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levobunolol hydrochloride
Overview
What is BETAGAN?
BETAGAN
Chemical Name:
S
tert
2H
Structural Formula:
Contains: Active:
Preservative:
Inactives:
What does BETAGAN look like?
What are the available doses of BETAGAN?
Sorry No records found.
What should I talk to my health care provider before I take BETAGAN?
Sorry No records found
How should I use BETAGAN?
BETAGAN
®
The recommended starting dose is one to two drops of
ophthalmic solution 0.5% in the affected eye(s) once a day. In patients with more severe or uncontrolled glaucoma,
0.5% can be administered b.i.d. As with any new medication, careful monitoring of patients is advised. Dosages above one drop of
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. Patients should not typically use two or more topical ophthalmic beta-adrenergic blocking agents simultaneously.
What interacts with BETAGAN?
Sorry No Records found
What are the warnings of BETAGAN?
Sorry No Records found
What are the precautions of BETAGAN?
Sorry No Records found
What are the side effects of BETAGAN?
Sorry No records found
What should I look out for while using BETAGAN?
BETAGAN
®
WARNINGS
WARNINGS
As with other topically applied ophthalmic drugs,
may be absorbed systemically. The same adverse reactions found with systemic administration of beta-adrenergic blocking agents may occur with topical administration. For example, severe respiratory reactions and cardiac reactions, including death due to bronchospasm in patients with asthma, and rarely death in association with cardiac failure, have been reported with topical application of beta-adrenergic blocking agents (see ). Additionally, ophthalmic beta-blockers may impair compensatory tachycardia and increase risk of hypotension.
What might happen if I take too much BETAGAN?
No data are available regarding overdosage in humans. Should 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). The most common signs and symptoms to be expected with overdosage with administration of a systemic beta-adrenergic blocking agent are symptomatic bradycardia, hypotension, bronchospasm, and acute cardiac failure. Should these symptoms occur, discontinue
therapy and initiate appropriate supportive therapy. The following supportive measures should be considered:
1. 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. In refractory cases the use of a transvenous cardiac pacemaker should be considered.
2. Hypotension: Use sympathomimetic pressor drug therapy, such as dopamine, dobutamine or levarterenol. In refractory cases the use of glucagon hydrochloride may be useful.
3. Bronchospasm: Use isoproterenol hydrochloride. Additional therapy with aminophylline may be considered.
4. Acute cardiac failure: Conventional therapy with digitalis, diuretics and oxygen should be instituted immediately. In refractory cases the use of intravenous aminophylline is suggested. This may be followed, if necessary, by glucagon hydrochloride which may be useful.
5. Heart block (second or third degree): Use isoproterenol hydrochloride or a transvenous cardiac pacemaker.
How should I store and handle BETAGAN?
Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from moisture.BETAGAN5 mL in 10 mL bottle NDC 0023-4385-0510 mL in 15 mL bottle NDC 0023-4385-1015 mL in 15 mL bottle NDC 0023-4385-15Storage:Revised: 12/2017© 2018 Allergan. All rights reserved.All trademarks are the property of their respective owners. Irvine, CA 92612Made in the U.S.A.71602US15BETAGAN5 mL in 10 mL bottle NDC 0023-4385-0510 mL in 15 mL bottle NDC 0023-4385-1015 mL in 15 mL bottle NDC 0023-4385-15Storage:Revised: 12/2017© 2018 Allergan. All rights reserved.All trademarks are the property of their respective owners. Irvine, CA 92612Made in the U.S.A.71602US15BETAGAN5 mL in 10 mL bottle NDC 0023-4385-0510 mL in 15 mL bottle NDC 0023-4385-1015 mL in 15 mL bottle NDC 0023-4385-15Storage:Revised: 12/2017© 2018 Allergan. All rights reserved.All trademarks are the property of their respective owners. Irvine, CA 92612Made in the U.S.A.71602US15BETAGAN5 mL in 10 mL bottle NDC 0023-4385-0510 mL in 15 mL bottle NDC 0023-4385-1015 mL in 15 mL bottle NDC 0023-4385-15Storage:Revised: 12/2017© 2018 Allergan. All rights reserved.All trademarks are the property of their respective owners. Irvine, CA 92612Made in the U.S.A.71602US15BETAGAN5 mL in 10 mL bottle NDC 0023-4385-0510 mL in 15 mL bottle NDC 0023-4385-1015 mL in 15 mL bottle NDC 0023-4385-15Storage:Revised: 12/2017© 2018 Allergan. All rights reserved.All trademarks are the property of their respective owners. Irvine, CA 92612Made in the U.S.A.71602US15BETAGAN5 mL in 10 mL bottle NDC 0023-4385-0510 mL in 15 mL bottle NDC 0023-4385-1015 mL in 15 mL bottle NDC 0023-4385-15Storage:Revised: 12/2017© 2018 Allergan. All rights reserved.All trademarks are the property of their respective owners. Irvine, CA 92612Made in the U.S.A.71602US15BETAGAN5 mL in 10 mL bottle NDC 0023-4385-0510 mL in 15 mL bottle NDC 0023-4385-1015 mL in 15 mL bottle NDC 0023-4385-15Storage:Revised: 12/2017© 2018 Allergan. All rights reserved.All trademarks are the property of their respective owners. Irvine, CA 92612Made in the U.S.A.71602US15BETAGAN5 mL in 10 mL bottle NDC 0023-4385-0510 mL in 15 mL bottle NDC 0023-4385-1015 mL in 15 mL bottle NDC 0023-4385-15Storage:Revised: 12/2017© 2018 Allergan. All rights reserved.All trademarks are the property of their respective owners. Irvine, CA 92612Made in the U.S.A.71602US15BETAGAN5 mL in 10 mL bottle NDC 0023-4385-0510 mL in 15 mL bottle NDC 0023-4385-1015 mL in 15 mL bottle NDC 0023-4385-15Storage:Revised: 12/2017© 2018 Allergan. All rights reserved.All trademarks are the property of their respective owners. Irvine, CA 92612Made in the U.S.A.71602US15BETAGAN5 mL in 10 mL bottle NDC 0023-4385-0510 mL in 15 mL bottle NDC 0023-4385-1015 mL in 15 mL bottle NDC 0023-4385-15Storage:Revised: 12/2017© 2018 Allergan. All rights reserved.All trademarks are the property of their respective owners. Irvine, CA 92612Made in the U.S.A.71602US15BETAGAN5 mL in 10 mL bottle NDC 0023-4385-0510 mL in 15 mL bottle NDC 0023-4385-1015 mL in 15 mL bottle NDC 0023-4385-15Storage:Revised: 12/2017© 2018 Allergan. All rights reserved.All trademarks are the property of their respective owners. Irvine, CA 92612Made in the U.S.A.71602US15BETAGAN5 mL in 10 mL bottle NDC 0023-4385-0510 mL in 15 mL bottle NDC 0023-4385-1015 mL in 15 mL bottle NDC 0023-4385-15Storage:Revised: 12/2017© 2018 Allergan. All rights reserved.All trademarks are the property of their respective owners. Irvine, CA 92612Made in the U.S.A.71602US15BETAGAN5 mL in 10 mL bottle NDC 0023-4385-0510 mL in 15 mL bottle NDC 0023-4385-1015 mL in 15 mL bottle NDC 0023-4385-15Storage:Revised: 12/2017© 2018 Allergan. All rights reserved.All trademarks are the property of their respective owners. Irvine, CA 92612Made in the U.S.A.71602US15BETAGAN5 mL in 10 mL bottle NDC 0023-4385-0510 mL in 15 mL bottle NDC 0023-4385-1015 mL in 15 mL bottle NDC 0023-4385-15Storage:Revised: 12/2017© 2018 Allergan. All rights reserved.All trademarks are the property of their respective owners. Irvine, CA 92612Made in the U.S.A.71602US15
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Levobunolol HCl is a noncardioselective beta-adrenoceptor blocking agent, equipotent at both beta and beta receptors. Levobunolol HCl is greater than 60 times more potent than its dextro isomer in its beta-blocking activity, yet equipotent in its potential for direct myocardial depression. Accordingly, the levo isomer, levobunolol HCl, is used. Levobunolol HCl does not have significant local anesthetic (membrane-stabilizing) or intrinsic sympathomimetic activity.
Beta-adrenergic receptor blockade reduces cardiac output in both healthy subjects and patients with heart disease. In patients with severe impairment of myocardial function, beta-adrenergic receptor blockade may inhibit the stimulatory effect of the sympathetic nervous system necessary to maintain adequate cardiac function.
Beta-adrenergic receptor blockade in the bronchi and bronchioles results in increased airway resistance from unopposed parasympathetic activity. Such an effect in patients with asthma or other bronchospastic conditions is potentially dangerous.
BETAGAN
The onset of action with one drop of
can be detected within one hour after treatment, with maximum effect seen between 2 and 6 hours.
A significant decrease of IOP can be maintained for up to 24 hours following a single dose.
In controlled clinical studies of approximately two years duration, intraocular pressure was well-controlled in approximately 80% of subjects treated with
ophthalmic solution 0.5% twice daily (b.i.d.). The mean IOP decrease from baseline was between 7 mm Hg and 8 mm Hg. No significant effects on pupil size, tear production or corneal sensitivity were observed.
at the concentrations tested, when applied topically, decreased heart rate and blood pressure in some patients. The IOP-lowering effect of
was well maintained over the course of these studies.
In a three-month clinical study, a single daily application of 0.5%
ophthalmic solution controlled the IOP of 72% of subjects achieving an overall mean decrease in IOP of 7.0 mm Hg.
The primary mechanism of the ocular hypotensive action of levobunolol HCl in reducing IOP is most likely a decrease in aqueous humor production.
reduces IOP with little or no effect on pupil size or accommodation.
Non-Clinical Toxicology
BETAGAN®
WARNINGS
WARNINGS
As with other topically applied ophthalmic drugs, may be absorbed systemically. The same adverse reactions found with systemic administration of beta-adrenergic blocking agents may occur with topical administration. For example, severe respiratory reactions and cardiac reactions, including death due to bronchospasm in patients with asthma, and rarely death in association with cardiac failure, have been reported with topical application of beta-adrenergic blocking agents (see ). Additionally, ophthalmic beta-blockers may impair compensatory tachycardia and increase risk of hypotension.
Although ophthalmic solution used alone has little or no effect on pupil size, mydriasis resulting from concomitant therapy with and epinephrine may occur.
Close observation of the patient is recommended when a beta-blocker is administered to patients receiving catecholamine-depleting drugs such as reserpine, because of possible additive effects and the production of hypotension and/or marked bradycardia, which may produce vertigo, syncope, or postural hypotension.
Patients receiving beta-adrenergic blocking agents along with either oral or intravenous calcium antagonists should be monitored for possible atrioventricular conduction disturbances, left ventricular failure and hypotension. In patients with impaired cardiac function, simultaneous use should be avoided altogether.
The concomitant use of beta-adrenergic blocking agents with digitalis and calcium antagonists may have additive effects on prolonging atrioventricular conduction time.
Phenothiazine-related compounds and beta-adrenergic blocking agents may have additive hypotensive effects due to the inhibition of each other’s metabolism.
BETAGAN
Use with caution in patients with known diminished pulmonary function.
BETAGAN
Because of the potential effects of beta-adrenergic blocking agents on blood pressure and pulse rates, these medications must be used cautiously in patients with cerebrovascular insufficiency. Should signs or symptoms develop that suggest reduced cerebral blood flow while using ophthalmic solution, alternative therapy should be considered.
In patients with angle-closure glaucoma, the immediate objective of treatment is to reopen the angle. This requires, in most cases, constricting the pupil with a miotic. ophthalmic solution has little or no effect on the pupil. When is used to reduce elevated intraocular pressure in angle-closure glaucoma, it should be followed with a miotic and not alone.
The preservative in , 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 before reinserting soft contact lenses.
In clinical trials the use of ophthalmic solution has been associated with transient ocular burning and stinging in up to 1 in 3 patients, and with blepharoconjunctivitis in up to 1 in 20 patients. Decreases in heart rate and blood pressure have been reported (see and ).
The following adverse reactions have been reported rarely with the use of : iridocyclitis, headache, transient ataxia, dizziness, lethargy, urticaria, and pruritus.
Decreased corneal sensitivity has been noted in a small number of patients. Although levobunolol has minimal membrane-stabilizing activity, there remains a possibility of decreased corneal sensitivity after prolonged use.
The following additional adverse reactions have been reported either with ophthalmic solution or ophthalmic use of other beta-adrenergic receptor blocking agents:
BODY AS A WHOLE:
CARDIOVASCULAR:
DIGESTIVE:
PSYCHIATRIC:
SKIN:
RESPIRATORY:
UROGENITAL:
ENDOCRINE:
SPECIAL SENSES:
Other reactions associated with the oral use of non-selective adrenergic receptor blocking agents should be considered potential effects with ophthalmic use of these agents.
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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