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Intravenous omeprazole in children: pharmacokinetics and effect on 24-hour intragastric pH
C Faure1, L Michaud, E K Shaghaghi
1Service de Gastro-entérologie Pédiatrique, Hôpital Robert Debré, Paris, France. christophe.faure@rdb.ap-hop-paris.fr
Insights
A higher dose of intravenous omeprazole (40 mg/1.73 m2) is needed for infants to effectively maintain gastric pH above 4. The 20 mg/1.73 m2 dose was found to be ineffective in this patient population.
Area of Science:
- Pharmacology
- Pediatric Gastroenterology
Background:
- Omeprazole is a proton pump inhibitor used for gastric acid suppression.
- Intravenous omeprazole data is limited in pediatric populations, especially infants.
Purpose of the Study:
- To determine the pharmacokinetics of intravenous omeprazole.
- To establish the optimal dosage of intravenous omeprazole in patients younger than 30 months.
Main Methods:
- Nine children (4.5-27 months) received either 20 mg/1.73 m2 or 40 mg/1.73 m2 of intravenous omeprazole daily.
- Pharmacokinetic studies and 24-hour intragastric pH monitoring were conducted on day 3.
- Plasma concentrations were analyzed using high-performance liquid chromatography.
Main Results:
- The 40 mg/1.73 m2 group showed significantly higher median gastric pH (6.99 vs. 3.35) and time with pH >4 (90.6% vs. 44.8%).
- Area under the curve was significantly higher in the 40 mg/1.73 m2 group (3.95 vs. 0.78 microg. mL-1. h-1).
- Systemic clearance did not differ significantly between the groups.
Conclusions:
- The 20 mg/1.73 m2 dose of intravenous omeprazole is insufficient for maintaining adequate gastric pH in infants.
- A dose of 40 mg/1.73 m2 is required for effective gastric acid control in this age group.
- Intravenous omeprazole may be necessary in critical situations for infants.
Background:
Omeprazole is a proton pump inhibitor, acting selectively on the gastric parietal cell H+K+-adenosine triphosphatase. Data on the intravenous route are limited in children and not available in infants.
Objective:
This study was designed to determine the pharmacokinetics and the optimal dosage of intravenous omeprazole in patients younger than 30 months of age.
Methods:
Nine children (three girls), aged 4.5 to 27 months, with normal liver and renal functions requiring intravenous omeprazole were studied. After enrollment in the study and randomization, omeprazole was administered once daily, at 8 am, as a 1-hour infusion. Group 1, consisting of the first four patients, received 20 mg/1.73 m2, and group 2, consisting of the following five patients, received 40 mg/1.73 m2. At day 3, a 24-hour intragastric pH and a pharmacokinetic study of omeprazole were performed. Plasma concentrations were measured by high-performance liquid chromatography.
Results:
Patients in group 2 had a significantly higher median pH (6.99 vs. 3.35; P = 0.01) and percent of monitored time with gastric pH >4 than children given 20 mg/1.73 m2 (90.6% vs. 44.8%; P < 0.01). Four had a pH more than 4 during more than 90% of the time versus none of the patients of group 1. The plasma concentration versus time curves showed rapid elimination of the drug. The median area under the curve of omeprazole was 0.78 microg. mL-1. h-1 (range, 0.55-1.64 microg. mL-1. h-1) and 3.95 microg. mL-1. h-1 (range, 1.9-4.9 microg. mL-1. h-1), respectively, in groups 1 and 2 (P < 0.05). Systemic clearance was not different between the two groups: median values were 0.68 and 0.42 L. kg-1. h-1 (P = 0.22).
Conclusions:
In critical situations, intravenous administration of omeprazole may be required in infants. The authors demonstrate that the dose of 20 mg/1.73 m2 is not effective in maintaining 24-hour gastric pH of more than 4 and that a dose of 40 mg/1.73 m2 is required.