7MB pdf - American Society for Gastrointestinal Endoscopy

Clean Freak
Effective cleansing in all bowel segments, including the right colon
Percent of patients with NO RESIDUAL STOOL by colon segment 1 *
Colon Segment
SUPREP Bowel
Prep Kit split-dose
regimen (n=63)
4-Liter Prep
same-day regimen ‡
(n=66) §
Cecum 91% † 67%
Ascending 91% † 69%
Descending 92% 84%
Transverse 92% 82%
Sigmoid/Rectum 94% 81%
*This clinical trial was not included in the product labeling. † P≤0.02 vs 4-Liter Prep. Statistically significant difference.
‡
Standard 4-Liter Prep (sulfate-free PEG electrolyte lavage solution).
§
One patient was excluded who took the preparation but refused colonoscopy. Three patients had one or more
segments that could not be evaluated because the procedure was stopped for poor preparation before cecal intubation.
SUPREP Bowel Prep Kit achieved “excellent” bowel
cleansing in patients based on investigator grading 1,2
• Split-dose regimens of SUPREP Bowel Prep Kit
and MoviPrep ®|| were equivalent in colon
cleansing 2
• Significantly more patients had “excellent” preps
with SUPREP Bowel Prep Kit compared to MoviPrep
(63% vs 53%, respectively; P=0.043 ) 2
||
MoviPrep (PEG-3350, sodium sulfate, sodium chloride, potassium chloride, sodium ascorbate
and ascorbic acid for oral solution) is a registered trademark of Salix Pharmaceuticals, Inc.
Statistically significant difference.
Important Safety Information
SUPREP ® Bowel Prep Kit (sodium sulfate, potassium sulfate and magnesium sulfate) Oral Solution is an osmotic laxative indicated for cleansing of the colon as a preparation
for colonoscopy in adults. Most common adverse reactions (>2%) are overall discomfort, abdominal distention, abdominal pain, nausea, vomiting and headache.
Use is contraindicated in the following conditions: gastrointestinal (GI) obstruction, bowel
perforation, toxic colitis and toxic megacolon, gastric retention, ileus, known allergies to
components of the kit. Use caution when prescribing for patients with a history of seizures,
arrhythmias, impaired gag refl ex, regurgitation or aspiration, severe active ulcerative colitis,
impaired renal function or patients taking medications that may affect renal function or electrolytes.
Use can cause temporary elevations in uric acid. Uric acid fl uctuations in patients with gout may
precipitate an acute fl are. Administration of osmotic laxative products may produce mucosal
aphthous ulcerations, and there have been reports of more serious cases of ischemic colitis
requiring hospitalization. Patients with impaired water handling who experience severe vomiting
should be closely monitored including measurement of electrolytes. Advise all patients to hydrate
adequately before, during, and after use. Each bottle must be diluted with water to a fi nal volume
of 16 ounces and ingestion of additional water as recommended is important to patient tolerance.
Please see brief summary of Prescribing Information on adjacent page.