For more information about Phospho-soda EZ-Prep®, please see the complete Prescribing Information.

IMPORTANT SAFETY INFORMATION: 
Acute phosphate nephropathy and renal failure, often resulting in permanent impairment of renal function, with some patients requiring dialysis and/or transplant, has been reported in patients using sodium phosphates for bowel cleansing; the majority of these reports occurred in patients taking drugs to treat hypertension or other drug products, such as diuretics or non-steroidal anti-inflammatory drugs (NSAIDs).  Patients at increased risk for acute phosphate nephropathy include those with conditions that affect renal perfusion or function, that may predispose to dehydration or those taking medications that may decrease glomerular filtration rate, such as diuretics, angiotensin converting enzyme inhibitors (ACE-Is), angiotensin receptor blockers (ARBs) or NSAIDs.  Patients at increased risk should be assessed for hydration status prior to use of purgative preparations and managed appropriately, and physicians should consider prescribing a 30 mL by 30 mL dosing regimen.

FLEET® Phospho-soda® has been associated with severe and potentially fatal cases of electrolyte disorders in elderly patients.  The benefit/risk ratio of Fleet® Phospho-soda® needs to be carefully considered before initiating treatment in this at-risk population.  Special attention should be taken when prescribing Fleet® Phospho-soda® to any patient with regard to known contraindications and the importance of adequate hydration and, in at-risk populations, the importance of also obtaining baseline and post-procedure serum electrolyte levels, and blood urea nitrogen and creatinine levels.  In at-risk patients, including elderly patients, consider prescribing a 30 mL by 30 mL dosing regimen. 

Additional liquids by mouth are recommended with all bowel cleansing dosages.  Encourage patients to drink large amounts of clear liquids before and during the bowel preparation process (minimum 72 fl. oz. of clear liquids) and after the procedure in order to help prevent dehydration.  Administration of intravenous fluids (500-1000 mL) during the procedure is recommended to help prevent dehydration.

See www.fleetez-prep.com and PDR for full prescribing information.

©2008 C.B. Fleet Company, Inc.
Fleet is a registered trademark and Fleet Laboratories and logo design are trademarks of C.B. Fleet Company, Inc.  Phospho-soda is a registered trademark and EZ-Prep is a trademark of C.B. Fleet Investment Corporation.