FLAVOR CHOICE IN BOWEL PREPARATION
Study Design2-4: This phase 3 trial was conducted in multiple sites. Of the 500 subjects who enrolled, 450 were evaluable for efficacy analyses. The primary endpoint was the percentage of subjects with successful cleansing, which was based on the US FDA Bowel Prep Scoring Scale. The goal of the study was to establish non-inferiority of SUFLAVE to SUPREP Bowel Prep Kit, using a 10% non-inferiority margin.
P<0.001 in this non-inferiority clinical trial.
SUFLAVE™ (polyethylene glycol 3350, sodium sulfate, potassium chloride, magnesium sulfate, and sodium chloride for oral solution) is an osmotic laxative indicated for cleansing of the colon in preparation for colonoscopy in adults.
DOSAGE AND ADMINISTRATION
A low residue breakfast may be consumed on the day before colonoscopy, followed by clear liquids up to 2 hours prior to colonoscopy. Administration of two doses of SUFLAVE are required for a complete preparation for colonoscopy. Each bottle must be reconstituted with water before ingestion. Each bottle and one flavor enhancing packet are equivalent to one dose. An additional 16 ounces of water must be consumed after each dose. Stop consumption of all fluids at least 2 hours before the colonoscopy.
Use is contraindicated in the following conditions: gastrointestinal obstruction or ileus, bowel perforation, toxic colitis or toxic megacolon, gastric retention, hypersensitivity to any ingredient in SUFLAVE.
WARNINGS AND PRECAUTIONS
Risk of fluid and electrolyte abnormalities: Encourage adequate hydration, assess concurrent medications and consider laboratory assessments prior to and after each use; Cardiac arrhythmias: Consider pre-dose and post-colonoscopy ECGs in patients at increased risk; Seizures: Use caution in patients with a history of seizures and patients at increased risk of seizures, including medications that lower the seizure threshold; Colonic mucosal ulcerations: Consider potential for mucosal ulcerations when interpreting colonoscopy findings in patients with known or suspected inflammatory bowel disease; Patients with renal impairment or taking concomitant medications that affect renal function: Use caution, ensure adequate hydration and consider laboratory testing; Suspected GI obstruction or perforation: Rule out the diagnosis before administration; Patients at risk for aspiration: Observe during administration; Hypersensitivity reactions, including anaphylaxis: Inform patients to seek immediate medical care if symptoms occur.
Most common adverse reactions (≥ 2%) are: nausea, abdominal distension, vomiting, abdominal pain, and headache.
Drugs that increase risk of fluid and electrolyte imbalance.
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