Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in clinical studies of another drug and may not reflect the rates observed in practice.
In a clinical study of HalfLytely and (10 mg vs. 20 mg) Bisacodyl Tablets Bowel Prep Kit multicentered, controlled clinical trials, abdominal pain/cramping, nausea, vomiting and headache were the most common adverse reactions (
The data in reflects exposure in 222 patients to HalfLytely and 10 mg bisacodyl tablets vs. 223 patients exposed to HalfLytely and 20 mg bisacodyl tablets. The HalfLytely and 10 mg Bisacodyl Tablets Bowel Prep Kit population was 20-85 years of age, 46% male, 54% female, 10% African American, 85% Caucasian, 8% Hispanic requiring a colonoscopy. The demographics of the comparator group were similar.
Table 2
Each [Polyethylene glycol (PEG) 3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution and bisacodyl delayed release tablets] consists of one 2 liter bottle of HalfLytely (PEG-3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution) powder for reconstitution and two 5 mg bisacodyl, delayed release tablets.
The colon cleansing efficacy of HalfLytely and Bisacodyl Tablets Bowel Prep Kit (with 10 mg of bisacodyl) was evaluated in a randomized, single blind, active-controlled, multicenter study. In this study, 444 adult patients were included in the efficacy analysis. Patients ranged in age from 19 to 86 years old (mean age 57 years old) with 53% female and 47% male patients. Race was distributed as follows: 86% Caucasian, 9% African American, 7% Hispanic or Latino, and 3% other.
Patients were randomized to one of the following two colon preparations: ) HalfLytely and Bisacodyl Tablets Bowel Prep Kit [20 mg of bisacodyl tablets were given at noon on the day before colonoscopy followed by 2 liters of HalfLytely (after the first bowel movement or maximum of 6 hours)] at a rate of 8 ounces every 10 minutes and ) a modified HalfLytely and Bisacodyl Tablets Bowel Prep Kit [containing 10 mg of bisacodyl tablets given at noon on the day before colonoscopy followed by 2 liters of HalfLytely (after the first bowel movement or maximum of 6 hours)] at a rate of 8 ounces every 10 minutes.
Patients were instructed to refrain from solid food and to have clear liquids on the day before colonoscopy. In addition, patients were instructed to consume nothing by mouth, except clear liquids, from the time the preparation was completed until midnight. Patients were instructed not to eat or drink anything from midnight until after the colonoscopy was completed.
The primary efficacy endpoint was the proportion of patients with successful colon cleansing (assessed by the colonoscopists), see below.
Each HalfLytely and Bisacodyl Tablets Bowel Prep Kit contains:
Lemon-Lime HalfLytely and Bisacodyl Tablets Bowel Prep Kit contains 1 gram lemon-lime flavoring ingredient. HalfLytely and Bisacodyl Tablets Bowel Prep Kit with Flavor Packs contains 3 packs (1 gram each Cherry, Lemon-Lime and Orange flavors).
