"LONDON, UK â€” The European Commission (EC) has followed the recommendation last year from its Committee for Medicinal Products for Human Use (CHMP) for an additional indication for the oral platelet inhibitor ticagrelor (Brilique, AstraZe"...
Renal Disease and Acute Phosphate Nephropathy
There have been rare, but serious reports of renal failure, acute phosphate nephropathy, and nephrocalcinosis in patients who received oral sodium phosphate products (including oral sodium phosphate solutions and tablets) for colon cleansing prior to colonoscopy. These cases often resulted in permanent impairment of renal function and several patients required long-term dialysis. The time to onset is typically within days; however, in some cases, the diagnosis of these events has been delayed up to several months after the ingestion of these products. Patients at increased risk of acute phosphate nephropathy may include patients with the following: hypovolemia, baseline kidney disease, increased age, and patients using medicines that affect renal perfusion or function [such as diuretics, angiotensin converting enzyme (ACE) inhibitors, angiotensin receptor blockers, and possibly nonsteroidal anti-inflammatory drugs (NSAIDs).
Use Visicol with caution in patients with impaired renal function, known or suspected electrolyte disturbances (such as dehydration), or people taking concomitant medications that may affect electrolyte levels (such as diuretics). Patients with electrolyte abnormalities such as hypernatremia, hyperphosphatemia, hypokalemia, or hypocalcemia should have them corrected before treatment with Visicol Tablets.
Advise all patients to hydrate adequately before, during, and after the use of Visicol. If a patient develops significant vomiting or signs of dehydration while or after taking Visicol, consider performing post-colonoscopy lab tests (electrolytes, creatinine, and BUN). Fluid and electrolyte disturbances can lead to serious adverse events including cardiac arrhythmias, seizures and renal impairment. [see DOSAGE AND ADMINISTRATION]
Patients with electrolyte abnormalities should have them corrected before treatment with Visicol. In addition, use caution when prescribing Visicol for patients with conditions, or who are using medications, that increase the risk for fluid and electrolyte disturbances or may increase the risk of adverse events of seizure, arrhythmias, and renal impairment. [see DRUG INTERACTIONS]
There have been rare reports of serious arrhythmias associated with the use of ionic osmotic laxative products for bowel preparation. Use caution when prescribing Visicol for patients at increased risk of arrhythmias (e.g., patients with a history of prolonged QT, uncontrolled arrhythmias, recent myocardial infarction, unstable angina, congestive heart failure, or cardiomyopathy). QT prolongation with sodium phosphate tablets has been associated with electrolyte imbalances, such as hypokalemia and hypocalcemia. Visicol should be used with caution in patients who are taking medications known to prolong the QT interval, since serious complications may occur. Pre-dose and post-colonoscopy ECGs should be considered in patients at increased risk of serious cardiac arrhythmias.
There have been rare reports of generalized tonic-clonic seizures and/or loss of consciousness associated with use of sodium phosphate products in patients with no prior history of seizures. The seizure cases were associated with electrolyte abnormalities (e.g., hyponatremia, hypokalemia, hypocalcemia, and hypomagnesemia) and low serum osmolality. The neurologic abnormalities resolved with correction of fluid and electrolyte abnormalities. Visicol should be used with caution in patients with a history of seizures and in patients at higher risk of seizure [patients using concomitant medications that lower the seizure threshold (such as tricyclic antidepressants), patients withdrawing from alcohol or benzodiazepines, or patients with known or suspected hyponatremia].
Use in Patients with Significant Gastrointestinal Disease
If gastrointestinal obstruction or perforation is suspected, perform appropriate diagnostic studies to rule out these conditions before administering Visicol. Use with caution in patients with severe active ulcerative colitis.
Patients should be instructed to drink 8 ounces of clear liquids with each 3-tablet (or each 2-tablet) dose of Visicol. Patients should take a total of 3.6 quarts of clear liquids with Visicol. Inadequate fluid intake, as with any effective purgative, may lead to excessive fluid loss and hypovolemia. Dehydration from purgation may be exacerbated by inadequate oral fluid intake, vomiting, and/or the use of diuretics. Patients should not take additional laxatives or purgatives, particularly additional sodium phosphate-based products.
Patients with a history of swallowing difficulties or anatomic narrowing of the esophagus, such as a stricture, may have difficulty swallowing Visicol Tablets. Undigested or partially digested Visicol Tablets may be seen in the stool or during colonoscopy. In addition, undigested tablets from other medications may be seen in the stool or during colonoscopy.
Colonic Mucosal Ulcerations and Ischemic Colitis
Administration of osmotic laxative products may produce colonic mucosal aphthous ulcerations, and there have been reports of more serious cases of ischemic colitis requiring hospitalization. The potential for mucosal ulcerations resulting from the bowel preparation should be considered when interpreting colonoscopy findings in patients with known or suspected inflammatory bowel disease (IBD).
Because published data suggests that sodium phosphate absorption may be enhanced in patient experiencing an acute exacerbation of chronic inflammatory bowel disease, Visicol Tablets should be used with caution in such patients.
Since Visicol Tablets were not studied in patients who recently had cardiac surgery (including coronary artery bypass graft surgery) Visicol should be used with caution in these patients.
Carcinogenesis, Mutagenesis, Impairment of Fertility
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 to evaluate the carcinogenic potential or to evaluate the possible impairment of fertility or mutagenic potential of Visicol.
Category C. Animal 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.
It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Visicol is administered to a nursing woman.
Safety and effectiveness of Visicol Tablets in pediatric patients have not been established.
Of the 980 subjects/patients in the Visicol studies, 284 (29%) subjects/patients were 65 years of age or older. Of the 548 subjects/patients who received Visicol in these studies, 146 (27%) were 65 years of age or older and 42 (8%) subjects/patients were 75 years of age or older.
In two phase 3 Visicol trials (Study A and Study B), no overall differences in safety or effectiveness were observed between geriatric patients and younger patients. Greater sensitivity of some older individuals cannot be ruled out; therefore, Visicol Tablets should be used with caution in geriatric 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. Since geriatric patients are more likely to have impaired renal function, consider performing baseline and post-colonoscopy labs (phosphate, calcium, potassium, sodium, creatinine, and BUN) in these patients (see WARNINGS).This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 3/20/2013
Additional Visicol Information
Visicol - User Reviews
Visicol User Reviews
Now you can gain knowledge and insight about a drug treatment with Patient Discussions.
Report Problems to the Food and Drug Administration
Find out what women really need.