What is the appropriate famotidine dosage for a 3‑month‑old infant weighing 12 lb (≈5.4 kg)?

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Famotidine Dosing for a 3-Month-Old Infant Weighing 12 Pounds

For a 3-month-old infant weighing 12 lb (5.4 kg), administer famotidine 0.5 mg/kg once daily, which equals approximately 2.7 mg once daily. 1

Age-Specific Dosing Rationale

  • Infants under 3 months of age require once-daily dosing due to immature renal function, which significantly decreases both plasma and renal clearance of famotidine compared to older infants. 1

  • Infants older than 3 months can receive famotidine every 12 hours, as their pharmacokinetic parameters approach those of older children and adults. 1

  • At 3 months of age, this infant sits at the transition point; conservative once-daily dosing is safer given the prolonged elimination half-life in younger infants. 1

Dose Calculation and Administration

  • Calculate the dose: 0.5 mg/kg × 5.4 kg = 2.7 mg once daily 1, 2

  • The dose can be administered either intravenously or orally, depending on clinical circumstances and the infant's ability to tolerate oral medications. 1

  • Oral bioavailability is approximately 50% in infants, similar to adult values, so oral dosing at 0.5 mg/kg is appropriate. 1, 3

Dose Adjustment Considerations

  • If inadequate response occurs after initial treatment, the dose may be individualized upward to 1.0 mg/kg once daily for infants under 3 months, though 0.5 mg/kg is the recommended starting dose. 2

  • Once the infant reaches 3 months of age and demonstrates adequate renal maturation, transition to twice-daily dosing (0.5 mg/kg every 12 hours) may provide better acid suppression. 1, 4

Safety Profile

  • Famotidine is generally well tolerated in infants, with the most common adverse effects being agitation, irritability (sometimes manifested as head-rubbing), somnolence, and anorexia. 2

  • No serious adverse events have been reported in controlled trials of infants receiving famotidine at these doses. 2

  • Unlike cimetidine and ranitidine, famotidine does not interact with cytochrome P450 enzymes, reducing the risk of drug interactions. 4

Clinical Efficacy

  • At 0.5 mg/kg dosing, famotidine significantly improves regurgitation frequency in infants with gastroesophageal reflux disease. 2

  • The 1.0 mg/kg dose may provide additional benefit for crying time and regurgitation volume, but should be reserved for cases with inadequate response to the lower dose. 2

  • Treatment duration of 8 weeks has demonstrated ulcer healing and symptom resolution in pediatric patients. 3

Important Caveats

  • Renal function is the primary determinant of famotidine clearance, and the dramatic developmental changes in renal function during the first year of life necessitate age-adjusted dosing. 1

  • Famotidine neutralizes gastric acidity during sleep but may not continuously maintain intragastric pH >5.0 throughout the day, even with twice-daily dosing in older infants. 3

  • For infants weighing less than 10 kg (22 lb), some clinicians have used three-times-daily dosing, though this is based on older literature and may not be necessary with current dosing recommendations. 5

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Professional Medical Disclaimer

This information is intended for healthcare professionals. Any medical decision-making should rely on clinical judgment and independently verified information. The content provided herein does not replace professional discretion and should be considered supplementary to established clinical guidelines. Healthcare providers should verify all information against primary literature and current practice standards before application in patient care. Dr.Oracle assumes no liability for clinical decisions based on this content.

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