LEVOBUNOLOL HYDROCHLORIDE

×

Overview

What is LEVOBUNOLOL HYDROCHLORIDE?

Levobunolol HCl ophthalmic solution, USP is a noncardioselective beta-adrenoceptor blocking agent for ophthalmic use. The solution is colorless to slightly light yellow in appearance with an osmolality range of 250-360 mOsm/kg. The shelf life pH range is 5.5 to 7.5.

Chemical Name:

S

tert

H

Structural Formula:

Contains: Active:

Preservative:

Inactives:

What does LEVOBUNOLOL HYDROCHLORIDE look like?

What are the available doses of LEVOBUNOLOL HYDROCHLORIDE?

Sorry No records found.

What should I talk to my health care provider before I take LEVOBUNOLOL HYDROCHLORIDE?

Sorry No records found

How should I use LEVOBUNOLOL HYDROCHLORIDE?

Levobunolol HCl 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.

The recommended starting dose is one to two drops of levobunolol HCl ophthalmic solution 0.5% in the affected eye(s) once a day. Typical dosing with levobunolol HCl 0.25% is one to two drops twice daily. In patients with more severe or uncontrolled glaucoma, levobunolol HCl 0.5% can be administered b.i.d. As with any new medication, careful monitoring of patients is advised.

Dosages above one drop of levobunolol HCl 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 dipivefrin and/or epinephrine, and/or pilocarpine and other miotics, and/or systemically administered carbonic anhydrase inhibitors, such as acetazolamide, can be instituted. Patients should not typically use two or more topical ophthalmic beta-adrenergic blocking agents simultaneously.

What interacts with LEVOBUNOLOL HYDROCHLORIDE?

Sorry No Records found

What are the warnings of LEVOBUNOLOL HYDROCHLORIDE?

Sorry No Records found

What are the precautions of LEVOBUNOLOL HYDROCHLORIDE?

Sorry No Records found

What are the side effects of LEVOBUNOLOL HYDROCHLORIDE?

Sorry No records found

What should I look out for while using LEVOBUNOLOL HYDROCHLORIDE?

Levobunolol HCl ophthalmic solution is contraindicated in those individuals with bronchial asthma or with a history of bronchial asthma, or severe chronic obstructive pulmonary disease (see ); sinus bradycardia; second and third degree atrioventricular block; overt cardiac failure (see ); cardiogenic shock; or hypersensitivity to any component of these products.

As with other topically applied ophthalmic drugs, levobunolol HCl 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 ).

What might happen if I take too much LEVOBUNOLOL HYDROCHLORIDE?

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 levobunolol HCl therapy and initiate appropriate supportive therapy. The following supportive measures should be considered:

How should I store and handle LEVOBUNOLOL HYDROCHLORIDE?

Levobunolol HCl ophthalmic solution, USP is supplied sterile in white low density polyethylene ophthalmic dispenser bottles and tips. Levobunolol HCl 0.25% strength units include a light blue high density polystyrene cap. Levobunolol HCl 0.5% strength units include a yellow high density polystyrene cap. Levobunolol HCl 0.25%Levobunolol HCl 0.5%Storage:Revised: 06/2014 © 2014 Allergan, Inc.Irvine, CA 92612, U.S.A.® mark owned by Allergan, Inc.Made in the U.S.A. 71593PY12Levobunolol HCl ophthalmic solution, USP is supplied sterile in white low density polyethylene ophthalmic dispenser bottles and tips. Levobunolol HCl 0.25% strength units include a light blue high density polystyrene cap. Levobunolol HCl 0.5% strength units include a yellow high density polystyrene cap. Levobunolol HCl 0.25%Levobunolol HCl 0.5%Storage:Revised: 06/2014 © 2014 Allergan, Inc.Irvine, CA 92612, U.S.A.® mark owned by Allergan, Inc.Made in the U.S.A. 71593PY12Levobunolol HCl ophthalmic solution, USP is supplied sterile in white low density polyethylene ophthalmic dispenser bottles and tips. Levobunolol HCl 0.25% strength units include a light blue high density polystyrene cap. Levobunolol HCl 0.5% strength units include a yellow high density polystyrene cap. Levobunolol HCl 0.25%Levobunolol HCl 0.5%Storage:Revised: 06/2014 © 2014 Allergan, Inc.Irvine, CA 92612, U.S.A.® mark owned by Allergan, Inc.Made in the U.S.A. 71593PY12Levobunolol HCl ophthalmic solution, USP is supplied sterile in white low density polyethylene ophthalmic dispenser bottles and tips. Levobunolol HCl 0.25% strength units include a light blue high density polystyrene cap. Levobunolol HCl 0.5% strength units include a yellow high density polystyrene cap. Levobunolol HCl 0.25%Levobunolol HCl 0.5%Storage:Revised: 06/2014 © 2014 Allergan, Inc.Irvine, CA 92612, U.S.A.® mark owned by Allergan, Inc.Made in the U.S.A. 71593PY12Levobunolol HCl ophthalmic solution, USP is supplied sterile in white low density polyethylene ophthalmic dispenser bottles and tips. Levobunolol HCl 0.25% strength units include a light blue high density polystyrene cap. Levobunolol HCl 0.5% strength units include a yellow high density polystyrene cap. Levobunolol HCl 0.25%Levobunolol HCl 0.5%Storage:Revised: 06/2014 © 2014 Allergan, Inc.Irvine, CA 92612, U.S.A.® mark owned by Allergan, Inc.Made in the U.S.A. 71593PY12Levobunolol HCl ophthalmic solution, USP is supplied sterile in white low density polyethylene ophthalmic dispenser bottles and tips. Levobunolol HCl 0.25% strength units include a light blue high density polystyrene cap. Levobunolol HCl 0.5% strength units include a yellow high density polystyrene cap. Levobunolol HCl 0.25%Levobunolol HCl 0.5%Storage:Revised: 06/2014 © 2014 Allergan, Inc.Irvine, CA 92612, U.S.A.® mark owned by Allergan, Inc.Made in the U.S.A. 71593PY12Levobunolol HCl ophthalmic solution, USP is supplied sterile in white low density polyethylene ophthalmic dispenser bottles and tips. Levobunolol HCl 0.25% strength units include a light blue high density polystyrene cap. Levobunolol HCl 0.5% strength units include a yellow high density polystyrene cap. Levobunolol HCl 0.25%Levobunolol HCl 0.5%Storage:Revised: 06/2014 © 2014 Allergan, Inc.Irvine, CA 92612, U.S.A.® mark owned by Allergan, Inc.Made in the U.S.A. 71593PY12

×

Clinical Information

Chemical Structure

No Image found

Clinical 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.

Levobunolol HCl ophthalmic solution, USP has been shown to be an active agent in lowering elevated as well as normal intraocular pressure (IOP) whether or not accompanied by glaucoma. Elevated IOP presents a major risk factor in glaucomatous field loss. The higher the level of IOP, the greater the likelihood of optic nerve damage and visual field loss.

The onset of action with one drop of levobunolol HCl can be detected within one hour after treatment, with maximum effect seen between 2 and 6 hours.

A significant decrease in IOP can be maintained for up to 24 hours following a single dose.

In two, separate, controlled studies (one three month and one up to 12 months duration) levobunolol HCl ophthalmic solution 0.25% b.i.d. controlled the IOP of approximately 64% and 70% of the subjects. The overall mean decrease from baseline was 5.4 mm Hg and 5.1 mm Hg respectively. In an open-label study, levobunolol HCl ophthalmic solution 0.25% q.d. controlled the IOP of 72% of the subjects while achieving an overall mean decrease of 5.9 mm Hg.

In controlled clinical studies of approximately two years duration, intraocular pressure was well-controlled in approximately 80% of subjects treated with levobunolol HCl ophthalmic solution 0.5% b.i.d. The mean IOP decrease from baseline was between 6.87 mm Hg and 7.81 mm Hg. No significant effects on pupil size, tear production or corneal sensitivity were observed. Levobunolol HCl ophthalmic solution at the concentrations tested, when applied topically, decreased heart rate and blood pressure in some patients. The IOP-lowering effect of levobunolol HCl was well maintained over the course of these studies.

In a three month clinical study, a single daily application of levobunolol HCl ophthalmic solution 0.5% 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. Levobunolol HCl reduces IOP with little or no effect on pupil size or accommodation in contrast to the miosis which cholinergic agents are known to produce. The blurred vision and night blindness often associated with miotics would not be expected and have not been reported with the use of levobunolol HCl ophthalmic solution. This is particularly important in cataract patients with central lens opacities who would experience decreased visual acuity with pupillary constriction.

Non-Clinical Toxicology

Levobunolol HCl ophthalmic solution is contraindicated in those individuals with bronchial asthma or with a history of bronchial asthma, or severe chronic obstructive pulmonary disease (see ); sinus bradycardia; second and third degree atrioventricular block; overt cardiac failure (see ); cardiogenic shock; or hypersensitivity to any component of these products.

As with other topically applied ophthalmic drugs, levobunolol HCl 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 ).

Although levobunolol HCl ophthalmic solution used alone has little or no effect on pupil size, mydriasis resulting from concomitant therapy with levobunolol HCl 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.

Levobunolol HCl 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.

Levobunolol HCl ophthalmic solution 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.

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 levobunolol HCl 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. Levobunolol HCl ophthalmic solution has little or no effect on the pupil. When levobunolol HCl is used to reduce elevated intraocular pressure in angle-closure glaucoma, it should be followed with a miotic and not alone.

In clinical trials the use of levobunolol HCl 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 effects have been reported rarely with the use of levobunolol HCl ophthalmic solution: 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 levobunolol HCl 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.

×

Review

×

Professional

Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72

×

Tips

×

Interactions

A total of 440 drugs (1549 brand and generic names) are known to interact with Imbruvica (ibrutinib). 228 major drug interactions (854 brand and generic names) 210 moderate drug interactions (691 brand and generic names) 2 minor drug interactions (4 brand and generic names) Show all medications in the database that may interact with Imbruvica (ibrutinib).

Disclaimer: