From the FDA Drug Label
Pediatric Patients Pharmacodynamics of famotidine, assessed by gastric pH, were evaluated in 5 pediatric patients 2 to 13 years of age using the sigmoid Emax model. In a study examining the effect of famotidine on gastric pH and duration of acid suppression in pediatric patients, four pediatric patients ages 11 to 15 years of age using the oral formulation at a dose of 0. 5 mg/kg, maintained a gastric pH above 5 for 13.5 ± 1.8 hours.
The safety of giving Pepcid (Famotidine) to an 11-year-old patient can be considered based on the available data.
- The drug label provides information on the pharmacodynamics of famotidine in pediatric patients, including those in the age range of 11 to 15 years.
- A study mentioned in the label showed that four pediatric patients ages 11 to 15 years maintained a gastric pH above 5 for 13.5 hours after receiving a dose of 0.5 mg/kg. However, it is essential to consult with a healthcare professional to determine the appropriate dosage and to discuss any potential risks or interactions 1.
From the Research
Famotidine (Pepcid) can be safely given to an 11-year-old patient under appropriate medical supervision. The recommended dose for children aged 1-11 years is 0.5 mg/kg once or twice daily, with a maximum of 40 mg per day 2. Famotidine is FDA-approved for children over 1 year of age for treating conditions like gastroesophageal reflux disease (GERD), heartburn, and stomach ulcers.
Important Considerations
- Before giving this medication to a child, it's essential to consult with a healthcare provider to confirm the diagnosis and appropriate dosing.
- Common side effects may include headache, dizziness, or constipation, though these are generally mild 2.
- The medication works by reducing stomach acid production by blocking histamine H2 receptors in the stomach lining, making it effective for acid-related conditions while having a good safety profile in the pediatric population.
- Parents should follow the prescribed dosage carefully and report any unusual symptoms to their child's doctor.
Safety and Efficacy
- Studies have shown that famotidine is effective in treating gastroesophageal reflux disease (GERD) in children, including non-erosive GERD 3.
- A study comparing the effectiveness of cimetidine, ranitidine, famotidine, and omeprazole in treating children with dyspepsia found that omeprazole was superior, but famotidine was still effective in relieving symptoms 4.
- Another study found that famotidine was effective in reducing regurgitation frequency and crying time in infants with gastroesophageal reflux disease 2.
Medical Supervision and Counseling
- It's crucial for pediatric primary care clinicians to discuss medication safety with patients and their parents, including safe storage, administration, and disposal of medications 5.
- Clinicians should be aware of the potential for medication exposures and poisonings in pediatric patients and take steps to prevent them.