PREPOPIK Rx

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 1^st dose evening before colonoscopy followed by five 8oz drinks of clear liquids before bed. Consume clear liquids within 5 hours. Take 2^nd 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 1^st dose in the afternoon or early evening before colonoscopy followed by five 8oz drinks of clear liquids before the next dose. Take 2^nd 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:

1/9/2013