Aceclofenac Pediatric Dosage
Aceclofenac is not recommended for use in pediatric patients, as there is no established pediatric dosing regimen and the drug lacks FDA or regulatory approval for children.
Evidence Base and Rationale
The available evidence does not support the use of aceclofenac in children:
No pediatric studies exist for aceclofenac specifically, and the drug has only been studied and approved for adult populations 1, 2.
The standard adult dosage is 100 mg twice daily orally, but no weight-based or age-based pediatric conversion has been validated 1, 2.
Aceclofenac is a phenylacetic acid derivative NSAID with pharmacodynamic properties similar to diclofenac, but unlike diclofenac, it has never been studied in children 2.
Alternative NSAID Options for Pediatric Patients
If NSAID therapy is required in children, use diclofenac or ibuprofen instead, as these have established pediatric dosing:
Diclofenac Dosing (Preferred Alternative)
- Oral: 1 mg/kg every 8 hours for children of all ages 3.
- Rectal suppository: 0.5-1 mg/kg every 8 hours 3.
- Intravenous: 0.3 mg/kg as a single dose 4.
- Maximum: Do not exceed 150 mg per dose 3.
Important Considerations
- Diclofenac has been extensively studied in children aged 1-12 years with validated pharmacokinetic data 4.
- An adequate trial period of at least 8 weeks is required for chronic inflammatory conditions, as the time to response is approximately 1 month 3.
- NSAIDs should be used with caution in children and require monitoring for gastrointestinal and renal adverse effects 3.
Critical Pitfall to Avoid
Do not attempt to extrapolate adult aceclofenac dosing to children using weight-based calculations or pediatric dosing rules (such as Clark's rule or body surface area formulas), as these methods are unreliable and potentially dangerous for drugs without established pediatric pharmacokinetic data 5, 6. The absence of pediatric dosage forms and therapeutic indications for aceclofenac increases the potential for serious dosing errors 5.