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Betoptic
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  • FDA PI

Betoptic

Generic name:betaxolol hydrochloride
Dosage form: ophthalmic solution
Drug class:Ophthalmic glaucoma agents

Medically reviewed by Drugs.com. Last updated on Sep 21, 2021.

DESCRIPTION

Betoptic® Sterile Ophthalmic Solution contains betaxolol hydrochloride, a cardioselective beta-adrenergic receptor blocking agent, in a sterile isotonic solution. Betaxolol hydrochloride is a white, crystalline powder, soluble in water, with a molecular weight of 343.89. The chemical structure is presented below:

Empirical Formula:
C18H29NO3•HCl
Chemical Name:
(±)-1-[p-[2-(Cyclopropylmethoxy)ethyl]phenoxy]-3-(isopropylamino)-2-propanol hydrochloride.

Each mL of Betoptic Ophthalmic Solution (0.5%) contains: Active: 5.6 mg betaxolol hydrochloride equivalent to betaxolol base 5 mg. Preservative: Benzalkonium Chloride 0.01%. Inactive: Edetate Disodium, Sodium Chloride, Hydrochloric Acid and/or Sodium Hydroxide (to adjust pH), and Purified Water. DM-00

CLINICAL PHARMACOLOGY

Betaxolol HCl, a cardioselective (beta-1-adrenergic) receptor blocking agent, does not have significant membrane-stabilizing (local anesthetic) activity and is devoid of intrinsic sympathomimetic action. Orally administered beta-adrenergic blocking agents reduce cardiac output in healthy subjects and patients with heart disease. In patients with severe impairment of myocardial function, beta-adrenergic receptor antagonists may inhibit the sympathetic stimulatory effect necessary to maintain adequate cardiac function.

When instilled in the eye, Betoptic Ophthalmic Solution has the action of reducing elevated as well as normal intraocular pressure, whether or not accompanied by glaucoma. Ophthalmic betaxolol has minimal effect on pulmonary and cardiovascular parameters.

Ophthalmic betaxolol (one drop in each eye) was compared to timolol and placebo in a three-way crossover study challenging nine patients with reactive airway disease who were selected on the basis of having at least a 15% reduction in the forced expiratory volume in one second (FEV1) after administration of ophthalmic timolol. Betaxolol HCl