NDA 19-270/S-031 Page 3 Betaxolol Hydrochloride Ophthalmic ...
 | Name : NDA 19-270/S-031 Page 3 Betaxolol Hydrochloride Ophthalmic ... File Type : Size : 55 KB |
NDA 19-270/S-031 Betaxolol Hydrochloride Ophthalmic Solution, 0.5% as base Sterile DESCRIPTION: Betaxolol Hydrochloride 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: Each mL of Betaxolol Hydrochloride Ophthalmic Solution (0.5%) contains: Active: 5.6 mg betaxolol hydrochloride equivalent to betaxolol base 5 mg. Preservative: Benzalkonium Chloride 0.1%. Inactives: Edetate Disodium, Sodium Chloride, Hydrochloric Acid and/or Sodium Hydroxide (to adjust pH), and Purified Water. DM-00 CLINICAL PHARMACOLOGY: Betaxolol Hydrochloride HCl, a cardioselective (beta-1adrenergic) 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 Ebook Relate: betaxolol ebook hydrochloride ebook solution ebook ophthalmic ebook receptor ebook betaxolol hydrochloride ebook hydrochloride ophthalmic ebook ophthalmic solution ebook beta adrenergic ebook betaxolol hydrochloride ophthalmic ebook hydrochloride ophthalmic solution ebook receptor blocking agent ebook |
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