Country: Taívan
Tungumál: kínverska
Heimild: 衛生福利部食品藥物管理署 (Ministry of Health and Welfare, Food And Drug Administration)
BRIMONIDINE TARTRATE
台灣愛力根藥品股份有限公司 台北市中正區羅斯福路2段102號9樓 (53529261)
S01EA05
點眼液劑
BRIMONIDINE TARTRATE (2408005310) MG
瓶裝
製 劑
須由醫師處方使用
ALLERGAN PHARMACEUTICALS IRELAND CASTLEBAR ROAD, WESTPORT, CO. MAYO, IRELAND IE
brimonidine
開放角隅青光眼或高眼壓。
註銷日期: 2023/04/07; 註銷理由: 自請註銷; 有效日期: 2024/10/18; 英文品名: ALPHAGAN OPHTHALMIC SOLUTION 0.2%
已註銷
1999-10-18
ALPHAGAN® 0.2% BRIMONIDINE TARTRATE OPHTHALMIC SOLUTION 0.2% DESCRIPTION EACH ML CONTAINS: brimonidine tartrate 2 mg (equivalent to 1.32 mg as brimonidine free base) with: benzalkonium chloride 0.05 mg, polyvinyl alcohol 14 mg; sodium chloride; sodium citrate; citric acid and purified water. CLINICAL PHARMACOLOGY ALPHAGAN® 0.2% is a relatively selective alpha-2 adrenergic agonist. It has a peak ocular hypotensive effect occurring at two hours post-dosing. Fluorophotometric studies in animals and humans suggest that brimonidine tartrate has a dual mechanism of action by reducing aqueous humor production and increasing uveoscleral outflow. After ocular administration of a 0.2% solution, plasma concentrations peaked within 1 to 4 hours and declined with a systemic half-life of approximately 3 hours. In humans, systemic metabolism of brimonidine is extensive. It is metabolized primarily by the liver. Urinary excretion is the major route of elimination of the drug and its metabolites. Approximately 87% of an orally-administered radioactive dose was eliminated within 120 hours, with 74% found in the urine. Elevated IOP presents a major risk factor in glaucomatous field loss. The higher the level of IOP, the greater the likelihood of optic nerve damage and visual field loss. ALPHAGAN® 0.2% has the action of lowering intraocular pressure with minimal effect on cardiovascular and pulmonary parameters. In comparative clinical studies with timolol 0.5%, lasting up to one year, the IOP lowering effect of ALPHAGAN® 0.2% was approximately 4-6 mm Hg compared with approximately 6 mm Hg for timolol. Eight percent of subjects were discontinued from studies due to inadequately controlled intraocular pressure, which in 30% of these patients occurred during the first month of therapy. Approximately 20% were discontinued due to adverse experiences. INDICATIONS AND USAGE ALPHAGAN® 0.2% is indicated for lowering intraocular pressure in patients with open-angle glaucoma or ocular hypertension. The IOP lowering efficacy of ALPHAGAN® Lestu allt skjalið