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Barium Sulfate Oral Suspension

[13 June 2013]

Products Affected - Description

Digibar 190 Barium Sulfate for Suspension, Bracco Diagnostics
190% w/v, 232 gram bottle (NDC 32909-0270-19)

Maxibar, Barium sulfate Suspension, Bracco Diagnostics
210% w/v, 120 mL bottle (NDC 32909-0150-08)

Liquid E-Z-Paque, Barium Sulfate Suspension, Bracco Diagnostics
60% w/v, 1900 mL jug (NDC 32909-0186-01)

Ultra-R, Barium Sulfate Suspension, Bracco Diagnostics
95% w/w, 170 gram bottle (NDC 32909-0753-01)

Liquid Polibar, Barium Sulfate Suspension, Bracco Diagnostics
100% w/v, 1900 mL jug (NDC 32909-0164-01)
 
Entero Vu, Barium Sulfate for Suspension, Bracco Diagnostics
24% w/v, 600 mL jug (NDC 32909-0145-06)

Liquid Entero Vu, Barium Sulfate Suspension, Bracco Diagnostics
13% w/v, 600 mL jug (NDC 32909-0140-06)

Entero H, Barium Sulfate Suspension, Bracco Diagnostics
80% w/v, 1900 mL jug (NDC 32909-0147-01)

E-Z-Disk, Barium Sulfate Tablets, Bracco Diagnostics
700 mg tablet, 100 count (NDC 10361-0778-31)

Reason for the Shortage

Bracco Diagnostics states the reason for the shortage is manufacturing delay, as well as increased demand. Bracco Diagnostics has provided a customer letter detailing the reason for the shortage and barium sulfate presentations affected.1 

Available Products

E-Z HD Barium Sulfate for Suspension, Bracco Diagnostics
98% w/w, 340 gram bottle (NDC 32909-0764-01)
 
Liquid E-Z-Paque, Barium Sulfate Suspension, Bracco Diagnostics
60% w/v, 355 mL bottle (NDC 32909-0186-02)

E-Z-Paque, Barium Sulfate for Suspension, Bracco Diagnostics
96% w/w, 1200 gram jug (NDC 32909-0750-01)
 
96% w/w, 10 kg pail (NDC 32909-0750-05)
96% w/w, 176 gram bottle (NDC 32909-0750-03)

Liquid Polibar Plus, Barium Sulfate Suspension, Bracco Diagnostics
105% w/v, 1900 mL jug (NDC 32909-0168-02)
 
E-Z-Paste, Barium Sulfate Esophageal Cream, Bracco Diagnostics
60% w/w, 454 gram tube (NDC 32909-0770-01)
 
Polibar ACB, Barium Sulfate Enema, Bracco Diagnostics
96% w/w, 397 gram bag (NDC 32909-0804-01)
96% w/w, 454 gram bag (NDC 32909-0804-02)

Entero Vu, Barium Sulfate for Suspension, Bracco Diagnostics
13% w/v, 100 gram packets, 12 count (NDC 32909-0754-01)

Readi-Cat 2, Barium Sulfate Suspension, Bracco Diagnostics
2.1% w/v, 450 mL bottle (NDC 32909-0723-01)

VoLumen, Barium Sulfate Suspension, Bracco Diagnostics
0.1% w/v, 450 mL bottle, 24 count (NDC 32909-0945-03)

Varibar, Barium Sulfate Suspension, Bracco Diagnostics
Nectar, 40% w/v, 240 mL bottle (NDC 32909-0115-01)
Honey, 40% w/v, 250 mL bottle (NDC 32909-0122-07)
Thin Honey, 40% w/v, 250 mL bottle (NDC 32909-0121-07)


Varibar Pudding, Barium Sulfate Esophageal Paste, Bracco Diagnostics
40% w/v, 230 mL tube (NDC 32909-0125-22)
 
E-Z-Cat Dry, Barium Sulfate for Suspension, Bracco Diagnostics
2% w/w, 23 gram packets, 50 count (NDC 32909-0727-01)

Tagitol V, Barium Sulfate Suspension, Bracco Diagnostics
40% w/v, three 20 mL bottles (NDC 32909-0814-53)

Estimated Resupply Dates

  • Bracco Diagnostics has several barium sulfate presentations on back order and the company cannot estimate a release date for many products. E-Z Disk tablets have an estimated release date of late-June 2013. Liquid Entero Vu jugs have an estimated release date of mid-June 2013. Check with your wholesaler for availability.1

Implications for Patient Care

  • Barium sulfate is an inert enteral contrast agent used for diagnostic imaging of the gastrointestinal tract.2-5 All barium sulfate products are unapproved drugs.6,7
  • Barium concentrations are expressed as percent by weight (%w/w) and percent weight-in volume (% w/v). Percent by weight is the number of grams of barium sulfate per 100 grams of final suspension. For barium powders, percent by weight is the proportion of total powder weight that is pure barium and the remainder is additives. For example, barium 100% w/w is pure barium with no additives. Percent weight-in volume is the number of grams of barium sulfate per 100 mL of final suspension.5
  • The density of barium can be estimated by dividing the percent w/v concentration by its percent w/w concentration.5
  • A single-contrast barium examination fills the lumen of the gut with a low-density barium preparation (eg, 40% w/w) and then x-ray films are taken. A double-contrast examination uses a high-density (eg, 85% w/w) barium to coat the gastrointestinal lumen and uses air or carbon dioxide gas to distend the surface of the bowel.5

Safety

  • Barium sulfate should not be used if there is potential for peritoneal leak, within one week of polypectomy or rectal biopsy, in infants with swallowing disorders, and in newborns with complete duodenal or jejunal obstruction with suspected small bowel or colon obstruction.8
  • Diatrizoate meglumine and diatrizoate sodium (Gastrografin®) should not be used in patients with contrast dye or iodine allergy. Also, this is a hypertonic solution that can cause hypovolemia and electrolyte imbalances.9
  • Iohexol is a hypertonic solution that can result in hypovolemia.10

Alternative Agents & Management

  • When choosing an alternative enteral contrast agent, it is important to consider the type of diagnostic test performed, the area of the gastrointestinal tract to be examined, co-morbid conditions, and cost. Table 1 summarizes the types of radiographic studies used for imaging the gastrointestinal tract and describes the type of contrast agent used for each type of study.
  • Both parenteral (eg, intravenous) and enteral (eg, oral, rectal) contrast agents are used for gastrointestinal studies.4,11 Parenteral agents may be used enterally in certain situations (eg, iohexol).10 Dosing depends on type of diagnostic study and size of the patient. Table 2 compares select commercially available enteral contrast agents including potential alternatives to barium products.

References

  1. Bracco Diagnostics (personal communications). August 16, September 24 and 26, October 8, November 7 and 9, and December 10, 2012; January 7, February 1, March 4, April 11, May 24, and June 13, 2013.
  2. Chen MYM, Pope TL, Ott DJ. Basic radiology : a Lange medical book. 2nd ed. New York: Lange Medical Books/McGraw-Hill, Medical Pub. Div.; 2004.
  3. Wickersham RM, Novak KK, managing eds., eds. Drug Facts and Comparisons (eFacts). Discontinued list. St. Louis, MO: Wolters Kluwer Health, Inc.; 2012.
  4. Contrast agents. In: Weissleder R, Wittenberg J, Harisinghani MG, Chen JW, eds. Primer of Diagnostic Imaging. 4th ed. Philadelphia, PA: Mosby Elsevier; 2007:975-987.
  5. Swanson DP, Chilton HM, Thrall JH. Pharmaceuticals in medical imaging. New York, NY: Macmillan Publishing 1990.
  6. Center for Drug Evaluation and Research. Drugs @ FDA. 2012; Food and Drug Administration, Department of Health and Human Services. Updated 2012. Accessed October 3, 2012..
  7. Electronic Orange Book - Approved products with therapeutic equivalence evaluations. Available online, Rockville, MD: U.S Department of Health and Human Services; 2012.
  8. Lexi-Drugs Online. Lexi-Comp, Inc.; 2012.
  9. Bracco Diagnostics Inc. Gastrografin (Diatrizoate meglumine and diatrizoate sodium) solution [product information]. Princeton, NJ: Bracco Diagnotics Inc.; 2007.
  10. GE Healthcare. Omnipaque (iohexol injection) [product information]. Princeton, NJ: GE Healthcare; February 2009.
  11. Lexi-Drugs Online. Lexi-Comp, Inc.; 2011. Accessed May 27, 2011.
  12. Jarman BT. Small bowel imaging. The Surgical clinics of North America. Feb 2011;91(1):109-125.
  13. Rubesin SE, Maglinte DD. Double-contrast barium enema technique. Radiologic clinics of North America. Mar 2003;41(2):365-376.
  14. Maglinte DD, Kohli MD, Romano S, Lappas JC. Air (CO2) double-contrast barium enteroclysis. Radiology. Sep 2009;252(3):633-641.
  15. McNamara MM, Lockhart ME, Fineberg NS, Berland LL. Oral contrast media for body CT: Comparison of diatrizoate sodium and iohexol for patient acceptance and bowel opacification. AJR. American journal of roentgenology. Nov 2010;195(5):1137-1141.
  16. Horton KM, Fishman EK. Current role of CT in imaging of the stomach. Radiographics : a review publication of the Radiological Society of North America, Inc. Jan-Feb 2003;23(1):75-87.
  17. Koo CW, Shah-Patel LR, Baer JW, Frager DH. Cost-effectiveness and patient tolerance of low-attenuation oral contrast material: milk versus VoLumen. AJR. American journal of roentgenology. May 2008;190(5):1307-1313.
  18. Maglinte DD, Sandrasegaran K, Lappas JC, Chiorean M. CT Enteroclysis. Radiology. Dec 2007;245(3):661-671.
  19. Fletcher JG. CT enterography technique: theme and variations. Abdominal imaging. May-Jun 2009;34(3):283-288.
  20. Ilangovan R, Burling D, George A, Gupta A, Marshall M, Taylor SA. CT enterography: review of technique and practical tips. The British journal of radiology. Jul 2012;85(1015):876-886.
  21. Feuerbach S. MRI enterography: the future of small bowel diagnostics? Dig Dis. 2010;28(3):433-438.
  22. Fidler J. MR imaging of the small bowel. Radiologic clinics of North America. Mar 2007;45(2):317-331.
  23. Grand DJ, Harris A, Loftus EV, Jr. Imaging for luminal disease and complications: CT enterography, MR enterography, small-bowel follow-through, and ultrasound. Gastroenterology clinics of North America. Jun 2012;41(2):497-512.
  24. Schreyer AG, Stroszczynski C. Radiological imaging of the small bowel. Dig Dis. 2011;29 Suppl 1:22-26.
  25. Masselli G, Gualdi G. MR imaging of the small bowel. Radiology. Aug 2012;264(2):333-348.
  26. Lin MF, Narra V. Developing role of magnetic resonance imaging in Crohn's disease. Current opinion in gastroenterology. Mar 2008;24(2):135-140.
  27. Bracco Diagnostics Inc. E-Z-Disk (barium sulfate) 700 mg [product information]. Princeton, NJ: Bracco Diagnotics Inc.; 2008.
  28. Bracco Diagnostics Inc. E-Z-HD (barium sulfate) 98% w/w suspension [product information]. Princeton, NJ: Bracco Diagnotics Inc.; 2011.
  29. Bracco Diagnostics Inc. Digibar 190 (barium sulfate) 190% w/w suspension [product information]. Princeton, NJ: Bracco Diagnotics Inc.; 2011.
  30. Bracco Diagnostics Inc. Maxibar (barium sulfate) 210% w/v, 80% w/w suspension [product information]. Princeton, NJ: Bracco Diagnotics Inc.; 2006.
  31. Bracco Diagnostics Inc. Liquid E-Z-Paque (barium sulfate) 60% w/v, 41% w/w suspension [product information]. Princeton, NJ: Bracco Diagnotics Inc.; 2006.
  32. Bracco Diagnostics Inc. Ultra-R (barium sulfate) 95% w/w suspension [product information]. Princeton, NJ: Bracco Diagnotics Inc.; 2011.
  33. Bracco Diagnostics Inc. E-Z-Paque (barium sulfate) 96% w/w suspension [product information]. Princeton, NJ: Bracco Diagnotics Inc.; 2006.
  34. Bracco Diagnostics Inc. Liquid Polibar (barium sulfate) 100% w/v, 58% w/w suspension [product information]. Princeton, NJ: Bracco Diagnotics Inc.; 2006.
  35. Bracco Diagnostics Inc. Liquid Polibar Plus (barium sulfate) 105% w/v, 58% w/w suspension [product information]. Princeton, NJ: Bracco Diagnotics Inc.; 2006.
  36. Bracco Diagnostics Inc. Readi-Cat 2 (barium sulfate) 2.1% w/v 2.0% w/w suspension [product information]. Princeton, NJ: Bracco Diagnotics Inc.; 2011.
  37. Bracco Diagnostics Inc. E-Z-Cat Dry (barium sulfate) 2% w/w suspension [product information]. Princeton, NJ: Bracco Diagnotics Inc.; 2009.
  38. Bracco Diagnostics Inc. Volumen (barium sulfate) 0.1% w/w suspension [product information]. Princeton, NJ: Bracco Diagnotics Inc.; 2006.
  39. Horton KM, Fishman EK, Gayler B. The use of iohexol as oral contrast for computed tomography of the abdomen and pelvis. Journal of computer assisted tomography. Mar-Apr 2008;32(2):207-209.

Updated

Updated June 13, 2013 by Leslie Jensen, PharmD, Drug Information Specialist. Created October 10, 2012, by Jane Chandramouli, PharmD, Drug Information Specialist. Copyright 2013, Drug Information Service, University of Utah, Salt Lake City, UT.

Disclaimer

This information is provided through the support of Novation to ASHP solely as a service to its members, which shall not use this information for their further commercial use. The content was prepared by the Drug Information Center of University of Utah. Novation, ASHP, and the University of Utah make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, which respect to such information, and specifically disclaim all such warranties. Users of this information are advised that decisions regarding the use of drugs and drug therapies are complex medical decisions and that in using this information, each user must exercise his or her own independent professional judgment. Neither Novation, ASHP nor the University of Utah assumes any liability for persons administering or receiving drugs or other medical care in reliance upon this information, or otherwise in connection with this bulletin. Neither Novation, ASHP nor University of Utah endorses or recommends the use of any drug.

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