国: アメリカ合衆国
言語: 英語
ソース: NLM (National Library of Medicine)
Betaxolol Hydrochloride (UNII: 6X97D2XT0O) (Betaxolol - UNII:O0ZR1R6RZ2)
Akorn
Betaxolol Hydrochloride
Betaxolol 5 mg in 1 mL
OPHTHALMIC
PRESCRIPTION DRUG
Betaxolol Ophthalmic Solution has been shown to be effective in lowering intraocular pressure and is indicated in the treatment of ocular hypertension and chronic open-angle glaucoma. It may be used alone or in combination with other anti-glaucoma drugs. In clinical studies, betaxolol ophthalmic solution was safely used to lower intraocular pressure in 47 patients with both glaucoma and reactive airway disease who were followed for a mean period of 15 months. However, caution should be used in treating patients with severe reactive airway disease or a history of asthma. Hypersensitivity to any component of this product. Betaxolol is contraindicated in patients with sinus bradycardia, greater than a first degree atrioventricular block, cardiogenic shock, or patients with overt cardiac failure.
Betaxolol Ophthalmic Solution 0.5% is a sterile, isotonic, aqueous solution of betaxolol hydrochloride, USP. Supplied as follows: 2.5 mL, 5 mL, 10 mL and 15 mL in plastic ophthalmic dropper tip bottles. NDC 17478-705-25 2.5 mL Bottle NDC 17478-705-10 5 mL Bottle NDC 17478-705-11 10 mL Bottle NDC 17478-705-12 15 mL Bottle Storage: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Akorn Manufactued by: Akorn, Inc. Lake Forest, IL 60045 BX00N Rev. 06/16
Abbreviated New Drug Application
BETAXOLOL- BETAXOLOL HYDROCHLORIDE SOLUTION/ DROPS AKORN ---------- Rx only DESCRIPTION Betaxolol Ophthalmic Solution USP, 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 343.90. The structural formula is presented below: Molecular Formula: C H NO •HCl Chemical Name: (±)-1[_p_-[2-(Cyclopropylmethoxy)ethyl]phenoxy]-3-(isopropylamino)-2- propanol hydrochloride. Each mL of Betaxolol Ophthalmic Solution for ophthalmic administration contains: ACTIVE: 5.6 mg betaxolol hydrochloride equivalent to betaxolol base 5 mg; INACTIVES: Edetate Disodium, Sodium Chloride, Hydrochloric Acid and/or Sodium Hydroxide may be added to adjust pH and Water for Injection; PRESERVATIVE: Benzalkonium Chloride 0.01%. CLINICAL PHARMACOLOGY Betaxolol, 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, Betaxolol 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 (FEV ) after administration of ophthalmic timolol. Betaxolol had no significant effect on pulmonary function as 完全なドキュメントを読む