What are the guidelines for pediatric therapeutic dosing?

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Last updated: December 12, 2025View editorial policy

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Pediatric Therapeutic Dosing Guidelines

Pediatric drug dosing must be calculated based on weight (mg/kg) for most medications, with specific age-based adjustments for neonates and infants under 3 months due to immature organ function, and doses should never simply be scaled down from adult doses. 1, 2

General Dosing Principles by Age Group

Neonates and Infants <3 Months

  • Maximum amoxicillin dose is 30 mg/kg/day divided every 12 hours due to incompletely developed renal function affecting drug elimination 3
  • Glucuronidation pathways are immature in this age group, making certain medications unsafe (e.g., ambrisentan should be avoided in neonates and infants) 4
  • For acetaminophen in infants under 3 months, use 15 mg/kg per dose if weight is less than 10 kg 5
  • Oseltamivir dosing for term infants 0-8 months: 3 mg/kg/dose twice daily for 5 days 1

Infants 3-12 Months

  • Oseltamivir for infants 9-11 months: 3.5 mg/kg/dose twice daily 1
  • Most antibiotics can be dosed by weight, but therapeutic drug monitoring is recommended for narrow therapeutic index drugs 4, 2

Children >12 Months and <40 kg

  • Weight-based dosing (mg/kg) is the standard approach for most medications 3, 2
  • Amoxicillin for mild/moderate infections: 25 mg/kg/day divided every 12 hours or 20 mg/kg/day divided every 8 hours 3
  • Amoxicillin for severe infections: 45 mg/kg/day divided every 12 hours or 40 mg/kg/day divided every 8 hours 3
  • Acetaminophen: 10-15 mg/kg per dose every 4-6 hours, maximum 60 mg/kg/day 5
  • Ibuprofen: 10 mg/kg per dose every 6-8 hours (not recommended for infants <6 months) 5

Children ≥40 kg

  • Transition to adult dosing protocols for most medications 6, 3
  • Body surface area (BSA) normalization becomes more appropriate after maturation is complete 2

Specific Drug Classes and Dosing

Antibiotics for Community-Acquired Pneumonia

For Streptococcus pneumoniae (fully susceptible):

  • Parenteral: Penicillin G 200,000-250,000 units/kg/day divided every 4-6 hours, or ampicillin 150-200 mg/kg/day divided every 6 hours 4
  • Oral: Amoxicillin 90 mg/kg/day divided twice daily (maximum 4 g/day) 4

For Methicillin-Resistant Staphylococcus aureus (MRSA):

  • Parenteral: Vancomycin 40-60 mg/kg/day divided every 6-8 hours (or dosed to achieve AUC/MIC ratio >400) 4
  • Oral: Clindamycin 30-40 mg/kg/day in 3-4 doses, or linezolid 30 mg/kg/day in 3 doses for children <12 years and 20 mg/kg/day in 2 doses for children ≥12 years 4

For Mycoplasma pneumoniae:

  • Parenteral: Azithromycin 10 mg/kg on days 1-2, then transition to oral 4
  • Oral: Azithromycin 10 mg/kg on day 1, then 5 mg/kg/day once daily on days 2-5 4

Tuberculosis Treatment

  • Rifampin: 10-20 mg/kg daily (maximum 600 mg) 4
  • Pyrazinamide: 15-30 mg/kg daily (maximum 2 g) 4
  • Ethambutol: 15-20 mg/kg daily (maximum 1 g) 4

Pulmonary Hypertension Medications

  • Epoprostenol: Starting dose 1-2 ng/kg/min IV, stable dose usually 50-80 ng/kg/min 4
  • Treprostinil: Starting dose 2 ng/kg/min IV or SC, stable dose usually 50-80 ng/kg/min 4
  • Sildenafil: Use in children <5 years is unstudied; avoid in neonates/infants 4

Emergency Medications

  • Epinephrine for anaphylaxis: 0.01 mg/kg (0.01 mL/kg of 1:1000 solution) IM, maximum 0.3 mg per dose, repeat every 5 minutes as needed 1
  • Glucose for hypoglycemia: 0.5-1.0 g/kg as D10W (2-4 mL/kg of D25W or 1-2 mL/kg of D50W) 4
  • Lorazepam for seizures: 0.05-0.15 mg/kg IV/IM, maximum single dose 5 mg 4

Dose Rounding and Safety Considerations

Rounding Tolerance

  • Narrow therapeutic index drugs should be rounded only to the nearest 0.1 mL or not rounded at all 1
  • Standard medications can tolerate wider rounding percentages (up to 10% for some drugs like metoclopramide) after expert consensus 1
  • Dose-dependent toxicity drugs should be rounded down to easily administered doses while respecting maximum dose guidelines 1

Common Pitfalls to Avoid

  • Never exceed acetaminophen maximum of 60 mg/kg/day or 5 doses in 24 hours to prevent hepatotoxicity 5
  • Do not use 875 mg amoxicillin dose in patients with GFR <30 mL/min 3
  • Avoid ibuprofen in infants <6 months due to immature renal function 5
  • Rectal acetaminophen has erratic absorption; oral syrup is preferred for consistent response 5

Treatment Duration and Monitoring

Standard Treatment Courses

  • Most infections require minimum 48-72 hours of therapy beyond symptom resolution 3
  • Streptococcus pyogenes infections require at least 10 days of treatment to prevent acute rheumatic fever 3
  • Community-acquired pneumonia: 10-day courses are best studied, though shorter courses may be effective for mild disease 4
  • CA-MRSA infections may require longer treatment than S. pneumoniae infections 4

Clinical Response Assessment

  • Assess clinical and laboratory improvement within 48-72 hours of starting therapy 4, 6
  • If no improvement or clinical deterioration occurs within 48-72 hours, perform further investigation 4, 6

Renal Impairment Adjustments

For amoxicillin in patients with severe renal impairment:

  • GFR 10-30 mL/min: 500 mg or 250 mg every 12 hours 3
  • GFR <10 mL/min: 500 mg or 250 mg every 24 hours 3
  • Hemodialysis: 500 mg or 250 mg every 24 hours, with additional dose during and at end of dialysis 3

References

Guideline

Pediatric Drug Dosing Guidelines

Praxis Medical Insights: Practical Summaries of Clinical Guidelines, 2025

Guideline

Guideline Directed Topic Overview

Dr.Oracle Medical Advisory Board & Editors, 2025

Guideline

Pediatric Acetaminophen and Ibuprofen Dosing Guidelines

Praxis Medical Insights: Practical Summaries of Clinical Guidelines, 2025

Guideline

Levetiracetam Dosing and Administration in Pediatric Patients

Praxis Medical Insights: Practical Summaries of Clinical Guidelines, 2025

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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