Pharmacy Services

Kaopectate and Generic Kaolin-Pectin Products - Reformulation

August 2, 2006

FDA Safety Page - 04/19/2004 - http://pharmacyservices.utah.edu/alerts/alert-31.pdf

Kaopectate brand products have been reformulated.1 The liquid products now contain bismuth subsalicylate instead of attapulgite. All generic attapulgite-containing medications have been discontinued. The tablets were reformulated to contain bismuth subsalicylate in 2003.

Kaopectate brand products have not contained kaolin and pectin since the early 1990’s when the products were reformulated to contain attapulgite. All generic pectin-containing medications have been discontinued. In 1992, the FDA banned the use of pectin in over-the-counter products, due to insufficient data about its safety and efficacy. No pectin-containing products are currently available although some marketed products may have names such as Kapectolin, Kaopek, Kaolinpec, or K-Pek.

The contents of the current bismuth subsalisylate formulations are as follows:

Kaopectate Regular 262 mg bismuth subsalicylate / 15 mL
Kaopectate Extra-Strength 525 mg bismuth subsalicylate / 15 mL
Kaopectate Children's Cherry 87 mg bismuth subsalicylate / 5 mL
Kaopectate tablets 262 mg bismuth subsalicylate

 
Precautions

  • Avoid using bismuth subsalicylate in patients receiving chronic warfarin therapy and in patients who are aspirin sensitive.2
  • Monitor patients on valproic acid or methotrexate therapy carefully as bismuth subsalicylate may increase the concentrations of these medications.2
  • Avoid bismuth subsalicylate in children and teenagers recovering from chicken pox or flu as these patients are at risk of aspirin-induced Reye's syndrome.2
  • Bismuth subsalicylate was FDA-approved for the treatment of acute diarrhea in children as young as 3 years of age. The American Academy of Pediatrics does not recommend bismuth subsalicylate use in young children.2 As of April 17, 2004, bismuth subsalicylate-containing products will no longer have FDA-approved pediatric labeling.3
  • Be aware that several formulations of Kaopectate are still available.  Consult with prescribers to ensure that patients receive the appropriate medication.

References

  1. Pharmacia, medical information (personal communication). March 4, 2003, and April 23, 2004.
  2. Walker PC. Diarrhea. In: Berardi RR, DeSimone EM, Newton GD et al eds. Handbook of Nonprescription Drugs. 13th edition. Washington, DC: AphA; 2002:335-359.
  3. Kim-Jung LY, Holquist C, Phillips J. Kaopectate reformulation and upcoming labeling changes. Drug Topics. 2004 (April 19):60-61.

Updated
August 2, 2006; September 9, 2005; April 28, 2004; University of Utah, Drug Information Service. Copyright 2009, Drug Information Service, University of Utah, Salt Lake City, UT.