(RxWiki News) Cleaning out the colon is one of the things people hate about having a colonoscopy. A new preparation formula is now available for this unpleasant task.
The US Food and Drug Administration (FDA) has approved Prepopik (sodium picosulfate, magnesium oxide and citric acid) for clearing the colon in preparation for a colonoscopy.
"Colorectal cancer screening usually starts at age 50."
The preparation comes in two packets, which are dissolved in cold water, and usually taken the night before and the morning of the colonoscopy.
Alternatively, Prepopik Split-Dose regimen can be taken in the afternoon and evening on the day before the procedure.
The most common side effects of the medication include headache, nausea and vomiting.
“The choice of a bowel cleansing regimen for colonoscopy should be based on a patient’s health and personal preferences,” said Victoria Kusiak, MD, deputy director of the Office of Drug Evaluation III in FDA’s Center for Drug Evaluation and Research. “Today’s approval provides a new treatment option for patients and doctors to consider.”
The medication was approved following two clinical trials involving 1,200 adults scheduled to have a colonoscopy.
Patients were randomly assigned to take either the Prepopik Split-Dose regimen, the Day-Before regimen, or a control prep consisting of polyethylene glycol plus electrolytes (PEG+E) solution and two 5-milligram bisacodyl tablets.
Researchers found that the Split-Dose, Day-Before method was better at clearing the colon than the standard preparation, which happens the day before the colonoscopy.
Patients must drink additional fluids during and after taking the preparation to reduce the risk of fluid and electrolyte imbalance.
As part of this approval, the FDA is requiring that Prepopik manufacturer - Ferring Pharmaceuticals - carry out safety and effectiveness studies with children.
The formal approval of this medication took place on July 16, 2012.
