BlackBoxRX
 
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Sodium Phosphate (Oral)

Acute Phosphate Nephropathy

  • There have been rare, but serious reports of acute phosphate nephropathy in patients who received oral sodium phosphate products for colon cleansing prior to colonoscopy.
  • Some cases have resulted in permanent impairment of renal function and some patients required long term dialysis.
  • While some cases have occurred in patients without identifiable risk factors, patients at increased risk of acute phosphate nephropathy may include those with increased age, hypovolemia, increased bowel transit time (such as bowel obstruction), active colitis, or baseline kidney disease, and those using medicines that affect renal perfusion or function (such as diuretics, angiotensin converting enzyme [ACE] inhibitors, angiotensin receptor blockers [ARBs], and possibly nonsteroidal anti-inflammatory drugs [NSAIDs]. [See warnings]
  • It is important to use the dose and dosing regimen as recommended (pm/am split dose).

FDA and Industry Communications

Black Box Added: FDA Information (December 2008)

Medication Guides

OsmoPrep

Visicol

Package Inserts

Sodium Phosphate

Additional Information

Updated January 2018