Levobunolol

What is Levobunolol?

• Levobunolol (AKBeta; Betagan) is a noncardioselective beta-adrenoceptor blocking agent used in the form of eye drops to manage ocular hypertension (high pressure in the eye) and open-angle glaucoma.

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Levobunolol

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Levobunolol structural formulae

What are the uses of this medicine?

• Levobunolol (AKBeta; Betagan) is a ophthalmic solution has been shown to be effective in lowering intraocular pressure and may be used in patients with chronic open-angle glaucoma or ocular hypertension.

• Levobunolol is not useful for the treatment of closed-angle glaucoma.

How does this medicine work?

• The hydrochloride salt form of levobunolol, a naphthalenone and non-cardioselective adrenergic beta-receptor antagonist with anti-glaucoma activity.
• Levobunolol HCl is a noncardioselective beta-adrenoceptor blocking agent, equipotent at both beta1 and beta2 receptors.
• Upon administration in the eye, levobunolol blocks beta-adrenergic receptors, thereby causing vasoconstriction.
• Levobunolol also decreases ciliary's body production of aqueous humor, leading to a decrease in aqueous humor.

Who Should Not Use this medicine ?

This medicine cannot be used in patients with:

• bronchial asthma, or with a history of bronchial asthma
• severe chronic obstructive pulmonary disease
• sinus bradycardia
• second and third degree atrioventricular block
• overt cardiac failure
• cardiogenic shock
• hypersensitivity to any component of these products

What drug interactions can this medicine cause?

Tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention any of the following:

• other eye medications, beta blockers, such as atenolol (Tenormin), carteolol (Cartrol), labetalol (Normodyne, Trandate), metoprolol (Lopressor), nadolol (Corgard), propranolol (Inderal), sotalol (Betapace), or timolol (Blocadren)
• quinidine (Quinidex, Quinaglute Dura-Tabs)
• verapamil (Calan, Isoptin)
• vitamins

Is this medicine FDA approved?

• Yes, it was FDA approved.

How should this medicine be used?

Recommended dosage:

• The recommended starting dose is one to two drops of BETAGAN® ophthalmic solution 0.5% in the affected eye(s) once a day.
• Dosages above one drop of BETAGAN® 0.5% b.i.d. are not generally more effective.
• If the patient’s IOP is not at a satisfactory level on this regimen, concomitant therapy with other ophthalmic IOP-lowering agents can be instituted.

Administration:

• Ophthalmic levobunolol comes as a solution (liquid) to instill in the eyes.
• Levobunolol eye drops are usually instilled once or twice a day.
• Levobunolol eye drops control glaucoma but do not cure it.
• Continue to use levobunolol eye drops even if you feel well.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As levobunolol hydrochloride ophthalmic solution

This medicine is available in fallowing brand namesː

• AKBeta; Betagan

What side effects can this medication cause?

The most common side effects of this medicine include:

• ocular burning and stinging
• Headache
• asthenia
• chest pain
• Bradycardia
• arrhythmia
• hypotension
• syncope
• heart block
• cerebral vascular accident
• cerebral ischemia
• congestive heart failure
• palpitation
• cardiac arrest
• Nausea
• diarrhea
• Depression
• confusion
• increase in signs and symptoms of myasthenia gravis
• paresthesia
• Hypersensitivity
• including localized and generalized rash
• alopecia
• Stevens-Johnson Syndrome
• Bronchospasm (predominantly in patients with pre-existing bronchospastic disease)
• respiratory failure
• dyspnea
• nasal congestion
• Impotence
• Masked symptoms of hypoglycemia in insulin-dependent diabetics
• Signs and symptoms of keratitis or eye allergy
• blepharoptosis
• visual disturbances including refractive changes (due to withdrawal of miotic therapy in some cases)
• diplopia
• ptosis
• foreign body sensation in eye

The following adverse reactions have been reported rarely with the use of BETAGAN®: iridocyclitis, headache, transient ataxia, dizziness, lethargy, urticaria, and pruritus.

What special precautions should I follow?

• BETAGAN® (levobunolol hydrochloride ophthalmic solution, USP) sterile should be used with caution in patients with known hypersensitivity to other beta-adrenoceptor blocking agents.
• Use with caution in patients with known diminished pulmonary function.
• BETAGAN® should be used with caution in patients who are receiving a beta-adrenergic blocking agent orally, because of the potential for additive effects on systemic beta-blockade or on intraocular pressure. Patients should not typically use two or more topical ophthalmic beta-adrenergic blocking agents simultaneously.
• BETAGAN® ophthalmic solution has little or no effect on the pupil. When BETAGAN® is used to reduce elevated intraocular pressure in angle-closure glaucoma, it should be followed with a miotic and not alone.
• Beta-adrenergic blockade has been reported to potentiate muscle weakness consistent with certain myasthenic symptoms (e.g., diplopia, ptosis and generalized weakness).
• BETAGAN® may potentiate syndromes associated with vascular insufficiency (i.e. Raynaud’s phenomenon), and therefore, should be used with caution in these patients.
• In patients undergoing elective surgery, gradual withdrawal of beta-adrenergic blocking agents may be appropriate. If necessary during surgery, the effects of beta-adrenergic blocking agents may be reversed by sufficient doses of such agonists as isoproterenol, dopamine, dobutamine or levarterenol.
• Beta-adrenergic blocking agents may mask the signs and symptoms of acute hypoglycemia. Beta-adrenergic blocking agents should be administered with caution in patients subject to spontaneous hypoglycemia or to diabetic patients (especially those with labile diabetes) who are receiving insulin or oral hypoglycemic agents.
• Beta-adrenergic blocking agents may mask certain clinical signs (e.g., tachycardia) of hyperthyroidism.
• These products contain sodium metabisulfite, a sulfite that may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people.
• If you are having surgery, including dental surgery, tell the doctor or dentist that you are using levobunolol eye drops.
• If you are using another topical eye medication, instill it at least 10 minutes before or after you instill levobunolol eye drops.

What to do in case of emergency/overdose?

Symptoms of overdosage may include:

• bradycardia
• hypotension
• bronchospasm
• acute cardiac failure

Treatment of overdosage:

• accidental ocular overdosage occur, flush eye(s) with water or normal saline.
• If accidentally ingested, efforts to decrease further absorption may be appropriate (gastric lavage).

Symptomatic bradycardia:

• Use atropine sulfate intravenously in a dosage of 0.25 mg to 2 mg to induce vagal blockade.
• If bradycardia persists, intravenous isoproterenol hydrochloride should be administered cautiously.

Hypotension:

• Use sympathomimetic pressor drug therapy, such as dopamine, dobutamine or levarterenol.
• In refractory cases the use of glucagon hydrochloride may be useful.

Bronchospasm:

• Use isoproterenol hydrochloride.
• Additional therapy with aminophylline may be considered.

Acute cardiac failure:

• Conventional therapy with digitalis, diuretics and oxygen should be instituted immediately.
• In refractory cases the use of intravenous aminophylline is suggested.

Heart block (second or third degree):

• Use isoproterenol hydrochloride or a transvenous cardiac pacemaker.

Can this medicine be used in pregnancy?

• There are no adequate and well-controlled studies in pregnant women.
• BETAGAN® ophthalmic solution should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Can this medicine be used in children?

• Safety and effectiveness in pediatric patients have not been established.

What are the active and inactive ingredients in this medicine?

Active:

• levobunolol HCl 0.5%.

Preservative:

• benzalkonium chloride 0.004%

Inactives:

• edetate disodium; polyvinyl alcohol 1.4%; potassium phosphate, monobasic; purified water; sodium chloride; sodium metabisulfite; sodium phosphate, dibasic; and hydrochloric acid or sodium hydroxide to adjust pH.

Who manufactures and distributes this medicine?

Distributed by:

* Allergan, USA Inc., Madison NJ

What should I know about storage and disposal of this medication?

• Protect from light.
• Store at 15°-25°C (59°-77°F).

• Dailymed label info on Levobunolol
• FDA Levobunolol

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