(HealthDay) -- Prepopik (sodium picosulfate, magnesium oxide and citric acid) has been approved by the U.S. Food and Drug Administration for adults preparing for a colonoscopy, a diagnostic procedure to inspect the colon's inner lining.
The cleansing regimen consists of two packets of powder, each dissolved in water, to be taken at different times before a colonoscopy, the FDA said in a news release. Additional fluid intake is needed to prevent dehydration and electrolyte imbalance, the agency warned.
In two clinical studies involving about 1,200 adults preparing for a colonoscopy, the most common side effects of Prepopik included nausea, headache and vomiting.
As a condition of approval, maker Ferring Pharmaceuticals must conduct additional studies to evaluate the product's safety and effectiveness among children, the FDA said.
Ferring is based in Parsippany, N.J.
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To learn more about colonoscopy, visit the National Digestive Diseases Information Clearinghouse.