近日，美国食品和药物管理局（FDA）批准CLENPIQ（sodium picosulfate, magnesium oxide, and anhydrous citricacid）口服液上市，用于结肠镜检查的成年人结肠清洁。
批准日期：2017年11月29日  公司：Ferring Pharmac.icals Inc.
CLENPIQ(皮硫酸钠、氧化镁和无水柠檬酸[sodium picosulfate, magnesium oxide, and anhydrous citricacid])溶液,供口服使用
首次美国批准：2012
作用机理
皮硫酸钠被结肠细菌水解，形成活性代谢产物：双（对羟基苯基）-吡啶基-2-甲烷，BHPM，它直接作用于结肠粘膜以刺激结肠蠕动。氧化镁和柠檬酸在溶液中与柠檬酸甲酯反应，柠檬酸甲酯是一种渗透剂，使水滞留在胃肠道内。
适应症及用法
CLENPIQ是皮硫酸钠、兴奋性泻药、氧化镁和无水柠檬酸的组合，它们形成柠檬酸镁，一种渗透性泻药，用于清洁结肠，作为成人结肠镜检查的制剂。
剂量与给药
管理：
CLENPIQ已经准备好喝酒了。它不需要在给药前稀释。一瓶CLENPIQ相当于一剂。
两个剂量的CelpIQ需要完整的结肠镜检查准备。优选的方法是“分割剂量”方法。另一种方法是“前一天”方法。
在每次口服CLENPIQ后，必须消耗更多的液体。
每次服用后1小时内不要服用口服药物。
如果服用四环素或氟喹诺酮类抗生素、铁、地高辛、氯丙嗪或青霉胺，在服用CLENPIQ前至少2小时和不少于6小时服用这些药物。
有关结肠镜检查前的准备和给药方案的完整信息，请参阅完整的处方信息。
分割剂量给药方案（优选方法）
第一剂量：在结肠镜检查之前的晚上给药。第二剂量：第二天，在结肠镜检查之前的早晨给药。
前天剂量方案（替代方法），如果分裂剂量是适当的。
第一剂量：在结肠镜检查前的下午或傍晚进行。
第二次剂量：在结肠镜检查前6小时晚间服用。
剂型和强度
CLENPIQ口服液：每瓶含10毫克微硫酸钠、3.5克氧化镁和12克无水柠檬酸，每瓶含160毫升溶液。
禁忌症
肾功能严重减退的患者（肌酐清除率小于30mL/分钟）。
胃肠道梗阻或肠梗阻。
肠穿孔。
中毒性结肠炎或中毒性巨结肠。
胃潴留。
对CLENPIQ的任何成分过敏。
警告和注意事项
液体和电解质异常、心律失常、癫痫发作和肾损害的风险：鼓励充分的水合，评估同时使用的药物，并在使用前和之后考虑实验室评估。
用于肾损害患者或同时服用影响肾功能的药物：使用谨慎，确保足够的水合，以及考虑测试。
粘膜溃疡：当解释已知或可疑的炎症性肠病患者的结肠镜检查结果时，考虑粘膜溃疡的可能性。
疑似胃肠道梗阻或穿孔：排除用药前诊断。
有抽吸风险的患者：在给药期间观察。
不良反应
最常见的不良反应（＞1%）是恶心、头痛和呕吐。
要报告预期的不良反应，请联系FerringPharmac.icalsInc.在1-888-Ferring(1-888-337-7464)或FDA在1-800-FDA-1088或www.fda.gov/med.。
药物相互作用
由于液体和电解质变化而增加风险的药物。
包装供应/储存和搬运
供应
CLENPIQ装在一个装有两个瓶子的纸箱里，每个瓶子装有160毫升蔓越莓味的、无色到微黄色的透明口服溶液，可能存在可见的颗粒。每瓶含有10毫克微硫酸钠，3.5克氧化镁和12克无水柠檬酸。还提供了用于测量水合流体的八盎司杯。
CLENPIQ蔓越莓口味：NDC
保管部
在25°C（77°F）存储克伦皮克。允许在15°C到30°C（59°F到86°F）的偏移。参见美国药典控制的室温。不要冷藏或冷冻。

完整资料附件：http://www.ferringusa.com/wp-content/uploads/2018/10/CLENPIQ-PI-Aug2018.pdf
CLENPIQ(sodium picosulfate, magnesium oxide, and anhydrous citricacid)oral solution
Indication and Important Safety Information
Indication
CLENPIQ 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.