Label Changes for:

OsmoPrep (sodium phosphate monobasic monohydrate, USP and sodium phosphate dibasic anhydrous, USP) Tablets

March 2009

Changes have been made to the BOXED WARNING and ADVERSE REACTIONS sections of the safety label.

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- March 2009

 

The detailed view includes drug products with safety labeling changes to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, or PATIENT PACKAGE INSERT/MEDICATION GUIDE sections. Deletions or editorial revisions made to these sections are not included in this summary.


Summary View

Sections Modified

 

Sections Modified

Summary of Changes to Contraindications and Warnings

BOXED WARNING

  • New

ADVERSE REACTIONS

  • Postmarketing Experience
    • General
      • Added (tongue) ..swelling of the lips and tongue..
    • Cardiovascular: Arrhythmias
    • Nervous system: Seizures
    • Renal
      • acute phosphate nephropathy added

MEDICATION GUIDE

  • New

BOXED WARNING

  • 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 ....
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