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Pharmacokinetic evaluation of cimetidine in newborn infants
Insights
Cimetidine pharmacokinetics in neonates show that a dose of 5 to 7 mg/kg effectively suppresses gastric acid. This study analyzed drug concentrations and half-life in newborn infants with reflux esophagitis or stress ulcer.
Area of Science:
- Neonatal pharmacology
- Gastroenterology
- Drug metabolism
Background:
- Reflux esophagitis and stress ulcers are common in neonates.
- Gastric acid suppression is crucial for managing these conditions in newborns.
Purpose of the Study:
- To investigate the pharmacokinetics of cimetidine in newborn infants.
- To determine appropriate dosing for effective gastric acid suppression in neonates.
Main Methods:
- Studied three newborn infants with reflux esophagitis or stress ulcer.
- Administered cimetidine intravenously (5 mg/kg and 10 mg/kg) and orally (10 mg).
- Measured serum drug concentrations and calculated half-life.
Main Results:
- Serum concentrations varied based on dosage and administration route.
- Effective concentrations (>0.5 micrograms/ml) were maintained for several hours.
- Drug half-life ranged from 1.10 to 2.18 hours.
Conclusions:
- Preliminary data suggest 5 to 7 mg/kg cimetidine is effective for gastric acid suppression in neonates.
- Further pharmacokinetic studies are warranted to confirm optimal dosing in this population.
Abstract:
The pharmacokinetics of cimetidine were studied in three newborn infants with reflux esophagitis or stress ulcer. One infant was given 5 mg/kg intravenously (IV), one was given 10 mg/kg IV, and one was given 10 mg orally. Serum concentrations 30 minutes after administration were 1.2 micrograms/ml, 5 micrograms/ml, and 4.2 micrograms/ml, respectively. Concentrations greater than 0.5 micrograms/ml were measured 1, 6, and 9 hours, respectively, after administration. The half-life of the drug ranged from 1.10 to 2.18 hours. These preliminary data suggest that a dose of 5 to 7 mg/kg would effectively suppress gastric acid secretion in neonates.