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All prescription oral sodium phosphate products for bowel cleansing prior to colonoscopy, including OsmoPrep Tablets, have added a Boxed Warning to the labeling.The final Boxed Warning label is below.
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 antiinflammatory drugs [NSAIDs]). It is important to use the dose and dosing regimen as recommended (PM/AM split dose).[1]
OsmoPrep Tablets are indicated to cleanse the colon as a preparation for colonoscopy in adults 18 years of age or older.[1] This unique, virtually tasteless tablet formulation can be taken with any clear liquid, an attribute that may help to enhance patient compliance and satisfaction.[2] In clinical trials, 97% of patients were fully compliant with the OsmoPrep regimen.[3] OsmoPrep has demonstrated consistently acceptable efficacy, resulting in a 100% excellent or good rating in ascending colon cleansing when used with the PM/AM split dosing regimen.[4]* It is important to use the dose and dosing regimen as recommended (PM/AM split dose) and patients should be advised to adequately hydrate before, during, and after the use of OsmoPrep.[1] To date, over four million prescriptions of sodium phosphate tablets have been written.[3]
* Data taken from a phase 2, randomized, investigator-blinded study with 12 study arms comparing various dosing regimens of sodium phosphate tablets. A rating of “excellent” or “good” was considered a response. The results reported here are from 1 arm (n=33), with a 32-tablet, split-dose regimen of OsmoPrep.
