What is the recommended dose of dicyclomine (anticholinergic) per kilogram (kg) for pediatric patients?

Dicyclomine Dosing for Pediatric Patients

Dicyclomine is contraindicated in infants less than 6 months of age due to potential serious adverse effects including respiratory symptoms, seizures, syncope, and death. 1

Safety Concerns and Contraindications

• Dicyclomine is explicitly contraindicated in infants under 6 months of age according to FDA labeling 1
• Serious adverse events reported in infants include:
  • Respiratory symptoms (dyspnea, shortness of breath, respiratory collapse, apnea)
  • Neurological effects (seizures, syncope, coma)
  • Cardiovascular effects (pulse rate fluctuations)
  • Muscular hypotonia
  • Death

Dosing Recommendations for Children Over 6 Months

For children over 6 months where dicyclomine is deemed necessary:

Dosing for Infantile Colic (off-label use):

• 3 mg/kg/day divided into multiple doses 2

This dosage has been studied specifically for infantile colic in infants aged 3-12 weeks, though it's important to note that current guidelines no longer recommend dicyclomine for this indication due to safety concerns.

Important Clinical Considerations:

1. Alternative Treatments: For infantile colic, dietary modifications have shown better efficacy than dicyclomine (95.4% vs 53.3% improvement) 2

2. Monitoring: When dicyclomine must be used in children over 6 months:

   • Monitor for respiratory symptoms
   • Watch for neurological changes
   • Assess for cardiovascular effects
   • Evaluate for muscular hypotonia

3. Drug Interactions: Be aware of potential interactions, particularly with diuretics like HCTZ which can lead to contraction alkalosis 3

Pediatric Pharmacokinetic Considerations

Pediatric patients require individualized dosing based on:

• Age
• Size
• Organ maturity level

Children are not simply "small adults" and require careful dose calculations to optimize efficacy while preventing serious adverse effects 4.

Clinical Recommendation

For children over 6 months where dicyclomine is absolutely necessary, use 3 mg/kg/day divided into multiple doses, but strongly consider safer therapeutic alternatives given the significant safety concerns with this medication in the pediatric population. 1, 2

The absence of FDA approval for pediatric use and the explicit contraindication in infants under 6 months should prompt extreme caution when considering this medication in any pediatric patient.