2012年7月16日，美国食品与药物管理局（FDA）批准了Prepopik（有效成分：匹可硫酸钠、氧化镁和柠檬酸）用于辅助成人患者在行结肠镜检查的准备阶段净化结肠。
一剂用量Prepopik包含2包粉剂，患者在不同时间段用冷水冲服每包粉剂。服用时间为患者行结肠镜检查的前一天晚上和当天早上（分次剂量法），若不能按照上述服用方法服用，患者也可在行结肠镜检查的前一天下午和晚上服用（前一天服用法）。
作为结肠净化方案的一部分，服用Prepopik的患者还必须在服用期间和服用之后使用其他的液体，这种额外的液体能量摄入对于减少患者体液和电解质失衡风险也非常重要。已报告的服用Prepopik的成人患者的最常见不良反应包括恶心、呕吐和头痛。
伴随着Prepopik的获准，制造厂家还必须进行确定儿童使用该药的安全性和有效性研究。
制造商：
辉凌制药公司
药理分类：
兴奋剂+渗透性泻药。
“活性成分”（词）：
钠picosulfate 10毫克，镁氧化物3.5克的，无水柠檬酸酸12克的每个数据包粉口服液后重建。
指示（S）：
结肠镜检查前的肠道清洁。
药理作用：
picosulfate钠是由结肠细菌水解，以形成一种活性代谢物：双 - （对 - 羟基 - 苯基） - 吡啶基-2 - 甲烷，BHPM，直接作用于结肠的粘膜刺激结肠的蠕动。氧化镁和柠檬酸反应创建柠檬酸镁溶液中，这是一个使水保留在胃肠道内的渗透剂。
临床试验：
非劣效性评价的功效Prepopik针对比较在两个研究者随机，双盲，活性药物对照，多中心美国临床试验涉及1195名患者有一个肠镜检查计划。患者随机分配到Prepopik在这两项研究分别用两种给药方案中的一个。在研究1，Prepopik是由“分割剂量给药。在研究2中，Prepopik是由“第一天”之前剂量。比较器是一个含有两个升聚乙二醇加电解质溶液（PEG + E）和两个比沙可啶5毫克的片剂，给药前一天的程序制备。
主要疗效终点是成功的结肠清洗患者的比例，如失明的colonoscopists使用Aronchick规模评估。成功的结肠清洗被定义为> 90％的黏膜看到，大多是液体粪便，被评为优秀或良好的大肠镜检查医师的肠道准备。在这两项研究中，Prepopik非劣效性比较（研究1：84.2％和74.4％;研究2：83.0％和79.7％，分别）。此外，在研究1中结肠清洗的比较优势，分次剂量给药Prepopik提供符合预先指定的标准。
法律分类：
接收
成人：
分次剂量方案（首选）：结肠镜检查的前一天晚上由的58盎司饮料透明液体睡前服用第一剂。在5小时内，消费透明液体。第二剂结肠镜检查前约5个小时，到了第二天，至少有三个8盎司透明液体饮料。消费透明液体，在5小时内，直到前2个小时的过程。天前方案（二选一）：第一剂结肠镜检查前透明液体之前下一个剂量由的58盎司饮料在下午或傍晚。第二剂在晚上约6小时后，结肠镜检查的前一天晚上，然后由的38盎司饮料透明液体睡前。在5小时内，消费透明液体。
儿童：
不成立的。
禁忌（S）：
严重肾功能不全（肌酐清除率<30ml/min者）。胃肠道阻塞。肠梗阻。肠穿孔。中毒性肠炎或巨结肠。胃潴留。
警告/注意事项：
纠正水/电解质异常后方可使用。史或癫痫发作的风险。肾功能损害，考虑基线和结肠镜检查的实验室测试。心律失常的风险增加，考虑剂量和结肠镜检查心电图。黏膜溃疡的发生;解释研究结果时，在炎症性肠道疾病。前管理，排除消化道梗阻/穿孔。严重的活动性溃疡性结肠炎。咽反射受损。返流或吸入的危险。保持充足的水分。怀孕（B类）。哺乳期的母亲。
互动（补）：
注意药物的液体/电解质异常（如利尿剂，糖皮质激素，强心甙类，非甾体抗炎药，三环，SSRIs类药物，抗精神病药物，卡马西平），或影响肾功能（如ACE抑制剂，ARB类药物）的风险增加。在1小时内开始服用口服药物不能被人体吸收。独立剂量的四环素类，氟喹诺酮类，铁，地高辛，氯丙嗪，或青霉胺前至少2小时或6小时后Prepopik。抗生素可能会降低疗效。注意降低癫痫发作阈值的药物。
不良反应（S）：
恶心，头痛，呕吐。
如何提供：
纸箱 - 1（定量杯的瓦特2包）
最后更新：
2012年10月22号
PREPOPIK
Manufacturer:
Ferring Pharmaceuticals, Inc.
Pharmacological Class:
Stimulant + osmotic laxative.
Active Ingredient(s):
Sodium picosulfate 10mg, magnesium oxide 3.5g, anhydrous citric acid 12g; per packet; powder for oral solution after reconstitution.
Indication(s):
Bowel cleansing before colonoscopy.
Pharmacology:
Sodium picosulfate is hydrolyzed by colonic bacteria to form an active metabolite: bis-(p-hydroxy-phenyl)-pyridyl-2-methane, BHPM, which acts directly on the colonic mucosa to stimulate colonic peristalsis. Magnesium oxide and citric acid react to create magnesium citrate in solution, which is an osmotic agent that causes water to be retained within the gastrointestinal tract.
Clinical Trials:
The efficacy of Prepopik was evaluated for non-inferiority against a comparator in two randomized, investigator-blinded, active-controlled, multicenter US trials involving 1,195 patients scheduled to have an elective colonoscopy. Patients randomized to Prepopik in the two studies were treated with one of two dosing regimens. In Study 1, Prepopik was given by “Split-Dose” dosing. In Study 2, Prepopik was given by “Day-Before” dosing. The comparator was a preparation containing two liters of polyethylene glycol plus electrolytes solution (PEG + E) and two bisacodyl 5mg tablets, administered the day before the procedure.
The primary efficacy endpoint was the proportion of patients with successful colon cleansing, as assessed by blinded colonoscopists using the Aronchick Scale. Successful colon cleansing was defined as bowel preparations with >90% of the mucosa seen and mostly liquid stool that were graded excellent or good by the colonoscopist. In both studies, Prepopik was non-inferior to the comparator (Study 1: 84.2% vs. 74.4%; Study 2: 83.0% vs. 79.7%; respectively). In addition, Prepopik provided by Split-Dose dosing met the pre-specified criteria for superiority to the comparator for colon cleansing in Study 1.
Legal Classification:
Rx
Adults:
Split-Dose regimen (preferred): Take 1st dose evening before colonoscopy followed by five 8oz drinks of clear liquids before bed. Consume clear liquids within 5 hours. Take 2nd dose, the next day approximately 5 hours before colonoscopy followed by at least three 8oz drinks of clear liquids. Consume clear liquids within 5 hours up until 2 hours before procedure. Day-Before regimen (alternative): Take 1st dose in the afternoon or early evening before colonoscopy followed by five 8oz drinks of clear liquids before the next dose. Take 2nd dose approximately 6 hours later in the late evening, the night before colonoscopy followed by three 8oz drinks of clear liquids before bed. Consume clear liquids within 5 hours.
Children:
Not established.
Contraindication(s):
Severe renal impairment (CrCl <30mL/min). GI obstruction. Ileus. Bowel perforation. Toxic colitis or megacolon. Gastric retention.
Warnings/Precautions:
Correct fluid/electrolyte abnormalities before use. History or risk of seizures. Renal impairment; consider baseline and post-colonoscopy lab tests. Increased risk of arrhythmias; consider pre-dose and post-colonoscopy ECGs. Mucosal ulcerations may occur; consider when interpreting findings in inflammatory bowel disease. Rule out GI obstruction/perforation before administering. Severe active ulcerative colitis. Impaired gag reflex. Risk of regurgitation or aspiration. Maintain adequate hydration. Pregnancy (Category B). Nursing mothers.
Interaction(s):
Caution with drugs that increase risk of fluid/electrolyte abnormalities (eg, diuretics, corticosteroids, cardiac glycosides, NSAIDs, tricyclics, SSRIs, antipsychotics, carbamazepine) or that affect renal function (eg, ACEIs, ARBs). Oral drugs given within 1 hour of start of administration may not be absorbed. Separate dosing of tetracyclines, fluoroquinolones, iron, digoxin, chlorpromazine, or penicillamine by at least 2 hours before or >6 hours after Prepopik. Antibiotics may reduce efficacy. Caution with drugs that lower seizure threshold.
Adverse Reaction(s):
Nausea, headache, vomiting.
How Supplied:
Carton—1 (2 packets w. dosing cup)