Patients should be instructed to drink 8 ounces of clear liquids with administration of Visicol® Tablets. Inadequate fluid intake, as with any effective purgative, may lead to excessive fluid loss and hypovolemia.

Undigested or partially digested Visicol® Tablets may be seen in the watery diarrhea stool or during colonoscopy. In addition, undigested tablets from other medications may be seen.

Patients should be instructed not to administer additional agents, particularly additional sodium phosphate-based purgative or enema products.

Prolongation of the QT interval has been observed in some patients who were dosed with Visicol® Tablets. QT prolongation with Visicol® Tablets has been associated with electrolyte imbalances, such as hypokalemia and hypocal-cemia. Visicol® Tablets should be used with caution in patients who are taking medications known to prolong the QT interval, since serious complications may occur. In these studies, prolongation of the QT interval was also observed in some patients treated with PEG-salt solution.

There have been reports of generalized tonic-clonic seizures and/or loss of consciousness associated with Visicol® use in patients with no prior history of seizures. Cases of seizure were associated with electrolyte abnormalities (e.g., hyponatremia, hypokalemia, hypochloremia, hypocalcemia, hypomag-nesemia) and low serum osmolality. Neurologic abnormalities resolved with correction of fluid and electrolyte abnormalities. Other purgatives, including sodium phosphates solution and PEG-3350 containing products, have also been associated with seizures and alterations of consciousness in patients with and without a prior history of seizures. Visicol® should be used with caution in patients with risk factors for hyponatremia, e.g., SIADH, a history of electrolyte abnormalities, inadequately treated hypothyroidism, use of other drugs associated with hyponatremia, e.g., thiazide diuretics, or adrenal insufficiency, or with risk factors for development of tonic-clonic seizures, e.g., a history of seizures, use of drugs that lower the seizure threshold such as tricyclic antidepressants, or withdrawal from alcohol or benzodiazepines.

Administration of Visicol® Tablets may induce colonic mucosal aphthous ulcerations, an endoscopic finding observed with other sodium phosphate cathartic preparations. This colonoscopic finding should be considered in patients with known or suspect inflammatory bowel disease.

Because published data suggest that sodium phosphate absorption may be enhanced in patients experiencing an acute exacerbation of chronic inflammatory bowel disease, Visicol® Tablets should be used with caution in such patients.

Visicol® Tablets were not studied in patients within 3 months of an acute myocardial infarction or cardiac surgery, including coronary artery bypass graft surgery, and therefore should be used with caution in such patients.

Long-term studies in animals have not been performed to evaluate the carcinogenic potential of Visicol®. Studies to evaluate the effect of Visicol® on fertility or its mutagenic potential have not been performed.

Category C. Reproduction studies have not been conducted with Visicol®. It is also not known whether Visicol® can cause fetal harm when administered to a pregnant woman, or can affect reproduction capacity. Visicol® Tablets should be given to a pregnant woman only if clearly needed.

Safety and efficacy of Visicol® Tablets have not been demonstrated for patients less than 18 years of age.

Of the total number of subjects in clinical studies of Visicol® Tablets, 27.7 percent were over 65, while 8.3 percent were over 75. No overall differences in safety or effectiveness were observed between these subjects and younger subjects. However, greater sensitivity of some older individuals cannot be ruled out. Visicol® Tablets should be used with caution in elderly patients.

Sodium phosphate is known to be substantially excreted by the kidney, and the risk of adverse reactions with sodium phosphate may be greater in patients with impaired renal function. Elderly patients are more likely to have impaired renal function, and it may be useful to assess renal function.

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