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4 Use of Proton Pump Inhibitors in Children

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4 Use of Proton Pump Inhibitors in Children Pediatric Pharmacotherapy A Monthly Newsletter for Health Care Professionals Children’s Medical Center at the University of Virginia Volume 5 Number 4 April 1999 Using Proton Pump Inhibitors in Children Marcia L. Buck, Pharm.D., FCCP roton pump inhibitors (PPIs) offer a from 5 to 26 months (average 12 months). P distinctly different mechanism for reducing Dosages were titrated based on the results of 24 - gastric acidity than H 2 blockers or hour intraesophageal pH studies and anticholinergics. These agents, omeprazole and symptomatic improvement. The effective dose lansoprazole, have been found to be successful in ranged from 0.7 to 3.3 mg/kg/day, with a mean the treatment of gastric and duodenal ulcers, of 2 mg/kg/day. At the 4 -6 month follow -up, all including those related to Helicobact er pylori patients had healing of erosions and experienced infection, gastroesophageal reflux disease improvement in clinical symptoms. (GERD), and chronic hypersecretory conditions such as Zollinger -Ellison syndrome. 1-4 That same year, Cucchiara et al 7 conducted a randomized, controlled trial in 32 children (aged Mechanism of Action 6 months to 13 years) comparing omeprazole to Omeprazole and lansoprazole act by inhibiting ranitidine for refract ory esophagitis. Patients parietal cell H +/K + ATPase, the “proton pump.” received either omeprazole 40 mg/1.73m 2 given The PPIs are both prodrugs, which once released once daily or ranitidine 10 mg/kg given twice from their granular coating, are converted in an daily for 8 weeks. Symptomatic improvement acidic environment to the active sulfenamide occurred in 83% of children given omeprazole form. The active drug then forms a covalent and 69% of children given ranitidine . bond to cysteine residues of actively secreting Esophageal healing, as determined by proton pumps. As a result of this irreversible endoscopy, was noted in 75% of the children in bond, the inhibition of gastric acid productio n is the omeprazole group and 62% of the children nearly complete and lasts until new pumps are receiving ranitidine. None of the differences synthesized. Because the PPIs act at the final were statistically significant . The authors point of gastric acid production, they are concluded that om epraz ole was as effective as effective regardless of the source of stimulus: ranitidine in treating GERD in children. histamine, gastrin, or acetylcholine. 1-3 A number of subsequent studies have added Indications support for the role of omeprazole in infants and The PPIs are currently approved by the Food and children with GERD. 9-15 Many of these studies Drug Administration for the treatment of gastric have included children with neurologic and duodenal ulcers, GERD, and hypersecretory impairment who have difficulties with conditions in adults. 4 swallowing and severe reflux disease. In these patients, long -term use of omeprazole appears to Use in Children offer a useful alternative to antireflux surgery. Despite their indication for adults and the lack of pediatric dosage formulations, PPIs have gained Although peptic ulcer disease is much less wide -spread use in the treatment of gastric acid common in children than GERD, there have been disorders in children. 2,5 -21 Several groups have rep orts of using PPIs to heal ulcers and to examined the efficacy of omeprazole in the eradicate H. pylori .16-20 Kato and colleagues 17 treatment of GERD in infants and children. 6-15 In studied 22 children (aged 8 to 16 years) with 1993, Gunasekarn and Hassall 6 reported their gastric and duodenal ulcers who were given experience using omeprazole to treat 15 children omeprazole as part of a multidrug regimen to (ages 10 months to 17 years) with grade 3 or 4 eradicate H. pylori . Patients received either a GERD. Therapy was initiated with doses of 10 dual drug regimen of omeprazole 0.6 mg/kg with or 20 mg per day. Patients remained on therapy amoxicillin 30 mg/kg given twice daily for 2 weeks or a three drug regimen including the first data suggest a more rapid clearance of two agents plus clarithromycin 15 mg/kg twice omeprazole in children compared to adults. 2 daily. In children with active ulcers, omeprazole was continued for an additional 4 weeks. Half -life is not correlated to duration of action. Comparisons of endoscopic biopsy results from Duration of gastric acid suppress ion is better the time of initiation to completion revealed estimated by the length of time that the drugs healing of all ulcers. H. pylori was eradicated in bind to the parietal H +/K + ATPase enzyme . For 70% of the children on the dual regimen and both agents, the duration of action in adults is 92% on the triple regimen. greater than 24 hours, allowing once daily dosing in most patients .2,4 In the past year, several other groups have replicated the success demonstrated in Kato’s Elimination half -life is increased for both drugs study using triple drug regimens for a one -week in patients with hepatic dysfunction. There is a period. 18-20 Researchers from both Sweden and greater effect on lansoprazole, with area under Israel ha ve found a one -week course of the curve values increasing by 500% in some omeprazole, clarithromycin, and metronidazole patients. It is recommended that the dose of to be 85 -90% effective in eradicating H. pylori in lansoprazole be reduced in patients with children. 18-19 Kato’s group has also published significant hepatic disease . No dosage their results demonstrating the efficacy of adjustments are necessary for either agent in lansoprazole as an alternative to omeprazole. 20 patients with renal impairment. 4 PPIs have been used in children to treat Barrett’s Drug Interactions esophagus, hyperpepsinogenemia type I with PPIs have the potential for a number of drug antral G cell hyperfunction (pseudo Zollinger - interactions. Because of their effect on gastric Ellison syndrome), and complications resulting acidity, PPIs can reduce the bioavailability of from gastrocystoplasty. The se agents h ave also drugs that require a low pH for absorption, such been used to reduce gastric residual volume and as ampicillin, cyanocobalamin, digoxin, iron, or increase pH prior to surgery, and to improve fat ketoconazole. Sucralfate decreases the absorption in children with cystic fibrosis. 2,5,21 absorption of omeprazole and lansoprazole; administration of these agents should be Pharmacokinetics and Pharmacodynamics separated by at least 30 minutes. 4 Both omeprazole and lansoprazole are degraded in an acidic medium. If given alone, the active The metabolism of o meprazole and lansoprazole drug would be degraded in the stomach before by cytochrome P450 enzymes is another reaching the site of activity. As a result, both potential s ource of drug interactions. drugs are produced as capsules which contain Omeprazole is involved with more drug enteric -coated granules. 2 Absorption of the drug interactions because of its greater activity at is rapid once the granules ente r the small CYP2C19. It inhibits the metabolism of intestine. Absolute bioavailability of clarithromycin, benzodiazepines, phenytoin, and lansoprazole is 80%. The bioavailability of warfarin. The clinical significance of these omeprazole is only 30 to 40% with initial doses, reactions is highly variable among patients. but increases with continued administration. Lansoprazole inhibits the metabolism of Both drugs are more than 95% protein bound. 4 theophylline. Patients receiving any of these combinations should be closely monitored for Both drugs are metabolized by hepatic signs of drug accumulation. cytoch rome P450 enzymes. Omeprazole is metabolized by CYP2C19, while lansoprazole is The drug interaction between omeprazole and metabolized by CYP3A4/5 and CYP2C19 clarithromycin is unique . E ach drug inhibits the enzymes. Both drugs form inactive metabolites. metabol ism of the other, resulting in increased Approximately 77% of an omepr azole dose is serum concentrations of both agents. The result eliminated unchanged in the urine, compared to of this interaction may actually be beneficial to 33% of a lansoprazole dose. The elimination the patient during short -term therapy. The half -life of omeprazole ranges from 0.5 to 3.5 success of multidrug regimens to eradicate H. hours in adults. Lansoprazole has an average pylori may be due to the higher concentrations of half -life of 1.7 hours in adults. 4 There are no the drugs achieved when given together. 3,4 pharmacokinetic studies of these agents in children published at this time, but unpublished Adverse Effects In general, PPIs are well tolerated. The most Lansoprazole is available in 15 and 30 mg frequently reported adverse effects during capsules (Prevacid ; TAP Pharm.) In adults, the clinical trials in adults and children were diarrhea starting dose for duodenal ulcers is 15 mg once (3-4% of patients), abdominal pain (1 -4%), daily; for gastric ulcers or erosive esophagiti s, nausea (1 -2%), headache (1 -9%), dizziness (1 - the dose is 30 mg once daily. For duodenal 2%), and rash (1%). 4 The incidence of these ulcers associated with H. pylori , the regimen for adverse effects has not been significantly adults is 30 mg lansoprazole plus 500 mg different between omeprazole and lansoprazole clarithromycin and 1 gram amoxicillin t wice in trials conducted to date. 22 daily for 2 weeks. 4 Omeprazole has been associated with rare cases There are limited data in children using of pancreatitis, agranulocytosis, and toxic lansoprazole. In the study by Kato and epidermal necrolysis. Some of these cases have coworkers, a lansoprazole dose of 0.75 mg/kg been fatal. 4 There have also been reports of was given twice daily for 1 week as part of a interstitial nephritis and optic neuritis with PPI triple drug therapy for eradicating H. pylori . use. 1 All of thes e severe reactions appear to be idiosyncratic, with no relation to dose.
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