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FDA Approves Suprep

FDA Approves Suprep Bowel Prep Kit

August 5, 2010 -- The United States Food and Drug administration has approved Suprep Bowel Prep Kit (sodium sulfate, potassium sulfate, magnesium sulfate) oral solution concentrate for cleansing of the colon in preparation for colonoscopy in adults.

The osmotic laxative will be marketed by Braintree Laboratories, Inc.

Suprep is administered as a split-dose oral regimen over two days. The Suprep Bowel Prep Kit contains two bottles each containing concentrated solution which must be diluted prior to use. The first dose is taken the evening before the colonoscopy and the second the following morning. Each dose must be followed with additional water in the hour post dose.

Suprep should not be used in patients who are allergic to any of the product ingredients, or patients with gastrointestinal obstruction, bowel perforation, gastric retention or ileus.

Suprep should be used with caution in patients who are at risk of fluid and electrolyte abnormalities, arrhythmias, seizures and renal impairment. Suprep should also be used with caution in patients with renal insufficiency and in patients at risk for aspiration.

In clinical trials, the most common adverse events were overall discomfort, abdominal fullness, nausea, abdominal cramping, and vomiting and affected 3% or more of the trial participants.

Each Suprep Bowel Prep Kit contains two 6 oz bottles of oral solution and a 19 oz mixing container with a 16 oz fill line.

Posted: August 2010

Suprep (sodium sulfate, potassium sulfate, magnesium sulfate) FDA Approval History

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