Diclofenac Dosing in Children
For children aged 1-12 years, the recommended dose of diclofenac is 1 mg/kg orally, 0.5 mg/kg rectally, or 0.3 mg/kg intravenously as a single dose for acute pain management. 1
Route-Specific Dosing Recommendations
Oral Administration
- 1 mg/kg as a single dose is the evidence-based recommendation for children aged 1-12 years 2, 1
- This dose produces similar drug exposure (AUC) in children as a 50 mg dose in adults, which is the optimal adult dose for acute pain 2, 1
- The most commonly used dose in clinical practice is 1 mg/kg, administered every 8 hours 3
- Oral route is the most frequently used (81% of practitioners) 3
Rectal Administration
- 0.5 mg/kg as a single dose via suppository 1
- Rectal administration is commonly used (80% of practitioners) and has a bioavailability of 0.63 3, 1
Intravenous Administration
- 0.3 mg/kg as a single dose 1
- Intravenous use is less common (9% of practitioners) but provides the most predictable bioavailability 3, 1
Age and Weight Considerations
- Diclofenac is licensed for children over 1 year of age for juvenile rheumatoid arthritis 3
- Allometric size models adequately predict changes in clearance and volume of distribution with age, supporting weight-based dosing across the 1-12 year age range 2
- No dosage adjustments are required for elderly patients or children based on age alone, as no drug accumulation occurs 4
Dosing Interval
- Every 8 hours is the most commonly employed dosing schedule (53% of practitioners) 3
- The elimination half-life is approximately 1.5 hours in plasma, though the drug persists longer in synovial fluid 4, 5
Important Clinical Considerations
Bioavailability Differences
- Oral suspension has a bioavailability of 0.36, requiring higher mg/kg dosing 1
- Suppositories have a bioavailability of 0.63 1
- Dispersible tablets have a bioavailability of 0.35 1
- These differences explain why oral dosing (1 mg/kg) is higher than rectal (0.5 mg/kg) or IV (0.3 mg/kg) to achieve equivalent drug exposure 1
Common Pitfalls to Avoid
- Do not exceed 1 mg/kg for oral dosing: Higher doses are unlikely to provide additional benefit, as this dose already achieves optimal adult-equivalent exposure 2
- Avoid use in infants under 1 year: Pharmacokinetic and pharmacodynamic data are lacking in this age group, despite off-label use by some practitioners 3
- Consider renal function: While dosage adjustments may not be required for mild-moderate renal impairment, conjugate accumulation can occur in end-stage renal disease 4
Drug Interactions
- Significant interactions have been demonstrated with aspirin, lithium, digoxin, methotrexate, cyclosporin, cholestyramine, and colestipol 4
- These interactions should be considered when prescribing diclofenac in children on multiple medications 4