What is the recommended weight‑based dosing of pantoprazole (Pantop) for children, including infants, for gastro‑oesophageal reflux disease, ulcer healing, and Helicobacter pylori eradication, with maximum daily limits, available formulations, and contraindications?

Pantoprazole Dosing in Pediatrics

Pantoprazole 20 mg once daily is recommended for children aged 5–16 years weighing 15–40 kg, and 40 mg once daily for those weighing >40 kg, based on FDA-approved dosing that achieves similar systemic exposure to adults. 1, 2

Weight-Based Dosing by Age Group

Infants (1 month to <12 months)

• Low dose: 0.6 mg/kg equivalent once daily 3
• High dose: 1.2 mg/kg equivalent once daily 3
• Administer approximately 30 minutes before breakfast using delayed-release granules 3
• The 1.2 mg/kg dose achieves similar exposure to adult 40 mg dosing 3
• Important caveat: Wide interindividual variability in drug exposure has been documented in this age group, requiring clinical monitoring 3

Young Children (1 year to <6 years)

• Low dose: 0.6 mg/kg equivalent once daily 3
• High dose: 1.2 mg/kg equivalent once daily 3
• Use delayed-release granules formulation 3
• Exposure with 1.2 mg/kg dose is slightly lower than adult 40 mg dosing but clinically effective 3
• Clearance increases with age across this range, which explains the dosing adjustments 3

School-Age Children (5–11 years)

• 10 mg once daily: Least effective, not recommended as first-line 2
• 20 mg once daily: Effective for symptom reduction, significantly superior to 10 mg at week 1 2
• 40 mg once daily: Most effective dose, significantly reduces GERD symptoms as early as 1 week 2
• Recommendation: Start with 20 mg for mild-moderate symptoms; use 40 mg for severe or refractory symptoms 2

Adolescents (12–16 years)

• 20 mg once daily for patients weighing 15–40 kg 1
• 40 mg once daily for patients weighing >40 kg 1
• Pharmacokinetic profile is dose-independent and similar to adults 1
• No evidence of drug accumulation with multiple dosing 1

Available Formulations

• Delayed-release tablets: 20 mg and 40 mg for children ≥5 years 1, 2
• Delayed-release granules: For infants and young children 1 month to <6 years who cannot swallow tablets 3
• Granules must be administered approximately 30 minutes before meals for optimal acid suppression 3

Maximum Daily Limits

• Infants and children <5 years: Maximum 1.2 mg/kg/day 3
• Children 5–16 years: Maximum 40 mg/day 1, 2
• No evidence supports exceeding these doses, and higher doses do not improve efficacy 2

Clinical Efficacy Timeline

• Week 1: Significant symptom reduction with 20 mg and 40 mg doses (but not 10 mg) 2
• Week 8: All doses show significant improvement from baseline, but 20 mg and 40 mg maintain superior efficacy throughout 2
• Both 20 mg and 40 mg are superior to ranitidine and equivalent to omeprazole for ulcer healing and symptom relief 4

Safety Profile

• Generally well tolerated across all pediatric age groups 1, 3, 2
• Most common adverse events: diarrhea (1.5%), headache (1.3%), dizziness (0.7%) 4
• No serious drug-related adverse events reported in pediatric trials 1, 3
• Critical advantage: Pantoprazole has lower affinity for hepatic cytochrome P450 than omeprazole or lansoprazole, minimizing drug-drug interaction risk 4
• No evidence of drug accumulation with chronic dosing 1, 3

Contraindications and Precautions

While the provided evidence does not specify absolute contraindications for pantoprazole specifically, general PPI precautions apply:

• Avoid in physiologic reflux ("happy spitters") without complications, as acid suppression increases infection risk 5
• Do not use for isolated respiratory symptoms without documented GERD symptoms (heartburn, regurgitation, epigastric pain) 6
• Long-term use concerns (>2.5 years): Risk of enterochromaffin cell hyperplasia, lower respiratory tract infections, vitamin B12 deficiency, and bone fractures 6, 5
• Limit treatment duration to 4–8 weeks initially, with reassessment before continuing 6, 5

Treatment Algorithm

1. Confirm indication: Document clear GERD symptoms (heartburn, regurgitation, dysphagia, or endoscopic esophagitis) before initiating therapy 6, 5

2. Select appropriate dose:

   • Infants 1–12 months: Start 1.2 mg/kg granules once daily 3
   • Children 1–5 years: Start 1.2 mg/kg granules once daily 3
   • Children 5–11 years: Start 20 mg tablets once daily; escalate to 40 mg if inadequate response 2
   • Adolescents 12–16 years: 20 mg if <40 kg, 40 mg if ≥40 kg 1

3. Administration: Give 30 minutes before breakfast for optimal acid suppression 3

4. Reassess at 4–8 weeks: If symptoms persist, refer to pediatric gastroenterology rather than continuing indefinitely 6, 5

Common Pitfalls to Avoid

• Do not use 10 mg dose in children 5–11 years as first-line therapy—it is significantly less effective than 20 mg or 40 mg 2
• Do not extrapolate adult dosing to infants and young children; use weight-based mg/kg dosing instead 3
• Do not combine with H2-receptor antagonists—sequential therapy (switching if inadequate response) is preferred over combination 5
• Do not prescribe for chronic cough alone without typical GERD symptoms 6
• Do not continue beyond 8 weeks without specialist evaluation and documented need 6, 5