Visicol (sodium phosphate, diabasic, anhydrous, sodium phosphate, monobasic, monohydrate) tablets are indicated for the cleansing of the bowel as a preparation for colonoscopy, in adults 18 years of age and older.
A total of 957 adult subjects were enrolled and treated in the controlled clinical trials of Visicol™ Tablets. Males and females were about equally represented. Approximately 87% of the study population was Caucasian. Visicol™ Tablets were found to be comparable in cleansing efficacy to the comparison drug, a commercially available polyethylene glycol-salt (PEG-salt solution) solution (Cherry Flavor NuLYTELY®). Two identical, single (investigator) blind, randomized, multicenter trials were conducted comparing the efficacy and safety of Visicol™ Tablets and the PEG-salt solution comparator as a colon cleansing agent in subjects undergoing routine diagnostic colonoscopy. In each study, over 200 subjects were randomized to self-administer the Visicol™ Tablets and over 200 were randomized to self-administer the PEG-salt solution comparator. Colonoscopy was generally performed within 5 hours of the second dose. Physicians used a four-point, validated Physician Questionnaire to assess efficacy. The distribution of "excellent", "good", "fair" and "inadequate", as evaluated by the physician performing the colonoscopy, was comparable in both groups.
The efficacy of overall colonic cleansing with the Visicol™ Tablets was comparable to the PEG-salt solution. In addition, the incidence of "Inadequate" colon cleansing ratings due to poor purgative preparation was similar between Visicol™ Tablets and the PEG-salt solution comparator. Also, cleansing efficacy in the ascending colon with Visicol™ Tablets was comparable to the PEG-salt solution. (From Company Web Site)
Visicol™ Tablets are contraindicated for patients with congestive heart failure, ascites, unstable angina pectoris, gastric retention, ileus or acute obstruction or pseudo-obstruction, severe chronic constipation, bowel perforation, acute colitis, toxic megacolon, or hypomotility syndrome (such as hypothyroidism, scleroderma).
Visicol™ Tablets are contraindicated for patients with a known allergy or hypersensitivity to sodium phosphate salts or any of its ingredients.
Common side effects include, but are not limited to:
Most of these side effects also occurred in patients taking the comparator drug.
Visicol™ Tablets, taken two doses of 30 grams approximately twelve hours apart, induce a diarrhea, which rapidly and effectively cleanses the entire colon. Each administration has a purgative effect for approximately 1 to 3 hours. The primary mode of action is thought to be through osmotic action of sodium, causing large amounts of water to be drawn into the bowel, promoting bowel evacuation. (From Company Web Site)
For more information concerning Visicol go to the company web site at: Inkine Pharmaceuticals