From the Guidelines
Lansoprazole is not recommended for a 2-month-old male infant due to limited safety data and potential increased risk of adverse effects. For infants with suspected gastroesophageal reflux disease (GERD), initial management should focus on non-pharmacological approaches such as:
- Smaller, more frequent feedings
- Proper positioning after feeds (keeping the infant upright for 20-30 minutes)
- Thickening feeds if appropriate If medication is deemed necessary after these measures fail, famotidine is typically the preferred first-line medication for infants this young, starting at 0.5-1 mg/kg/dose given twice daily 1. Proton pump inhibitors like lansoprazole should be reserved for severe cases that don't respond to other treatments, and only under specialist guidance. This is because PPIs have limited safety data in infants under 1 year and may be associated with increased risk of respiratory infections, intestinal infections, and potential effects on nutrient absorption in developing infants 1. Additionally, many symptoms attributed to GERD in infants are often part of normal physiological reflux that resolves spontaneously by 12-18 months of age without medication. The use of PPIs in infants has been linked to serious adverse events, including lower respiratory tract infections, as shown in a study where the number of children with chronic cough after 4 weeks of lansoprazole compared with placebo were not significantly different between groups, but serious adverse events were significantly higher in the PPI-treated group 1.
From the FDA Drug Label
The safety and effectiveness of lansoprazole have been established in pediatric patients one year to 17 years of age for short-term treatment of symptomatic GERD and erosive esophagitis. Lansoprazole was not effective in pediatric patients with symptomatic GERD one month to less than one year of age in a multicenter, double-blind, placebo-controlled study Therefore, safety and effectiveness have not been established in patients less than one year of age.
Lansoprazole is not recommended for a 2-month-old male, as safety and effectiveness have not been established in patients less than one year of age 2.
From the Research
Lansoprazole Dosage and Administration for 2-Month-Old Male
- The dosage of lansoprazole for a 2-month-old male patient is not explicitly stated in the provided studies. However, based on the study by 3, lansoprazole was administered to neonates (<28 days of age) at a dose of 0.5 or 1.0 mg/kg/day, and to infants (>28 days but <1 year of age) at a dose of 1.0 or 2.0 mg/kg/day.
- Another study by 4 evaluated the clinical efficacy of two dosing regimens of lansoprazole in infants with gastroesophageal reflux disease (GERD). The study found that both regimens, 15 mg given once per day and 7.5 mg given twice per day, were effective in reducing GERD symptoms in infants.
Safety and Efficacy of Lansoprazole in Infants
- The study by 3 found that lansoprazole was well tolerated in neonates and infants, with only a few treatment-related adverse events reported.
- The study by 4 also found that both dosing regimens of lansoprazole were well tolerated in infants, with no significant differences in adverse events between the two groups.
- The efficacy of lansoprazole in healing erosive esophagitis and relieving GERD-related symptoms in children has been demonstrated in several studies, including those by 5, 6, and 7.
Pharmacokinetics and Pharmacodynamics of Lansoprazole in Children
- The study by 7 evaluated the pharmacokinetics and pharmacodynamics of lansoprazole in children between 13 and 24 months of age with GERD. The study found that lansoprazole displayed pharmacokinetic and pharmacodynamic parameters in this age group that were similar to those observed in older children and adults.
- The study by 3 also found that lansoprazole increased the percentage of time that intragastric pH was above 3,4,5, and 6 over the 24-hour post-dose period on days 1 and 5 when compared with baseline, indicating its effectiveness in reducing gastric acidity in infants.