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当前位置:药品说明书与价格首页 >> 消化系统药物 >> FDA批准新口服液Clenpiq用于结肠镜检查肠道准备

FDA批准新口服液Clenpiq用于结肠镜检查肠道准备

2018-02-06 02:06:38  作者:新特药房  来源:互联网  浏览次数:0  文字大小:【】【】【
简介:CLENPIQ是一种匹可硫酸钠,一种刺激性泻药,氧化镁和无水柠檬酸,形成柠檬酸镁,一种渗透性泻药,用于清洗结肠作为准备成人肠镜检查。近日,美国食品药品监督管理局(FDA)已批准辉凌制药公司认同销售的组合匹可硫 ...
CLENPIQ是一种匹可硫酸钠,一种刺激性泻药,氧化镁和无水柠檬酸,形成柠檬酸镁,一种渗透性泻药,用于清洗结肠作为准备成人肠镜检查。
近日,美国食品药品监督管理局(FDA)已批准辉凌制药公司认同销售的组合匹可硫酸钠、氧化镁和无水柠檬酸的口服液(Clenpiq)用于成人行结肠镜检查前的结肠清洁。随着在2018年第一季度的计划可用性,这种组合将是FDA批准的唯一“即饮型”结肠镜准备处方。
在美国,结肠直肠癌是第三大常见癌症和第二大导致癌症死亡的原因。结肠镜检查可以帮助减少结肠直肠癌的发病率以及与该疾病有关的死亡。
“成功的肠道准备对肠胃科医师在结肠镜检查过程中清楚地看到结肠内部至关重要。纽约大学医学院临床助理医学教授 Edward Brettholz MD 说:“规定的肠道准备溶液的绝对体积可能会成为一些患者完成准备方案的障碍,从而导致结肠的可视化不佳。“预混合口服溶液中有即饮、小体积结肠镜检查准备剂,是让患者为可帮助检测和预防结肠直肠癌的重要手术做好准备的良好开端。”
关于组合
批准的溶液是一种即饮型橙味双作用组合,由匹可硫酸钠(一种兴奋性泻药)以及氧化镁和无水柠檬酸(两者形成柠檬酸镁)组成,是一种渗透性泻药,适用于在成人中为结肠镜准备的结肠清洁。
CLENPIQ(Sodium Picosulfate Oral Solution)
CLENPIQTM oral solution is indicated for cleansing of the colon as a preparation for colonoscopy in adults.
Important Safety Information
•CLENPIQ is contraindicated in the following conditions: patients with severe renal impairment (creatinine clearance less than 30mL/minute), gastrointestinal obstruction or ileus, bowel perforation, toxic colitis or toxic megacolon, gastric retention, or in patients with a known hypersensitivity to any of the ingredients in CLENPIQ.
•Patients should be advised to hydrate adequately (before, during and after use of CLENPIQ), and post-colonoscopy lab tests should be considered if a patient develops significant vomiting or signs of dehydration, including orthostatic hypotension, after taking CLENPIQ. Patients with electrolyte abnormalities should have them corrected before treatment. Use caution when prescribing CLENPIQ for patients that have conditions or are using medications that increase the risk for fluid and electrolyte abnormalities.
•Use caution in patients who have conditions, or are taking concomitant medications that increase the risk for seizures, such as those taking medications that lower the seizure threshold, patients withdrawing from alcohol or benzodiazepines or patients with known or suspected hyponatremia.
•Use caution in patients with impaired renal function or taking medications that may affect renal function, as well as patients at increased risk of arrhythmias, including those patients with a history of prolonged QT, recent myocardial infarction, unstable angina, congestive heart failure, or cardiomyopathy.
•Osmotic laxatives may produce colonic mucosal aphthous ulcerations and there have been reports of more serious cases of ischemic colitis requiring hospitalization. Concurrent use of additional stimulant laxatives with CLENPIQ may increase this risk.
•Use with caution in patients with severe active ulcerative colitis.
•Use with caution in patients with impaired gag reflex as they may be at risk for regurgitation or aspiration during administration of CLENPIQ.
•The safety of CLENPIQ has been established from adequate well controlled trials of another oral formulation of sodium picosulfate, magnesium oxide and anhydrous citric acid. The most common adverse reactions in those trials were nausea, headache, and vomiting.
•CLENPIQ can reduce the absorption of co-administered drugs. Do not take oral medications within one hour of starting CLENPIQ. Administer tetracycline and fluoroquinolone antibiotics, iron, digoxin, chlorpromazine and penicillamine, at least 2 hours before and not less than 6 hours after administration of CLENPIQ to avoid chelation with magnesium.

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