|
盐酸普萘洛尔 别名：心得安、萘心安 【作用与用途】 本品为β-受体阻断药，阻断心肌的β受体，减慢心率,抑制心脏收缩力与传导、循环血量减少、心肌耗氧量降低。临床主要用于治疗多种原因所致的心律失常，也可用于心绞痛高血压嗜铬细胞瘤(手术前准备)等。
InnoPran XL (propranolol hydrochloride) is a nonselective, beta-adrenergic receptor- blocking agent for oral administration, available as an extended release product. InnoPran XL is available as 80 mg and 120 mg capsules which contain sustained-release beads. Each of the beads contains propranolol hydrochloride and is coated with dual membranes. These membranes are designed to retard release of propranolol hydrochloride for several hours after ingestion followed by the sustained release of propranolol. The active ingredient in InnoPran XL is a synthetic beta-adrenergic receptor-blocking agent chemically described as 1-(Isopropylamino)-3-(1-naphthyloxy)-2-propanol hydrochloride. Its structural formula is: Propranolol hydrochloride is a stable, white, crystalline solid, which is readily soluble in water and ethanol. Its molecular weight is 295.81. Each capsule for oral administration contains sugar spheres, ethylcellulose, povidone, hypromellose phthalate, diethyl pthalate, hypromellose, polyethylene glycol, gelatin, titanium dioxide and black iron oxide. In addition, InnoPran XL 120-mg capsules contain yellow iron oxide. InnoPran XL (propranolol hydrochloride) Extended Release Capsules Each gray/white capsule, imprinted with "80", 2 segmented bands, "InnoPran XL", and Reliant logo contains 80 mg of propranolol hydrochloride in bottles of 30 (NDC 65726-250- 10), bottles of 100 (NDC 65726-250-25), bottles of 500 (NDC 65726-250-35), and a Unit Dose package of 100 (NDC 65726-250-90). Each gray/off-white capsule, imprinted with "120", 3 segmented bands, "InnoPran XL", and Reliant logo contains 120 mg of propranolol hydrochloride in bottles of 30 (NDC 65726-251- 10) bottles of 100 (NDC 65726-251-25), bottles of 500 (NDC 65726-251-35), and a Unit Dose package of 100 (NDC 65726-251-90). Store at 25ºC (77ºF); excursions permitted to 15 - 30ºC (59 - 86ºF) [see USP Controlled Room Temperature] in a tightly closed container. The unit dose packaging should be stored in the carton. --------------------------------------------------------------- 美国FDA批准盐酸普萘洛尔择时控释胶囊上市 美国FDA批准信赖制药（Reliant Pharmaceuhcals）公司新颖的盐酸普蒂洛尔（Propranolol Hydrochloride）择时控释制剂上市，商品名：InnoPran XL。临睡前服用，治疗高血压。 1日服用1次InnoPran XL控制血压24小时，且有80mg至120mg灵活的剂量选择范围。它是此类批准晚上服药的唯一产品。InnoPranXL可单独使用或和其他抗高血压药合用。临床研究显示，藉傍晚服药可降低清晨时段的血压且持续控制一整天。 作为首个β受体阻滞剂普萘洛尔已经过30余年使用证明其安全、有效。InnoPran XL系信赖制药公司实施国内发展规划获FDA批准的，是该公司发展中的一个重要的里程碑。InnoPran XL代表了一个治疗高血压的前卫观念。信赖制药公司的战略是制备模拟人体昼夜生物节律波动的释药制剂，使其在心血管疾病发作最危险时段发挥最大抗高血压作用。 在一对434名轻至中度高血压进行的双盲平行剂量——反应对照研究中，1日1次晚上10点左右服用InnoPran XL 80mg-640mg。16小时测得的坐位收缩压和舒张压显著降低。还观察到InnoPran XL对65岁及其以上病人抗高血压有效。其他临床试验显示，单次或多次服用InnoPran XL 80mg、120mg和160mg后，剂量与血药浓度成正比。在稳态血浓度时，InnoPran XL 160mg的生物利用度与普通盐酸普萘洛尔长效胶囊无统计意义上的差异。InnoPran XL最常见的不良反应是乏力、眩晕和便秘。它禁用于心源性休克、窦性心动过缓和大于I度房室阻滞、支气管哮喘和对盐酸普萘洛尔高敏性病人。 InnoPran XL是与尤兰德（Eurand）公司合作采用其Diffucaps专利技术开发的，胶囊剂量规格：80mg，120mg/粒
Drug Name Innopran XL (Propranolol) Drug Uses This medication is a beta-blocker, used to treat high blood pressure. Lowering high blood pressure helps prevent strokes, heart attacks and kidney problems. This drug works by blocking the action of certain natural chemicals in your body (such as epinephrine) that affect the heart and blood vessels. This results in a lowering of heart rate, blood pressure, and strain on the heart. How to use Take this medication by mouth usually once daily at bedtime; or as directed by your doctor. Swallow the capsules whole; do not crush or chew the capsules. Use this medication regularly in order to get the most benefit from it. Remember to use it at the same time each day. This drug is not effective if you use it only when a chest pain or a migraine headache occurs. It is very important to take this medication regularly as prescribed to help prevent these conditions. The dosage is based on your medical condition and response to therapy. It may take 1 or 2 weeks before the full benefit of this drug takes effect. It is important to continue taking this medication even if you feel well. Most people with high blood pressure do not feel sick. Do not suddenly stop taking this medication without consulting your doctor. Your condition may become worse when the drug is suddenly stopped. Drug Class and Mechanism The mechanism of the antihypertensive effects of innopran XL has not been established. Among the factors that may be involved are decreased cardiac output, inhibition of renin release by the kidneys, and diminution of tonic sympathetic nerve outflow from vasomotor centers in the brain. It has been suggested, but not established, that propranolol may achieve a better antihypertensive effect in patients with normal or elevated plasma renin activity (PRA) than those with low PRA. Missed Dose If you miss a dose, take it as soon as you remember, but not if it is within 8 hours of the next dose. If it is within 8 hours of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up. Storage Store at room temperature (77 degrees F or 25 degrees C) away from light and moisture. Brief storage between 59-86 degrees F (15-30 degrees C) is permitted. Do not store in the bathroom. Keep all medicines away from children and pets. |
盐酸普萘洛尔择时控释胶囊InnoPran,XL（Propranolol Hydrochloride）简介：
盐酸普萘洛尔
别名：心得安、萘心安
【作用与用途】 本品为β-受体阻断药，阻断心肌的β受体，减慢心率,抑制心脏收缩力与传导、循环血量减少、心肌耗氧量降低。临床主要用于治疗多种原因所致的心律 ... 责任编辑：admin |
最新文章更多推荐文章更多热点文章更多
|
中国新特药网-第一时间提供全球医药资讯
注： 本站药品信息仅供医药研发机构作参考-
在线咨询：
- 鲁ICP备05035203号 @