Visicol Tablet
The following drug information is obtained from various newswires, published
medical journal articles, and medical conference presentations.
For cleansing of the bowel as a preparation for colonoscopy, in adults 18 years of age and older
General Information
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.
Clinical Results
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)
Side Effects
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:
- nausea
- vomiting
- abdominal bloating
- abdominal pain
- dizziness
- headache
Most of these side effects also occurred in patients taking the
comparator drug.
Mechanism of Action
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)
Additional Information
