国家: 加拿大
语言: 英文
来源: Health Canada
BETAXOLOL (BETAXOLOL HYDROCHLORIDE)
NOVARTIS PHARMACEUTICALS CANADA INC
S01ED02
BETAXOLOL
0.25%
SUSPENSION
BETAXOLOL (BETAXOLOL HYDROCHLORIDE) 0.25%
OPHTHALMIC
5ML/10ML
Prescription
BETA-ADRENERGIC AGENTS
Active ingredient group (AIG) number: 0131365002; AHFS:
APPROVED
2017-03-08
_BETOPIC_ _*_ _ S Betaxolol Hydrochloride Ophthalmic Suspension (0.25% w/v) _ _Page 1 of 32 _ _ _ _ _ PRODUCT MONOGRAPH PR BETOPTIC * S Betaxolol Hydrochloride Ophthalmic Suspension (betaxolol 0.25% w/v) ^ as base Antiglaucoma Agent (Ophthalmic) Novartis Pharmaceuticals Canada Inc. Date of Preparation: 385 Bouchard Blvd. May 17, 2013 Dorval, Quebec Date of Revision: H9S 1A9 March 6, 2017 www.novartis.ca CONTROL #202017 *a trademark of Novartis ©2015 Novartis _BETOPIC_ _*_ _ S Betaxolol Hydrochloride Ophthalmic Suspension (0.25% w/v) _ _Page 2 of 32 _ _ _ _ _ PRODUCT MONOGRAPH PR BETOPTIC * S Betaxolol Hydrochloride Ophthalmic Suspension THERAPEUTIC CLASSIFICATION Antiglaucoma Agent (Ophthalmic) ACTION AND CLINICAL PHARMACOLOGY Betaxolol is a cardioselective (beta-1-adrenergic) receptor blocking agent. It does not have significant membrane-stabilizing (local anesthetic) activity and is devoid of intrinsic sympathomimetic action. OCULAR: When instilled in the eye, betaxolol reduces elevated as well as normal intraocular pressure, whether or not accompanied by glaucoma. When used as a solution, the onset of action occurs within 30 minutes and the maximal effect is usually attained approximately two hours after instillation. Although the time of onset of action, and time of maximal effect for the suspension have not been determined, controlled double masked studies show that the magnitude and duration of the ocular hypotensive effect of betaxolol 0.5% solution and BETOPTIC * S 0.25% suspension were clinically equivalent. A single dose provides a 12-hour reduction in intraocular pressure and twice daily administration maintains the IOP below 22 mmHg in most patients. Betaxolol has no effect on pupil size or accommodation. _BETOPIC_ _*_ _ S Betaxolol Hydrochloride Ophthalmic Suspension (0.25% w/v) _ _Page 3 of 32 _ _ _ _ _ SYSTEMIC: Ophthalmic betaxolol is virtually devoid of systemic effects. Following oral administration, the elimination half-life of betaxolol is 14-22 hours and it is metabolized mainly 阅读完整的文件