国家: 爱尔兰
语言: 英文
来源: HPRA (Health Products Regulatory Authority)
BETAXOLOL HYDROCHLORIDE
G & A Licensing Limited
BETAXOLOL HYDROCHLORIDE
0.5 %w/v
Eye Drops Solution
Product subject to prescription which may be renewed (B)
Withdrawn
2013-02-27
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Betoptic 0.5% w/v, Eye Drops, Solution. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Betaxolol 0.5%w/v (as hydrochloride) Excipients-Contains Benzalkonium Chloride For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Eye drops solution _Product imported from Greece_: A clear, colourless to pale yellow sterile, eye drops solution 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Betoptic is indicated for the reduction of elevated intraocular pressure in patients with ocular hypertension and chronic open angle glaucoma. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION When using nasolacrimal occlusion or closing the eyelids for 2 minutes, the systemic absorption is reduced. This may result in a decrease in systemic side effects and an increase in local activity. _Adults (including the elderly)_ The usual dose is one drop to be instilled into the affected eye(s) twice daily. _Children_ Betoptic is not recommended for use in children. 4.3 CONTRAINDICATIONS Hypersensitivity to the active substance (substances), or to any of the excipients. Reactive airway disease including severe bronchial asthma or a history of severe bronchial asthma, severe chronic obstructive pulmonary disease. Sinus bradycardia, sick sinus syndrome sino-atrial block, second or third degree atrioventricular block not controlled with pace-maker. Overt cardiac failure, cardiogenic shock. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Like other topically applied ophthalmic agents Betaxolol is absorbed systemically. Due to beta adrenergic component, Betaxolol, the same types of cardiovascular, pulmonary and other adverse reactions seen with systemic beta-adrenergic blocking agents may occur. Incidence of systemic ADRs after topical ophthalmic administration is 阅读完整的文件