Lactation
Pregnancy
There are no adequate and well-controlled studies in pregnant women; ophthalmic solution should be used during pregnancy only if potential benefit justifies potential risk to fetus
Lactation
It is not known whether drug is excreted in human milk; systemic beta-blockers and topical timolol maleate are known to be excreted in human milk; exercise caution when administered to a nursing woman
Pregnancy Categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk. C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done. D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk. X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist. NA: Information not available.Pharmacology
Mechanism of Action
Nonselective beta-adrenergic receptor blocker; reduces IOP by reducing production of aqueous humor
Pharmacokinetics
Peak Plasma Time: 30 min
Onset of action: 1hr
Peak effect: 2-6hr
Duration: Up to 24hr
Images
| BRAND | FORM. | UNIT PRICE | PILL IMAGE |
|---|---|---|---|
| levobunolol ophthalmic (eye) - | 0.5 % drops |  | |
| levobunolol ophthalmic (eye) - | 0.5 % drops |  |
Copyright © 2010 First DataBank, Inc.
Patient Handout
levobunolol ophthalmic (eye)
LEVOBUNOLOL - OPHTHALMIC
(lee-voe-BYOO-noe-lole)
COMMON BRAND NAME(S): Betagan
USES: This medication is used alone or with other medications to treat high pressure inside the eye due to glaucoma (open-angle type) or other eye diseases (such as ocular hypertension). Lowering high pressure inside the eye helps to prevent blindness. Levobunolol belongs to a class of drugs known as beta blockers and works by decreasing the amount of fluid production within the eye.
HOW TO USE: To apply eye drops, wash your hands first. To avoid contamination, do not touch the dropper tip or let it touch your eye or any other surface.If you are wearing contact lenses, remove them before using eye drops. Wait at least 15 minutes before replacing your contact lenses.Tilt your head back, look upward, and pull down the lower eyelid to make a pouch. Hold the dropper directly over your eye and place one drop into the pouch, usually once or twice daily or as directed by your doctor. Look downward and gently close your eyes for 1 to 2 minutes. Place one finger at the corner of your eye (near the nose) and apply gentle pressure. This will prevent the medication from draining out. Try not to blink and do not rub your eye. Repeat these steps for your other eye if so directed or if your dose is for more than 1 drop.Do not rinse the dropper. Replace the dropper cap after each use.If you are using another kind of eye medication (such as drops or ointments), wait at least 5 to 10 minutes before using the other medications. Use eye drops before eye ointments to allow the eye drops to enter the eye.Use this medication regularly in order to get the most benefit from it. To help you remember, use it at the same time(s) each day. Keep using this medication even if you feel well. Most people with glaucoma or high pressure in the eyes do not feel sick.
SIDE EFFECTS: Temporary burning/stinging of the eye, itchy/red eyes, headache, or dizziness may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.Tell your doctor right away if you have any serious side effects, including: eye pain/swelling/discharge, reduced feeling in eye, slow/irregular heartbeat, muscle weakness, hair loss, mental/mood changes, vision changes, tiredness, swelling of the ankles/feet, sudden/unexplained weight gain.Get medical help right away if you have any very serious side effects, including: trouble breathing, chest pain, weakness on one side of the body, trouble speaking, confusion.A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
PRECAUTIONS: Before using levobunolol, tell your doctor or pharmacist if you are allergic to it; or to other beta-blockers (such as timolol, metipranolol); or if you have any other allergies. This product may contain inactive ingredients (such as preservatives like benzalkonium chloride, sulfites), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.Before using this medication, tell your doctor or pharmacist your medical history, especially of: breathing problems (such as asthma, chronic obstructive pulmonary disease-COPD), heart problems (such as heart failure, sinus bradycardia, second- or third-degree atrioventricular block), blood circulation problems (such as cerebrovascular insufficiency, Raynaud's disease), overactive thyroid (hyperthyroidism), muscle weakness disorders (such as myasthenia gravis).Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).This drug may make you dizzy or temporarily blur your vision. Do not drive, use machinery, or do anything that needs alertness or clear vision until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).If you have diabetes, this product may mask the fast/pounding heartbeat you would usually feel when your blood sugar level falls too low (hypoglycemia). Other symptoms of a low blood sugar level, such as dizziness/sweating, are unaffected by this drug.During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.It is not known if this medication passes into breast milk. Consult your doctor before breast-feeding.
DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.Some products that may interact with this drug are: digoxin, drugs for high blood pressure (including clonidine, oral beta blockers such as propranolol, calcium channel blockers such as diltiazem), epinephrine, phenothiazines (such as prochlorperazine).
OVERDOSE: This medicine may be harmful if swallowed. If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. If this product is accidentally swallowed, you may experience symptoms such as trouble breathing, slow/irregular heartbeat.
NOTES: Do not share this medication with others.Lab and/or medical tests (such as eye exams) should be done while you are using this medication. Keep all medical and lab appointments. Consult your doctor for more details.
MISSED DOSE: If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Use your next dose at the regular time. Do not double the dose to catch up.
STORAGE: Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.
Information last revised November 2022. Copyright(c) 2023 First Databank, Inc.
IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.
Formulary
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