Betaxolol Hydrochloride (Betoptic S)

Trade Name : Betoptic S

Alcon Laboratories, Inc.

SUSPENSION/ DROPS

Strength 2.8 mg/mL

BETAXOLOL 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 Betaxolol Hydrochloride (Betoptic S) which is also known as Betoptic S and Manufactured by Alcon Laboratories, Inc.. It is available in strength of 2.8 mg/mL per ml. Read more

Betaxolol Hydrochloride (Betoptic S) 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

Packaging and Delivery

Validated Cold Chain Shipment

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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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
  • BETOPTIC S Ophthalmic Suspension 0.25% is indicated for the treatment of elevated intraocular pressure (IOP) in patients with chronic open-angle glaucoma or ocular hypertension.
  • BETOPTIC S Ophthalmic Suspension 0.25% is a beta-adrenergic receptor inhibitor indicated for the treatment of elevated intraocular pressure (IOP) in patients with chronic open-angle glaucoma or ocular hypertension ().
  • Instill one drop of BETOPTIC S Ophthalmic Suspension 0.25% in the affected eye(s) twice daily. BETOPTIC S may be used alone or in combination with other IOP lowering medications.
  • Instill one drop in the affected eye(s) twice daily ()
  • Bottle filled with 10 and 15 mL of 0.25% sterile ophthalmic suspension
  • Bottles filled with 10 and 15 mL of 0.25% sterile ophthalmic suspension ()
  • BETOPTIC S Ophthalmic Suspension 0.25% is contraindicated in patients with:
  • Hypersensitivity to any component of this product ()
  • Sinus bradycardia, second or third degree atrioventricular block, overt cardiac failure, and cardiogenic shock ()
  • No data
  • Same adverse reactions found with systemic administration of beta-adrenergic receptor inhibitors may occur with topical ophthalmic administration ()
  • Treatment should be discontinued at the first signs of cardiac failure ()
  • Beta-adrenergic receptor inhibitors may mask the signs and symptoms of acute hypoglycemia and should be administered with caution in diabetic patients subject to hypoglycemia ()
  • Beta-adrenergic receptor inhibitors may mask certain clinical signs (e.g., tachycardia) or hyperthyroidism ()
  • The most frequent adverse reaction is transient ocular discomfort ()n n
  • To report SUSPECTED ADVERSE REACTIONS, contact Alcon Laboratories, Inc. at 1-800-757-9195 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
  • No data
  • Oral beta-adrenergic receptor inhibitors may have additive effects )
  • Catecholamine-depleting drugs may have additive effects ()
  • Concomitant adrenergic psychotropic drugs may have additive effects ()
  • No data
  • No information is available on overdosage in humans. The oral LD of the drug ranged from 350 - 920 mg/kg in mice and 860 - 1050 mg/kg in rats. The symptoms which might be expected with an overdose of a systemically administered beta-adrenergic receptor inhibitor are bradycardia, hypotension, bronchospasm and acute cardiac failure.
  • A topical overdose of BETOPTIC S Ophthalmic Suspension 0.25% may be flushed from the eye(s) with warm tap water.u00a0 If overdose occurs, treatment should be symptomatic and supportive.
  • BETOPTIC S Ophthalmic Suspension 0.25% contains betaxolol hydrochloride, a cardioselective beta-adrenergic receptor inhibitor, in a sterile resin suspension formulation. Betaxolol hydrochloride is a white, crystalline powder, with a molecular weight of 343.89. The chemical structure is presented below.n n n
  • Empirical Formula: CHNOu2022HCln Chemical Name:(u00b1)-1-[p-[2-(cyclopropylmethoxy) ethyl]phenoxy]-3-(isopropylamino)-2-propanol hydrochloride.
  • Each mL of BETOPTIC S Ophthalmic Suspension 0.25% contains: betaxolol HCl 2.8u00a0mg equivalent to 2.5u00a0mg of betaxolol base. benzalkonium chloride 0.01%. mannitol, poly (styrene-divinyl benzene) sulfonic acid, carbomeru00a0934P, edetate disodium, hydrochloric acid or sodium hydroxide (to adjust pH) and purified water.
  • BETOPTIC S Ophthalmic Suspension 0.25% has pH of approximately 7.6 and an osmolality of approximately 290u00a0mOsmol/kg.
  • No data
  • Lifetime studies with betaxolol HCl have been completed in mice at oral doses of 6, 20 or 60u00a0mg/kg/day and in rats at 3, 12 or 48u00a0mg/kg/day; betaxolol HCl demonstrated no carcinogenic effect. Higher dose levels were not tested.
  • In a variety of and bacterial and mammalian cell assays, betaxololu00a0HCl was nonmutagenic.
  • In controlled, double-masked studies, the magnitude and duration of the ocular hypotensive effect of BETOPTIC S Ophthalmic Suspension 0.25% and BETOPTIC S Ophthalmic Solution 0.5% were clinically equivalent. BETOPTIC S Suspension was significantly more comfortable than BETOPTIC Solution.
  • BETOPTIC S Ophthalmic Suspension 0.25% is supplied as follows:u00a010 and 15u00a0mL in plastic ophthalmic DROP-TAINER dispensers. Tamper evidence is provided with a shrink band around the closure and neck area of the DROP-TAINER package.
  • 10 mL 0065-0246-1015 mL 0065-0246-15
  • Storage and Handlingn
  • No data
  • No data
  • No data

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