Levobunolol Hydrochloride (Betagan)

Trade Name : BETAGAN

Allergan, Inc.

SOLUTION/ DROPS

Strength 5 mg/mL

LEVOBUNOLOL HYDROCHLORIDE Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC]

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Levobunolol Hydrochloride (Betagan) which is also known as BETAGAN and Manufactured by Allergan, Inc.. It is available in strength of 5 mg/mL per ml. Read more

Levobunolol Hydrochloride (Betagan) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials.  Click to know price.     Read less

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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About GNH

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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  • No data
  • BETAGAN
  • Chemical Name:n- Sn- tertn- 2H
  • u00a0
  • Structural Formula:
  • Contains: Active:n- Preservative:n- Inactives:
  • 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 n 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 n ophthalmic solution 0.5% twice daily (b.i.d.).u00a0The 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. n at the concentrations tested, when applied topically, decreased heart rate and blood pressure in some patients. The IOP-lowering effect of n was well maintained over the course of these studies.
  • In a three-month clinical study, a single daily application of 0.5% n 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. n reduces IOP with little or no effect on pupil size or accommodation.
  • BETAGAN
  • u00ae
  • BETAGAN
  • u00ae
  • As with other topically applied ophthalmic drugs, n 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 ).u00a0Additionally, ophthalmic beta-blockers may impair compensatory tachycardia and increase risk of hypotension.
  • No data
  • In clinical trials the use of n 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 n : 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 n ophthalmic solution or ophthalmic use of other beta-adrenergic receptor blocking agents:
  • BODY AS A WHOLE:n- CARDIOVASCULAR:n- DIGESTIVE:n- PSYCHIATRIC:n- SKIN:n- RESPIRATORY:n- UROGENITAL:n- ENDOCRINE:n- 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.
  • 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 n 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.u00a0Hypotension: 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.
  • The recommended starting dose is one to two drops of n ophthalmic solution 0.5% in the affected eye(s) once a day. In patients with more severe or uncontrolled glaucoma, n 0.5% can be administered b.i.d. As with any new medication, careful monitoring of patients is advised. Dosages above one drop of n 0.5% b.i.d. are not generally more effective. If the patientu2019s IOP is not at a satisfactory level on this regimen, concomitant therapy with other ophthalmic IOP-lowering agents can be instituted.u00a0Patients should not typically use two or more topical ophthalmic beta-adrenergic blocking agents simultaneously.
  • BETAGAN
  • 5 mL in 10 mL bottlenttu00a0u00a0u00a0u00a0u00a0ntu00a0NDC 0023-4385-0510 mL in 15 mL bottleu00a0u00a0NDC 0023-4385-1015 mL in 15 mL bottleu00a0u00a0NDC 0023-4385-15
  • Storagen- :
  • Revisedn- : n- 12n- /n- 2017
  • u00a9 2018u00a0Allergan. All rights reserved.
  • All trademarks are the property of their respective owners.
  • Irvine, CA 92612
  • Made in the U.S.A.
  • 71602US15
  • NDC 0023-4384-05Rx OnlyBETAGAN(levobunolol hydrochloride ophthalmic solution, USP)0.5%sterile5 mL

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