What is the maximum dose of omeprazole (proton pump inhibitor) I can give to a 16 kg child?

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Maximum Omeprazole Dose for a 16 kg Child

For a 16 kg child, the maximum dose of omeprazole is 20 mg twice daily (total 40 mg/day) when treating eosinophilic esophagitis, or 10 mg once daily for standard GERD/erosive esophagitis. 1, 2, 3, 4

Standard FDA-Approved Dosing

For children aged 2-16 years weighing 10 to less than 20 kg (which includes your 16 kg patient):

  • Symptomatic GERD: 10 mg once daily for up to 4 weeks 4, 3
  • Erosive esophagitis: 10 mg once daily for 4-8 weeks 4, 3
  • Maintenance of healing: 10 mg once daily (controlled studies don't extend beyond 12 months) 4, 3

This represents the standard maximum for typical acid-related conditions in this weight range. 4

Higher Dosing for Specific Conditions

For eosinophilic esophagitis specifically, substantially higher doses are appropriate and evidence-based:

  • Initial treatment: 1 mg/kg twice daily (up to maximum 40 mg twice daily) 1, 2
  • For a 16 kg child, this calculates to 16 mg twice daily (32 mg/day total) 1
  • The guideline explicitly states "up to 40 mg twice daily" as the maximum, meaning your 16 kg patient could receive up to 20 mg twice daily if needed 1, 2
  • Treatment duration should be 8-12 weeks before assessing histological response 1, 2

The higher dosing regimen (omeprazole 20 mg twice daily or equivalent) has demonstrated superior response rates (50.8%) compared to standard doses (35.8%) for eosinophilic esophagitis. 1, 2

Severe Refractory GERD in Younger Children

For infants and children under 2 years with severe or refractory GERD (though your patient is likely older):

  • Starting dose: 0.7 mg/kg/day 3, 5, 6, 7
  • May escalate to: 1.4-2.8 mg/kg/day in divided doses 3, 5
  • For a 16 kg child, this would translate to 11.2 mg/day starting dose, escalating up to 44.8 mg/day if needed 5

Research demonstrates that children under 2 years may require doses ranging from 0.7 to 3.3 mg/kg/day (mean 1.9 mg/kg) for adequate reflux control, with some requiring up to 2.8 mg/kg/day. 5, 6

Clinical Decision Algorithm

Choose your maximum dose based on indication:

  1. Standard GERD or erosive esophagitis: Maximum 10 mg once daily 4, 3

  2. Eosinophilic esophagitis: Maximum 20 mg twice daily (40 mg/day total) 1, 2

  3. Severe refractory GERD with documented inadequate response: May escalate up to 2.8 mg/kg/day (44.8 mg/day for 16 kg child) in divided doses, guided by pH monitoring 5, 6

Important Caveats

  • Weight-based dosing on a per-kilogram basis is much greater in children than adults to achieve equivalent acid suppression 7
  • Doses should be titrated based on clinical response and, ideally, 24-hour pH monitoring for refractory cases 5, 6
  • Once an effective dose is established for conditions like eosinophilic esophagitis, doses should not be reduced in primary care 2
  • Long-term use (>2.5 years) may be associated with enterochromaffin cell hyperplasia in up to 50% of children 3
  • Monitor for elevated gastrin levels with chronic use, though clinical significance in children remains uncertain 6

Administration for This Weight

For a 16 kg child unable to swallow capsules, open the capsule and mix pellets with one tablespoon of applesauce, then swallow immediately without chewing the pellets. 4, 3

References

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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