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Comment: Proton Pump Inhibitor Formulary Considerations in the Acutely Ill. Part 1: Pharmacology, Pharmacodynamics, and Available Formulations

Professor of Medicine, Emergency Medicine, Pediatrics and Anesthesiology, Louisiana State University Health Sciences Center, PO Box 33932, Shreveport, Louisiana 71130-3932, fax 318/675-6878, sconrad{at}lsuhsc.edu

Published Online, April 11, 2006. www.theannals.com, DOI 10.1345/aph.1G126a

Immediate-release omeprazole powder for oral suspension is approved by the Food and Drug Administration for administration via nasogastric and orogastric tubes.² The product is indicated for several acid-related conditions, including the reduction of risk of upper gastrointestinal bleeding in critically ill patients, most of whom will receive the suspension via nasogastric or orogastric tube.

Conrad et al.³ recently published the results of a double-blind, double-dummy, randomized trial of immediate-release omeprazole suspension and intravenous cimetidine for preventing upper gastrointestinal bleeding in 359 critically ill adult patients. There were no restrictions for patients entering the study on the allowed size of the nasogastric or orogastric tubes. During the course of the 14 day study, more than 1300 doses of immediate-release omeprazole suspension and more than 1300 doses of placebo suspension were administered to patients via nasogastric or orogastric tubes. There were no reports of enteral tube obstruction or the need to replace the tubes because of residue accumulation within the tubes.

A recent study by Messaouik et al.,⁴ which compared the administration of delayed-release esomeprazole, lansoprazole, and omeprazole via nasogastric tube, found that lansoprazole and omeprazole enteric-coated granules obstructed nasogastric tubes 42% of the time. However, there were no cases of nasogastric tube obstruction with the 48 doses of esomeprazole administered via tube. The authors concluded that large granule size and heterogeneity of granule size are risk factors for nasogastric tube obstruction.

Immediate-release omeprazole powder for oral suspension was specifically developed for administration via nasogastric, orogastric, or other enteral tubes. The potential for this formulation to obstruct enteral tubes is minimal for the following reasons:

1. Active particles in omeprazole powder for suspension are micronized and uncoated. The vast majority of the particles are less than 25 µm in diameter,⁵ far smaller than enteric-coated granules found in delayed-release PPI formulations (ie, 600 µm for esomeprazole, 1100 µm for lansoprazole, 1900 µm for omeprazole).⁴
   
2. All other constituents in the powder for suspension readily dissolve in water.
   
3. Although xanthan gum serves as a suspending agent in the formulation, it is present in small quantities and does not significantly hinder passage of the suspension through a narrow-bore tube.
   

In summary, immediate-release omeprazole powder for oral suspension is approved for administration through nasogastric and orogastric tubes to critically ill patients. A large, well-controlled clinical trial has demonstrated that the formulation is not associated with enteral tube obstruction.

Footnotes

The author has conducted a funded clinical trial for Santarus, Inc., the manufacturers of immediate-release omeprazole, the topic of this letter.

References

1. Devlin JW, Welage LS, Olsen KM. Proton pump inhibitor formulary considerations in the acutely ill. Part 1: pharmacology, pharmacodynamics, and available formulations. Ann Pharmacother 2005;39: 1667-77. Epub 23 Aug 2005. DOI 10.1345/aph.1G126[Abstract/Free Full Text]
2. Prescribing information. Zegerid (omeprazole). San Diego: Santarus, January 2005.
3. Conrad S, Gabrielli A, Margolis B, et al. A randomized double-blind comparison of immediate-release omeprazole oral suspension vs.intravenous cimetidine for the prevention of upper gastrointestinal bleeding in critically ill patients. Crit Care Med 2005;33:760-5.
4. Messaouik D, Sautou-Miranda V, Bagel-Boithias S, Chopineau J. Comparative study and optimisation of the administration mode of three proton pump inhibitors by nasogastric tube. Int J Pharm 2005;299:65-72.[CrossRef][Medline]
5. Data on file. San Diego: Santarus, 2004.

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