结肠清肠粉-PREPOPIK(sodium picosulfate, magnesium oxide, and anhydrous citric acid)
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.
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。
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 eva luated 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)
Last Updated:
10/22/2012
