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Ranitidine treatment in newborn infants: effects on gastric acidity and serum prolactin levels
M Fontana1, R Tornaghi, M Petrillo
1Fourth Department of Pediatrics, University of Milan Medical School, Italy.
Insights
Ranitidine use in newborns with upper gastrointestinal bleeding was studied. A continuous intravenous infusion of 0.2 mg/kg/h and oral therapy of 5 mg/kg twice daily were evaluated for safety and efficacy in neonates.
Area of Science:
- Neonatal Medicine
- Gastroenterology
- Pharmacology
Background:
- Limited data exists on ranitidine use in early postnatal period.
- Upper gastrointestinal bleeding is a concern in neonates.
Purpose of the Study:
- To evaluate the safety and efficacy of ranitidine in term newborn infants with upper gastrointestinal bleeding.
- To determine appropriate dosing regimens for intravenous and oral ranitidine in neonates.
Main Methods:
- 30 term newborn infants (< 2 days old) with bleeding erosions were treated.
- Continuous intravenous infusion (0.2 mg/kg/h for 48h) followed by oral therapy (5 mg/kg twice daily for 1 month).
- Gastric pH, serum ranitidine concentrations, and safety parameters (cardiorespiratory rate, creatinine, aminotransferase, prolactin) were monitored.
Main Results:
- Ranitidine increased mean gastric pH from 4.27 to 5.70 (IV) and 5.55 (oral).
- Serum ranitidine concentrations showed wide interindividual variation with a weak correlation to gastric pH.
- No adverse effects on cardiorespiratory rate or laboratory values were observed. Mean serum prolactin was lower than controls.
Conclusions:
- A continuous intravenous infusion rate of < 0.2 mg/kg/h is advisable for neonates.
- A 5 mg/kg twice daily oral regimen is considered adequate for neonatal therapy.
- Ranitidine appears safe for short-term use in neonates with upper GI bleeding.
Abstract:
Data about the use of ranitidine in the early postnatal period are lacking. In this study, 30 term newborn infants < 2 days old with bleeding erosions in their upper gastrointestinal tracts were treated with ranitidine by continuous i.v. infusion (0.2 mg/kg/h) for 48 h and thereafter by mouth (5 mg/kg b.i.d.) for 1 month. Mean gastric pH (SD) rose from 4.27 (1.62) to 5.70 (0.95) during i.v. infusion; after oral therapy it was still 5.55 (1.25). Serum ranitidine concentrations were 642.4 (376.5) and 321.5 (368.2) ng/ml after i.v. and oral therapy, respectively, with wide interindividual variations; the correlation between serum ranitidine and gastric pH was found to be weak. No untoward effect was observed either on the cardiorespiratory rate or on creatinine and aminotransferase values. Mean serum prolactin concentration after i.v. therapy was found to be lower, although within the reference range, than in control infants; no significant correlation was observed between serum ranitidine and prolactin concentrations. From these data, a < 0.2 mg/kg/h rate seems to be advisable for continuous ranitidine infusion in neonates, whereas the 5 mg/kg b.i.d. regimen could be considered adequate for oral therapy.