Pharmacy & Therapeutics - March 2009 - (Page 144) PPIs in Enteral Nutrition ilar in oral administration. Larson et al. enrolled 10 healthy volunteers who were taking no other medications. Acid output was measured in 15-minute intervals over one hour. Peak acid output was determined to be the sum of the highest two consecutive measurements. In this crossover study, oral administration decreased peak acid output by 85%, compared with 79.6% via nasogastric tube. The difference was not significant (P = 0.30). Philips et al.12 Omeprazole given in a sodium bicarbonate solution has been shown to prevent stress-related mucosal bleeding and to raise GI pH in critically ill patients. Phillips et al. evaluated 75 patients on mechanical ventilation who received an omeprazole suspension until mucosal bleeding prophylaxis was no longer necessary. These patients received two doses of 40 mg, then a daily dose of 20 mg. Five patients had pre-existing GI bleeding, which resolved within 36 hours in all five. Of the 65 patients who received omeprazole as prophylaxis, none experienced GI bleeding. The mean baseline pH was 3.5 ± 1.9; after omeprazole therapy, the mean pH rose to 7.1 ± 1.1. Tuleu et al.13 underwent routine stomach aspiration, which was performed 18 hours after the last omeprazole dose was given. The nurse noticed that the contents contained a poppy seed–like substance. The authors reported that this phenomenon had also occurred in at least six other infants. Upon high-performance liquid chromatography (HPLC) mass spectroscopy, the “poppy seeds” were discovered to be omeprazole and its degradation products. The authors speculated that the premature degrading was possibly caused by delayed gastric emptying and by the use of water instead of sodium bicarbonate to make a solution. Sodium bicarbonate is often used for suspensions to protect the PPI molecule from premature degradation; however, for these patients in pediatric intensive care, sodium bicarbonate was not used because of ventilator exposure and potential chronic alkalosis. Haizlip et al.14 A case report by Tuleu et al. demonstrated the potential lack of efficacy of omeprazole in the pediatric population. An infant In a larger study of an omeprazole suspension in 18 critically ill pediatric patients, continuous gastric pH monitoring was used to determine efficacy. Patients were given the suspension at a dose of 1 mg/kg of body weight with titrations, as necessary, to a maximum of 20 mg. At the completion of the study, patients were classified according to their response to therapy. Patients were considered rapid responders if a goal pH of between 4 and 7 was maintained for most of the 12 hours after Table 1 Formulations of Proton Pump Inhibitors (PPIs) Available in the U.S. Solution or Granules for Oral Suspension Yes PPI Omeprazole Capsule or Tablet Yes; capsule (prescription); tablet (over the counter) Yes; immediate-release capsule Yes; capsule IV No FDA-Approved Indications Duodenal ulcer, H. pylori (combined with amoxicillin and/or clarithromycin), gastric ulcer, GERD, maintenance healing of erosive esophagitis, hypersecretory conditions Duodenal ulcer, gastric ulcer, GERD, maintenance healing of erosive esophagitis, upper GI bleeding risk reduction in critically ill patients GERD, NSAID-associated gastric ulcer risk reduction, H. pylori eradication (in combination with amoxicillin and clarithromycin), hypersecretory conditions Duodenal ulcer, H. pylori eradication (combined with clarithromycin and/or amoxicillin), maintenance of healed duodenal ulcers, active benign gastric ulcer, healing of and risk reduction of NSAID-associated gastric ulcer, GERD, maintenance healing of erosive esophagitis, hypersecretory conditions GERD-associated erosive esophagitis, maintenance healing of erosive esophagitis, hypersecretory conditions Healing or maintenance of erosive or ulcerative GERD, GERD, duodenal ulcers, H. pylori (combined with amoxicillin and clarithromycin), hypersecretory conditions Omeprazole/ sodium bicarbonate Esomeprazole Yes No Yes Yes Lansoprazole Yes; capsule, disintegrating tablet Yes Yes Pantoprazole Rabeprazole Yes; tablet Yes; tablet Yes No Yes No * All oral formulations are delayed-release unless otherwise denoted. GERD = gastroesophageal reflux disease; GI = gastrointestinal; H. pylori = Helicobacter pylori infection; IV = intravenous; NSAID = nonsteroidal anti-inflammatory drug. Data from Lexi-Drugs1 and package inserts for Nexium,5 Prevacid,6 Prilosec,7 Zegerid,8 Protonix,9 and Aciphex.10 144 P&T® • March 2009 • Vol. 34 No. 3
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