Cyclopam Dosing in Pediatric Patients
Critical Clarification
There is no established pediatric dosing for "Cyclopam" (cyclobenzaprine) because this medication is not approved for use in children. Cyclobenzaprine is a muscle relaxant indicated only for adults, and the available evidence exclusively addresses adult populations 1, 2.
Evidence Review
Adult Dosing (Not Applicable to Pediatrics)
The available studies demonstrate efficacy only in adult patients:
- Standard immediate-release formulation: 5-10 mg three times daily in adults, with the 5 mg dose showing similar efficacy to 10 mg but with reduced sedation 1
- Extended-release formulation: 15-30 mg once daily in adults 2
- Onset of relief: Apparent within 3-4 doses of the 5 mg regimen in adults 1
Why Pediatric Dosing Cannot Be Extrapolated
Pediatric patients cannot be dosed as "small adults" using simple weight-based calculations 3. Key pharmacokinetic differences include:
- Children ≥2 years: Differ from adults primarily in size, not maturation, but elimination does not scale linearly with weight 3
- Infants and neonates: Have immature drug elimination pathways, making them fundamentally different from older children 3
- Weight-based scaling (mg/kg): Results in doses that are too small in children and too large in neonates because elimination changes do not follow direct weight proportions 3
Safety Concerns
The most common adverse effects in adults include 1:
- Somnolence (dose-related, occurring in 0.8-7.3% depending on formulation)
- Dry mouth
- Constipation
- Dizziness
These risks would be unpredictable in pediatric patients without specific pharmacokinetic and pharmacodynamic studies 3.
Clinical Recommendation
Do not prescribe cyclobenzaprine to pediatric patients. The medication lacks:
- FDA approval for pediatric use
- Pediatric dosing guidelines from any authoritative source
- Safety and efficacy data in children
- Appropriate pediatric formulations 4
For pediatric muscle spasm, consult current pediatric guidelines for age-appropriate alternatives with established safety profiles in children.